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Coley Suspends Development of HCV Toll-Receptor Drug
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Coley Pharmaceutical Group Updates Hepatitis C Drug Development Strategy
Coley press release
January 23, 2007 - 6:56 AM
Company Suspends Independent Development of ACTILON(TM); Concentrates Efforts on Preclinical TLR Therapeutics(TM) Product Candidates
Coley Reduces In-house Drug Development Staff
"..... the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk.....suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear...."
WELLESLEY, Mass., Jan. 22 /PRNewswire-FirstCall/ -- Coley Pharmaceutical Group, Inc. (NASDAQ:COLY) today announced that the company has made the strategic decision to suspend the independent development of ACTILON, its product candidate for the treatment of Hepatitis C virus (HCV) infection. Coley will focus its resources towards discovering and developing new TLR Therapeutics(TM), including its preclinical pipeline of synthetic RNA-based drugs designed to stimulate Toll-like receptors (TLRs) 7 and 8, as well as other synthetic agonists and antagonists targeting TLRs 7, 8 and 9.
"The decision to suspend a drug development program is a difficult one," commented Robert L. Bratzler, Ph.D., President and Chief Executive Officer for Coley Pharmaceutical Group. "However, we are confident that the changes being made today are the right ones for our shareholders. As a result of these modifications to our drug development program, Coley plans to redirect the necessary resources in our efforts to expand and diversify our portfolio of product candidates and maintain our leadership position in the TLR Therapeutics space."
ACTILON Program Overview and Status
Coley's strategic decision to suspend its independent development of ACTILON for HCV was reached based on clinical data obtained from two separate, but concurrently-running clinical trials evaluating ACTILON for use among treatment-refractory patients with genotype 1 HCV:
Phase Ib clinical trial in relapsed HCV patients:
- In October 2006, updated safety and treatment response data were presented from the company's 12-week Phase Ib clinical study of ACTILON in various combinations with pegylated interferon and ribavirin. Among previously-treated relapsed patients, the triple combination of ACTILON plus pegylated interferon and ribavirin therapy was generally well tolerated, and most adverse events were categorized as transient and consistent with administration of an immunomodulatory agent. At 24 weeks on therapy, 7 of 14 patients receiving ACTILON remained HCV viral negative.
- These 7 patients completed 48 weeks of therapy by year-end 2006 and were followed to determine if a sustained virologic response (SVR), defined as continued viral clearance for six months after cessation of treatment, was achieved. Today, the company reported that 2 of 7 patients remained HCV viral negative at one- and four-months, respectively, following the cessation of treatment.
- Coley intends to present data from this trial by publishing the data in a peer-reviewed journal or presenting at an upcoming scientific conference.
Phase II clinical trial in null and partial responder HCV patients:
- In November 2006, Coley provided an update on its 48-week, three-arm Phase II clinical trial of ACTILON in combination with pegylated interferon and ribavirin in the null and partial responder treatment refractory patient population. Coley reported that no meaningful differences in viral load reduction were observed in any of the treatment arms in the null patient population.
- Data has not been collected from the partial responders enrolled in the trial to date and Coley will suspend further enrollment of partial responder patients.
Coley has not evaluated ACTILON in combination with pegylated interferon and ribavirin in the treatment-naive patient population, nor has it investigated ACTILON's potential as a replacement therapy for pegylated interferon.
Dr. Bratzler continued, "Coley adopted a speed-to-market strategy by evaluating ACTILON in the treatment-refractory HCV patient population. The data generated to date shows the need for Coley to capture a portion of the naive patient population to maximize its commercial opportunity in HCV. However, the competitive landscape for the naive patients is rapidly evolving, making drug development complex, expensive and high risk. We have made the decision to mitigate risk by suspending further investment in ACTILON until we find a partner to share in development costs or until the market opportunity and development path for a second-generation immunomodulating agent becomes clear. Until then, we believe that Coley's resources will be better deployed on the discovery and development of new medicines that exploit the broad potential of our TLR Therapeutics platform."
In accordance with this business decision, Coley has reduced its workforce (predominately drug development staff) by approximately 22 percent, or 33 employees, and will look to outsource its drug development activities moving forward.
Employees affected by the reduction have been offered severance and outplacement support. The estimated termination charges will be approximately $1.1 million and will be incurred primarily in the first quarter of 2007. In addition, the company will adjust its non-cash stock compensation expense related to former employees in the first quarter of 2007.
About Coley Pharmaceutical Group
Coley Pharmaceutical Group, Inc. is an international biopharmaceutical company, headquartered in Wellesley, Massachusetts, USA, that discovers and develops TLR Therapeutics(TM), a new class of investigational drug candidates that direct the human immune system to fight cancers, infectious diseases and respiratory disorders. Coley has established a pipeline of TLR Therapeutic product candidates currently advancing through clinical development with partners and has additional product candidates in preclinical development. Coley has product development, research and license agreements with Pfizer, sanofi-aventis, Novartis Vaccines & Diagnostics (formerly Chiron), GlaxoSmithKline and the United States government. For further information on Coley Pharmaceutical Group please visit www.coleypharma.com.
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