ACAD
30.43
+0.34
+1.13%
AEMD
2.06
+0.01
+0.49%
APRI
1.08
-0.02
-1.82%
ARNA
24.05
+0.47
+1.99%
ATEC
1.725
-0.065
-3.631%
CNAT
6.04
0.00
0.00%
CRXM
0.169
0.00
0.00%
CYTX
1.11
-0.01
-0.89%
DXCM
69.52
-0.49
-0.70%
GNMK
12.05
-0.21
-1.71%
HALO
13.53
+0.27
+2.04%
ILMN
172.75
+0.78
+0.45%
INNV
0.116
-0.005
-4.132%
INO
6.01
0.00
0.00%
ISCO
1.23
-0.1
-7.52%
ISIS
57.56
0.00
0.00%
LGND
123.05
+2.36
+1.96%
LPTN
2.93
-2.93
-100.00%
MBVX
0.96
+0.03
+3.23%
MEIP
3.02
-0.05
-1.63%
MNOV
5.43
+0.12
+2.26%
MRTX
4.9
+0.25
+5.38%
MSTX
0.131
-0.007
-5.278%
NBIX
47.07
-0.72
-1.51%
NUVA
79.92
-1.19
-1.47%
ONCS
1.08
-0.04
-3.57%
ONVO
2.37
+0.05
+2.16%
OREX
2.47
-0.13
-5.00%
OTIC
18.9
+0.15
+0.80%
QDEL
37.71
-0.02
-0.05%
RCPT
231.96
0.00
0.00%
RGLS
0.98
+0.1
+11.36%
RMD
77
-1.03
-1.32%
SCIE
0
0.00
-14.2857%
SPHS
2.07
0.00
0.00%
SRNE
2.05
0.00
0.00%
TROV
0.96
-0.03
-3.03%
VICL
2.66
+0.01
+0.37%
VOLC
18
0.00
0.00%
ZGNX
13.4
-0.2
-1.47%
ACAD
30.43
+0.34
+1.13%
AEMD
2.06
+0.01
+0.49%
APRI
1.08
-0.02
-1.82%
ARNA
24.05
+0.47
+1.99%
ATEC
1.725
-0.065
-3.631%
CNAT
6.04
0.00
0.00%
CRXM
0.169
0.00
0.00%
CYTX
1.11
-0.01
-0.89%
DXCM
69.52
-0.49
-0.70%
GNMK
12.05
-0.21
-1.71%
HALO
13.53
+0.27
+2.04%
ILMN
172.75
+0.78
+0.45%
INNV
0.116
-0.005
-4.132%
INO
6.01
0.00
0.00%
ISCO
1.23
-0.1
-7.52%
ISIS
57.56
0.00
0.00%
LGND
123.05
+2.36
+1.96%
LPTN
2.93
-2.93
-100.00%
MBVX
0.96
+0.03
+3.23%
MEIP
3.02
-0.05
-1.63%
MNOV
5.43
+0.12
+2.26%
MRTX
4.9
+0.25
+5.38%
MSTX
0.131
-0.007
-5.278%
NBIX
47.07
-0.72
-1.51%
NUVA
79.92
-1.19
-1.47%
ONCS
1.08
-0.04
-3.57%
ONVO
2.37
+0.05
+2.16%
OREX
2.47
-0.13
-5.00%
OTIC
18.9
+0.15
+0.80%
QDEL
37.71
-0.02
-0.05%
RCPT
231.96
0.00
0.00%
RGLS
0.98
+0.1
+11.36%
RMD
77
-1.03
-1.32%
SCIE
0
0.00
-14.2857%
SPHS
2.07
0.00
0.00%
SRNE
2.05
0.00
0.00%
TROV
0.96
-0.03
-3.03%
VICL
2.66
+0.01
+0.37%
VOLC
18
0.00
0.00%
ZGNX
13.4
-0.2
-1.47%
Home » Archive by Category

