SEC Info  
    Home      Search      My Interests      Help      Sign In      Please Sign In

Avax Technologies Inc – ‘8-K’ for 7/26/00 – EX-99.4

On:  Wednesday, 7/26/00, at 2:00pm ET   ·   For:  7/26/00   ·   Accession #:  912057-0-33224   ·   File #:  0-29222

Previous ‘8-K’:  ‘8-K’ on / for 7/26/00   ·   Next:  ‘8-K’ on 9/8/00 for 8/24/00   ·   Latest:  ‘8-K’ on / for 3/26/09

Find Words in Filings emoji
 
  in    Show  and   Hints

  As Of                Filer                Filing    For·On·As Docs:Size              Issuer               Agent

 7/26/00  Avax Technologies Inc             8-K:5,7     7/26/00    7:43K                                    Merrill Corp/FA

Current Report   —   Form 8-K
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 8-K         Current Report                                         5     18K 
 2: EX-99.1     Miscellaneous Exhibit                                  2     12K 
 3: EX-99.2     Miscellaneous Exhibit                                  2     12K 
 4: EX-99.3     Miscellaneous Exhibit                                  2±    10K 
 5: EX-99.4     Miscellaneous Exhibit                                  2±    11K 
 6: EX-99.5     Miscellaneous Exhibit                                  2     14K 
 7: EX-99.6     Miscellaneous Exhibit                                  2     14K 


EX-99.4   —   Miscellaneous Exhibit

EX-99.4TOCTopPreviousNextBottomJust 1st
 

EXHIBIT 99.4 Company Contact: Ernest W. Yankee, Ph.D. AVAX Technologies, Inc. (816) 960-1333 Investors/Media: Olga Fleming/Lisa Bradlow CPR Financial Communications (201) 641-2408 AVAX INITIATES A PHASE 1/2 STUDY OF L-VAX-TM- IN ACUTE MYELOGENOUS LEUKEMIA - STUDY AT M.D. ANDERSON CANCER CENTER EXTENDS APPLICATION OF THE AC VACCINE-TM- TECHNOLOGY TO FOURTH CANCER INDICATION - KANSAS CITY, MO, MAY 15, 2000 -- AVAX TECHNOLOGIES, INC. (NASDAQ: AVXT) today announced that it has initiated a Phase 1/2 study of L-Vax-TM-, its autologous therapeutic cancer vaccine for leukemia, in patients with acute myelogenous leukemia (AML), a rapidly progressing cancer of the blood affecting immature cells of the bone marrow. The L-Vax vaccine will be prepared from blood samples of the patients obtained after their first relapse. Patients in second remission will receive seven weekly L-Vax vaccinations followed by a six-month booster. The purpose of the study will be to evaluate L-Vax's ability to induce an immune response against the patients' leukemia cells and to prevent or delay another relapse. Approximately 40 patients will participate in the study. As with all applications of the AC Vaccine technology, the L-Vax vaccine will be an individualized therapy for cancer manufactured at AVAX's centralized manufacturing facility. The Phase 1/2 trial is being directed by Guillermo Garcia-Manero M.D., Assistant Professor of Medicine, The University of Texas M.D. Anderson Cancer Center, in collaboration with David Berd, M.D., Professor of Medicine, Thomas Jefferson University, the inventor of the AC Vaccine-TM- technology. Over 10,000 new cases of acute myelogenous leukemia are diagnosed annually in the U.S. Currently, the only therapy available to patients is intensive chemotherapy, sometimes with bone marrow transplant. Patients who achieve a remission after chemotherapy have a high rate of relapse (50-80%). Following relapse, few patients achieve another remission even with further chemotherapy. Jeffrey M. Jonas, M.D., President and CEO of AVAX Technologies, Inc., stated, "We are very pleased to be working with the M.D. Anderson Cancer Center to begin evaluating the AC Vaccine technology in a fourth tumor type, AML. This study further demonstrates that not only are we able to manufacture an autologous vaccine from solid tumors, but also from tumor cells in blood. Results from this study will enhance ongoing activities in our other studies in melanoma, ovarian and breast cancers, and further support additional new studies in other cancer indications." AVAX's AC Vaccines are made from the patient's own cancer cells by modifying the tumor cells with a molecule called a "hapten." This process, known as "haptenization," alters the tumor cells and makes them appear foreign to the patient's immune system. When the hapten-modified cells are injected into patients, they stimulate the immune system to recognize the cancer cells and destroy them. The company's lead product candidate, M-Vax-TM-, is currently being evaluated in a multi-center pivotal registration for stage III melanoma and in a Phase 2 trial for stage IV melanoma. To date, more than 350 patients have been treated with M-Vax, which has received orphan drug status in the U.S. M-Vax is expected to become commercially available to patients in Australia by mid-2000. The AC Vaccine technology is also being evaluated in a Phase 2 trial in ovarian cancer and in Japan for use in the treatment of breast cancer. AVAX Technologies, Inc. specializes in the development and commercialization of novel biotechnologies, immunotherapies and pharmaceuticals for cancer and other life-threatening diseases using three core technologies: autologous cell (AC) vaccines, topoisomerase inhibitors and anti-estrogens. # # # EXCEPT FOR STATEMENTS THAT ARE HISTORICAL, THE STATEMENTS IN THIS RELEASE ARE "FORWARD-LOOKING" STATEMENTS THAT ARE MADE PURSUANT TO THE SAFE HARBOR 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 ABILITY TO ACHIEVE THE STATED OUTCOMES AND TO DEVELOP SUCCESSFULLY AND COMMERCIALIZE ITS PRODUCT CANDIDATES, INCLUDING THE ABILITY TO OBTAIN AND MAINTAIN ALL NECESSARY PATENTS OR LICENSES, TO DEMONSTRATE THE SAFETY AND EFFICACY OF PRODUCT CANDIDATES AT EACH STAGE OF DEVELOPMENT, TO MEET APPLICABLE REGULATORY STANDARDS AND RECEIVE REQUIRED REGULATORY APPROVALS, TO MEET OBLIGATIONS AND REQUIRED MILESTONES UNDER ITS LICENSE AGREEMENTS, TO BE CAPABLE OF PRODUCING DRUG CANDIDATES IN COMMERCIAL QUANTITIES AT REASONABLE COSTS, TO COMPETE SUCCESSFULLY AGAINST OTHER PRODUCTS, TO OBTAIN SUBSTANTIAL ADDITIONAL FUNDS, AND TO MARKET PRODUCTS IN A PROFITABLE MANNER, 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 31,1999. AVAX DOES NOT UNDERTAKE ANY OBLIGATION TO RELEASE PUBLICLY ANY REVISIONS TO THESE FORWARD-LOOKING STATEMENTS OR TO REFLECT THE OCCURRENCE OF UNANTICIPATED EVENTS.

Dates Referenced Herein   and   Documents Incorporated by Reference

This ‘8-K’ Filing    Date    Other Filings
Filed on / For Period End:7/26/008-K
5/15/00
 List all Filings 
Top
Filing Submission 0000912057-00-033224   –   Alternative Formats (Word / Rich Text, HTML, Plain Text, et al.)

Copyright © 2024 Fran Finnegan & Company LLC – All Rights Reserved.
AboutPrivacyRedactionsHelp — Sun., Apr. 28, 10:09:25.1am ET