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Sherpa Clinical Packaging announces completion of move to a new GMP clinical Packaging and Distribution facility in San Diego
SAN DIEGO, Feb. 22, 2016 /PRNewswire/ — Sherpa, a clinical packaging company strategically located in the heart of the San Diego biotech community, demonstrates commitment to its clinical trial materials management business by investing in infrastructure. The new state-of-the-art facility is 37,500 ft2 and offers enhanced capabilities and a strict cold chain management infrastructure. The expansion was needed to support the company’s increased demand for Phase 2 and Phase 3 clinical studies and is a result of continued growth serving new and existing clients.
The new facility offers purpose built space for primary and secondary clinical labeling and packaging, GMP storage for refrigerated (2-8oC), frozen (-20oC, -80oC and LN2), and controlled room temperature (20-25oC), and temperature controlled shipping dispatch. The facility also comprises an ISO 8 clean room for primary packaging of solid dose products. Sherpa now also specializes in cold form and thermoform blistering, blister strip carding, pouching and API storage.
Sherpa was able to successfully move its operations to the new facility without service interruptions. “When they moved to their new facility, we were in the middle of a clinical trial,” David R., of OrthoTrophix reflected, “The transition was seamless and they did not miss a beat. As a small, virtual company, we rely heavily on our contractors to be an extension of our team. Sherpa filled that role beautifully for us as they managed the distribution of our drug to clinical sites.”
“The new Sherpa facility will help sustain the continued growth of our company,” said Mark Paiz, president of Sherpa Clinical Packaging. “We are excited to be able to provide the diversity and quality of services to a large number of clients in all phases of clinical trials. Sherpa’s mission is to be the customer service leader in the clinical trial materials management business and we offer each client the trusting and reliable relationship that people vested in clinical trials seek.”
Sherpa Clinical Packaging is a privately owned provider of clinical trial material management services for clinical studies phases I-IV, including packaging, labeling, distribution and returns/reconciliation, for pharmaceutical, biotechnology, medical device and dietary supplement companies. Sherpa is located in San Diego, California and partners with companies locally and globally. Sherpa distributes clinical supplies to hundreds of sites across the US, Canada and abroad. For more information, visit www.sherpaclinical.com or call (858) 997-1491.
SOURCE Sherpa Clinical Packaging
FDA Accepts For Review Supplemental New Drug Application for XTANDI® (enzalutamide) Capsules in Metastatic Castration-resistant Prostate Cancer with Data from Head-to-Head Studies of Enzalutamide Versus Bicalutamide
TOKYO and SAN FRANCISCO, Feb. 22, 2016 /PRNewswire/ — Astellas Pharma Inc. (TSE: 4503) and Medivation, Inc. (Nasdaq: MDVN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) that they have submitted for XTANDI® (enzalutamide) capsules in metastatic castration-resistant prostate cancer (mCRPC), which includes findings from the Phase 2 TERRAIN and STRIVE studies, to update the relevant clinical sections within the current indication. Enzalutamide is approved by the FDA for the treatment of patients with mCRPC. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is October 22, 2016.
A Type-II variation to update the Summary of Product Characteristics (SmPC) has also been submitted to the European Medicines Agency.
About the TERRAIN trial
The Phase 2 TERRAIN trial enrolled 375 patients in North America and Europe. The trial enrolled patients with metastatic prostate cancer whose disease progressed despite treatment with a luteinizing hormone-releasing hormone (LHRH) analogue therapy or following surgical castration. The primary endpoint of the trial was progression-free survival (PFS), defined as time from randomization to centrally confirmed radiographic progression, skeletal-related event, initiation of new anti-neoplastic therapy or death, whichever occurred first. The trial was designed to evaluate enzalutamide at a dose of 160 mg taken orally once daily versus bicalutamide at a dose of 50 mg taken once daily, the approved dose in combination with an LHRH analogue.
About the STRIVE trial
The Phase 2 STRIVE trial enrolled 396 CRPC patients in the U.S. The trial randomized 257 patients with metastatic prostate cancer and 139 patients with non-metastatic prostate cancer whose disease progressed despite treatment with a LHRH analogue therapy or following surgical castration. The primary endpoint of the trial was PFS, defined as time from randomization to radiographic (bone or soft tissue) progression, prostate-specific antigen (PSA) progression (defined by Prostate Cancer Working Group 2 criteria), or death due to any cause, whichever occurs first. The trial was designed to evaluate enzalutamide at a dose of 160 mg taken once daily (n=198) versus bicalutamide at a dose of 50 mg taken once daily (n=198), the approved dose in combination with a LHRH analogue.