Syndication

Neuraltus Announces Completion of Enrollment in Confirmatory Phase 2 Study of NP001 in ALS Patients with Systemic Inflammation

July 12, 2017 – 4:00 am

SAN BRUNO, Calif., July 12, 2017 /PRNewswire/ — Neuraltus Pharmaceuticals, Inc., a privately-held biopharmaceutical company dedicated to developing innovative therapeutics for neurodegenerative diseases, announced that it has completed enrollment of 138 patients with amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease) in the confirmatory Phase 2 study (NCT02794857) of NP001. The last patient visit is expected to occur in early 2018, with top line results anticipated in the first quarter of 2018. The Company plans to meet with the U.S. Food and Drug Administration (FDA) after the study results are analyzed to review the complete clinical data set and discuss the regulatory path forward for NP001. 

“Reaching the completion of enrollment in the confirmatory Phase 2 study of NP001 is a significant milestone for ALS patients, clinical investigators, and our team,” said Rich Casey, chief executive officer, Neuraltus Pharmaceuticals. “Over the past 20 years, only two therapeutic agents have been approved to treat patients with ALS, a rare condition with a significant unmet need. We plan to request a meeting with the FDA to review all of the NP001 clinical and pharmacology data and, if the results are positive, discuss the required next steps to advance NP001 toward regulatory filing.”

The confirmatory Phase 2 study is being conducted with the intent of replicating the previous Phase 2 clinical study findings in ALS patients with elevated levels of baseline inflammation. This second Phase 2 study of NP001 is a randomized, double-blind, placebo-controlled, multicenter trial which has enrolled 138 ALS patients with evidence of systemic inflammation at 22 sites across North America.  Patients are receiving either NP001 2mg/kg or placebo over a period of 6 months. The study is designed to evaluate the change from baseline of an individual’s ALS Functional Rating Score Revised (ALSFRS-R) during the study, and generate additional data about NP001’s safety and tolerability. Secondary end points include a change in pulmonary function as measured by vital capacity readings. Further information about the study is available at https://clinicaltrials.gov.

About Amyotrophic Lateral Sclerosis

Amyotrophic lateral sclerosis (ALS, or Lou Gehrig’s disease) is a rare and fatal neurodegenerative disease characterized by degeneration of motor neurons in the spinal cord and brain. The cause of the disease is currently unknown, but there is increasing evidence that implicates neuroinflammation with the progression of the disease. It is believed that in people with ALS, there are increased levels of inflammatory (activated) macrophages, a type of white blood cell, resulting in the release of factors in the central nervous system that damage motor neurons. NP001, a regulator of macrophage activation, exerts its effect by converting these activated inflammatory macrophages back to their normal state. There are approximately 400,000 ALS patients worldwide. 

About Neuraltus Pharmaceuticals, Inc.

Neuraltus Pharmaceuticals, Inc. is a privately-held biopharmaceutical company dedicated to developing and commercializing innovative therapeutics that address critical unmet needs for patients and physicians in the treatment of neurodegenerative diseases. The Company is collaborating with global ALS specialists and seeking input from patient advocacy organizations to help inform the clinical development path and better understand the needs of people affected by the disease.

For more information, please visit www.neuraltus.com.

Contact: Edie DeVine, GCI Health
Office: +1 (209) 814-9564

View original content with multimedia:http://www.prnewswire.com/news-releases/neuraltus-announces-completion-of-enrollment-in-confirmatory-phase-2-study-of-np001-in-als-patients-with-systemic-inflammation-300486740.html

SOURCE Neuraltus Pharmaceuticals, Inc.

Trovagene Announces Agreement with Novogene for NextCollect(TM) in China

July 12, 2017 – 4:00 am

SAN DIEGO, July 12, 2017 /PRNewswire/ — Trovagene, Inc. (NASDAQ: TROV), today announced that they have entered into an agreement with Novogene Co. Ltd., a leading global provider of genomic services and solutions with cutting edge next-generation sequencing (NGS) and the largest sequencing capacity in the world.  Through this agreement, Novogene will purchase NextCollect™, Trovagene’s proprietary urine collection and nucleic acid preservation device for validation in the Chinese market.

