ACAD
37.03
+0.18
+0.49%
AEMD
1.66
-0.03
-1.78%
APRI
1.73
+0.01
+0.58%
ARNA
25.2
+0.27
+1.08%
ATEC
2.14
+0.01
+0.47%
CNAT
5.63
-0.04
-0.71%
CRXM
0.141
-0.031
-18.11518%
CYTX
0.365
-0.02
-5.178%
DXCM
70.06
-0.17
-0.24%
GNMK
9.533
-0.027
-0.2783%
HALO
16.53
-0.15
-0.90%
ILMN
200.235
-2.855
-1.406%
INNV
0.1
0.00
+2.56%
INO
6.39
+0.34
+5.62%
ISCO
1.7
+0.07
+4.29%
ISIS
57.56
0.00
0.00%
LGND
136.62
+0.24
+0.18%
LPTN
2.93
-2.93
-100.00%
MBVX
0.82
-0.03
-3.53%
MEIP
2.745
+0.055
+2.045%
MNOV
5.95
+0.29
+5.12%
MRTX
10.45
0.00
0.00%
MSTX
0.13
-0.01
-5.28%
NBIX
58.085
+1.285
+2.262%
NUVA
54.445
+0.775
+1.444%
ONCS
0.98
-0.01
-1.01%
ONVO
2.04
-0.02
-0.97%
OREX
2.29
-0.01
-0.43%
OTIC
3.5
+0.1
+2.94%
QDEL
43.3
-0.24
-0.55%
RCPT
231.96
0.00
0.00%
RGLS
1.35
-0.02
-1.46%
RMD
77.74
-1.86
-2.34%
SCIE
0
0.00
0.00%
SPHS
2.34
0.00
0.00%
SRNE
1.775
+0.075
+4.412%
TROV
0.703
+0.033
+4.8642%
VICL
2.43
0.00
0.00%
VOLC
18
0.00
0.00%
ZGNX
13.5
-0.1
-0.74%
ACAD
37.03
+0.18
+0.49%
AEMD
1.66
-0.03
-1.78%
APRI
1.73
+0.01
+0.58%
ARNA
25.2
+0.27
+1.08%
ATEC
2.14
+0.01
+0.47%
CNAT
5.63
-0.04
-0.71%
CRXM
0.141
-0.031
-18.11518%
CYTX
0.365
-0.02
-5.178%
DXCM
70.06
-0.17
-0.24%
GNMK
9.533
-0.027
-0.2783%
HALO
16.53
-0.15
-0.90%
ILMN
200.235
-2.855
-1.406%
INNV
0.1
0.00
+2.56%
INO
6.39
+0.34
+5.62%
ISCO
1.7
+0.07
+4.29%
ISIS
57.56
0.00
0.00%
LGND
136.62
+0.24
+0.18%
LPTN
2.93
-2.93
-100.00%
MBVX
0.82
-0.03
-3.53%
MEIP
2.745
+0.055
+2.045%
MNOV
5.95
+0.29
+5.12%
MRTX
10.45
0.00
0.00%
MSTX
0.13
-0.01
-5.28%
NBIX
58.085
+1.285
+2.262%
NUVA
54.445
+0.775
+1.444%
ONCS
0.98
-0.01
-1.01%
ONVO
2.04
-0.02
-0.97%
OREX
2.29
-0.01
-0.43%
OTIC
3.5
+0.1
+2.94%
QDEL
43.3
-0.24
-0.55%
RCPT
231.96
0.00
0.00%
RGLS
1.35
-0.02
-1.46%
RMD
77.74
-1.86
-2.34%
SCIE
0
0.00
0.00%
SPHS
2.34
0.00
0.00%
SRNE
1.775
+0.075
+4.412%
TROV
0.703
+0.033
+4.8642%
VICL
2.43
0.00
0.00%
VOLC
18
0.00
0.00%
ZGNX
13.5
-0.1
-0.74%
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Leading Independent Proxy Advisory Firm Glass Lewis & Co. Recommends CytRx Corp. Stockholders Vote “FOR” the Proposed Reverse Stock Split

September 21, 2017 – 5:00 am

LOS ANGELES, Sept.  21, 2017 /PRNewswire/ — CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that Glass Lewis & Co. has recommended that CytRx stockholders vote “FOR” the proposed reverse stock split at the upcoming special meeting of stockholders scheduled for October 17, 2017 at 10:00 a.m. PT.

Glass Lewis is widely recognized as one of the leading independent proxy voting and corporate governance advisory firms, and its recommendations are relied upon by thousands of major institutional investment firms, mutual funds and other fiduciaries throughout the United States.

In its report dated September 20, 2017, Glass Lewis stated, “We agree with the board that it is in the best interest of the Company to reduce the number of shares of common stock outstanding and thereby attempt to proportionally raise the per share price of the Company’s common stock….  A higher stock price may help to increase investor interest, attract and retain employees.”1  

In response to the favorable recommendation, Dr. Louis Ignarro, Nobel Laureate and Lead Director of CytRx said, “We are pleased that Glass Lewis, a highly regarded, independent, leading proxy advisory firm understands the importance of maintaining a NASDAQ Global Market listing and increasing our common stock price to a level that allows us to attract a broader and more diverse shareholder base.”

CytRx stockholders are urged to vote as Glass Lewis recommends by voting “FOR” the proposed reverse stock split.  Stockholders with questions may call Saratoga Proxy Consulting LLC at (888) 368-0379 or (212) 257-1311 or by email at info@saratogaproxy.com.

1Permission to use quotation was neither sought nor obtained.

How to Vote

If you are a stockholder of record at the close of business on August 28, 2017, you can vote your shares in one of two ways: either by proxy or in person at the special meeting. If you chose to submit a proxy, you may do so by telephone, via the internet or by mail. If you hold shares of CytRx common stock in multiple accounts, you should vote your shares as described in each set of proxy materials you receive. CytRx highly recommends stockholders vote electronically or by phone without delay. Please have your proxy card with you while voting.

You may transmit your proxy voting instructions via the Internet by accessing www.proxyvote.com and following the instructions. You may also transmit your proxy voting instructions by calling the telephone number specified on the proxy card. If you chose to vote via the Internet or phone, you do not have to return the proxy card.

For stockholders who still need assistance voting their shares, or have questions regarding the special meeting, please contact CytRx’s proxy solicitation firm, Saratoga Proxy Consulting, either by telephone: (888) 368-0379 or (212) 257-1311 or by email: info@saratogaproxy.com.

This press release is not a proxy statement or solicitation of a proxy, consent or authorization with respect to any securities or in respect of the proposed reverse stock split. STOCKHOLDERS ARE URGED TO READ CAREFULLY AND IN ITS ENTIRETY THE DEFINITIVE PROXY STATEMENT AND ANY AMENDMENTS FILED WITH THE SEC, AND OTHER RELEVANT MATERIALS, BECAUSE THEY DO AND WILL CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY AND THE PROPOSED REVERSE STOCK SPLIT.  The definitive proxy statement was mailed to stockholders of record as of August 28, 2017.  The amended definitive proxy statement will be mailed to shareholders on or about September 13, 2017.  Stockholders may obtain free copies of the Company’s definitive proxy statement, any amendments to the proxy statement and its other SEC filings electronically by accessing the SEC’s home page at http://www.sec.gov.  Copies can also be obtained, free of charge, upon written request to CytRx Corporation, Attn: Corporate Secretary, 11726 San Vicente Blvd., Suite 650, Los Angeles, CA 90049.