About XTANDI® (enzalutamide) capsules
XTANDI is approved by the U.S. Food and Drug Administration for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC).
Enzalutamide Mechanism of Action
Enzalutamide is an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. In preclinical studies, enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors, and inhibit androgen receptor nuclear translocation and interaction with DNA. The clinical significance of this MOA is unknown.
Important Safety Information
Contraindications XTANDI is not indicated for women and is contraindicated in women who are or may become pregnant. XTANDI can cause fetal harm when administered to a pregnant woman.
Warnings and Precautions
Seizure In Study 1, conducted in patients with metastatic castration-resistant prostate cancer (CRPC) who previously received docetaxel, seizure occurred in 0.9% of XTANDI patients and 0% of placebo patients. In Study 2, conducted in patients with chemotherapy-naive metastatic CRPC, seizure occurred in 0.1% of XTANDI patients and 0.1% of placebo patients. There is no clinical trial experience re- administering XTANDI to patients who experienced a seizure, and limited safety data are available in patients with predisposing factors for seizure. Study 1 excluded the use of concomitant medications that may lower threshold; Study 2 permitted the use of these medications. Because of the risk of seizure associated with XTANDI use, patients should be advised of the risk of engaging in any activity during which sudden loss of consciousness could cause serious harm to themselves or others. Permanently discontinue XTANDI in patients who develop a seizure during treatment.
Posterior Reversible Encephalopathy Syndrome (PRES) In post approval use, there have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES.
Adverse Reactions The most common adverse reactions (≥ 10%) reported from two combined clinical studies that occurred more commonly (≥ 2% over placebo) in XTANDI patients were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo.
In Study 1, Grade 3 and higher adverse reactions were reported among 47% of XTANDI patients and 53% of placebo patients. Discontinuations due to adverse events were reported for 16% of XTANDI patients and 18% of placebo patients. In Study 2, Grade 3-4 adverse reactions were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to adverse events were reported for 6% of both study groups.
- Lab Abnormalities: Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and 6% of placebo patients (0.5% Grade 3-4). Grade 1-4 thrombocytopenia occurred in 6% of XTANDI patients (0.3% Grade 3-4) and 5% of placebo patients (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of XTANDI patients (0.2% Grade 3-4) and 16% of placebo patients (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients (0.1% Grade 3-4) and 2% of placebo patients (no Grade 3-4).
- Infections: In Study 1, 1% of XTANDI patients compared to 0.3% of placebo patients died from infections or sepsis. In Study 2, 1 patient in each treatment group (0.1%) had an infection resulting in death.
- Falls (including fall-related injuries), occurred in 9% of XTANDI patients and 4% of placebo patients. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients, and included non-pathologic fractures, joint injuries, and hematomas.
- Hypertension occurred in 11% of XTANDI patients and 4% of placebo patients. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in < 1% of all patients.
Effect of Other Drugs on XTANDI Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co-administration is necessary, reduce the dose of XTANDI.
Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. If co-administration is necessary, increase the dose of XTANDI.
Effect of XTANDI on Other Drugs Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring.
For Full Prescribing Information for XTANDI (enzalutamide) capsules, please visit http://www.astellas.us/docs/us/12A005-ENZ-WPI.pdf?v=1
You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.fda.gov/medwatch or call 1-800-FDA-1088.
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on Urology, Oncology, Immunology, Nephrology and Neuroscience as prioritized therapeutic areas while advancing new therapeutic areas and discovery research leveraging new technologies/modalities. We are also creating new value by combining internal capabilities and external expertise in the medical/healthcare business. Astellas is on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at www.astellas.com/en.
About Medivation, Inc.
Medivation, Inc. is a biopharmaceutical company focused on the development and commercialization of medically innovative therapies to treat serious diseases for which there are limited treatment options. Medivation aims to transform the treatment of these diseases and offer hope to critically ill patients and their families. For more information, please visit us at http://www.medivation.com
About the Medivation/Astellas Collaboration
In October 2009, Medivation (NASDAQ: MDVN) and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. The companies are collaborating on a comprehensive development program that includes studies to develop enzalutamide across the full spectrum of advanced prostate cancer as well as advanced breast cancer. The companies jointly commercialize XTANDI in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States.
