Gilead Reports Phase 2 Data for Sofosbuvir Plus GS-5816; ArQule Announces Collaboration With NIH For ARQ 092 Print E-mail
By Marilyn Mullen   
Tuesday, 11 November 2014 20:16
Below is a look at some of the headlines for companies that made news in the healthcare sector on November 11, 2014.

Gilead Sciences, Inc. (Nasdaq: GILD) announced data from two Phase 2 studies evaluating investigational all-oral regimens containing the nucleotide analog polymerase inhibitor sofosbuvir (SOF) for the treatment of chronic hepatitis C virus (HCV) infection. These data are being presented this week at the 49th Annual Meeting of the European Association for the Study of the Liver (The International Liver Congress 2014) in London.

The first study, ELECTRON2 (Oral #6), is an ongoing, open-label Phase 2 clinical trial evaluating a once-daily fixed-dose combination of SOF 400 mg and the NS5A inhibitor ledipasvir (LDV) 90 mg, with and without ribavirin (RBV) twice-daily (1,000 or 1,200 mg/day), among HCV-infected patient populations.

In this study, 100 percent (n=26/26) of treatment-naïve genotype 3 patients receiving 12 weeks of LDV/SOF plus RBV and 64 percent (n=16/25) of treatment-naïve genotype 3 patients receiving 12 weeks of LDV/SOF without RBV achieved a sustained virologic response 12 weeks after completing therapy (SVR12). Among genotype 1-infected patients who had failed prior treatment with SOF plus RBV, 100 percent (19/19) achieved SVR12 following 12 weeks of LDV/SOF plus RBV. Additionally, 65 percent (n=13/20) of genotype 1-infected patients with decompensated or Child-Turcotte-Pugh Class B cirrhosis receiving 12 weeks of LDV/SOF without RBV achieved SVR12. LDV/SOF with and without RBV was well-tolerated, including among patients with more advanced liver disease.

“The ELECTRON2 data suggest that an all-oral regimen of LDV/SOF plus RBV has the potential to provide high cure rates for genotype 3 patients in just 12 weeks – half the duration of current all-oral treatment regimens,” said Professor Edward Gane, MD, Deputy Director and Hepatologist, New Zealand Liver Transplant Unit, Auckland City Hospital in New Zealand, and principal investigator of the ELECTRON2 study. “These results also suggest that LDV/SOF may be an effective treatment regimen for HCV genotype 1-infected patients who have failed a previous sofosbuvir-based regimen and those with advanced liver disease, including decompensated cirrhosis.”

A second study, Study GS-US-342-0102 (Oral #111), is an ongoing randomized Phase 2 clinical trial in which treatment-naïve, non-cirrhotic patients with genotypes 1-6 HCV infection received a 12-week course of SOF plus the pan-genotypic NS5A inhibitor GS-5816. Patients received SOF 400 mg and either GS-5816 25 mg (n=77) or GS-5816 100 mg (n=77). In this study, 94.8 percent (n=73/77) of patients receiving the 25 mg dose of GS-5816 and 96.1 percent (n=74/77) of patients receiving the 100 mg dose achieved SVR12.

“The results of this study of sofosbuvir with a new pan-genotype NS5A inhibitor demonstrate the curative potential of this combination,” said Gregory T. Everson, MD, Professor of Medicine and Director, Section of Hepatology, University of Colorado, Denver, and principal investigator of Study GS-US-342-0102. “The combination was not only effective across all genotypes and patient subgroups, but also was well tolerated. These results warrant additional study in future trials, with the hope of providing a potent, pan-genotypic combination with few side effects and a high chance for cure.”

The most common adverse events occurring in more than 10 percent of patients were fatigue, headache and nausea. There were no treatment discontinuations due to adverse events, and no evidence of treatment-related laboratory abnormalities.



ArQule, Inc. (NASDAQ: ARQL) announced an agreement with the National Human Genome Research Institute (NHGRI) of the National Institutes of Health (NIH) providing for the clinical development of ARQ 092, an orally available, selective small molecule inhibitor of AKT, in Proteus syndrome, a rare disease characterized by overgrowth of the skeleton, skin, adipose tissue and central nervous system.

The NIH Proteus syndrome team is led by researchers who originally discovered the somatic single (point) mutation in the AKT 1 oncogene that causes Proteus syndrome1. On that basis, the NIH entered into a collaboration with ArQule focused on pre-clinical testing of ARQ 092. Results from that pre-clinical research recently presented by the NIH team at the 2014 meeting of the American Society of Human Genetics (ASHG, Abstract # 2180M2) demonstrate that treatment with ARQ 092 caused a rapid shutdown of AKT signaling and a reduction in the viability of Proteus syndrome cells taken from patients compared to untreated diseased cells. These findings represent pre-clinical proof-of-concept for advancement of ARQ 092 into clinical testing in this indication.

“This collaboration provides the opportunity to clinically investigate the therapeutic impact of ARQ 092 in a rare, genetic disorder that has no approved therapy and for which the only current treatment is surgery,” said Dr. Leslie G. Biesecker, M.D., Chief of the Medical Genomics and Metabolic Genetics Branch at the National Human Genome Research Institute. “We believe the goal of treatment for Proteus syndrome will be early diagnosis and administration of therapy over years to mitigate the abnormal cell signaling initiated by the point mutation.”

“The need for medical treatment of Proteus syndrome is high,” said Brian Schwartz, M.D., chief medical officer of ArQule. “Characterized by non-cancerous overgrowths of tissue, Proteus syndrome is the first non-oncology rare indication to enter clinical testing for ARQ 092. We are hopeful that intervention in a single aberrant pathway responsible for this disease may hold potential for a therapeutic advance.”

