|Achillion Unable to Resolve Clinical Hold; Bristol-Myers' Yervoy Study Reveals Survival Rate of 22%|
|By Staff and Wire Reports|
|Friday, 27 September 2013 23:55|
Achillion Pharmaceuticals, Inc. (Nasdaq: ACHN) provided an update on development of compounds in its pipeline of therapies for the treatment of chronic hepatitis C virus, or HCV. Achillion today received a response from the U. S. Food and Drug Administration, or FDA, on the clinical hold related to sovaprevir, Achillion's NS3 protease inhibitor. The FDA response indicated that, while Achillion's submission addressed all issues noted in the FDA's June 29, 2013 letter, the FDA concluded that the removal of the clinical hold is not warranted.
"While we are disappointed that we were not able to resolve the clinical hold at this time despite having addressed all the issues, we believe the breadth of our portfolio allows us to quickly advance other all oral combination regimens for the treatment of HCV," stated Milind Deshpande, President and Chief Executive Officer of Achillion. "With our Phase 2 NS5A inhibitor, ACH-3102, we are in a position to rapidly initiate combination studies with ACH-2684, our protease inhibitor, with results expected in 2014. Further, we continue to advance our uridine-analog nucleotide, ACH-3422, with which we anticipate initiating clinical trials in the first half of 2014."
ACH-2684 has completed all of the necessary preclinical and clinical trials necessary to support advancement into Phase 2 combination development. Achillion previously reported robust anti-viral activity with ACH-2684 as monotherapy including Phase 1b data in both non-cirrhotic and cirrhotic treatment-naïve HCV genotype (GT) 1 patients. In addition, Achillion will continue to work to resolve the clinical hold related to sovaprevir.
Phase 2 -007 Trial of Sovaprevir and ACH-3102 with Ribavirin
Achillion also announced interim data from the ongoing -007 Phase 2a clinical trial evaluating two doses of sovaprevir, either 200 mg or 400 mg once daily, in combination with 50 mg once daily of ACH-3102 and ribavirin (rbv) twice daily for 12 weeks in patients with treatment-naïve GT 1a or 1b hepatitis HCV.
The Phase 2 trial is a double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of 12 weeks of sovaprevir, ACH-3102 and rbv in up to 50 treatment-naïve patients with chronic GT 1a or GT 1b HCV. The first segment enrolled 30 patients who were randomized to receive a combination of either 200 mg or 400 mg sovaprevir once daily in combination with a 150 mg loading dose followed by a 50 mg daily dose of ACH-3102, and twice daily doses of rbv, or matching placebos. The primary endpoints for this trial include safety, tolerability, and sustained viral response 4 weeks after the completion of dosing (SVR4). The trial is being conducted at sites in the United States, Canada, New Zealand and Australia.
All patients achieved a very rapid virologic response (vRVR) with HCV RNA less than 25 IU/ml by week 2. Potent efficacy was observed against GT 1b HCV with 100% of patients achieving rapid viral response, or RVR, with HCV RNA levels less than 10 IU/mL at week 4. RVR was achieved in 79% of GT1 patients overall.
To date, the combination of sovaprevir and ACH-3102 with rbv for up to 12 weeks has been well tolerated with no drug-related serious adverse events, no clinically significant changes in vital signs or electrocardiograms. There have been no graded increases in liver function tests, including ALT or AST, for patients receiving active treatment to date. No other laboratory abnormalities were noted with the exception of decreases in hemoglobin observed and attributed to ribavirin.
Bristol-Myers Squibb Company (NYSE: BMY) announced results from a pooled analysis of survival data for 12 studies (n=1,861) in patients with metastatic or locally advanced or unresectable melanoma who were treated with Yervoy® (ipilimumab) at different doses and regimens. A plateau in the survival curve begins at approximately three years, with follow-up of up to ten years in some patients. Approximately 22% of patients were alive at three years. The data will be presented at the 2013 European Cancer Congress on September 28 at 1:00 p.m. CEST and were highlighted at a Congress press briefing (Abstract # 24LBA, “Pooled analysis of long-term survival data from Phase 2 and Phase 3 trials of ipilimumab in metastatic or locally advanced, unresectable melanoma”).
Safety data were not included in this analysis. However, safety data from these individual studies have been reported. Overall, the types of adverse events (AEs) attributed to Yervoy are generally mechanism (immune)-based. Yervoy can result in severe and fatal immune-related adverse reactions due to T-cell activation and proliferation. In these clinical trials, adverse events associated with Yervoy were managed with protocol-specific guidelines, including the administration of systemic corticosteroids, dose interruption/discontinuation and/or other immunosuppressants.
“This pooled analysis reinforces the long-term survival data seen in the individual studies and provides additional insight into the overall survival of metastatic melanoma patients treated with Yervoy,” said Brian Daniels, senior vice president, Global Development and Medical Affairs. “The durability and consistency of long-term survival observed in this analysis is encouraging as we continue to advance the research and development of our immuno-oncology portfolio.”
“In this analysis, approximately 26% of treatment-naïve and 20% of previously-treated patients were alive at three years after being treated with an ipilimumab regimen,” said F. Stephen Hodi, M.D., Department of Medicine, Harvard Medical School, Dana-Farber Cancer Institute. “This pooled analysis is encouraging, particularly when considering that metastatic melanoma is one of the most aggressive forms of cancer and historically, average survival was just six to nine months.”
Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today provided an update on development of compounds in its pipeline of therapies for the treatment of chronic hepatitis C virus, or HCV.
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Generex Biotechnology Corporation (OTCBB:GNBT) today provided an update in respect of the previously announced conference call on the Company's proprietary Generex Oral-lyn™ buccal insulin spray program.
Medicure Inc. (TSX VENTURE:MPH), (PINKSHEET:MCUJD), a specialty pharmaceutical company, today reported its results from operations for the fiscal year ended May 31, 2013.
Novavax, Inc. (Nasdaq:NVAX) today announced the closing of its previously announced underwritten public offering of 31,846,950 shares of its common stock, including 4,153,950 shares of common stock that were issued upon the exercise in full of the over-allotment option granted to the underwriters.
Sigma-Aldrich Corporation (NASDAQ: SIAL), a leading Life Science and High Technology company (the "Company" or "Sigma-Aldrich"), announces a quarterly cash dividend of $0.215 per common share.
Unilens Vision Inc. (OTCQB: UVIC) (TSX VENTURE: UVI), which develops, licenses, manufactures, distributes and markets specialty contact lenses, today announced that it has applied for and received approval from the TSX Venture Exchange (TSXV) to voluntarily delist the trading of its common stock on the TSXV.
VIVUS, Inc. (Nasdaq:VVUS) announced that Peter Y. Tam will resign as president effective October 12, 2013.
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