This press release contains forward-looking statements regarding the supplemental New Drug Application (sNDA) for XTANDI® (enzalutamide) capsules, which are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and are subject to risks and uncertainties. Actual results may differ substantially for a number of reasons, including if the data from STRIVE and/or TERRAIN are not incorporated into the prescribing information for XTANDI and other risks detailed in Medivation’s filings with the Securities and Exchange Commission, or SEC, including its quarterly report on Form 10-Q for the quarter ended September 30, 2015, which was filed on November 6, 2015. You are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date of this press release. Medivation disclaims any obligation or undertaking to update, supplement or revise any forward-looking statements contained in this press release.
SOURCE Astellas Pharma Inc.
Tamir Continues To Advance Clinical Progress
SAN DIEGO, Feb. 22, 2016 /PRNewswire/ — Tamir Biotechnology, a clinical stage company developing ranpirnase as a novel broad-spectrum anti-viral, announced results today from a pre-clinical investigational study at the Institute of Antiviral Research at Utah State University. The study evaluated the anti-viral activity of ranpirnase in an established cell model of Zika virus infection. Overall, the study revealed that ranpirnase was active in blocking Zika virus relative to a control. In previous cell based studies, ranpirnase exhibited no cytotoxic effects at therapeutically effective dose levels.
“We are very pleased to see that ranpirnase demonstrated strong antiviral activity against Zika in this established model,” noted Tom Hodge, PhD, Director of Antiviral Research at Tamir. Added Dr. Hodge, “We look forward to rapidly bringing ranpirnase to treat Zika infected patients into clinical phases.”
The clinical work with the Zika virus builds on years of work with other virally-caused pathologies such as Ebola. Results from a recent NIH-sponsored study on the Ebola virus gave 100% survival in ranpirnase-treated animals administered with therapeutic levels of the drug post-infection. The virus was undetectable in the serum of ranpirnase-treated mice at eight days post-infection.
Tamir’s clinical program is led by their phase II investigation of a topical formulation of ranpirnase in the treatment of HPV genital warts. This study is expected to begin enrollment in South America in February 2016. There are an estimated 14 million new and recurrent HPV infections per year in the US alone and the global HPV market is estimated to be over $US2B in 2020. Ranpirnase for injection has been safely administered to over 1,000 subjects in previous oncology clinical trials.
Tamir is a clinical stage anti-viral therapeutics company engaged in the development of a new class of prophylactic and therapeutic drugs for the treatment of viral infections and other virally-caused pathologies. Tamir’s current target is the human papilloma virus (HPV), the worldwide leading cause of genital warts. Tamir is also targeting the acute treatment of the Ebola (EBV), Zika, and Dengue viruses.
SOURCE Tamir Biotechnology
SAN DIEGO, Feb. 22, 2016 /PRNewswire/ — Trovagene, Inc. (NASDAQ: TROV), a developer of cell-free molecular diagnostics, announced today that it has entered into an Agreement with Fortified Provider Network (Fortified), a direct-contracted preferred provider network administering benefits nationally for over 4 million covered lives. Based on the agreement, Trovagene’s Precision Cancer Monitoring® (PCM) services are covered as an in-network participating laboratory provider for members of Fortified’s network, which includes self-funded employer groups, insurance carriers and regional and local provider networks that process end-user patient claims.
“Offering the best solutions to our members for their healthcare needs is a key goal at Fortified,” stated Kristin Martin, director of network operations of Fortified Provider Network. “With the significant advances in molecular genetics, particularly as it relates to the diagnosis and treatment of cancer, we are excited to facilitate health benefit access to Trovagene’s Precision Cancer Monitoring service for patients in our network that are fighting cancer.”
“Becoming a Fortified Provider Network member is an important milestone for Trovagene, as we expand the number of covered lives with health insurance access to our Precision Cancer Monitoring technology,” said Matt Posard, chief commercial officer of Trovagene. “We continue to execute on our strategy to commercialize our novel liquid biopsy platform, and we look forward to playing a significant role in improving the care of Fortified’s cancer patients with our non-invasive tests for the detection and monitoring of medically relevant oncogene mutations.”
About Fortified Provider Network
Based in Scottsdale, Arizona, Fortified Provider Network is a national direct-contracted preferred provider network that administers benefits for approximately 4 million covered lives. Fortified’s goal is for end-user patients to receive excellent care in the location of their choice from high-quality providers at a reasonable cost. Fortified works to ensure that its valued healthcare providers benefit from attractive reimbursement levels, fast reimbursement terms and superior customer service.
