06.09.2005 15:31:00
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AVAX Technologies Announces the Filing of IND for the Treatment of Patients with Non Small Cell Lung Cancer
David Berd, MD, Chief Medical Officer of AVAX stated, "We arehappy to have submitted this IND and look forward to working with theUniversity of Pennsylvania to begin the study and to be able to offerNSCLC patients a potential new treatment. With this indication, andthe ongoing studies treating melanoma in the United States andmetastatic peritoneal cancer in France, we are confident we will beable to demonstrate the utility of the AC Vaccine Therapeutic as aplatform technology." Berd added "Based upon previous observations ofregression of melanoma lung metastases after administration of M-Vax,our AC Vaccine Therapeutic for the treatment of melanoma, we feelthere is a strong rationale for testing the vaccine in thisindication. Moreover, the fact that NSCLC is a chemically-inducedcancer makes it likely to be immunogenic and responsive to appropriateimmunotherapy."
Richard Rainey, President of AVAX stated: "Given our previousfindings in lung metastases, the potential to utilize the AC Vaccinein NSCLC represents a significant step in AVAX's corporate strategy.NSCLC is a terribly common disease with about 175,000 new cases peryear in the United States and a similar number in Europe. About 25% ofthese are stage I or II patients that could be candidates for ourvaccine approach." Rainey added: "This trial represents a significantadvance for AVAX. By the end of this year we will be treating patientsin three separate cancer indications and we will have treated morepatients with M-Vax than in any previous year of the Company'shistory."
During June 2005, AVAX initiated enrollment of patients into itsmelanoma study. Currently there are two sites accruing patients andtwo more that will be initiated in the coming week. Three additionalsites are expected to be operational in September. In addition, theCompany continues to make M-Vax available to patients in Europe on acompassionate use basis. M-Vax is distributed in Europe through GROUPOFERRAR, S.A.
Information for Patients
Patients and clinicians interested in learning more about thecurrent clinical trial of melanoma or who want a list of theparticipating sites may contact Dr. David Berd at (215) 241-9760X1306.
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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