Trovagene will sell Novogene the NextCollectTM urine collection and stabilization device, in addition to reagents and methods to extract cell-free DNA (cfDNA) from urine. Novogene plans to validate the urine DNA extraction methods at their facilities, including their lab in Tianjin, China, which is accredited by the College of American Pathologists (CAP).

NextCollectTM is a first of its kind, proprietary urine collection and nucleic acid preservation device for research use only (RUO) by pharmaceutical companies, clinical research organizations and genomics laboratories.  NextCollectTM is designed to preserve urinary DNA in applications such as oncology, infectious disease, urology, and transplantation.  NextCollectTM stabilizes up to 200 ml’s of a urine sample for 2 weeks at room temperature, and can be directly incorporated into laboratory processing without the need for an initial sample transfer.  When coupled with Trovagene’s proprietary nucleic acid isolation methods, NextCollectTM enables a significant advancement in the quality and quantity of DNA isolated from urine.

“We are excited to partner with Novogene, who is now the largest genomics service provider in the world,” said Bill Welch, Chief Executive Officer of Trovagene. “This agreement enables Trovagene to leverage Novogene’s large next-generation sequencing capacity and bioinformatic services in China.”

“We are delighted to work with Trovagene. We look forward to validating their proprietary urine collection, stabilization and cfDNA extraction technology in our laboratories, and to developing innovative urine-based tests for the Chinese market,” said Dr. David Jiang, Senior Vice President of Corporate Development of Novogene.

The first shipments of NextCollectTM are planned for July 2017 to support the Novogene partnership and Trovagene’s biomarker testing services with pharmaceutical companies, including AstraZeneca.

About Novogene

Novogene is a leading provider of genomic services and solutions with cutting edge NGS and bioinformatics expertise and the largest sequencing capacities in the world. Novogene utilizes scientific excellence, a commitment to customer service and unsurpassed data quality to help our clients realize their research goals in the rapidly evolving world of genomics. With 1,300 employees, multiple locations around the world, 49 NGS related patents, and over 240 publications in top tier journal such as Nature and Science, the company has rapidly become a world-leader in NGS services. For more information, please visit https://en.novogene.com.

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

Novogene Contact:
Joyce Peng, Ph.D.
Global Marketing Director
626-222-5584
joyce.peng@novogene.com  

 

View original content with multimedia:http://www.prnewswire.com/news-releases/trovagene-announces-agreement-with-novogene-for-nextcollect-in-china-300486641.html

SOURCE Trovagene, Inc.

E-Scape Bio Series A Extension Brings Total Round to $63 Million to Fund Neurodegenerative Disease Pipeline

July 12, 2017 – 3:30 am

SAN FRANCISCO, July 12, 2017 /PRNewswire/ — E-Scape Bio, a biopharmaceutical company developing therapies to treat neurodegenerative diseases, today announced it has closed an extension of its Series A financing bringing the total amount raised in the round to $63 million. The original investment was led by OrbiMed, with participation from Novo Holding A/S, Johnson & Johnson Innovation – JJDC Inc. (JJDC), Novartis Venture Fund and Osage University Partners. New investors include Lilly Asia Ventures and Sutter Hill Ventures.

E-Scape Bio is developing small-molecule drugs that target the inherited genetic drivers of neurodegenerative disorders and correct the dysfunctional proteins at the root of the disease. The lead program targets the Apolipoprotein E4 (ApoE4) protein structure — a major genetic risk factor for Alzheimer’s disease. Co-founded by Robert Mahley, M.D., Ph.D., and Yadong Huang, M.D., Ph.D., from the Gladstone Institutes, E-Scape Bio is built on their pioneering research to understand the role of Apolipoprotein E (ApoE) in the nervous system, and linking ApoE4—a variant of ApoE—to the pathogenesis of Alzheimer’s disease.

