This was worth all of $0.02 at the close of trading today. Doesn't anyone even scan the contents of PRs any more? Sure struck me as if BCRX has got a winner for an unmet medical need that is killing about 36.000 annually in the US.
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BioCryst Reports Results From the First-Ever Completed Active-Controlled Phase 2 Study in Hospitalized Influenza
prnews
Management to Host Conference Call at 8:30 a.m. Eastern Time Today to Discuss Results
BIRMINGHAM, Ala., Oct. 27 /PRNewswire-FirstCall/ -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced results of an exploratory Phase 2 trial of intravenous (i.v.) peramivir, a neuraminidase inhibitor, in patients hospitalized for acute serious or potentially life-threatening influenza. The Phase 2 trial compared the efficacy and safety of five days of therapy with either 200 mg i.v. peramivir per day, 400 mg i.v. peramivir per day or 75 mg oral oseltamivir twice a day, in patients who required hospitalization related to influenza. These results will be submitted to an upcoming medical meeting.
The primary objective of the study was to evaluate time to clinical stability, which is a composite endpoint comprised of normalization of temperature, oxygen saturation, respiratory rate, systolic blood pressure and heart rate. This type of endpoint has previously been used in pneumonia studies, but not in influenza. Secondary objectives of the study included evaluation of viral shedding, mortality, clinical relapse and time to resumption of usual activities.
In the primary efficacy population, for all groups combined, the study demonstrated a median of 25.3 hours to clinical stability, a median of 2.0 log reduction in time weighted change from baseline in viral titer, zero mortality, no clinical relapse and a median of 10.8 days of time to resumption of usual activities. There were no statistically significant differences in any of the efficacy endpoints between the three treatment arms. Peramivir was generally safe and well-tolerated at these dose levels.
"This landmark study provides us great insight into the course of treatment for patients who are hospitalized for influenza. The results indicate a potential role for antiviral therapy, which is critical as currently there are no antivirals approved for patients hospitalized for acute serious or potentially life-threatening influenza," said Dr. Michael Ison, Assistant Professor, Divisions of Infectious Diseases and Organ Transplantation at Northwestern University Feinberg School of Medicine and Principal Investigator in the study.
"We are very encouraged by how quickly the virus cleared, how well the patients did overall and the safety profile of peramivir in this study," said Dr. William P. Sheridan, BioCryst's Chief Medical Officer. "According to the U.S. Centers for Disease Control, 36,000 people die of complications from influenza each year. Therefore, the observed zero mortality in patients with confirmed influenza in this study is an important finding."
The multicenter, randomized, double-blind, double-dummy, active- controlled, Phase 2 study enrolled 137 patients, who tested positive by rapid antigen test (RAT) for influenza and had one or more criteria for hospitalization, namely: age greater than or equal to 60 years, chronic lung disease, congestive heart failure, diabetes mellitus, low oxygen saturation, low blood pressure, or severity of illness requiring supportive care. Of the 137 patients randomized, 122 age 19 to 101 years had influenza confirmed by polymerase chain reaction (PCR) testing and were included in the intent-to- treat infected (ITTI) patient population; 41 patients received oseltamivir 75 mg orally twice-daily, 41 patients received 200 mg i.v. peramivir once-daily and 40 patients received 400 mg i.v. peramivir once-daily.
The study was conducted in the United States, Canada, Hong Kong, Singapore, Australia, New Zealand, and South Africa.
Health and Human Services Contract
BioCryst is advancing the clinical development of peramivir under terms of a contract from the U.S. Department of Health and Human Services (HHS) which on January 3, 2007 awarded BioCryst a $102.6 million, four-year contract to develop peramivir for the treatment of seasonal and life-threatening influenza. Funding from the contract has supported the Phase 2 development activities of peramivir in outpatient and hospitalized flu, including manufacturing of clinical lots, process validation, clinical studies and other product approval requirements toward U.S. licensure. BioCryst has retained all of its development and commercialization rights to peramivir worldwide except in Japan, Korea and recently Taiwan where BioCryst is in a strategic partnership with Shionogi & Co. Ltd. in Japan and Taiwan, and Green Cross in Korea.
Conference Call and Web cast
BioCryst's management team will host a conference call and Web cast on Monday, October 27 at 8:30 a.m. Eastern Time to discuss the results further. To participate in the conference call, please dial 1-877-627-6585 (United
States) or 1-719-325-4896 (International). No passcode is needed for the call. The Web cast can be accessed by logging onto biocryst.com. Please connect to the Web site at least 15 minutes prior to the start of the conference call to ensure adequate time for any software download that may be necessary.
About Peramivir
Peramivir is an antiviral agent that inhibits the interactions of influenza neuraminidase, an enzyme which is critical to the spread of influenza within a host. In laboratory tests, peramivir has shown activity against viral strains that are resistant to currently available treatments and has been safely administered to healthy subjects at high dose levels. Peramivir is currently being studied in hospitalized and outpatient influenza, utilizing either an intramuscular or intravenous formulation. A Phase 2 trial in outpatient influenza is currently ongoing, the Phase 2 trial in hospitalized influenza was recently completed and BioCryst's partner, Shionogi & Co., Ltd. is preparing for a pivotal Phase 3 trial of peramivir in outpatient influenza.
About BioCryst
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