AVAX Technologies Announces the Commencement of Two Clinical Trials; Positive Results in Patients Treated With M-Vax Presented at International Symposium in Lyon, France.PHILADELPHIA -- AVAX Technologies, Inc. (OTCMarket: AVXT.OB) today announced it has initiated enrollment to its clinical trial of M-Vax for the treatment of patients with Stage III and IV melanoma in the United States. The study is a multi-center trial that will include up to seven clinical sites. In addition, the Company has initiated a clinical trial in patients with metastatic Metastatic The term used to describe a secondary cancer, or one that has spread from one area of the body to another. Mentioned in: Coagulation Disorders metastatic pertaining to or of the nature of a metastasis. peritoneal peritoneal /peri·to·ne·al/ (per?i-to-ne´al) pertaining to the peritoneum. peritoneal pertaining to the peritoneum. cancer in France. Both studies will measure safety and include an immunological measure of vaccine activity as measured by Delayed Type Hypersensitivity hypersensitivity, heightened response in a body tissue to an antigen or foreign substance. The body normally responds to an antigen by producing specific antibodies against it. The antibodies impart immunity for any later exposure to that antigen. Testing (DTH (Direct-To-Home) Typically refers to satellite TV broadcasting directly to a dish antenna on the roof of a house. See DBS. ). To assist in the performance and evaluation of the U. S. study, the Company has established a Data Safety Monitoring Board. David Berd, MD, Chief Medical Officer of AVAX stated, "We are pleased to be able to begin these important clinical studies which reestablish AVAX's clinical development program for the AC Vaccine and we acknowledge the support and assistance of our clinical sites and our Data Safety Monitoring Board in helping us to successfully launch these programs." In addition, the Company reported that Dr. David Berd participated in an international investigators meeting in Lyon, France that was sponsored by GROUPO FERRER, S.A., the Company's distribution partner for the AC Vaccine in a number of countries in Europe and Latin America. Following Dr. Berd's talk, Dr. J-P Hermanne, Head of Hemato-Oncology, CHR CHR canine hypoxic rhabdomyolysis. Namur, Belgium and Dr. Luis Miguel Real, Technical Director, NeoCodex, Seville, Spain, gave presentations on the immunological and clinical effects seen in melanoma patients treated with M-Vax. Dr. Andres Crespo, General Manager of Genopoietic, AVAX's wholly owned French subsidiary, stated "We were very impressed with the presentations given at the symposium. The clinical and immunological data presented by the clinicians demonstrated a clear consistency with the historic findings published previously by Dr. Berd." Both doctors have been treating patients on a compassionate basis with Stage III & IV melanoma. Richard Rainey, President of AVAX noted "With the closing of our private placement in April and the launching of our clinical programs we are in position to build our organization and continue to explore the utility of the vaccine. In addition to our existing clinical programs, we are also planning clinical trials in France and the United States that will include lung cancer lung cancer, cancer that originates in the tissues of the lungs. Lung cancer is the leading cause of cancer death in the United States in both men and women. Like other cancers, lung cancer occurs after repeated insults to the genetic material of the cell. and metastatic colon and ovarian cancers. Initiation of these programs will allow us to build momentum towards the commercial launch of our vaccine in addition to demonstrating the universal applicability of the AC Vaccine as a platform technology for the treatment of cancer". Information for Patients Patients and clinicians interested in learning more about the current clinical trial of melanoma or who want a list of the participating sites may contact Dr. David Berd at (215) 241-9760 X1306. About AVAX Technologies, Inc. AVAX Technologies, Inc. is a biotechnology company with operations in the United States and Europe. The Company is engaged in the research, clinical and commercial development of biological products and cancer therapeutics. AVAX's AC Vaccine platform is a therapeutic treatment for cancer. In addition, the Company performs contract-manufacturing services for biological products to other pharmaceutical and biotechnology companies. The AC Vaccines therapeutic is prepared by attaching a small chemical to the patient's tumor cells in a process known as haptenization. This hapten hapten /hap·ten/ (hap´ten) partial antigen; a specific nonprotein substance which does not itself elicit antibody formation but does elicit the immune response when coupled with a carrier protein. modification allows the tumor cells to stimulate a T cell-based immune response immune response n. An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. to a patients own tumor cells. An early indicator of T cell immune activity is DTH. A previously published article in the Journal of Clinical Oncology The Journal of Clinical Oncology is a medical journal published by the American Society of Clinical Oncology. The Journal was founded in 1983 and publishes original research and review articles on topics relating to cancer. It is published 3 times a month. , February 2004 reported actual five-year survival five-year survival Epidemiology The timespan that a person survives with a particular dread disease, in particular CA; 5YS facilitates standardization of survival statistics. See Cancer-free survival. data for a group of 214 patients with clinically evident Stage III melanoma treated with the AC Vaccine following surgery. The study demonstrated five-year survival of 45% and showed a highly statistically significant relationship between survival and DTH to patients' own tumor cells. Notably, based upon these results, DTH appears to be a viable "surrogate marker surrogate marker Lab medicine A parameter or measured to detect a pathologic condition when a more specific test doesn't exist, is impractical or not cost-effective; surrogate testing has been used for non-A, non-B hepatitis, measuring ALT and antibodies to HBV " for survival and an early indicator for clinical effectiveness of current and future product candidates. Previously clinical trials in ovarian and renal cell carcinoma renal cell carcinoma or hypernephroma Malignant tumour of the cells that cover and line the kidney. It usually affects persons over age 50 who have vascular disorders of the kidneys. It seldom causes pain, unless it is advanced. , demonstrated strong DTH responses consistent with those reported for melanoma patients. Except for statements that are historical, the statements in this release are "forward-looking" statements that are made pursuant to the safe harbor Safe Harbor 1. A legal provision to reduce or eliminate liability as long as good faith is demonstrated. 2. A form of shark repellent implemented by a target company acquiring a business that is so poorly regulated that the target itself is less attractive. provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements involve significant risks and uncertainties, and in light of the significant uncertainties inherent in such statements, the inclusion of such information should not be regarded as a representation by AVAX that the objectives and plans of the Company will be achieved. In fact, actual results could differ materially from those contemplated by such forward-looking statements. Many important factors affect the Company's prospects, including (1) the results of clinical and laboratory testing of its vaccine technologies, (2) possible future FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. or AFSSAPS AFSSAPS Agence Francaise de Securite Sanitaire des Produits de Sante questions regarding the Company's products and manufacturing processes, (3) the Company's need for additional capital in the future to continue its development programs, (4) the Company's ability to maintain its rights under license agreements and to meet funding requirements under its license agreements, (5) the Company's ability to demonstrate the safety and efficacy of product candidates at each stage of development and to meet applicable regulatory standards and receive required regulatory approvals, (6) the Company's ability to manufacture, receive and ship its vaccine products for clinical and commercial distribution, as well as other risks detailed from time to time in AVAX's public disclosure filings with the Securities and Exchange Commission, including its Annual Report on Form 10-KSB for the year ended December 31, 2004. AVAX does not undertake any obligation to release publicly any revisions to these forward-looking statements or to reflect the occurrence of unanticipated events. |
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