The NIH is currently developing a protocol for a Phase 1 trial with ARQ 092 in this indication, with input from ArQule. The Company will also be providing compound for the planned NIH clinical trial, which is currently expected to begin in 2015.

Also Tuesday:

Affimed Therapeutics (Nasdaq: AFMD) today announced that on November 18, 2014, the Company will release its financial results for the quarter ended September 30, 2014.

Amedica Corporation (Nasdaq:AMDA)
, a biomaterial company that has developed silicon nitride ceramics as a material platform to manufacture and commercialize orthopedic implants, is pleased to announce that it has entered into a multi-year original equipment manufacturer (OEM) agreement with Spinal Kinetics, a leading innovator of advanced spinal implant technologies.  

AngioDynamics (Nasdaq:ANGO)
, a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, announced today the company will present at the following investor conferences in November:  On Wednesday, November 19, 2014, at 1:50 p.m. ET, Joseph M. DeVivo, President and Chief Executive Officer, is scheduled to present at the Stifel 2014 Healthcare Conference in New York City -- On Thursday, November 20, 2014, at 2 p.m. ET, Joseph M. DeVivo, President and Chief Executive Officer, is scheduled to participate in a Q&A session at the Canaccord Genuity 2014 Medical Technology & Diagnostics Forum in New York City. 

Acasti Pharma Inc. (Nasdaq:ACST) (TSX-V:APO)
, an emerging biopharmaceutical company focused on the research, development and commercialization of new krill oil-based forms of omega-3 phospholipid therapies for the treatment and prevention of certain cardiometabolic disorders, announces that on November 7, 2014 it received notification from the NASDAQ Listing Qualifications Department for failing to maintain a minimum bid price of US$1.00 per share for the last 30 consecutive business days, as required by NASDAQ Listing Rule 5550(a)(2) – bid price.

Bacterin International Holdings, Inc. (NYSE:BONE) today announced its CEO Dan Goldberger will be a guest on FOX Business Network's After the Bell with Liz Claman at approximately 4:15 PM/ET on Tuesday, November 11, 2014.

Cara Therapeutics, Inc. (Nasdaq:CARA), a biopharmaceutical company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors, today announced that Dr. Derek Chalmers, President and CEO, will present a company overview at the 2014 Stifel Healthcare Conference on Tuesday, November 18, 2014, at 2:25 p.m. ET in New York City.

Conatus Pharmaceuticals Inc. (Nasdaq:CNAT)
, a biotechnology company focused on the development and commercialization of novel medicines to treat liver disease, today announced its scheduled presentation to provide an overview of the company's programs and outlook at the Stifel 2014 Healthcare Conference at 1:50 p.m. ET on Wednesday, November 19, 2014, in New York.

Cutera, Inc. (Nasdaq:CUTR), a leading provider of laser and other energy-based aesthetic systems for practitioners worldwide, announced today that Kevin Connors, the Company's President and Chief Executive Officer, will be presenting at the Canaccord Genuity Medical Technology & Diagnostics Forum to be held November 20, 2014 as well as the Piper Jaffray 26th Annual Healthcare Conference to be held December 2-3, 2014.

Fate Therapeutics, Inc. (Nasdaq:FATE)
, a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, today provided program updates and announced financial results for the third quarter ended September 30, 2014.

Galena Biopharma, Inc. (Nasdaq:GALE)
, a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major medical needs across the full spectrum of cancer care, today announced the dosing of the first patient in a new NeuVax™ (nelipepimut-S) Phase 2 clinical trial to prevent breast cancer recurrence in high risk HER2 3+ and/or HER2 gene-amplified breast cancer patients in combination with Herceptin® (trastuzumab; Genentech/Roche).

Inogen, Inc. (Nasdaq:INGN), a medical technology company offering innovative respiratory products for use in the homecare setting, today reported financial results for the third quarter ended September 30, 2014.

MacroGenics, Inc. (Nasdaq:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, today provided a corporate progress update and reported financial results for the quarter ended September 30, 2014.

RedChip Companies, Inc., today announced it has issued a research note on Actinium Pharmaceuticals, Inc. (NYSE MKT:ATNM), a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers.

Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN)
, a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced that Peter D. Suzdak, PhD, the Company's Chief Executive Officer, will present at the Stifel 2014 Healthcare Conference. The presentation will be on Tuesday, November 18th at 10:20 AM EST.

Rockwell Medical, Inc. (Nasdaq:RMTI)
, a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today the presentation schedule for three individual Triferic clinical abstracts selected by ASN's Program Committee for poster presentation at the ASN Kidney Week 2014 Annual Meeting, November 11-16 in Philadelphia, PA.

SAGE Therapeutics (Nasdaq:SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-threatening, rare central nervous system (CNS) disorders, today reported pipeline updates and reported business and financial results for the quarter ended Sept. 30, 2014., Inc. (SCV) announced today that a new audio interview with BioCorRx, Inc. (OTCQB:BICX), a leader in addiction treatment programs, is now available.

Union Dental Holdings, Inc.  (OTC PK: UDHI) A Company that operates and manages a network of dentists throughout the United States for union members announced the financial results for the quarter ending September 30, 2014. 

Manny Villafaña, Chairman and CEO of Kips Bay Medical, Inc. (OTCQB:KIPS), announced that on November 4, 2014, cardiac surgeons at The Valley Hospital's Heart and Vascular Institute in Ridgewood, New Jersey, performed their first implant of an eSVS® Mesh.

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