About Trovagene, Inc.
Headquartered in San Diego, California, Trovagene is leveraging its proprietary technology for the detection and monitoring of cell-free DNA in urine. The Company’s technology detects and quantitates oncogene mutations in cancer patients for improved disease management. Trovagene’s precision cancer monitoring platform is designed to provide important clinical information beyond the current standard of care, and is protected by significant intellectual property including multiple issued patents and pending patent applications globally.
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, substantial competition; our need for additional financing; uncertainties of patent protection and litigation; 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; uncertainties of government or fourth party payer reimbursement; limited sales and marketing efforts and dependence upon fourth parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that any of our technologies or products will be utilized by physicians or other service providers or that our strategy to commercialize our novel liquid biopsy platform will prove to be commercially successful. Trovagene does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in Trovagene’s Form 10-K for the year ended December 31, 2014 and other periodic reports filed with the Securities and Exchange Commission.
David Moskowitz and Amy Caterina
Canale Communications, Inc.
SOURCE Trovagene, Inc.
Mast Therapeutics Completes Patient Enrollment In Pivotal Phase 3 “EPIC” Study For The Treatment Of Sickle Cell Crisis
Company anticipates top-line data in Q2 2016
SAN DIEGO, Feb. 22, 2016 /PRNewswire/ — Mast Therapeutics, Inc. (NYSE MKT: MSTX), a biopharmaceutical company developing novel, clinical-stage therapies for sickle cell disease and heart failure today announced that it has completed patient enrollment in its Phase 3 clinical study of vepoloxamer for the treatment of patients with sickle cell disease experiencing vaso-occlusive crisis, known as the EPIC study. Consistent with prior guidance, the Company expects to report top-line results in the second quarter of 2016.
The EPIC study was conducted under the direction of Principal Investigator James F. Casella, M.D., Rainey Professor and Chief, Division of Pediatric Hematology, Vice Chair for Research, Pediatrics and Director of the Basic and Translational Research Program in Sickle Cell Disease, Comprehensive Sickle Cell Center at Johns Hopkins University School of Medicine.
“The full enrollment of EPIC is an important achievement in the history of sickle cell disease clinical development, as it represents the largest placebo-controlled clinical trial conducted to date for our patients with this disease,” stated Mark T. Gladwin, M.D., Jack D. Myers Professor and Chair, Chairman of the Department of Medicine, Director, Pittsburgh Heart, Lung, Blood and Vascular Medicine Institute, UPMC and the University of Pittsburgh School of Medicine, and member of the Executive Steering Committee for EPIC. “Interventional treatment of acute painful crisis represents an important unmet medical need, and has remained elusive to large, multicenter randomized trials necessary to support registration of a new drug. EPIC has set a new standard for the field, and the learnings from this study will have an important impact on the design of future studies. The patients and their families, our committed clinical investigators, and Mast Therapeutics should be applauded for this important achievement.”
“As physicians, we are frustrated by our inability to offer patients a disease-modifying treatment for an ongoing crisis,” stated Gregory J. Kato, M.D., Professor of Medicine, Division of Hematology/Oncology, Director, Sickle Cell Center of Excellence, UPMC and the University of Pittsburgh School of Medicine, and member of the Executive Steering Committee for EPIC. “This is a challenging condition for which multiple underlying pathologies may need to be addressed simultaneously to achieve clinical outcomes. In non-clinical studies, vepoloxamer has demonstrated multiple activities that may improve the complex pathologies occurring during sickle cell crisis. We are anxious to review the data from the trial, once unblinded, to determine how vepoloxamer’s pharmacodynamic activity translates to clinical benefit for sickle cell patients.”
“We are proud to have completed enrollment in the EPIC study,” stated Brian M. Culley, Chief Executive Officer. “We wish to express our deep gratitude to the courageous patients and their family members and the committed investigators and study coordinators around the globe who have helped us achieve this goal.”
“Following the last patient’s discharge from the hospital and 30-day safety observation period, there will be an extensive and rigorous review of the blinded data for quality control, ultimately leading to database lock. Study unblinding then will be performed by the study biostatistician. After the biostatistician’s work is complete, Mast will learn the top-line outcome of the study from the biostatistician and will be able to report top-line results to the public,” continued Mr. Culley.