Participation in Solicitation

This press release may constitute soliciting material under SEC Rule 14a-12, and CytRx and its directors, executive officers, and advisors may be deemed to be participants in the solicitation of proxies from the holders of CytRx common stock in respect of the proposed reverse stock split.  Investors may obtain additional information regarding the interest of those participants by reading the Company’s definitive proxy statement, any amendments to the definitive proxy statement and other relevant proxy materials, and the Company’s annual reports on Form 10-K and quarterly reports on Form 10-Q, as filed with the SEC.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical company specializing in research and clinical development of novel anti-cancer drug candidates that employ linker technologies to enhance the accumulation and release of drug at the tumor. Aldoxorubicin, CytRx’s most advanced drug conjugate, is an improved version of the widely used chemotherapeutic agent doxorubicin and has been out-licensed to NantCell, Inc.  CytRx is also rapidly expanding its pipeline of ultra-high potency oncology candidates at its laboratory facilities in Freiburg, Germany, through its LADR™ (Linker Activated Drug Release) technology platform, a discovery engine designed to leverage CytRx’s expertise in albumin biology and linker technology for the development of a new class of potential breakthrough anti-cancer therapies.

Forward-Looking Statements

This press release contains forward-looking statements. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks and uncertainties relating to plans for regaining compliance with the NASDAQ rules and higher share price of our common stock; the ability of NantCell, Inc., to obtain regulatory approval for its products that use aldoxorubicin; the ability of NantCell, Inc., to manufacture and commercialize products or therapies that use aldoxorubicin; the amount, if any, of future milestone and royalty payments that we may receive from NantCell, Inc.; our ability to develop new ultra-high potency drug candidates based on our LADRTM technology platform; and other risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx’s most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Relations Contact: 
Argot Partners 
Michelle Carroll 
(212) 600-1902 
michelle@argotpartners.com

 

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SOURCE CytRx Corporation

Audentes Therapeutics Announces Dosing of First Patient in ASPIRO, a Phase 1/2 Clinical Trial of AT132 for the Treatment of X-Linked Myotubular Myopathy

September 21, 2017 – 4:00 am

Preliminary data from ASPIRO expected to be available in the fourth quarter of 2017

SAN FRANCISCO, Sept. 21, 2017 /PRNewswire/ — Audentes Therapeutics, Inc. (Nasdaq: BOLD), a biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases, today announced it has commenced dosing of patients in ASPIRO, a Phase 1/2 clinical trial of AT132 for the treatment of X-Linked Myotubular Myopathy (XLMTM).  ASPIRO is a multicenter, multinational, open-label, ascending dose study to evaluate the safety and preliminary efficacy of AT132 in approximately twelve XLMTM patients less than five years of age. Preliminary data from ASPIRO is expected to be available in the fourth quarter of 2017.

“XLMTM is a severe rare disease characterized by profound muscle weakness, respiratory failure and early death,” stated Suyash Prasad, M.D., Senior Vice President and Chief Medical Officer.  “Over 50 percent of the boys affected by XLMTM do not live to celebrate their second birthday, and no currently approved treatment options exist for these patients, their families and care-givers.”

Dr. Prasad continued, “We are grateful to the many expert collaborators, patient advocacy organizations and parents who have supported Audentes and helped guide our efforts.  Most of all we are thankful to the children and families affected by XLMTM for their participation in ASPIRO. We look forward to working together with our partners to advance AT132 as a potentially transformative therapy to treat this devastating disease.”

In addition to ASPIRO, the clinical development program for AT132 includes RECENSUS, a retrospective medical chart review, for which Audentes has previously announced data from an initial analysis of 112 male subjects. This analysis confirmed and expanded upon the understanding of the significant disease burden of XLMTM on patients, families and the healthcare system. Audentes is also conducting INCEPTUS, a prospective natural history run-in study. The primary objectives of INCEPTUS are to characterize the clinical condition of children with XLMTM, identify subjects for potential enrollment in ASPIRO, and serve as a longitundinal baseline and within-patient control for ASPIRO. Audentes plans to announce preliminary data from INCEPTUS in the third quarter of 2017.

About AT132 for X-Linked Myotubular Myopathy
AT132 is the Audentes product candidate being developed to treat XLMTM, a rare monogenic disease characterized by extreme muscle weakness, respiratory failure and early death, with an estimated 50% mortality rate by 18 months of age. XLMTM is caused by mutations in the MTM1 gene, which encodes a protein called myotubularin. Myotubularin plays an important role in the development, maintenance and function of skeletal muscle cells. AT132 is comprised of an AAV8 vector containing a functional copy of the MTM1 gene. Multiple studies in animal models of XLMTM have demonstrated that a single administration of AT132 improved disease symptoms and survival rates, with no significant AT132-related adverse events or safety findings. In one study these effects have lasted more than four and a half years years. Audentes is developing AT132 in collaboration with Genethon (www.genethon.fr).

About ASPIRO, the Phase 1/2 Clinical Study of AT132
ASPIRO is designed as a multicenter, multinational, open-label, ascending dose study to evaluate the safety and preliminary efficacy of AT132 in approximately 12 XLMTM patients less than five years of age. The study is expected to include nine AT132 treated subjects and three delayed-treatment concurrent control subjects. Primary endpoints include safety (adverse events and certain laboratory measures) and efficacy (assessments of neuromuscular and respiratory function). Secondary endpoints include the burden of disease and health related quality-of-life, and muscle tissue histology and biomarkers. The primary efficacy analysis is expected to be conducted at 12 months, with interim evaluations expected to be conducted at earlier time points. After the primary 12-month assessment, subjects are expected to be followed for another four years to assess long term safety, durability of effect and developmental progression.

About Audentes Therapeutics, Inc.
Audentes Therapeutics (Nasdaq: BOLD) is a biotechnology company focused on developing and commercializing gene therapy products for patients living with serious, life-threatening rare diseases.  We have four product candidates in development, AT132 for the treatment of X-Linked Myotubular Myopathy (XLMTM), AT342 for the treatment of Crigler-Najjar Syndrome, AT982 for the treatment of Pompe disease, and AT307 for the treatment of the CASQ2 subtype of Catecholaminergic Polymorphic Ventricular Tachycardia (CASQ2-CPVT).  We are a focused, experienced and passionate team committed to forging strong, global relationships with the patient, research and medical communities.

For more information regarding Audentes, please visit www.audentestx.com.

About Genethon
Genethon, located in Evry, France, is a non-profit R&D organization dedicated to the development of biotherapies for orphan genetic diseases, from research to clinical validation.  Genethon is specialized in the discovery and development of gene therapy drugs and has multiple ongoing programs at clinical, preclinical and research stage for neuromuscular, blood, immune system, liver and eye diseases.

