New Independent Data Monitoring Committee Established by Hemispherx to Accelerate Global Drug Development
PHILADELPHIA, May 3, 2010 (GLOBE NEWSWIRE) -- Hemispherx Biopharma, Inc. (NYSE AMEX:HEB) (the "Company") announced today the formation of an Independent Data Monitoring Committee (DMC) which will oversee the Company's various drug development programs. The principal role of an independent DMC is to perform interim analyses of the clinical outcome data and to insure the safety of patients in clinical trials. The DMC also plays a critical role in studies that may use Adaptive Design wherein trial design modifications can be made after patient enrollment has started. Adaptive Design will enable Hemispherx to respond to data collected during the trial which may include dropping a treatment arm, modifying the sample size, etc, to increase statistical probability of reaching the desired therapeutic outcome.
The three members of the DMC are Thomas R. Zimmerman Jr., MD, F.A.A.N., Philip R. Roane, Jr., Ph.D. and Anita F. Das, Ph.D. Dr. Zimmerman will act as chairman. They will be the core members of the DMC and, from time to time, their skills and knowledge may be supplemented by experts who bring knowledge of a given indication, geographic familiarity, etc. to the Committee for particular studies.
Dr. Zimmerman has over 12 years of medical monitoring experience for all phases of clinical trials, including safety reporting and narrative writing for NDA's and is a Clinical Associate Professor of Neurology at Robert Wood Johnson Medical School. Dr. Roane is an Associate Professor and Vice Chairman of the Department of Microbiology at Howard University and has served on numerous scientific review panels for the National Institutes of Health and the Department of Defense. Dr. Das is President and Principal Biostatistician of AxiStat, Inc. She serves on the Data and Safety Monitoring Committee established by the Best Pharmaceuticals for Children Act which seeks to improve pediatric therapeutics.
By having a formal independent DMC, the Company puts in place a cumulative and broad knowledge gained by DMC members over the course of multiple clinical studies in multiple treatment indications thus further accruing to the benefit and safety of patients suffering from serious diseases without adequate present therapies. The Company has in the planning stages a number of studies for Ampligen® , an investigational therapeutic, and Alferon N Injection®, both in the U.S. and abroad, including the recently announced initiative in India with Alferon N Injection® for the treatment of seriously ill patients hospitalized with influenza, scheduled to begin in the upcoming monsoon season.
About Hemispherx Biopharma
Hemispherx Biopharma, Inc. is an advanced specialty pharmaceutical company engaged in the clinical development of new drug entities for treatment of seriously debilitating disorders. Hemispherx' flagship products include Alferon N Injection® (FDA approved for a category of sexually transmitted diseases) and the experimental therapeutics Ampligen® and Alferon LDO. Ampligen® represents experimental RNA nucleic acids being developed for globally important debilitating diseases and disorders of the immune system. Hemispherx' platform technology includes agents for potential treatment of various severely debilitating and life threatening diseases. Hemispherx has an extensive number of patents comprising its core intellectual property estate and a fully commercialized product (Alferon N Injection®). The Company wholly owns and exclusively operates a GMP certified manufacturing facility in the United States for commercial products. For more information please visit www.hemispherx.net.
Information contained in this news release, other than historical information, should be considered forward-looking and is subject to various risk factors and uncertainties. For instance, the strategies and operations of Hemispherx involve risk of competition, changing market conditions, change in laws and regulations affecting these industries and numerous other factors discussed in this release and in the Company's filings with the Securities and Exchange Commission. Any specifically referenced investigational drugs and associated technologies of the Company (including Ampligen® and Alferon® LDO) are experimental in nature and as such are not designated safe and effective by a regulatory authority for general use and are legally available only through clinical trials with the referenced disorders. The forward-looking statements represent the Company's judgment as of the date of this release. The Company disclaims, however, any intent or obligation to update these forward-looking statements. Clinical trials for other potential indications of the approved biologic Alferon N Injection® do not imply that the product will ever be specifically approved commercially for these other treatment indications. Further, the commencement of clinical trials in June, 2010 by Max Neeman in India is its target date but cannot be guaranteed due to a variety of risk factors outside of the parties control and should be regarded only as a forward looking estimate.
CONTACT: Hemispherx Biopharma, Inc.