“The ApoE4 allele is not only the strongest genetic risk factor for late-onset Alzheimer’s disease, it is considered a driver of disease in patients with one or more copies of the allele,” said Robert Mahley, M.D., Ph.D., co-founder of E-Scape Bio and president emeritus and senior investigator at the Gladstone Institutes.

Yadong Huang, M.D., Ph.D., co-founder of E-Scape Bio and senior investigator at Gladstone added: “Our work demonstrates that ApoE4 structure is the key to unlocking small molecules capable of targeting the most prominent genetic risk factor for developing Alzheimer’s disease.”

Alzheimer’s disease is the most common form of dementia, affecting approximately 5.5 million Americans, and one in 10 people over the age of 65. According to a report by the Alzheimer’s Association, total annual payments for health care, long-term care and hospice care for people with Alzheimer’s or other dementias are projected to increase from $259 billion in 2017 to more than $1.1 trillion in 2050. The greatest risk factors for late-onset Alzheimer’s are older age, having a family history of Alzheimer’s and carrying the ApoE4 gene. Carrying the ApoE4 gene increases risk of developing disease, is associated with earlier onset of disease progression, and is the strongest prognostic factor for Alzheimer’s.

“Our investors were attracted to our novel technology for targeting the genetic drivers of Alzheimer’s disease and Parkinson’s disease, two diseases that are rapidly growing in prevalence as our population continues to live longer into old age,” said Leon Chen, Ph.D., interim chief executive officer of E-Scape Bio. “We believe we have a solution for these challenging genetic targets that clearly have a role in the progression of these diseases, and will apply our resources to rapidly build our pipeline and advance towards the clinic.”

About E-Scape Bio
E-Scape Bio is a biopharmaceutical company focused on the discovery and development of small-molecule drugs to treat genetically-defined subpopulations in neurodegenerative diseases, including Alzheimer’s disease and Parkinson’s disease. The company’s therapeutic programs are designed to restore normal function disrupted by inherited genetic mutations causing the disease. For additional information, please visit www.e-scapebio.com.

 

View original content:http://www.prnewswire.com/news-releases/e-scape-bio-series-a-extension-brings-total-round-to-63-million-to-fund-neurodegenerative-disease-pipeline-300486605.html

SOURCE E-Scape Bio

Viking Therapeutics Completes Enrollment in Phase 2 Study of VK5211 in Patients Recovering from Hip Fracture

July 12, 2017 – 3:00 am

Top-Line Results Expected in the Fourth Quarter

SAN DIEGO, July 12, 2017 /PRNewswire/ — Viking Therapeutics, Inc. (“Viking”) (NASDAQ: VKTX), a clinical-stage biopharmaceutical company focused on the development of novel therapies for metabolic and endocrine disorders, today announced that enrollment has been completed in the company’s ongoing Phase 2 clinical trial of VK5211 in patients who recently suffered a hip fracture.  VK5211, the company’s lead program for muscle and bone disorders, is an orally available, non-steroidal selective androgen receptor modulator (SARM) designed to selectively stimulate muscle and bone formation with reduced activity in peripheral tissues such as skin and prostate.  The company believes these characteristics may provide important benefits to patients recovering from hip fracture. 

The Phase 2 clinical trial is a randomized, double-blind, placebo-controlled, parallel group study designed to evaluate the efficacy, safety and tolerability of VK5211 in patients recovering from hip fracture surgery.  A total of 108 patients have been randomized to receive once-daily VK5211 doses of 0.5 mg, 1.0 mg, 2.0 mg, or placebo for 12 weeks.  The study’s primary endpoint will evaluate the effects of VK5211 on lean body mass after 12 weeks of treatment.  Secondary and exploratory objectives include assessments of functional performance, quality-of-life, and activities of daily living, as well as safety, tolerability and pharmacokinetics.  Viking expects to announce results from this trial in the fourth quarter.