Discover Genethon’s pipeline: http://www.genethon.fr/produits/

Forward Looking Statements
This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to: the timing of preliminary data from ASPIRO, the timing of data presentation from INCEPTUS and the ability of INCEPTUS to serve as a longitudinal baseline and within patient control for ASPIRO, and the potential of AT132 to be a transformative therapy for patients living with XLMTM.  All statements other than statements of historical fact are statements that could be deemed forward-looking statements. Although the company believes that the expectations reflected in such forward-looking statements are reasonable, the company cannot guarantee future events, results, actions, levels of activity, performance or achievements, and the timing and results of biotechnology development and potential regulatory approval is inherently uncertain. Forward-looking statements are subject to risks and uncertainties that may cause the company’s actual activities or results to differ significantly from those expressed in any forward-looking statement, including risks and uncertainties related to the company’s ability to advance its product candidates, obtain regulatory approval of and ultimately commercial its product candidates, the timing and results of preclinical and clinical trials, the company’s ability to fund development activities and achieve development goals, the company’s ability to protect intellectual property and other  risks and uncertainties described under the heading “Risk Factors” in documents the company files from time to time with the Securities and Exchange Commission. These forward-looking statements speak only as of the date of this press release, and the company undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date hereof.

Audentes Contacts:

Investor Contact:
Thomas Soloway, CFO
415.818.1040
ir@audentestx.com

Media Contact:
Paul Laland
415.519.6610
media@audentestx.com

 

View original content with multimedia:http://www.prnewswire.com/news-releases/audentes-therapeutics-announces-dosing-of-first-patient-in-aspiro-a-phase-12-clinical-trial-of-at132-for-the-treatment-of-x-linked-myotubular-myopathy-300523381.html

SOURCE Audentes Therapeutics, Inc.

Patara Pharma’s Phase 2 Study Results for Treatment of Persistent Cough in IPF Patients Published in The Lancet Respiratory Medicine

September 21, 2017 – 4:00 am

SAN DIEGO, Sept. 21, 2017 /PRNewswire/ — Patara Pharma, a clinical-stage biopharmaceutical company developing therapeutics that significantly improve the lives of patients with chronic inflammatory lung diseases and immune disorders, today announced that the positive results from its phase 2 clinical trial of lead drug candidate PA101 have been published in The Lancet Respiratory Medicine. The study, “A novel formulation of inhaled sodium cromoglycate (PA101) in idiopathic pulmonary fibrosis and chronic cough: a randomized, double-blind, proof of concept, phase 2 trial,” appears in the September 2017 issue.

In the 24-patient Phase 2 trial, PA101 demonstrated a statistically significant reduction in daytime and 24-hour cough frequency among idiopathic pulmonary fibrosis (IPF) patients versus placebo following 14 days of treatment. The reduction was supported by positive trends in cough-specific quality of life and cough severity, as assessed by patients in the study. The therapy was well tolerated, with no significant treatment-related adverse events.

The study also evaluated a second cohort of patients with chronic idiopathic cough, a condition unrelated to IPF. While PA101 was well tolerated in this group, the drug did not provide a treatment benefit, suggesting that PA101’s benefits are disease specific.

“The publication of our Phase 2 results in The Lancet Respiratory Medicine is an important milestone in our program to treat persistent cough in IPF patients, an often debilitating and difficult-to-treat symptom of IPF,” said Bill Gerhart, CEO of Patara Pharma. “An independent commentary accompanying the article described the findings as an important advancement in the treatment of this significant unmet medical need.”

Patara now plans to move forward with a robust Phase 2b study to identify the optimal dose for PA101.

IPF is a chronic and progressive lung disease of unknown cause, with a mean survival rate of 3-5 years post diagnosis.  Most patients with IPF suffer from a dry, non-productive cough that is disruptive to daily activities; it’s associated with pain, morbidities and psycho-social complications. Although the exact mechanism of cough in IPF patients is unknown and heterogenic, release of mast cell mediators and other inflammatory processes have been implicated. 

Patara’s lead candidate, PA101, is a novel inhaled formulation of cromolyn sodium, a mast cell stabilizer with pleotropic immune modulating properties. PA101 is delivered via a proprietary closed-system version of the eFlow electronic nebulizer device that achieves high, therapeutically relevant lung doses of cromolyn safely and conveniently.

Visit The Lancet Respiratory Medicine online to read the full study and the accompanying commentary article.

About Patara Pharma

Patara Pharma is a clinical-stage biopharmaceutical company developing new therapeutics that significantly improve the lives of patients with chronic inflammatory lung diseases and immune disorders.  The company’s lead candidate, PA101, is an inhaled formulation of an anti-inflammatory therapeutic delivered via a proprietary electronic nebulizer device. A robust phase 2b clinical trial is planned for the treatment of IPF patients with persistent cough.  Patara maintains its corporate headquarters in San Diego. For more information about Patara Pharma, please visit www.patarapharma.com.

 

View original content:http://www.prnewswire.com/news-releases/patara-pharmas-phase-2-study-results-for-treatment-of-persistent-cough-in-ipf-patients-published-in-the-lancet-respiratory-medicine-300523366.html

SOURCE Patara Pharma

Former Lawyer Sues Synthetic Genomics “Boys Club” over Gender Bias

September 20, 2017 – 8:05 pm

Against a contentious backdrop of a gender gap in the life sciences, a lawyer who spent more than eight years managing intellectual property at San Diego’s Synthetic Genomics (SGI) has sued the…

[[Click headline to continue reading.]]

Natera Selected for Circulating Tumor DNA Study in Bladder Cancer

September 20, 2017 – 7:03 am

Denmark’s Aarhus University to Use Signatera(TM) ctDNA Technology in Longitudinal Study

SAN CARLOS, Calif., Sept. 20, 2017 /PRNewswire/ — Natera, Inc., (NASDAQ: NTRA), a global leader in cell-free DNA testing, has entered into a research collaboration with Denmark’s Aarhus University to leverage the company’s Signatera™ (RUO) personalized liquid biopsy technology to evaluate circulating tumor DNA (ctDNA) as a useful biomarker in the diagnosis and treatment of bladder cancer. Signatera™ was recently launched for research use only (RUO) for oncology researchers and biopharmaceutical companies, and is not for use in diagnostic procedures. It is expected to be available for clinical use next year.

The study will evaluate over 400 prospectively obtained plasma samples from patients who underwent treatment for bladder cancer, and whose blood was collected serially through chemotherapy and surgery. Sequencing data from each patient’s tumor will be provided by Aarhus University and run through the Signatera™ proprietary ctDNA bioinformatics pipeline, resulting in custom ctDNA assays being designed for each patient. Personalized ctDNA analysis will be performed at multiple time points per patient to correlate ctDNA levels with clinical outcomes.

Aarhus University’s significant expertise in bladder cancer research, as well as its extensive repository of longitudinal patient tumor and blood samples, make it an ideal partner,” said Jimmy Lin, MD, PhD, MHS, Chief Science Officer, Oncology, at Natera. “We expect that this study, plus additional research efforts in other cancer types, will help us build toward clinically validating Signatera. If validated, Signatera could enable earlier diagnosis, more precise monitoring, better determination of prognosis, and individualized treatment of disease.”

