Generex Biotechnology Announces Interim Results of Clinical Breast Cancer Trials
Wednesday January 25, 8:00 am ET
Collaboration With Walter Reed Army Medical Center Demonstrates Good Response to Novel Peptide Vaccine
TORONTO--(MARKET WIRE)--Jan 25, 2006 -- Generex Biotechnology Corporation (NasdaqSC:GNBT - News) announced today interim results of an ongoing clinical trial designed to assess the safety and immunological potency of a novel peptide vaccine in patients with breast cancer. The therapeutic vaccine is being developed by its wholly owned subsidiary, Antigen Express.
The compound, AE37, is a second-generation peptide vaccine designed to stimulate a potent and specific immune response against tumors expressing the HER-2/neu oncogene. A significant percentage of breast cancers as well as cancers of the lung, colon, stomach and pancreas express this oncogene. A strong immune response against HER-2/neu offers the potential to kill tumor cells that have spread to parts of the body distant from the primary tumor.
The trials are being conducted at the Walter Reed Army Medical Center (WRAMC) in collaboration with the Clinical Breast Care Project (CBCP). The CBCP is a Congressionally-mandated civilian-military collaboration between WRAMC, the Windber Research Institute (Windber, PA), and The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. The mission of the CBCP is to undertake advanced research in breast cancer prevention, diagnosis, and treatment.
Clinical trials were initiated in April of 2005 to establish safety and immunological response to AE37. The trial will include up to 15 patients with stage II breast cancer when completed, including three patients treated at a low dose of peptide (100 micrograms), three at an intermediate dose (500 micrograms), three at a high dose (1000 micrograms) and an additional six at whichever of those doses induces the best immune response in the absence of toxicity. Each dose group will receive six doses of AE37 at monthly intervals. The initial 100 microgram dose group has completed all six vaccinations and all patients developed peptide-specific responses to the immunizing peptide. The response of patients was measured by reactivity of their T cells to AE37 as measured both by their ability to proliferate after being exposed to the peptide and to secrete cytokines. While the proliferation assay showed consistent responses among the patients, the cytokine responses were more variable, with one low responder, one intermediate and one high responder. The responses of patients in the 500 microgram group have come much sooner than was seen in the 100 microgram group. After only two inoculations, the proliferative responses of patients' T cells were 2.7 to 5.7 times the highest levels observed in patients receiving 100 micrograms. In addition, cytokine responses in patients receiving two inoculations in the 500 microgram group were already greater than the highest response observed in any patient of the 100 microgram group. In short, AE37 appears to be safe, well-tolerated and exhibits a dose-dependent immunologic response. Once this initial trial is completed, it is planned to conduct a pivotal trial looking at efficacy with a larger number of breast cancer patients.
Antigen Express is engaged in the development of immunotherapeutic vaccines that stimulate T helper cells. This is accomplished by coupling a small portion of the MHC class II-associated invariant chain (Ii Protein) to a known MHC class II antigenic epitope. The discovery that the resulting 'hybrid' peptide is much more potent than the antigenic epitope alone in stimulating T helper cells forms the basis of a proprietary technology platform at Antigen Express. Hybrid vaccine peptides for the potentially pandemic H5N1 avian influenza virus as well as for HIV using the same platform are also under development.
"The demonstration of biological activity in the clinic is an important milestone for Antigen Express both in terms of product development and as validation for one of their platform technologies," said Anna Gluskin, President & Chief Executive Officer of Generex. "We look forward to further results from these trials and in advancing additional immunotherapeutics based on this technology for oncology and in the area of infectious disease."
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