BLAINE, Wash., March 4 /PRNewswire-FirstCall/ -- GeneMax Corp. (OTC Bulletin Board: GMXX; Frankfurt and Berlin: GX1) today announced that its contract manufacturer expects to complete the first phase of the manufacture of the gene vector for use in GeneMax's patented immunotherapy for the treatment of cancer in early March 2004. The first phase of the project will deliver a number of quality-controlled, vector clones to GeneMax for evaluation. The results of this evaluation will be used to select a candidate for the establishment of the "Master Viral Bank" from which clinical grade vector will be produced under Good Manufacturing Practice for use in the Company's pending human clinical trials.
The "vector" is a bio-engineered, non-replicating virus that is designed to deliver the TAP (transporters associated with antigen processing) gene to the tumor cells without negatively affecting the patient. The vector is designed for clinical use and incorporates the use of a proprietary, leading edge adenovirus-based technology, which was licensed and announced by GeneMax in August 2003.
The vector production and subsequent pre-clinical program are designed to support an Investigational New Drug Application ("IND") with the Food and Drug Administration and/or Health Canada in support of the Company's upcoming Phase I/IIa clinical trials. The program (will) include(s) animal toxicology, biodistribution, and pharmacokinetic studies conducted under Good Laboratory Practice and the design of a Phase I clinical studies, under Good Clinical Practice guidelines, to assess safety in humans.
About Clinical Trials: Clinical trials to support IND's are typically conducted in three sequential phases, although the phases may overlap. During Phase I, there is an initial introduction of the therapeutic candidate into healthy human subjects or patients. The drug is tested to assess metabolism, pharmacokinetics and pharmacological actions and safety, including side effects associated with increasing doses. Phase II usually involves studies in a limited patient population to: (i) assess the clinical activity of the drug in specific targeted indications; (ii) assess dosage tolerance and optimal dosage; and (iii) continue to identify possible adverse effects and safety risks. If the therapeutic candidate is found to be potentially effective and to have an acceptable safety profile in Phase II evaluations, Phase III trials are undertaken to further demonstrate clinical efficacy and to further test for safety within an expanded patient population at geographically disperse clinical trial sites.
GeneMax Lead Product: "TAP (Transporters Associated With Antigen Processing)" -- An Immunotherapy for Many Forms of Cancer. The global market for effective cancer treatments is large. Immunotherapies represent potential treatments for metastatic cancer, a substantial unmet need in the area of oncology. GeneMax's lead product is a therapeutic that enables a body's immune system to recognize the cancer cells as "foreign," and kill them. The technology is aimed at a group of cancers that include lung cancer, liver cancer, kidney cancer, head and neck cancer, breast cancer, melanoma, prostate cancer, colorectal cancer, and cervical cancer. These cancers are characterized by defects in the cellular, antigen presentation pathway, which results in the cancers becoming invisible to the immune system. This allows the cancers to continue to proliferate and eventually spread. GeneMax's lead technology increases the activity of the antigen presentation pathway thus providing sufficient information to the immune system to cause rejection and elimination of tumors from the body. The proof of principle was established in mice bearing metastatic small cell lung cancer tumors. This study was published in Nature Biotechnology (Vol. 18, pp 515-520, May 2000). Development Stage: Pre-clinical, in preparation for Phase I/IIa Clinical Trials.
About GeneMax Corp.: GeneMax Corp. is a biotechnology company specializing in the discovery and development of immunotherapeutics aimed at the treatment and eradication of cancer, and therapies for infectious diseases, autoimmune disorders and transplant tissue rejection.
SAFE HARBOR STATEMENT
THIS NEWS RELEASE INCLUDES FORWARD-LOOKING STATEMENTS WITHIN THE MEANING OF SECTION 27A OF THE UNITED STATES SECURITIES ACT OF 1933, AS AMENDED, AND SECTION 21E OF THE UNITED STATES SECURITIES AND EXCHANGE ACT OF 1934, AS AMENDED. THESE STATEMENTS ARE MADE UNDER THE "SAFE HARBOR" PROVISIONS OF THE UNITED STATES PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995. EXCEPT FOR THE HISTORICAL INFORMATION PRESENTED HEREIN, MATTERS DISCUSSED IN THIS PRESS RELEASE CONTAIN FORWARD-LOOKING STATEMENTS THAT ARE SUBJECT TO CERTAIN RISKS AND UNCERTAINTIES THAT COULD CAUSE ACTUAL RESULTS TO DIFFER MATERIALLY FROM ANY FUTURE RESULTS, PERFORMANCE OR ACHIEVEMENTS EXPRESSED OR IMPLIED BY SUCH STATEMENTS. STATEMENTS THAT ARE NOT HISTORICAL FACTS, INCLUDING STATEMENTS THAT ARE PRECEDED BY, FOLLOWED BY, OR THAT INCLUDE SUCH WORDS AS "ESTIMATE," "ANTICIPATE," "BELIEVE," "PLAN" OR "EXPECT" OR SIMILAR STATEMENTS ARE FORWARD-LOOKING STATEMENTS. RISKS AND UNCERTAINTIES FOR GENEMAX CORP. INCLUDE BUT ARE NOT LIMITED THE RISKS ASSOCIATED WITH PRODUCT DISCOVERY AND DEVELOPMENT AS WELL AS THE RISKS SHOWN IN GENEMAX'S MOST RECENT ANNUAL REPORT ON FORM 10-KSB AND ON FORM 10-QSB AND FROM TIME-TO-TIME IN OTHER PUBLICLY AVAILABLE INFORMATION REGARDING GENEMAX. OTHER RISKS INCLUDE RISKS ASSOCIATED WITH OBTAINING GOVERNMENT GRANTS, THE SUCCESS OF PRECLINICAL AND CLINICAL TRIALS, THE PROGRESS OF RESEARCH AND PRODUCT DEVELOPMENT PROGRAMS, THE REGULATORY APPROVAL PROCESS, COMPETITIVE PRODUCTS, FUTURE CAPITAL REQUIREMENTS, AND GENEMAX'S ABILITY AND LEVEL OF SUPPORT FOR ITS RESEARCH ACTIVITIES. THERE CAN BE NO ASSURANCE THAT GENEMAX'S DEVELOPMENT EFFORTS WILL SUCCEED, THAT SUCH PRODUCTS WILL RECEIVE REQUIRED REGULATORY CLEARANCE, OR THAT EVEN IF SUCH REGULATORY CLEARANCE WERE RECEIVED, THAT SUCH PRODUCTS WOULD ULTIMATELY ACHIEVE COMMERCIAL SUCCESS. GENEMAX DISCLAIMS ANY INTENT OR OBLIGATIONS TO UPDATE THESE FORWARD-LOOKING STATEMENTS.