“We are pleased to collaborate with Natera on this important research project involving a challenging cancer with high recurrence and mortality rates,” said Dr. Lars Dyrskjøt Andersen, Professor, Department of Clinical Medicine at Aarhus University. “We expect that this study will provide new insights that may help improve patient outcomes. We have a long track record in translational bladder cancer research, and we anticipate that this collaboration with Natera will significantly accelerate development of molecular diagnostic tests for this disease.” 

Signatera™ differs from currently available liquid biopsy tests, which test for a generic panel of genes independent of an individual’s tumor. It provides a customized blood test tailored to match the mutations found in an individual’s tumor tissue, which maximizes sensitivity and specificity. Signatera™ also allows researchers to track additional mutations of interest, up to several hundred mutations, for clinical studies. A recent study of patients with early stage non-small cell lung cancer (NSCLC) showed the value of Natera’s customized ctDNA analysis for use in cancer research. The study, which was featured on the cover of the journal Nature, demonstrated Signatera’s™ potential to detect residual disease, measure treatment response, and identify recurrence up to 11 months earlier than the standard of care.1

About Aarhus University
Aarhus University is a prestigious research institution located in Aarhus, Denmark. Founded in 1928, it is Denmark’s second oldest university and its largest, with 42,500 enrolled students, 11,500 staff members, and a budget of 840 million Euros. Aarhus University’s ambition is to be a globally oriented university with a commitment to excellence in research and education, and a strong engagement with the development community. Owing to its size and impressive results as a research-intensive university, Aarhus has a strong reputation and influence across the entire spectrum of disciplines locally, nationally, and globally. For more information, visit www.au.dk/en/.

About Natera
Natera is a global leader in cell-free DNA testing. The mission of the company is to transform the diagnosis and management of genetic diseases. Natera operates an ISO 13485-certified and CAP-accredited laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA) in San Carlos, Calif. It offers a host of proprietary genetic testing services to inform physicians who care for pregnant women, researchers in cancer including biopharmaceutical companies, and genetic laboratories through its cloud-based software platform. For more information, visit www.natera.com.

Forward-looking statements
This release contains forward-looking statements. All statements other than statements of historical facts contained in this press release are forward-looking statements. Any forward-looking statements contained in this press release are based upon Natera’s historical performance and its current plans, estimates, and expectations, and are not a representation that such plans, estimates, or expectations will be achieved. These forward-looking statements represent Natera’s expectations as of the date of this press release.

Subsequent events may cause these expectations to change, and Natera disclaims any obligation to update the forward-looking statements for any reason after the date of this press release. These forward-looking statements are subject to a number of known and unknown risks and uncertainties that may cause actual results to differ materially, including with respect to Natera’s efforts to develop and commercialize new product offerings, Natera’s ability to successfully increase demand for and grow revenues for its product offerings, whether the results of clinical studies will support the use of its product offerings, Natera’s expectations of the reliability, accuracy and performance of its screening tests, or of the benefits of its screening tests and product offerings to patients, providers and payers.

Additional risks and uncertainties are discussed in greater detail in the sections entitled “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Natera’s Form 10-Q for the quarter ended June 30, 2017. Further information on potential risks that could affect actual results will be included in other filings Natera makes with the SEC from time to time. These documents are available for free on the company’s website at www.natera.com in the “Investor Relations” section, and on the SEC’s website at www.sec.gov.

Contacts:
Investor Relations
Mike Brophy, CFO, Natera, 650-249-9091 x1471, Mbrophy@natera.com

Media
Barbara Sullivan, Sullivan & Associates, 714-374–6174, bsullivan@sullivanpr.com

  1. Reference:
    Abbosh C. et al. Phylogenetic ctDNA analysis depicts early-stage lung cancer evolution. Nature 545, 446–451 (2017) http://doi.org/10.1038/nature22364

 

View original content with multimedia:http://www.prnewswire.com/news-releases/natera-selected-for-circulating-tumor-dna-study-in-bladder-cancer-300522887.html

SOURCE Natera

Zavante Therapeutics To Present ZOLYD(TM) Data From Pivotal ZEUS Study At ID Week 2017

September 20, 2017 – 4:18 am

SAN DIEGO, Sept. 20, 2017 /PRNewswire/ — Zavante Therapeutics, Inc., a biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients, and its research collaborators will present eight posters related to investigational antibiotic ZOLYD™ (fosfomycin for injection, also known as ZTI-01), at ID Week 2017 to be held October 4-8, 2017 in San Diego.

“Zavante welcomes the opportunity to present in a peer review forum detailed results from our pivotal ZEUS Phase 2/3 clinical trial,” said Evelyn J. Ellis-Grosse, Ph.D., Chief Scientific Officer of Zavante Therapeutics. “In the ZEUS study, ZOLYD met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam in patients with complicated urinary tract infections, and we believe these data support our forthcoming new drug application for U.S. registration.”

ZEUS was a multicenter, randomized, double-blind Phase 2/3 trial designed to evaluate the safety and efficacy of ZOLYD for the treatment of hospitalized adults with complicated urinary tract infections (cUTI), including acute pyelonephritis (AP), versus piperacillin/tazobactam. New positive ZEUS results to be presented at ID Week include a post-hoc analysis of the primary outcome (defined as clinical cure plus microbiologic eradication at the test-of-cure visit) based upon molecular strain typing of bacterial pathogens in both treatment arms.

The ID Week poster presentations also feature the ZEUS safety and efficacy data in a subset of patients with infections caused by resistant bacteria. In vitro studies evaluating activity of ZOLYD combined with meropenem or cefepime in different resistance models will also be presented at the meeting.

In addition to the company’s poster presentations, Dr. Ellis-Grosse will participate in a symposium titled, “New Antibiotics: What’s in the Pipeline?” on Thursday, October 5th, from 2:00 p.m. to 3:30 p.m. Pacific Time and a meet-the-professor session titled, “Pipeline 2.0,” on Friday, October 6th, from 7:00 a.m. to 8:15 a.m. Pacific Time.

Poster details for the meeting are as follows. The complete program can be accessed at the ID Week 2017 website at www.idweek.org.

Friday, October 6, 2017, 12:30 p.m.2:00 p.m.

Session 147 – Expanded Spectrum – New Antimicrobial Susceptibility Testing

  • Poster 1224: In vitro Activity of Fosfomycin, Alone and Combined with Cefepime and Meropenem, Against Carbapenemase-Producing Gram-Negative Bacteria

Session 167 – Preclinical Study with New Antibiotics and Antifungals

  • Poster 1517: ZTI-01 Treatment Improves Survival of Animals Infected with Multidrug Resistant Pseudomonas aeruginosa
  • Poster 1523: Fosfomycin (FOS) Plus Meropenem (MER) Suppresses Resistance Emergence Against P. aeruginosa (PA) PAO1 in the Hollow Fiber Infection Model (HFIM)

Saturday, October 7, 2017, 12:30 p.m.2:00 p.m.