“We are excited to have reached this important milestone with our VK5211 program and look forward to reporting top-line data later this year,” said Brian Lian, Ph.D., chief executive officer of Viking.  “Prior results from studies evaluating VK5211 in animals and humans have demonstrated promising anabolic effects on bone and muscle mass.  These characteristics highlight the potential benefits VK5211 may provide in patients recovering from hip fracture, an injury that results in more than 300,000 hospitalizations in the U.S. each year.  Following the fracture, patients are prone to accelerated losses of bone and muscle, resulting in prolonged disability, morbidity, and risk of mortality.  We believe VK5211’s potent anabolic effects on bone and muscle have the potential to address many of the key unmet needs of these individuals.” 

About VK5211
VK5211 is an orally available, non-steroidal selective androgen receptor modulator (SARM) in Phase 2 development for the treatment of patients recovering from non-elective hip fracture surgery.  VK5211 belongs to a family of novel orally available, non-steroidal SARM compounds based on tissue-specific gene expression and other functional, cell-based technologies.  Viking believes that VK5211 has the potential to produce the therapeutic benefits of testosterone with improved safety, tolerability and patient acceptance due to a tissue-selective mechanism of action and an oral route of administration.  In Phase 1 clinical trials, VK5211 demonstrated statistically significant increases in lean body mass among treated subjects following 21 days of treatment.  In a pre-clinical model of osteoporosis, VK5211 demonstrated improvements in bone mineral density, bone mineral content, bone strength, and other measures.

About Viking Therapeutics, Inc.
Viking Therapeutics, Inc. is a clinical-stage biopharmaceutical company focused on the development of novel, first-in-class or best-in-class therapies for metabolic and endocrine disorders.  The company’s research and development activities leverage its expertise in metabolism to develop innovative therapeutics designed to improve patients’ lives.  Viking has exclusive worldwide rights to a portfolio of five therapeutic programs in clinical trials or preclinical studies, which are based on small molecules licensed from Ligand Pharmaceuticals Incorporated.  The company’s clinical programs include VK5211, an orally available, non-steroidal selective androgen receptor modulator, or SARM, in Phase 2 development for the treatment and prevention of lean body mass loss in patients who have undergone hip fracture surgery, VK2809, a small molecule thyroid beta agonist in Phase 2 development for hypercholesterolemia and fatty liver disease, and VK0612, a first-in-class, orally available drug candidate in Phase 2 development for type 2 diabetes.  Viking is also developing novel and selective agonists of the thyroid beta receptor for GSD Ia and X-linked adrenoleukodystrophy, as well as two earlier-stage programs targeting metabolic diseases and anemia.

Follow Viking on Twitter @Viking_VKTX.

Forward-Looking Statements
This press release contains forward-looking statements regarding Viking Therapeutics, including statements about Viking’s expectations regarding its development activities, timelines and milestones, as well as the company’s goals and plans regarding VK5211 and VK5211’s prospects. Forward-looking statements are subject to risks and uncertainties that 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: risks associated with the success, cost and timing of Viking’s product candidate development activities and clinical trials, including those for VK5211 and VK2809; risks that prior clinical and pre-clinical results may not be replicated; and risks regarding regulatory requirements, among others. These forward-looking statements speak only as of the date hereof.  Viking disclaims any obligation to update these forward-looking statements.

 

View original content:http://www.prnewswire.com/news-releases/viking-therapeutics-completes-enrollment-in-phase-2-study-of-vk5211-in-patients-recovering-from-hip-fracture-300486755.html

SOURCE Viking Therapeutics, Inc.

Asterias Biotherapeutics Completes Enrollment and Dosing of SCiStar Study’s AIS-B 10 Million Cell Cohort

July 12, 2017 – 3:00 am

First enrolled cohort comprised of patients with motor complete, sensory incomplete paralysis

FREMONT, Calif., July 12, 2017 /PRNewswire/ — Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company pioneering the field of regenerative medicine, today announced completion of enrollment and dosing of the AIS-B 10 million cell cohort in the company’s ongoing SCiStar Phase 1/2a clinical study of AST-OPC1 in complete cervical spinal cord injury (SCI). In this cohort, five patients with AIS-B grade SCIs were administered 10 million AST-OPC1 cells. The company expects to report top-line six-month results from this cohort in January 2018.