About the EPIC Study
The EPIC study is a randomized, double-blind, two-arm, placebo-controlled, Phase 3 clinical trial of vepoloxamer in patients with sickle cell disease hospitalized for treatment of vaso-occlusive crisis. The primary objective of the study is to demonstrate that vepoloxamer reduces the duration of vaso-occlusive crisis, with the duration of crisis measured from the time a patient is randomized to the time at which the patient receives the last dose of parenteral opioid analgesic for the treatment of vaso-occlusive crisis prior to hospital discharge. A total of 388 patients, ages four to 46 were enrolled in EPIC. Secondary efficacy endpoints are to compare the rates of re-hospitalization for vaso-occlusive crisis within 14 days of initial hospital discharge and the occurrence of acute chest syndrome within 120 hours of randomization between the treatment and control groups.
About Sickle Cell Disease and Vaso-Occlusive Crisis
Sickle cell disease is a chronic, genetic blood disorder that affects millions worldwide and an estimated 90,000 to 100,000 people in the United States, where it is classified as a rare, or orphan, disease. The hallmark of sickle cell disease is recurring episodes of severe, debilitating pain commonly known as sickle cell crisis or vaso-occlusive crisis. The intense pain experienced by patients is the result of obstruction of blood vessels by “sickled” red blood cells, which are rigid and highly adherent to the vessel walls and to each other. This obstruction leads to reduced blood flow to organs, including the bone marrow, not only causing severe pain, but also cumulative tissue damage and, ultimately, loss of vital organ function and significantly reduced lifespan. There are between 80,000 to 100,000 hospitalizations annually in the U.S. related to vaso-occlusive crisis and no approved treatment option to shorten the duration or reduce the severity of a crisis once underway.
About Mast Therapeutics
Mast Therapeutics, Inc. is a publicly traded biopharmaceutical company headquartered in San Diego, California. The Company is leveraging its MAST (Molecular Adhesion and Sealant Technology) platform, derived from over two decades of clinical, nonclinical and manufacturing experience with purified and non-purified poloxamers, to develop vepoloxamer (also known as MST-188), its lead product candidate, for serious or life-threatening diseases and conditions typically characterized by impaired microvascular blood flow and damaged cell membranes. The Company is also developing AIR001, a sodium nitrite solution for inhalation via nebulization, for the treatment of heart failure with preserved ejection fraction (HFpEF).
Vepoloxamer is an investigational new drug being evaluated in a pivotal Phase 3 study called EPIC for the treatment of vaso-occlusive crisis in patients with sickle cell disease and in a Phase 2 study for the treatment of patients with chronic heart failure. AIR001 is in Phase 2 clinical development for the treatment of patients with HFpEF. More information can be found on the Company’s web site at www.masttherapeutics.com. (Twitter: @MastThera)
Mast Therapeutics™ and the corporate logo are trademarks of Mast Therapeutics, Inc.
Forward Looking Statements
Mast Therapeutics cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are based on the Company’s current expectations and assumptions. Such forward-looking statements may be identified by the use of forward-looking words such as “intend,” “plan,” “anticipate,” “believe,” “expect,” among others, and include, but are not limited to, statements relating to prospects for successful development and commercialization of the Company’s product candidates, including vepoloxamer for the treatment of vaso-occlusive crisis of sickle cell disease, and anticipated timing of achievement of development milestones, such as completion of clinical studies and announcement of study data. There are a number of factors that could cause or contribute to material differences between actual events or results and the expectations indicated by the forward-looking statements. These factors include, but are not limited to: the inherent uncertainty of outcomes in ongoing and future studies of the Company’s product candidates and the risk that its product candidates may not demonstrate adequate safety, efficacy or tolerability in one or more such studies, including vepoloxamer in EPIC; delays in the commencement or completion of clinical studies, including as a result of difficulties in obtaining regulatory agency agreement on clinical development plans or clinical study design, opening trial sites, enrolling study subjects, manufacturing sufficient quantities of clinical trial material, being subject to a “clinical hold,” and/or suspension or termination of a clinical study, including due to patient safety concerns or lack of funding; delays in clinical study closeouts, including blinded data review and quality control and assurance procedures; the risk that, even if current and planned clinical studies are successful, the FDA or other regulatory agencies may determine they are not sufficient to support a new drug application; the potential that, even if clinical studies of a product candidate in one indication are successful, clinical studies in another indication may not be successful; the Company’s dependence on third parties to assist with important aspects of development of its product candidates, including conduct of its clinical studies and supply and manufacture of clinical trial material, and, if approved, commercial product, and the risk that such third parties may fail to perform as expected, leading to delays in product candidate development or approval or inability to meet market demand for approved products, if any; the risk that the Company may be required to repay its outstanding debt obligations on an accelerated basis and/or at a time that could be detrimental to its financial condition, operations and/or business strategy; risks associated with the Company’s ability to manage operating expenses and/or obtain additional funding to support its operations on a timely basis or on acceptable terms, or at all; the potential for the Company to delay, reduce or discontinue current and/or planned development activities, including clinical studies, or partner its product candidates at inopportune times if it is unable to raise sufficient additional capital as needed; the risk that, even if the Company successfully develops a product candidate in one or more indications, it may not realize commercial success and may never achieve profitability; the risk that the Company is not able to obtain and maintain effective patent coverage or other market exclusivity protections for its products, if approved, without infringing the proprietary rights of others; and other risks and uncertainties more fully described in the Company’s press releases and periodic filings with the Securities and Exchange Commission. The Company’s public filings with the Securities and Exchange Commission are available at www.sec.gov.