Session 231 – Clinical Study with New Antibiotics and Antifungals

  • Poster 1830: Phenotypic Antibiotic Resistance in ZEUS: Multi-center, Randomized, Double-Blind Phase 2/3 Study of ZTI-01 versus Piperacillin-Tazobactam (P-T) in the Treatment of Patients with Complicated Urinary Tract Infections (cUTI) including Acute Pyelonephritis (AP)
  • Poster 1833: Per Pathogen Outcomes from the ZEUS study, a Multi-center, Randomized, Double-Blind Phase 2/3 Study of ZTI-01 (fosfomycin for injection) versus Piperacillin-Tazobactam (P-T) in the Treatment of Patients with Complicated Urinary Tract Infections (cUTI) including Acute Pyelonephritis (AP)
  • Poster 1837: Safety Results from the ZEUS Study: Multi-center, Randomized, Double-Blind Phase 2/3 Study in Hospitalized Adults with Complicated Urinary Tract Infections (cUTI) Including Acute Pyelonephritis (AP) who Received Intravenous Fosfomycin (ZTI-01)
  • Poster 1845: Intravenous Fosfomycin (ZTI-01) for the Treatment of Complicated Urinary Tract Infections (cUTI) Including Acute Pyelonephritis (AP): Results from a Multi-center, Randomized, Double-Blind Phase 2/3 Study in Hospitalized Adults (ZEUS)
  • Poster 1848: Population Pharmacokinetic (PPK) Analysis of ZTI-01 (Fosfomycin for Injection) Using Data from Healthy Subjects and Patients with Complicated Urinary Tract Infections (cUTI)

About ZOLYD (fosfomycin for injection, also known as ZTI-01) 
ZOLYD is an investigational, first-in-class injectable epoxide antibiotic with a broad spectrum of activity in vitro against Gram-negative and Gram-positive bacteria, including activity against most multi-drug resistant strains that are of particular concern to public health. ZOLYD has a differentiated mechanism of action that acts at an earlier step in cell wall synthesis inhibition, providing activity against pathogens that are often resistant to other classes of antibiotics. Zavante recently reported that ZOLYD met the primary endpoint of statistical non-inferiority to piperacillin/tazobactam in the pivotal ZEUS clinical trial in hospitalized patients with cUTI, including AP.  

The U.S. Food and Drug Administration has granted Fast Track and Qualified Infectious Disease Product designations for the investigation of ZOLYD for cUTI, hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP) infections, acute bacterial skin and skin structure infections (ABSSSI), and complicated intra-abdominal infections (cIAI). These designations make ZOLYD eligible for certain incentives available for the development of new antibiotics, including priority FDA review and an additional five years of market exclusivity under the Generating Antibiotic Incentives Now (GAIN) Act.

ZOLYD is an investigational medication that has not been approved by the FDA for any indication.

About Zavante Therapeutics, Inc.
Zavante Therapeutics, Inc. is a privately-held, late clinical-stage biopharmaceutical company focused on developing novel therapies to improve the outcomes of hospitalized patients. Additional information is available at www.zavante.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements within the meaning of U.S. federal securities laws. Such statements may be preceded by the words such as “believe” and similar words. Forward-looking statements contained in this press release include statements about the company’s belief that data from the ZEUS study will be sufficient to support a new drug application (NDA) for U.S. registration of ZOLYD. Forward-looking statements are not historical facts or assurances of the company’s future performance, but are based on management’s current beliefs, expectations and assumptions and are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and may be outside of the company’s control.  Because the company’s actual results and financial condition may differ materially from those indicated in the forward-looking statements, you should not rely on any such forward-looking statements. Important factors that could cause the company’s actual results to differ materially from those indicated in this release include, among others, the following: whether the results of the ZEUS clinical trial are deemed by FDA to be sufficient to support approval of an NDA for ZOLYD in the treatment of patients with cUTI; unanticipated delays that may occur, or unanticipated findings that may emerge, in analyzing the safety or efficacy data from the ZEUS clinical trial; the company’s ability to successfully complete necessary manufacturing and related development activities for ZOLYD on time and at reasonable costs; the company’s ability to obtain additional financing required to complete development activities and prepare for the commercialization of ZOLYD, if approved by FDA; and potential changes in the FDA’s regulatory policies that could negatively impact FDA approval of an NDA for ZOLYD or the Fast Track or QIDP designations granted by FDA for ZOLYD. Forward-looking statements contained in this press release are based only on information currently available to the company and speak only as of the date made. Zavante undertakes no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

ZOLYD and ZAVANTE are trademarks or registered trademarks of Zavante Therapeutics, Inc.

 

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SOURCE Zavante Therapeutics, Inc.

Trovagene Strengthens Board of Directors with Appointment of Oncology Development Veteran Dr. Athena Countouriotis

September 20, 2017 – 4:00 am

Dr. Athena Countouriotis joins Trovagene’s Board of Directors, bringing significant experience in oncology clinical development and orphan indications

SAN DIEGO, Sept. 20, 2017 /PRNewswire/ — Trovagene, Inc. (NASDAQ: TROV), a precision medicine biotechnology company, today announced the expansion and strengthening of its Board of Directors with the appointment of Athena Countouriotis, M.D.

Dr. Countouriotis brings significant experience leading clinical development programs, from preclinical through clinical stages, and approval.  Over the course of her career, she has been involved in multiple clinical programs, with a focus within oncology, both hematologic and solid tumor indications, that have supported regulatory approvals in the U.S. and Europe.  Dr. Countouriotis currently serves as Senior Vice President, Chief Medical Officer at Adverum Biotechnologies. Prior to joining Adverum, she served as Senior Vice President and Chief Medical Officer at Halozyme Therapeutics.  Dr. Countouriotis was Chief Medical Officer at Ambit Biosciences through the initial development of quizartinib, a small molecule FLT3 inhibitor for the treatment of Acute Myeloid Leukemia, and ultimate acquisition of the company by Daiichi Sankyo. Dr. Countouriotis also worked at both Pfizer and Bristol-Meyers Squibb in various roles leading clinical development of oncology focused therapeutics. She holds a M.D. from Tufts University School of Medicine, completed her pediatric residency at the University of California, Los Angeles, and did additional training at Fred Hutchinson Cancer Research Center in the pediatric hematology-oncology program.

“We are pleased to welcome Dr. Countouriotis to our Board of Directors,” said Bill Welch, Chief Executive Officer of Trovagene. “Dr. Countouriotis has incredible expertise in the clinical development of oncology therapeutics, including multiple compounds in leukemia such as Sprycel, Mylotarg, Bosulif and Quizartinib, which is a FLT3 inhibitor in AML. We look forward to her contributions and guidance as we continue to advance PCM-075 for the treatment of patients with hematologic and solid tumor cancers.”

“It is an exciting time at Trovagene as we embark on moving PCM-075 into the clinic in AML.  This a great time to join the Board of Directors and share my expertise with the company, and I look forward to working with the Trovagene team,” added Dr. Countouriotis.

