Calypte Biomedical Affiliate Begins Testing on Multiple Sclerosis Patients at Harvard Teaching Hospitals
Thursday February 25, 8:07 am Eastern Time
ALAMEDA, Calif.--(BUSINESS WIRE)--Feb. 25, 1999--Calypte Biomedical Corporation (NASDAQ:CALY - news) announced today that its affiliated therapeutic company, Pepgen Corporation, will begin Phase I clinical trials of its oral interferon, Interferon Tau, in multiple sclerosis (MS) patients. The human studies will be conducted in conjunction with Harvard Medical School and its teaching hospitals, Brigham & Women's Hospital and Massachusetts General Hospital. The trials culminate more than five years of research and preclinical studies.
"As a company focused on chronic diseases, we're very excited to begin human clinical trials for Interferon Tau for the treatment of MS," said William Boeger, chairman & CEO of Calypte. "In pre-clinical studies, Interferon Tau has shown the potential to overcome the two major drawbacks of the current interferons on the market today. First, a patient can take Interferon Tau orally -- a key benefit for a medication that must be taken throughout a patient's life, as is the case with a chronic disease such as multiple sclerosis. Patients can only take all other interferons currently available by injection, either intermuscularly or subcutaneously (injected just below the skin). Secondly, Interferon Tau appears to have remarkably few side effects. It's very rewarding to have this drug make it to human trials -- a critical hurdle in the evolution of a marketable drug."
Interferons are naturally occurring proteins produced by human and other animals that inhibit viral replication, inhibit cell proliferation and regulate inflammatory responses. Combined worldwide revenues of interferons in 1998 are estimated to total approximately $3 billion. In addition, the total annual economic costs of MS in the United States was estimated to exceed $9 billion, according to a May 1998 report issued by the National Multiple Sclerosis Society.
Dr. Howard L. Weiner, professor of neurology at Harvard Medical School, director of the Partners Multiple Sclerosis Program at Brigham & Women's Hospital and Massachusetts General Hospital, and one of the nation's experts on the treatment of MS, will serve as principal investigator for the human trials.
"My colleagues and I are excited about this clinical trial," Dr. Weiner commented. "The currently approved interferon drugs for MS patients are administered by injection and can cause unfavorable side effects. This new Interferon Tau will be taken orally, and we are hopeful that it will not only be effective but will exhibit substantially fewer side effects than the current injectable interferon drugs."
Common side effects associated with currently approved Interferons (Alpha and Beta) can include: mild flu symptoms, fatigue, chills, fever, muscle aches, mild anemia, injection site reactions, depression, anxiety, chest tightness, shortness of breath and flushing.
"We are very enthusiastic to commence human trial on a potential drug which addresses a multi-billion dollar market," said Paul Freiman, a member of Calypte's board of directors, a former chairman & CEO of Syntex Corporation and former president of the Pharmaceutical Manufacturers Association (PMA). "Now that the compound is being administered to humans, we hope to attract, and have discussions with, larger pharmaceutical firms that can assist in funding the Phase II and III human trials, as well as invest in our other endeavors in the HIV arena."
The focus of the Phase I clinical trial of Interferon Tau will be to determine the drug's safety on multiple sclerosis patients. According to the latest statistics provided by the National Multiple Sclerosis Society, approximately 250,000 to 350,000 Americans had physician-diagnosed MS. Current treatments for MS are Avonex (Interferon Beta-1a), marketed by Biogen; Betaseron (Interferon Beta-1b), marketed by Berlex; and Copaxone (Glatiramer Acetate), marketed by Teva Marion Partners.
C.P. Liu, Ph.D., founder of Pepgen Corporation, said, "The results of our animal toxicity study were based on the ability of Interferon Tau to prevent the development of experimental allergic encephalomyelitis (EAE) in mice. EAE is an animal model of antigen-induced autoimmunity that is widely studied to gain insight into human multiple sclerosis. Interferon Tau proved to be very effective in this animal model. When mice were given high concentrations of Interferon Tau, there was no effect or cellular toxicity on either white blood cell counts or their percentage of lymphocytes. However, when mice were administered with Interferon Alpha or Beta, the result was severe lymphocyte depression. Under prolonged treatment of Interferon Tau at extremely high doses -- equivalent to 90 mg per day in a human patient -- there was still no dose-related toxicity. These are extremely significant results."
Pepgen is a 44-percent-owned subsidiary of Calypte Biomedical. Calypte also has the first right of refusal to purchase the 56 percent of Pepgen shares it does not already own. Pepgen shares scientific, administrative, and research facilities with Calypte. Pepgen has a second lead compound, Hybrid Interferon Alpha, which is intended to be a next-generation Interferon Alpha. Pepgen expects to complete pre-clinical studies for Hybrid Interferon Alpha this year and to file an IND early next year. Interferon Alpha is currently used to treat a variety of viral infections and various cancers.
In June 1998, the U.S. Food and Drug Administration approved the Calypte Biomedical urine HIV-1 Western blot test. The screening test had been approved previously by the FDA. The urine test system detects the presence of antibodies to HIV-1 in urine samples. Clinical studies have shown the urine diagnostic test system to be a highly accurate alternative to blood testing. Urine testing is also non-invasive, less costly, doesn't require sample storage or a trained health care worker for sample collection, and is safer because there are no risks of accidental needle sticks.
Statements in this press release that are not historical facts are forward-looking
statements, including statements regarding market adoption of the HIV-1
urine testing system. Actual results may differ materially from the above
forward-looking statements due to a number of important factors, and will
be independent upon the company's ability, directly or through third parties,
to successfully manufacture and market the HIV-1 urine testing system.
Factors which may impact the company's success are more fully discussed
in the company's most recent quarterly report on forms 10-Q and 10-K.
Jason Sherman/David Schulte
Bill Boeger, CEO/John DiPietro, COO
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