You are cautioned not to place undue reliance on forward-looking statements, which speak only as of the date when made. Mast Therapeutics does not intend to revise or update any forward-looking statement set forth in this press release to reflect events or circumstances arising after the date hereof, except as may be required by law.
SOURCE Mast Therapeutics, Inc.
SAN DIEGO, Feb. 19, 2016 /PRNewswire/ — OncoSec Medical Incorporated (“OncoSec”) (NASDAQ: ONCS), a company developing DNA-based intratumoral cancer immunotherapies, today announced that Chief Executive Officer Punit Dhillon received the honor of being named “2016 Most Admired CEO” by the San Diego Business Journal in the Small Public Company category.
Mr. Dhillon, who co-founded OncoSec in 2011, was recognized for his leadership and contributions to the Company’s growth, achievements, and innovation in the field of cancer immunotherapy. Over the past year, OncoSec has developed a state-of-the-art technology platform, fostered an employee culture aligned with the Company’s values, and focused its clinical pipeline to address one of the greatest challenges in oncology today. OncoSec also fulfilled a key corporate development goal by listing its common stock on The NASDAQ Stock Market LLC.
“It’s an honor for OncoSec to be recognized by the San Diego Business Journal and alongside several distinguished leaders who are making a meaningful impact in our city,” said Mr. Dhillon. “I’m pleased to represent OncoSec on behalf of our entire team and thank our dedicated employees, investors, and fellow associates who have supported the Company’s mission to deliver safer and more effective treatments for patients in the fight against cancer.”
The San Diego Business Journal’s 2016 Most Admired CEO Awards recognizes local industry leaders’ achievements within their companies and in the community. The winners and finalists are lauded for demonstrating determination and insight yielding successes for their organizations. Nominees were judged in the categories of nonprofit organization, business nonprofit, education, family-owned business, government agency, privately held company, and public company.
About OncoSec Medical Incorporated
OncoSec is a biotechnology company developing DNA-based intratumoral immunotherapies with an investigational technology, ImmunoPulse™, for the treatment of cancer. ImmunoPulse™ is designed to enhance the local delivery and uptake of DNA-based immune-targeting agents, such as IL-12. In Phase I and II clinical trials, ImmunoPulse™ IL-12 has demonstrated a favorable safety profile and evidence of anti-tumor activity in the treatment of various skin cancers as well as the potential to initiate a systemic immune response. OncoSec’s lead program, ImmunoPulse™ IL-12, is currently in Phase II development for several indications, including metastatic melanoma, squamous cell carcinoma of the head and neck, and triple-negative breast cancer. In addition to ImmunoPulse™ IL-12, the Company is also identifying and developing new immune-targeting agents for use with the ImmunoPulse™ platform. For more information, please visit www.oncosec.com.
