AVAX Technologies Announces Dr. David Berd Joins the Company as Chief Medical Officer.PHILADELPHIA -- AVAX Technologies, Inc. (OTCMarket:AVXT.OB) today announces that Dr. David Berd has joined the Company as its first full-time Chief Medical Officer. Dr. Berd will be responsible for overseeing the clinical development programs for the Company's Autologous autologous /au·tol·o·gous/ (aw-tol´ah-gus) related to self; belonging to the same organism. au·tol·o·gous adj. 1. Cell (AC) Vaccine therapeutic platform. Dr. Berd is the inventor of the AC Vaccine and has pioneered its clinical development. He has published extensively on the technology and has performed clinical trials for the AC Vaccine with almost 450 patients. Previously Dr. Berd served as a consultant to AVAX for the development of the AC Vaccine. For the past 20 years, Dr. Berd served as a Professor of Medicine at Jefferson Medical College of Thomas Jefferson University It began as Jefferson Medical College in 1824. On July 1, 1969 the institution officially became Thomas Jefferson University. The university is made up of three colleges:
adj the status of a dental specialist such as an orthodontist who has become a board diplomate by successfully completing the certification program of the recognized certification board in that area of practice. in Medical Oncology. While serving in his new role at AVAX, Dr. Berd will continue some patient responsibilities at Thomas Jefferson University Hospital. During his career at Jefferson, Dr. Berd conducted and participated in a number of clinical trials as primary clinical investigator, as well as establishing a number of successful research and clinical development programs. Richard Rainey, President of AVAX stated, "We are delighted to have David join our management team at this time to oversee our clinical development programs in the U.S. and abroad. David brings to AVAX a unique range of experiences in one person, including patient treatment, clinical development, product development, immunology and biological manufacturing, all of which will be valuable in guiding our clinical and development efforts. AVAX is poised to undergo significant growth as we prepare to submit for approval and then commercialize our first product, M-Vax, an autologous vaccine treatment for melanoma, in France. We are commencing a number of initiatives to demonstrate that the AC Vaccine approach is a universal platform with utility across a range of solid tumor cancers. Moreover, Dr. Berd will be an integral part of our team as we prepare to commence a Phase 3 trial in the U.S." "I am very excited to be joining the team at AVAX and am looking forward to starting the next phase of the clinical development for the AC Vaccine therapeutic," stated Dr. Berd. "We have been working hard to re-engineer a manufacturing platform for the vaccine that will be acceptable from a regulatory and commercial standpoint without changing the final composition of the vaccine. We believe our improved manufacturing platform satisfies all these criteria." AVAX is in the process of filing the French equivalent of a BLA BLA abbr. Bachelor of Liberal Arts with AFSSAPS AFSSAPS Agence Francaise de Securite Sanitaire des Produits de Sante the French regulatory authorities for treatment of patients with Stage 3 and 4 melanoma. The Company has been notified that the first of two required dossiers regarding cGMP manufacturing of its vaccine have been accepted. The Company is in the process of completing the second dossier to obtain regulatory approval. In addition, the company is plans to begin a Phase I/II clinical trial in the United States for melanoma as well as two Phase I/II trials in France capturing ovarian and colorectal cancers that have metastasized to the peritoneum peritoneum (pĕrətənē`əm), multilayered membrane which lines the abdominal cavity, and supports and covers the organs within it. The part of the membrane that lines the abdominal cavity is called the parietal peritoneum. and liver. Additional potential tumor targets are being evaluated and clinical programs being planned. About the AC Vaccine Therapeutic 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. In addition the Company offers contract-manufacturing services of biological products to other pharmaceutical and biotechnology companies. AVAX's AC Vaccine is a therapeutic treatment for cancer. Recently published (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) data for a group of 214 patients with Stage III melanoma showed 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. of 45% and a statistically significant relationship between survival and a 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, DTH (Direct-To-Home) Typically refers to satellite TV broadcasting directly to a dish antenna on the roof of a house. See DBS. (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. ). In addition, administration of the vaccine to patients with Stage IV melanoma caused objective regression of tumors in some patients, particularly those with lung metastases lung metastases Oncology Cancer that has spread from the original–primary tumor to the lung; primary lung cancer spreads to the brain, bone, BM, liver. See Metastasis. . In earlier reported 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. , administration of the vaccine induced DTH responses similar to those observed in melanoma patients, indicating that this approach is applicable to other human cancers. 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 Company's ability to obtain substantial additional capital to fund its development programs, (2) the results of laboratory testing of its vaccine technologies, (3) 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 questions regarding the Company's products and manufacturing processes, (4) the Company's ability to maintain its rights under license and research funding agreements and to meeting funding requirements under its license and research funding 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, 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, 2003 and its Registration Statement on Form SB-2 filed with the SEC on October 13, 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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