About PCM-075

PCM-075 is a highly-selective adenosine triphosphate (ATP) competitive inhibitor of the serine/threonine polo-like-kinase 1 (PLK 1) enzyme, which is over-expressed in multiple hematologic and solid solid tumor cancers. Studies have shown that inhibition of PLK1 can lead to tumor cell death, including multiple Phase 2 studies in Acute Myeloid Leukemia (AML) where response rates of up to 30% have been observed. A Phase 1 open-label, dose escalation safety study of PCM-075 has been completed in patients with advanced metastatic solid tumor cancers, and published in Investigational New Drugs. Trovagene plans to initiate a Phase 1b/2 clinical trial with PCM-075 in AML, since it has shown significant advantages over prior PLK1 inhibitors evaluated in this indication, including a higher selectivity, greater potency, oral bioavailability and shorter half-life. PCM-075 has demonstrated synergy in preclinical studies with over 10 chemotherapeutic and target agents used in hematologic and solid tumor cancers, including FLT3 and HDAC inhibitors, taxanes, and cytotoxins. Trovagene believes the combination of its targeted PLK-1 inhibitor, PCM-075, with other compounds has the potential for improved clinical efficacy in Acute Myeloid Leukemia (AML), Castration-Resistant Prostate Cancer (CRPC), Non-Hodgkin Lymphoma (NHL), Triple Negative Breast Cancer (TNBC) and Adrenocortical Carcinoma (ACC).

About Trovagene, Inc.

Trovagene is a precision medicine biotechnology company developing oncology therapeutics for improved cancer care by leveraging its proprietary Precision Cancer Monitoring® (PCM) technology in tumor genomics.  Trovagene has broad intellectual property and proprietary technology to measure circulating tumor DNA (ctDNA) in urine and blood to identify and quantify clinically actionable markers for predicting response to cancer therapies.  Trovagene offers its PCM technology at its CLIA/CAP – accredited laboratory and plans to continue to vertically integrate its PCM technology with precision cancer therapeutics.  For more information, please visit https://www.trovagene.com.

Forward-Looking Statements

Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Trovagene’s expectations, strategy, plans or intentions. These forward-looking statements are based on Trovagene’s current expectations and actual results could differ materially.  There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements.  These factors include, but are not limited to, our need for additional financing; our ability to continue as a going concern; clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; our ability to develop tests, kits and systems and the success of those products; regulatory, financial and business risks related to our international expansion and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations.  There are no guarantees that any of our technology or products will be utilized or prove to be commercially successful, or that Trovagene’s strategy to design its liquid biopsy tests to report on clinically actionable cancer genes will ultimately be successful or result in better reimbursement outcomes.  Additionally, there are no guarantees that future clinical trials will be completed or successful or that any precision medicine therapeutics will receive regulatory approval for any indication or prove to be commercially successful.  Investors should read the risk factors set forth in Trovagene’s Form 10-K for the year ended December 31, 2016, and other periodic reports filed with the Securities and Exchange Commission.  While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties.  Unlisted factors may present significant additional obstacles to the realization of forward-looking statements.  Forward-looking statements included herein are made as of the date hereof, and Trovagene does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Trovagene Contact:
Vicki Kelemen
VP, Corporate Communications
858-952-7652
vkelemen@trovagene.com

 

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SOURCE Trovagene, Inc.

Roivant Sciences Launches Datavant to Improve Clinical Trials with Artificial Intelligence

September 20, 2017 – 4:00 am

– Datavant aggregates and analyzes biomedical data to lower the time, cost, and risk of drug development- Tech industry veteran and former LiveRamp CEO Travis May to lead Datavant- Founders Fund joins Softbank Vision Fund in supporting mission of Roivant and Datavant

SAN FRANCISCO and BASEL, Switzerland, Sept. 20, 2017 /PRNewswire/ — Roivant Sciences, a global healthcare company focused on realizing the full value of promising biomedical research to improve the lives of patients and their families, today announced the launch of Datavant, a new company focused on employing artificial intelligence to improve the clinical trial process.

Datavant will be led by Travis May, a Silicon Valley technology veteran with a history of building industry-leading data companies. Mr. May was the co-founder and CEO of LiveRamp, an identity resolution provider offering data onboarding.

“As a technologist looking at the biopharma industry, it’s surprising and disconcerting how little data is shared as compared to other industries,” said Mr. May. “Biopharmaceutical data is siloed across big pharma companies, universities, healthcare consortia, CROs, research groups, hospital systems, regulatory bodies, patient registries, genomics companies, and EMRs. There is tremendous potential to apply analytics to this data more effectively, improve drug development, and ultimately save lives.”

Incubated by Roivant, Datavant has already compiled data from 85 different datasets comprising over 20 million patient visits. When appropriately joined and analyzed, these datasets can be used to inform the design and operations of clinical development programs – improving likelihood of success and time to market, and reducing the cost of clinical trials. Datavant is launching with initial financing led by Roivant and including a significant personal investment from Mr. May.

Datavant has also built a scientific and data science advisory board that includes:

  • Daniel Burch, MD, Chief Medical Officer of PPD Biotech
  • Emiko Higashi, Founder and Managing Director of Tohmon Capital Partners LLC
  • Min Li, PhD, SVP and Head of Neurosciences R&D at GlaxoSmithKline; former Professor of Neuroscience at Johns Hopkins University
  • Andrew Lo, PhD, Charles E. and Susan T. Harris Professor at the MIT Sloan School of Management
  • Atul Pande, MD, Former SVP, Head of Neurosciences R&D at GlaxoSmithKline
  • Eric Perakslis, PhD, SVP, R&D Informatics at Takeda Pharmaceuticals; former CIO and Chief Scientist (Informatics) at FDA; former Executive Director of the Harvard Medical School Center for Biomedical Informatics
  • Frank Rockhold, PhD, Professor of Biostatistics and Bioinformatics at the Duke Clinical Research Institute
  • Bryan Spielman, Former EVP at Medidata

“Despite the best efforts of consortia and data sharing initiatives, clinical trial data remains under-optimized today, reducing the odds of success for clinical trials and adding significant cost to the drug development process,” said Eric Perakslis. “I’m excited by Datavant’s approach to using sophisticated analytics and AI to unlock the potential of patient-level data, and believe it can ultimately improve the drug development process and bring value to patients.”

“Today’s announcement represents another step forward in achieving Roivant’s long-term goal of reducing the time and cost of the drug development process,” said Vivek Ramaswamy, Founder and CEO of Roivant Sciences.

Roivant recently completed a $1.1 billion equity investment led by the SoftBank Vision Fund. Founders Fund also participated in that round.

“We are impressed by Roivant’s bold vision for transforming healthcare, and see Datavant as an integral part of that vision,” said Founders Fund partner Brian Singerman. “Few sectors need innovation more than healthcare and Datavant is uniquely positioned to have a significant impact on the way medicines are developed across the industry.”

About Datavant

Datavant is dedicated to accelerating the discovery, development, and commercialization of new medicines through machine learning. We aim to partner with biomedical research institutions to eliminate silos of information and unlock insights from healthcare data.