OncoSec Medical Incorporated
SOURCE OncoSec Medical Incorporated
Orexigen Therapeutics to Provide Business Update and Discuss Fourth Quarter and Full Year 2015 Financial Results on February 26, 2016
SAN DIEGO, Feb. 19, 2016 /PRNewswire/ — Orexigen Therapeutics, Inc. (Nasdaq: OREX) will announce corporate and financial results for the fourth quarter and full year 2015 on Friday, February 26 before the market opens. Following the announcement, …
SAN DIEGO, Feb. 19, 2016 /PRNewswire/ — eFFECTOR Therapeutics, Inc., a biopharmaceutical company developing selective translation regulators for the treatment of cancer, today announced it has increased its Series B financing to a total of $56M. The new funding came from Sectoral Asset Management, a new investor in the syndicate, as well as existing investors. In conjunction with the increase, eFFECTOR has appointed Maha Katabi, Ph.D., CFA, partner, private equity at Sectoral Asset Management, to its board of directors. These developments further position eFFECTOR to pursue comprehensive clinical development of its lead product candidate, eFT508, a potent, highly selective, and orally bioavailable MNK1 and MNK2 inhibitor, across multiple tumor types. The funds will also be used to advance the company’s discovery pipeline addressing additional targets.
eFT508 is currently being evaluated in an open-label Phase 1/2 trial in patients with advanced solid tumors. The company expects to file a second IND for eFT508 in lymphoma in the first half of 2016 and open expansion arms in specific solid tumors as well as lymphoma. The company also plans to declare its second development candidate later this year.
“Cancer has proven to be a very difficult disease,” said Steve Worland, Ph.D., president and CEO of eFFECTOR. “If we are going to bring more effective therapy to patients, we need to think strategically about new approaches to treatment. Translation regulation targets such as MNK1 and MNK2, which simultaneously regulate multiple cancer-driving and immune-signaling pathways, are an ideal way to pursue this need. With this financial backing, eFFECTOR can make significant progress developing eFT508 and the remainder of our pipeline.”
Added Dr. Katabi, “Sectoral selects investments in healthcare companies developing products that can make a meaningful impact on the patients and healthcare systems they serve. Translation control is one of the most intriguing fields of research in oncology. We are very pleased to work with the experienced team of eFFECTOR to make eFT508 the first pharmacological treatment to affect the gene translation machinery, and develop a drug useful to patients with different types of cancer.”
About eFFECTOR Therapeutics
eFFECTOR Therapeutics is pioneering the discovery and development of selective translation regulators as a new class of small molecule therapeutics for cancer. The company’s investigational compounds are designed to restore translational control to halt underlying disease mechanisms while preserving healthy physiological processes. eFFECTOR’s lead drug candidate, eFT508, is a highly selective MNK1 and MNK2 inhibitor. MNK1 and 2 are kinases that act as signal integrators at the convergence of multiple oncogenic and immune signaling pathways to regulate production of disease-driving proteins. The company has additional translation regulation programs currently in discovery. eFFECTOR has raised $111M in financing from top-tier private and corporate venture funds. For more information visit www.effector.com
Heidi Chokeir, Ph.D.
SOURCE eFFECTOR Therapeutics
Veracyte Announces Publication of Study Reinforcing the Clinical Utility of the Afirma® Gene Expression Classifier in Thyroid Cancer Diagnosis
SOUTH SAN FRANCISCO, Calif., Feb. 19, 2016 /PRNewswire/ — Veracyte, Inc. (NASDAQ: VCYT), a molecular diagnostics company pioneering the field of molecular cytology, announced that an independent clinical utility study reinforcing the ability of the Afirma Gene Expression Classifier (GEC) to significantly reduce unnecessary surgeries in thyroid cancer diagnosis was published in the February issue of
Researchers from the David Geffen School of Medicine at the University of California at Los Angeles evaluated all thyroid nodule fine needle aspirations (FNAs) performed during a 20-month period following introduction of the Afirma GEC at the institution to determine its impact on clinical practice. The genomic test is used when patients’ thyroid nodule FNA results are deemed inconclusive by traditional cytopathology and helps identify patients whose thyroid nodules are actually benign – and who can thus safely avoid unnecessary diagnostic surgery.
Among 174 patients with indeterminate cytopathology results during the study period, the Afirma GEC identified 80 as benign (46 percent) and, of the five patients with benign Afirma GEC results who underwent surgery, all five nodules proved to be benign based on the histopathology findings. Additionally, in the two primary categories of indeterminate results (“AUS-FLUS” and “SFN-FN”), use of the Afirma GEC reduced overall surgeries – among all patients tested, regardless of test results – from 49 percent to 33 percent and from 63 percent to 50 percent, respectively. Similarly, use of the genomic test increased the overall rate of cancer found when surgery was performed, from 35 percent to 47 percent for AUS-FLUS and from 33 percent to 50 percent for SFN-FN cases, respectively.