“Completing enrollment and dosing of the first cohort of AIS-B patients marks another important milestone for our AST-OPC1 program,” said Dr. Edward Wirth, Chief Medical Officer of Asterias. “AIS-B patients have some levels of sensation following their injury but like AIS-A patients have severe spinal cord injuries and no meaningful motor function below the injury site. We have already reported meaningful improvements in arm, hand and finger function for AIS-A patients dosed with 10 million AST-OPC1 cells and we are looking forward to reporting initial efficacy and safety data for this cohort early in 2018.”

The SCiStar study has now completed enrollment and dosing in three of the five planned cohorts. The first completed cohort included three AIS-A patients who were administered a low dose of 2 million AST-OPC1 cells for the purpose of evaluating the safety of administering AST-OPC1 in the cervical spinal cord. The second completed cohort (Cohort 2) included six AIS-A patients who were administered 10 million AST-OPC1 cells, which is the first cohort dosed within the predicted efficacy dose range of 10 million to 20 million cells.  In June 2017, Asterias reported 9 month data from Cohort 2 that showed improvements in arm, hand and finger function observed at 3-months and 6-months following administration of AST-OPC1 were confirmed and in some patients further increased at 9-months. Asterias will report 12-month efficacy and safety data from Cohort 2 later this year after the 12-month results are collected for the entire cohort.

The company is currently enrolling AIS-A patients dosed with the highest dose of 20 million cells, and the study’s final cohort of AIS-B patients receiving 20 million AST-OPC1 cells is planned to begin enrollment later this quarter.  The company intends to complete enrollment of the entire SCiStar study later this year, with multiple safety and efficacy readouts anticipated during 2017 and 2018.

On July 10, 2017, Asterias announced that the U.S. Food and Drug Administration accepted the company’s amendment to the clinical research protocol for the SCiStar study. The amendment expands the eligibility criteria to include patients with a C-4 spinal cord injury and extends the dosing window from 14 to 30 days to 21 to 42 days post-injury.

About the SCiStar Trial

The SCiStar trial is an open-label, single-arm trial testing three sequential escalating doses of AST-OPC1 administered at up to 20 million AST-OPC1 cells in as many as 35 patients with subacute, C-4 to C-7, motor complete (AIS-A or AIS-B) cervical SCI. These individuals have essentially lost all movement below their injury site and experience severe paralysis of the upper and lower limbs. AIS-A patients have lost all motor and sensory function below their injury site, while AIS-B patients have lost all motor function but may have retained some minimal sensory function below their injury site. AST-OPC1 is being administered 21 to 42 days post-injury. Patients will be followed by neurological exams and imaging procedures to assess the safety and activity of the product.

The study is being conducted at six centers in the U.S. and the company plans to increase this to up to 12 sites to accommodate the expanded patient enrollment. Clinical sites involved in the study include the Medical College of Wisconsin in Milwaukee, Shepherd Medical Center in Atlanta, University of Southern California (USC) jointly with Rancho Los Amigos National Rehabilitation Center in Los Angeles, Indiana University, Rush University Medical Center in Chicago and Santa Clara Valley Medical Center in San Jose jointly with Stanford University.

Asterias has received a Strategic Partnerships Award grant from the California Institute for Regenerative Medicine, which provides $14.3 million of non-dilutive funding for the Phase 1/2a clinical trial and other product development activities for AST-OPC1.

Additional information on the Phase 1/2a trial, including trial sites, can be found at www.clinicaltrials.gov, using Identifier NCT02302157, and at the SCiStar Study Website (www.SCiStar-study.com).

