17.01.2006 14:55:00
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AVAX Technologies Announces the Initiation of its Clinical Study for the Treatment of Patients with Non Small Cell Lung Cancer
David Berd, MD, Chief Medical Officer of AVAX stated, "We arepleased to initiate this important study and we are looking forward toobtaining the first data on immunological responses from the studyearly this year. With this indication, and the ongoing studiestreating melanoma in the United States and metastatic peritonealcancer in France, we are confident we will be able to demonstrate theutility of the AC Vaccine Therapeutic as a platform technology." Berdadded "Based upon previous observations of regression of melanoma lungmetastases after administration of M-Vax, our AC Vaccine Therapeuticfor the treatment of melanoma plus initial results obtained in ouranimal model, we feel there is a strong rationale for testing thevaccine in lung cancer. Moreover, the fact that NSCLC is achemically-induced cancer makes it likely to be immunogenic andresponsive to appropriate immunotherapy."
The study will include patients whose lung cancers are completelyresectable. They will be assigned to one of three vaccine doses, andthe dose is measured by the number of cancer cells. Each dosage armwill include a maximum of 14 patients. The study subjects will receivevaccine treatment immediately after surgery and prior to any otheradjuvant treatment. Based upon anticipated enrollment the Companyexpects to obtain initial immunological data from the study in thesecond quarter of 2006.
Lung Cancer
Lung cancer is the leading killer of men and women. In the UnitedStates in 2002 it is estimated 169,400 new cases and 154,900 deathsfrom lung cancer. There are two major types of lung cancer, non smallcell lung cancer, which accounts for about 80% of the cases of lungcancer, and small cell lung cancer, which comprises the other 20%.About 25% of patients with non-small cell lung cancers are surgicallyresectable.
Information for Patients and Clinicians
Patients and clinicians interested in learning more about thecurrent clinical trial may contact Dr. David Berd AVAX Technologies at(215) 241-9760 X1306.
About AVAX Technologies, Inc.
AVAX Technologies, Inc. is a biotechnology company with operationsin the United States and Europe. The Company is engaged in theresearch, clinical and commercial development of biological productsand cancer therapeutics. AVAX's AC Vaccine platform is a therapeutictreatment for cancer. In addition, the Company performscontract-manufacturing services for biological products to otherpharmaceutical and biotechnology companies.
The AC Vaccines therapeutic is prepared by attaching a smallchemical to the patient's tumor cells in a process known ashaptenization. This hapten modification allows the tumor cells tostimulate a T cell-based immune response to a patients own tumorcells. An early indicator of T cell immune activity is DTH. Apreviously published article in the Journal of Clinical Oncology,February 2004 reported actual five-year survival data for a group of214 patients with clinically evident Stage III melanoma treated withthe AC Vaccine following surgery. The study demonstrated five-yearsurvival of 45% and showed a highly statistically significantrelationship between survival and DTH to patients' own tumor cells.Notably, based upon these results, DTH appears to be a viable"surrogate marker" for survival and an early indicator for clinicaleffectiveness of current and future product candidates. Previouslyclinical trials in ovarian and renal cell carcinoma, demonstratedstrong DTH responses consistent with those reported for melanomapatients.
Except for statements that are historical, the statements in thisrelease are "forward-looking" statements that are made pursuant to thesafe harbor provisions of Section 27A of the Securities Act of 1933and Section 21E of the Securities Exchange Act of 1934.Forward-looking statements involve significant risks anduncertainties, and in light of the significant uncertainties inherentin such statements, the inclusion of such information should not beregarded as a representation by AVAX that the objectives and plans ofthe Company will be achieved. In fact, actual results could differmaterially 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 vaccinetechnologies, (2) possible future FDA or AFSSAPS questions regardingthe Company's products and manufacturing processes, (3) the Company'sneed for additional capital in the future to continue its developmentprograms, (4) the Company's ability to maintain its rights underlicense agreements and to meet funding requirements under its licenseagreements, (5) the Company's ability to demonstrate the safety andefficacy of product candidates at each stage of development and tomeet applicable regulatory standards and receive required regulatoryapprovals, (6) the Company's ability to manufacture, receive and shipits vaccine products for clinical and commercial distribution, as wellas other risks detailed from time to time in AVAX's public disclosurefilings with the Securities and Exchange Commission, including itsAnnual Report on Form 10-KSB for the year ended December 31, 2004.AVAX does not undertake any obligation to release publicly anyrevisions to these forward-looking statements or to reflect theoccurrence of unanticipated events.
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