In the paper, the authors conclude, “Finally, the question remains whether Afirma GEC testing has refined the indeterminate thyroid category in cytology. The answer in our opinion is a qualified ‘yes’ because it excludes approximately 40 percent to 50 percent of the benign cases from surgery and results in a relatively higher percentage of malignant lesions in the surgical outcome.”
“These findings further reinforce the role of the Afirma GEC as a new standard of care in thyroid cancer diagnosis, where it has helped tens of thousands of patients across the country avoid unnecessary thyroid surgery, and the morbidity and anxiety that can accompany such surgery, while also reducing healthcare costs,” said Bonnie Anderson, president and chief executive officer of Veracyte.
According to the American Cancer Society, thyroid cancer is the fastest-increasing cancer in the United States, with more than 64,000 new cases expected in 2016. Among the approximately 525,000 fine-needle aspirations performed on patients with thyroid nodules each year in the United States, 15-30 percent of the results are inconclusive in ruling out cancer, and most physicians have traditionally recommended thyroid surgery for final diagnosis. Following surgery, however, 70-80 percent of these patients’ nodules are diagnosed as benign.
Veracyte’s Afirma Thyroid FNA Analysis is a comprehensive solution for improved thyroid nodule assessment. It centers on the Afirma Gene Expression Classifier, a 142-gene molecular test that identifies benign thyroid nodules among those deemed indeterminate by cytopathology, enabling these patients to potentially avoid an unnecessary surgery. An additional 25 genes are used to differentiate uncommon neoplasm subtypes. The company’s Afirma Malignancy Classifiers – comprising tests for medullary thyroid cancer and BRAF gene mutation status – are designed to inform surgical strategy for those patients headed to surgery based on their cytopathology or Afirma GEC results.
Veracyte (NASDAQ: VCYT) is pioneering the field of molecular cytology, offering genomic solutions that resolve diagnostic ambiguity and enable physicians to make more informed treatment decisions at an early stage in patient care. By improving preoperative diagnostic accuracy, the company aims to help patients avoid unnecessary invasive procedures while reducing healthcare costs. Veracyte’s Afirma Thyroid FNA Analysis centers on the proprietary Afirma Gene Expression Classifier and is becoming a new standard of care in thyroid nodule assessment. The Afirma test is recommended in leading practice guidelines and is covered for nearly 175 million lives in the United States, including through Medicare and many commercial insurance plans. Veracyte is expanding its molecular cytology franchise to other clinical areas, beginning with difficult-to-diagnose lung diseases. In April 2015, the company launched the Percepta
® Bronchial Genomic Classifier, a test to evaluate patients with lung nodules that are suspicious for cancer. Veracyte is developing a second product in pulmonology, targeting interstitial lung diseases, including idiopathic pulmonary fibrosis. For more information, please visit www.veracyte.com.
Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: “anticipate,” “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 our beliefs regarding the drivers of adoption of Afirma, our expectations with respect to the success of our entry into the pulmonology market, our expectations regarding full-year 2015 guidance and forecast for annual GEC test volume, and the value and potential of our technology and 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. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: our limited operating history and history of losses; our ability to increase usage of and reimbursement for Afirma and to obtain reimbursement for any future products we may develop or sell; our ability to continue our momentum and growth; our dependence on a few payers for a significant portion of our revenue; the complexity, time and expense associated with billing and collecting from payers for our tests; laws and regulations applicable to our business, including potential regulation by the Food and Drug Administration or other regulatory bodies; our dependence on strategic relationships and our ability to successfully convert new accounts resulting from such relationships; our ability to develop and commercialize new products and the timing of commercialization; our ability to successfully achieve adoption of and reimbursement for our Percepta
® Bronchial Genomic Classifier; our ability to achieve sales penetration in complex commercial accounts; the occurrence and outcome of clinical studies; the timing and publication of study results; the applicability of clinical results to actual outcomes; our inclusion in clinical practice guidelines; the continued application of clinical guidelines to our products; our ability to compete; our ability to expand into international markets and achieve adoption of our tests in such markets; our ability to obtain capital when needed; and other risks set forth in the company’s filings with the Securities and Exchange Commission, including the risks set forth in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2015. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims any obligation to update these forward-looking statements.
Veracyte, Afirma, Percepta, the Veracyte logo, and the Afirma logo are trademarks or registered trademarks of Veracyte, Inc.
Pouring rain? Hailstorms? Record-setting heat? Freakin’ gnarly wipeouts on killer waves? Desert blooms stretching for miles? Bald eagles stuck in trees? Yeah, we got those. Welcome to February…
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