About AST-OPC1

AST-OPC1, an oligodendrocyte progenitor population derived from human embryonic stem cells originally isolated in 1998, has been shown in animals and in vitro to have three potentially reparative functions that address the complex pathologies observed at the injury site of a spinal cord injury. These activities of AST-OPC1 include production of neurotrophic factors, stimulation of vascularization, and induction of remyelination of denuded axons, all of which are critical for survival, regrowth and conduction of nerve impulses through axons at the injury site. In preclinical animal testing, AST-OPC1 administration led to remyelination of axons, improved hindlimb and forelimb locomotor function, dramatic reductions in injury-related cavitation and significant preservation of myelinated axons traversing the injury site.

In a previous Phase 1 clinical trial, five patients with neurologically complete, thoracic spinal cord injury were administered two million AST-OPC1 cells at the spinal cord injury site 7-14 days post-injury. Based on the results of this study, Asterias received clearance from FDA to progress testing of AST-OPC1 to patients with cervical spine injuries in the current SCiStar study, which represents the first targeted population for registration trials.  Asterias has completed enrollment in the first three cohorts of this study. Results to date have continued to support the safety of AST-OPC1, with no serious adverse events related to AST-OPC1 or its administration.  Additionally, Asterias has recently reported results suggesting reduced cavitation and improved motor function in patients administered AST-OPC1 in the SCiStar trial.

About Asterias Biotherapeutics

Asterias Biotherapeutics, Inc. is a biotechnology company pioneering the field of regenerative medicine. The company’s proprietary cell therapy programs are based on its pluripotent stem cell and immunotherapy platform technologies. Asterias is presently focused on advancing three clinical-stage programs which have the potential to address areas of very high unmet medical need in the fields of neurology and oncology. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. AST-VAC1 (antigen-presenting autologous dendritic cells) is undergoing continuing development by Asterias based on promising efficacy and safety data from a Phase 2 study in Acute Myeloid Leukemia (AML), with current efforts focused on streamlining and modernizing the manufacturing process. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic cancer immunotherapy. The company’s research partner, Cancer Research UK, plans to begin a Phase 1/2a clinical trial of AST-VAC2 in non-small cell lung cancer in 2017. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.    

FORWARD-LOOKING STATEMENTS

Statements pertaining to future financial and/or operating and/or clinical research results, future growth in research, technology, clinical development, and potential opportunities for Asterias, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the businesses of Asterias, particularly those mentioned in the cautionary statements found in Asterias’ filings with the Securities and Exchange Commission. Asterias disclaims any intent or obligation to update these forward-looking statements.

 

View original content:http://www.prnewswire.com/news-releases/asterias-biotherapeutics-completes-enrollment-and-dosing-of-scistar-studys-ais-b-10-million-cell-cohort-300486753.html

SOURCE Asterias Biotherapeutics, Inc.

Associate Director / Director, Medical Writing – Ignyta – San Diego, CA

July 11, 2017 – 7:59 pm

5+ years or more of direct biotechnology or pharmaceutical industry experience as a medical writer with specific experience in writing major sections of NDAs…From Ignyta – Wed, 12 Jul 2017 03:59:36 GMT – View all San Diego, CA jobs

TEMP – Facilities & Electrical Technician (2017-23) – Pfenex Inc. – San Diego, CA

July 11, 2017 – 5:38 pm

Ability to digest complex data/information easily and communicates data back in a logical, effective and actionable manner….From Pfenex Inc. – Wed, 12 Jul 2017 01:38:39 GMT – View all San Diego, CA jobs

Research Analyst (UTC)

July 11, 2017 – 4:19 pm

Research Analyst, Meddevicetracker – Informa | Pharma Intelligence, San Diego, CA Informa Pharma Intelligence is seeking a Research Analyst to join its San Diego Meddevicetracker team. Informa’s Pharma Intelligence is the trusted partner of all of th […

Mechanical Design Engineer

July 11, 2017 – 12:05 pm

Senior Mechanical Design Engineer Pay: 40-46/hr.DOE Schedule: 1 st shift Location: San Diego, CA Duration: 3-6 Month assignment Job Summary : The Senior Mechanical DesignEngineer role contributes to the design and development of hardware for rapidin vit