Datavant is backed by Roivant Sciences, a global family of healthcare companies focused on innovative approaches to realizing the full value of promising biomedical research and shortening the timeline and cost of pharmaceutical development. Datavant is combining leading data scientists with Roivant’s biopharmaceutical research expertise to provide analytic solutions to our partners.

About Roivant Sciences

Roivant is dedicated to transformative innovation in healthcare. Roivant focuses on realizing the full potential of promising biomedical research by developing and commercializing novel therapies across diverse therapeutic areas. We partner with innovative biopharmaceutical companies and academic institutions to ensure that important medicines are rapidly developed and delivered to patients.

We advance our drug pipelines through wholly- or majority-owned subsidiary companies, including Axovant (neurology), Myovant (women’s health and endocrine diseases), Dermavant (dermatology), Enzyvant (rare diseases), and Urovant (urology). Roivant also pursues its mission by incubating and launching innovative healthcare companies operating outside of traditional biopharmaceutical development. Roivant’s long-range mission is to reduce the time and cost of developing and delivering new medicines for patients. For more information, please visit roivant.com.

Related Links

http://www.datavant.com

http://www.roivant.com

Media Contact:

Paul Davis
paul.davis@roivant.com
+1 (646) 495-5310

Datavant Contact:

Sam Roosz
sam@datavant.com 
+1 (765) 490-9385

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SOURCE Roivant Sciences

DURECT Appoints Dr. Myriam Theeuwes as Senior Vice President, Clinical Development

September 20, 2017 – 4:00 am

CUPERTINO, Calif., Sept. 20, 2017 /PRNewswire/ — DURECT Corporation (Nasdaq: DRRX) announced today that Dr. Myriam Theeuwes has joined DURECT as Senior Vice President, Clinical Development.  Dr. Theeuwes joins DURECT from Johnson & Johnson where she spent 18 years, most recently as Compound Development Team Leader for Janssen Pharmaceutical’s global public health initiatives where she led the development and launch of products including SIRTURO® (bedaquiline), the first drug with a new mechanism of action to treat tuberculosis in over 40 years.  Since its original FDA approval in 2012, the product has been widely registered in high burden areas and is available in over 100 countries globally.

“Dr. Theeuwes’ extensive experience and success in developing pharmaceuticals for both major and rare diseases is an ideal fit with DURECT’s pipeline of products,” stated James E. Brown, President and CEO of DURECT Corporation.  “We welcome her insights and leadership in guiding the development of DUR-928, our lead product candidate for the treatment of liver diseases, acute organ injuries and inflammatory skin conditions, as it advances into Phase 2 clinical testing.”

“I am excited to be joining a talented team that has in a few years taken this endogenous molecule from its discovery in an academic setting through an extensive pre-clinical development program and multiple Phase 1 studies,” said Dr. Theeuwes.  “The breadth of activity and safety profile of DUR-928 demonstrated to date suggests that it could potentially address multiple life threatening medical conditions with high unmet need.”

Prior to joining Janssen, Dr. Theeuwes spent 11 years at ALZA Corporation in positions of increasing responsibility culminating in her appointment as General Manager and Associate Medical Director for Europe.  Before her career in industry, Dr. Theeuwes was a practicing resident dentist at the University of California San Francisco (UCSF) and San Marcos Health Center in Honduras.  She received her dental degree from the University of Leuven, Belgium and obtained her California state dental license after completing the Advanced General Dentistry Residency Program at UCSF. 

About DURECT Corporation

DURECT is a biopharmaceutical company actively developing new therapeutics based on its Epigenetic Regulator Program and proprietary drug delivery platforms.  DUR‑928, a new chemical entity in Phase 1 development, is the lead candidate in DURECT’s Epigenetic Regulator Program.  An endogenous, orally bioavailable small molecule, DUR-928 has been shown in preclinical studies to play an important regulatory role in lipid homeostasis, inflammation, and cell survival.  Human applications may include acute organ injury, chronic metabolic diseases such as nonalcoholic fatty liver disease (NAFLD), nonalcoholic steatohepatitis (NASH) and other liver diseases with both broad and orphan populations, and inflammatory skin conditions such as psoriasis.  DURECT’s advanced oral, injectable, and transdermal delivery technologies are designed to enable new indications and enhanced attributes for small-molecule and biologic drugs. One late-stage product candidate in this category is POSIMIR® (SABER®-Bupivacaine), an investigational locally-acting, non-opioid analgesic intended to provide up to 3 days of continuous pain relief after surgery.  Another late stage product candidate is REMOXY® ER (oxycodone), an investigational pain control drug based on DURECT’s ORADUR® technology.  For more information, please visit www.durect.com.

NOTE: POSIMIR®, SABER®, and ORADUR® are trademarks of DURECT Corporation. Other referenced trademarks belong to their respective owners.  POSIMIR, DUR-928, and REMOXY ER are drug candidates under development and have not been approved for commercialization by the U.S. Food and Drug Administration or other health authorities.

DURECT Forward-Looking Statement

The statements in this press release regarding the potential benefits and uses of our drug candidates, including the potential use of POSIMIR to treat post-surgical pain, the potential use of REMOXY ER to treat pain, the potential use of DUR-928 to treat NASH, other liver diseases, acute organ injury or inflammatory skin conditions such as psoriasis,  and potential markets for POSIMIR, DUR-928 and REMOXY ER, are forward-looking statements involving risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, the risks that the PERSIST clinical trial of POSIMIR will result in data that will not support a successful NDA resubmission or product approval, possible adverse events associated with the use of POSIMIR, DUR-928 or REMOXY ER, delays and costs due to additional work or other requirements imposed by regulatory agencies for continued development, approval or sale of POSIMIR, DUR-928 or REMOXY ER, that results from Phase 1 clinical trials of DUR-928 will not be replicated in Phase 2 trials, our ability to manufacture, commercialize and obtain marketplace acceptance of POSIMIR, DUR-928 or REMOXY ER, and avoid infringing patents held by other parties and secure and defend patents of our own, and risks related to our ability to obtain capital to fund operations and expenses. Further information regarding these and other risks is included in DURECT’s Form 10-Q filed on August 9, 2017 under the heading “Risk Factors.”

 

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SOURCE DURECT Corporation

Nektar Therapeutics Announces Seven Abstracts Accepted for Presentation at 2017 Society for Immunotherapy of Cancer (SITC) 32nd Annual Meeting

September 20, 2017 – 3:24 am

Clinical Data for NKTR-214 in Combination with Nivolumab Accepted for Oral Presentation (PIVOT-02 Study)Additional Abstracts Showcase Complementary Mechanisms Targeting Non-Overlapping Immune Pathways of Nektar’s Wholly-Owned I-O Pipeline

SAN FRANCISCO, Sept. 20, 2017 /PRNewswire/ — Nektar Therapeutics (Nasdaq: NKTR) today announced that new data across its wholly-owned immuno-oncology (I-O) portfolio will be presented at the upcoming Society for Immunotherapy of Cancer (SITC) Annual Meeting, which is being held from November 10 to November 12, 2017, at the Gaylord National Hotel & Convention Center in National Harbor, Maryland.  Seven abstracts were selected for presentation for three Nektar I-O pipeline programs: NKTR-214, a CD122-biased agonist; NKTR-255, an IL-15 memory T cell stimulating cytokine; and NKTR-262, a novel toll-like receptor (TLR) agonist. 

