Healthcare Industry News: BioCryst Pharmaceuticals
News Release - January 25, 2007
BioCryst Initiates Phase II Influenza Clinical Trial to Evaluate PeramivirIntramuscular Peramivir to be Studied in Multinational Clinical Program
BIRMINGHAM, Ala., Jan. 25 (HSMN NewsFeed) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX ) today announced that it has initiated a Phase II clinical trial of peramivir, the company's lead influenza neuraminidase inhibitor, to determine the safety and efficacy of an intramuscular formulation of the drug in patients with influenza. Peramivir is in clinical development for the treatment of seasonal and potentially life- threatening human influenza.
"This study is based on the positive Phase I clinical data obtained in 2006 and reported at the 46th Annual ICAAC meeting, this past Fall," said J. Claude Bennett, M.D., Chief Operating Officer of BioCryst. "The safety and antiviral activity observed in previous studies indicate that injectable peramivir may be a valuable therapy in the treatment of acute influenza."
The double-blind, placebo-controlled trial will enroll patients with acute influenza at sites in North America, Europe and Southeast Asia. Two different doses of peramivir will be tested.
Funding for this trial will come from the U.S. Department of Health and Human Services (DHHS) which on January 4, 2007 awarded BioCryst a $102.6 million, four-year contract to develop peramivir for the treatment of seasonal and pandemic influenza towards U.S.-licensure. Under the terms of the contract, the company will be reimbursed for clinical manufacturing and evaluation of peramivir through to licensure.
"Starting this Phase II study is an important step forward in our comprehensive development program for peramivir," said Jon P. Stonehouse, Chief Executive Officer of BioCryst. "Seasonal influenza infections as well as the threat of life-threatening strains of influenza are a major worldwide health concern and we are committed to bringing forward this new treatment option."
Peramivir is a member of the class of antiviral agents that inhibit influenza viral neuraminidase, an enzyme that is essential for the spread of influenza virus within the host. In laboratory tests peramivir has been shown to be more potent than, and with activity against viral strains that are resistant to currently available neuraminidase inhibitors. Peramivir is an inhibitor of influenza A and B neuraminidases. At the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) injectable formulations of peramivir were shown to be safely administered at high dose levels to healthily subjects and, in preclinical studies, peramivir has been shown to promote survival in animals infected with highly pathogenic strains of the H5N1 virus. The availability of an intravenous form may be important in treating patients hospitalized with severe life-threatening influenza; the intramuscular formulation will avoid dosing issues with currently available oral or inhaled agents.
The influenza virus causes an acute viral disease of the respiratory tract. Unlike the common cold and some other respiratory infections, seasonal flu can cause severe illness, resulting in life-threatening complications. According to the Centers for Disease Control and Prevention, every year in the United States more than 200,000 people are hospitalized from flu complications, and about 36,000 people die from flu. Most at risk are young children, the elderly, and people with seriously compromised immune systems.
H5N1 avian influenza is caused by a subtype of the influenza A virus. Circulating among birds worldwide, the virus is considered extremely contagious in fowl.. It is believed that all species of birds are susceptible to avian influenza, but domestic poultry, including chickens and turkeys, are among the more susceptible to the highly pathogenic strain. According to the World Health Organization, at least 261 people have contracted H5N1 avian influenza, of which at least 157 have died. Almost all of these infections are believed to have resulted from contact with infected poultry.
BioCryst Pharmaceuticals, Inc. is a leader in the use of crystallography and structure-based drug design for the development of novel therapeutics to treat cancer, cardiovascular diseases, autoimmune diseases, and viral infections. The company is advancing multiple internal programs toward potential commercialization including Fodosine(TM) in oncology, BCX-4208 in transplantation and autoimmune diseases and peramivir in seasonal and life- threatening influenza. BioCryst has a worldwide partnership with Roche for the development and commercialization BCX-4208, and is collaborating with Mundipharma for the development and commercialization of Fodosine(TM) in markets across Europe, Asia, Australia and certain neighboring countries. In January, 2007 the U.S. Department of Health and Human Services (DHHS) awarded a $102.6 million, four-year contract to BioCryst for advanced development of peramivir to treat seasonal and life-threatening influenza. For more information about BioCryst, please visit the company's web site at http://www.biocryst.com.
These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performances or achievements expressed or implied by the forward-looking statements. These statements reflect our current views with respect to future events and are based on assumptions and subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Some of the factors that could affect the forward-looking statements contained herein include that DHHS could reduce or eliminate funding for peramivir, that we or our licensees may not be able to enroll the required number of subjects in planned clinical trials of our product candidates and that such clinical trials may not be successfully completed, that BioCryst or its licensees may not commence as expected additional human clinical trials with our product candidates, that our product candidates may not receive required regulatory clearances from the FDA, that ongoing and future clinical trials may not have positive results, that we may not be able to complete successfully the Phase IIb trial for Fodosine(TM) that is currently planned to be pivotal, that we or our licensees may not be able to continue future development of our current and future development programs, that our development programs may never result in future product, license or royalty payments being received by BioCryst, that BioCryst may not reach favorable agreements with potential pharmaceutical and biotech partners for further development of its product candidates, that BioCryst may not have sufficient cash to continue funding the development, manufacturing, marketing or distribution of its products and that additional funding, if necessary, may not be available at all or on terms acceptable to BioCryst. Please refer to the documents BioCryst files periodically with the Securities and Exchange Commission, specifically BioCryst's most recent Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, current reports on Form 8-K which identify important factors that could cause the actual results to differ materially from those contained in the projections or forward-looking statements.
Source: BioCryst Pharmaceuticals
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