Arena Pharmaceuticals Announces Proposed Public Offering of Common Stock

July 11, 2017 – 12:05 pm

SAN DIEGO, July 11, 2017 /PRNewswire/ — Arena Pharmaceuticals, Inc. (NASDAQ: ARNA) today announced that it intends to offer and sell, subject to market and other conditions, $150.0 million of shares of its common stock in an underwritten public offering.  Arena expects to grant the underwriters an option to purchase up to an additional $22.5 million of shares of its common stock at the public offering price, less the underwriting discounts and commissions.  All of the shares are being offered by Arena. There can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

Citigroup, Leerink Partners, Cantor Fitzgerald & Co. and UBS Investment Bank are acting as joint book-running managers for the offering.  JMP Securities is acting as a co-manager for the offering.

The shares of common stock described above are being offered by Arena pursuant to a shelf registration statement filed by Arena with the Securities and Exchange Commission (SEC) that became automatically effective on July 11, 2017.  A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at http://www.sec.gov.  Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; or from Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, or by telephone at (800) 808-7525 ext. 6132, or by email at syndicate@leerink.com; or from Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 6th Floor, New York, New York 10022, or by telephone at (212) 829-7122, or by email at prospectus@cantor.com; or from UBS Securities LLC, Attention: Prospectus Department, 1285 Avenue of the Americas, New York, NY 10019, or by telephone at (888) 827-7275.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Arena Pharmaceuticals

Arena Pharmaceuticals is a biopharmaceutical company focused on developing novel, small molecule drugs with optimized receptor pharmacology designed to deliver broad clinical utility across multiple therapeutic areas.  Our proprietary pipeline includes potentially first- or best-in-class programs for which we own global commercial rights.  Our three most advanced investigational clinical programs are ralinepag (APD811) which has completed Phase 2 evaluation for pulmonary arterial hypertension (PAH), etrasimod (APD334) in Phase 2 evaluation for multiple autoimmune indications including ulcerative colitis (UC), and APD371 in Phase 2 evaluation for the treatment of pain associated with Crohn’s disease.  In addition, Arena has collaborations with the following pharmaceutical companies: Eisai Co., Ltd. and Eisai Inc. (commercial stage), Axovant Sciences (Phase 2 candidate), and Boehringer Ingelheim International GmbH (preclinical candidate).

Forward-Looking Statements

Certain statements in this press release are forward-looking statements that involve a number of risks and uncertainties.  These statements may be identified by introductory words such as “may,” “expects,” “plan,” “believe,” “will,” “achieve,” “anticipate,” “would,” “should,” “subject to” or words of similar meaning, or by the fact that they do not relate strictly to historical or current facts.  Such forward-looking statements include statements regarding Arena’s expectations with respect to its proposed public offering. For such statements, Arena claims the protection of the Private Securities Litigation Reform Act of 1995.  Actual events or results may differ materially from Arena’s expectations.  Factors that could cause actual results to differ materially from the forward-looking statements include, but are not limited to, risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed offering; and those factors disclosed in Arena’s filings with the SEC, including our Form 10-Q for the quarter ended March 31, 2017.  These forward-looking statements represent Arena’s judgment as of the time of this release. Arena disclaims any intent or obligation to update these forward-looking statements, other than as may be required under applicable law.

Corporate Contact:
Kevin R. Lind
Arena Pharmaceuticals, Inc.
Executive Vice President and
Chief Financial Officer 
klind@arenapharm.com
858.210.3636

Media Contact:
Matt Middleman, M.D.
LifeSci Public Relations
matt.middleman@lifescipublicrelations.com
646.627.8384

 

View original content:http://www.prnewswire.com/news-releases/arena-pharmaceuticals-announces-proposed-public-offering-of-common-stock-300486484.html

SOURCE Arena Pharmaceuticals, Inc.