Clinical data from the PIVOT program evaluating NKTR-214 in combination with the checkpoint inhibitor nivolumab were accepted for an oral presentation in the Clinical Trials: Novel Combinations Session on November 11, 2017. The PIVOT trial is comprised of two stages, the dose-escalation stage (PIVOT-02, n=38) and the expansion cohort stage (PIVOT-04, n=250).  The dose-escalation stage, which has completed enrollment, is evaluating NKTR-214 in combination with nivolumab in I-O therapy-naïve patients with melanoma, renal cell carcinoma and non-small cell lung cancer.  The expansion cohort stage, which is actively enrolling patients, is evaluating NKTR-214 in combination with nivolumab in five tumor types and eight different indications. PIVOT is being conducted in a collaboration with Bristol-Myers Squibb with each company equally sharing costs of the combination therapy trials and Nektar maintaining its global commercial rights to NKTR-214.

NKTR-214 is an investigational immuno-stimulatory therapy designed to expand specific cancer-fighting CD8+ effector T cells and natural killer (NK) cells directly in the tumor micro-environment and increase expression of PD-1 on these immune cells. NKTR-214 targets CD122 specific receptors found on the surface of cancer-fighting immune cells in order to stimulate their proliferation and activation. In clinical and preclinical studies, treatment with NKTR-214 resulted in expansion of these cells and mobilization into the tumor.1,2 NKTR-214 has an antibody-like dosing regimen similar to the existing checkpoint inhibitor class of approved medicines.

Nektar is also enrolling a separate clinical trial (the PROPEL study) to evaluate NKTR-214 in combination with two additional checkpoint inhibitors (atezolizumab and pembrolizumab).

Details of the oral presentation of clinical data from the PIVOT-02 study are as follows:

Abstract Title: PIVOT-02: Preliminary safety, efficacy and biomarker results from the Phase 1/2 study of CD-122-biased agonist NKTR-214 plus nivolumab in patients with locally advanced/metastatic solid tumors
Presenter: Dr. Adi Diab, MD Anderson Cancer Center
Session Title, Date and Time: Clinical Trials: Novel Combinations, Saturday, November 11, 2017, 3:30 – 6:00 p.m. Eastern Time

Six abstracts were accepted for presentation in the following categories:

Biomarkers and Immune Monitoring

Data presentation for the clinical trial of single-agent NKTR-214 in patients with advanced solid tumors:

  • Bentebibel, S., et al., “The novel IL-2 cytokine immune agonist NKTR-214 harnesses the adaptive and innate immune system for the treatment of solid cancers.”

Cancer Vaccines

Data presentation for preclinical studies of NKTR-214 in combination with checkpoint blockade therapy or peptide-based vaccination:

  • Sharma, M., et al., “NKTR-214 enhances anti-tumor T cell immune responses induced by checkpoint blockade or vaccination.”

Combination Therapy

Data presentation for preclinical studies of NKTR-214 in combination with NKTR-262, a novel small molecule agonist that targets toll-like receptors (TLRs) found on innate immune cells in the body:

  • Kivimae, S., et al., “Harnessing the innate and adaptive immune system to eradicate treated and distant untreated solid tumors.”

Data presentation for preclinical studies of NKTR-214 with high-dose radiotherapy:

  • Walker, J, et al., “Combination of NKTR-214 and radiotherapy (RT) to reverse anergy and expand tumor-specific CD8 T Cells.”

Immune Modulation, Cytokines, and Antibodies

Data presentation for preclinical studies of NKTR-255, a memory T cell stimulating cytokine designed to engage the IL-15 pathway to induce long-term T cell activation and improve the quality of T cell memory response to treat cancer:

  • Kirk, P, et al., “Preclinical efficacy and tolerability of NKTR-255, a polymer-conjugated IL-15 for immuno-oncology.”

Personalized Vaccines and Technologies/Personalized Medicines

Data presentation for preclinical studies of NKTR-214 with novel neoantigens vaccine:

  • D’Alise, A.M., et al., “Great apes adenoviral vaccine encoding neoantigens synergizes with immunomodulators to cure established tumors in mice

About Nektar
Nektar Therapeutics is a research-based development stage biopharmaceutical company whose mission is to discover and develop innovative medicines to address the unmet medical needs of patients. Our R&D pipeline of new investigational medicines includes treatments for cancer, auto-immune disease and chronic pain. We leverage Nektar’s proprietary and proven chemistry platform in the discovery and design of our new therapeutic candidates. Nektar is headquartered in San Francisco, California, with additional operations in Huntsville, Alabama and Hyderabad, India. Further information about the company and its drug development programs and capabilities may be found online at http://www.nektar.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements which can be identified by words such as: “intend,” “plan,” “expect,” “believe,” “should,” “may,” “will” and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding the therapeutic potential of NKTR-214, both alone and in combination with one or more other agents (such as anti-PD1 and anti-PD-L1 agents), the synergistic activities of combinations of active agents (such as NKTR-214 in combination with anti-PD1 and anti-PD-L1 agents), and the potential of our technology and drug candidates in our research and development pipeline. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause our actual results to differ materially from those indicated in the forward-looking statements include, among others: (i) our statements regarding the therapeutic potential of NKTR-214 are based on findings and observations from preclinical findings and ongoing clinical studies; (ii) NKTR-214, both alone and in combination with other agents (such as anti-PD1 and anti-PD-L1 agents), is in early stages of clinical development and the risk of failure remains high and failure can unexpectedly occur due to efficacy, safety or other unpredictable factors prior to regulatory approval for numerous reasons, including negative safety and efficacy findings even after positive findings in previous clinical and preclinical studies; (iii) the timing of the commencement or end of clinical studies and the availability of clinical data may be delayed or unsuccessful due to regulatory delays, slower than anticipated patient enrollment, manufacturing challenges, changing standards of care, evolving regulatory requirements, clinical trial design, clinical outcomes, competitive factors, or delay or failure in ultimately obtaining regulatory approval in one or more important markets; (iv) scientific discovery of new medical breakthroughs is an inherently uncertain process and the future success of applying our technology platform to potential new drug candidates (such as NKTR-214) is therefore highly uncertain and unpredictable and one or more research and development programs could fail; (v) patents may not issue from our patent applications for our drug candidates including NKTR-214, patents that have issued may not be enforceable, or additional intellectual property licenses from third parties may be required; and (vi) certain other important risks and uncertainties set forth in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 2017. Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Contact:

For Investors: 
Jennifer Ruddock of Nektar Therapeutics
415-482-5585

Jodi Sievers of Nektar Therapeutics
415-482-5593

For Media:
Jennifer Paganelli 
347-658-8290 
jpaganelli@purecommunications.com

  1. Charych, D., et al., Clin Can Res; 22(3) February 1, 2016
  2. Diab, A., et al., Journal for ImmunoTherapy of Cancer 2016, 4(Suppl 1):P369

 

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SOURCE Nektar Therapeutics