Matrix Pharmaceutical (ticker: MATX, exchange: NASDAQ) News Release - Wednesday, May 12, 1999
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FDA Grants Matrix Fast Track Status for IntraDose in Head and Neck Cancer
Business Editors/Health & Medical Writers
FREMONT, Calif.--(BW HealthWire)--May 12, 1999--Matrix Pharmaceutical, Inc. (NNM:MATX) today announced that the U.S. Food and Drug Administration has granted fast track review status to the Company's lead cancer product candidate, IntraDose(TM) (cisplatin/epinephrine) Injectable Gel.
FDA guidelines include a six month goal for the review of new product applications identified as fast track. The fast track review process was authorized by the FDA Modernization Act of 1997 to expedite the review of treatments that have the potential to address unmet medical needs for serious life-threatening disease.
"We at Matrix appreciate the effort by the FDA to give IntraDose a more rapid review and to acknowledge the importance of new treatments for recurrent and refractory head and neck cancer," said Natalie McClure, Vice President for Regulatory Affairs and Quality Assurance. "Fast track status will permit us to pursue the fastest possible approval path for IntraDose including the potential to submit portions of our New Drug Application in advance of the final pivotal trial results."
Matrix anticipates completing its submission of the IntraDose New Drug Application (NDA) in last half of 2000 following completion of the two double-blind, placebo-controlled Phase III trials of IntraDose currently enrolling patients with recurrent and refractory head and neck cancer who are considered incurable with surgery or radiation. The planned NDA submission will also include the data from completed open-label Phase III studies of IntraDose in other solid tumors, including recurrent breast cancer, malignant melanoma, and esophageal cancer.
IntraDose is a novel cancer therapy designed to provide and retain high concentrations of the potent anticancer drug cisplatin within tumors through direct intratumoral injection while reducing the significant side effects normally associated with intravenous administration of cisplatin.
Located in Fremont, Matrix Pharmaceutical, Inc. is developing novel local and systemic treatments for cancer. In addition to the above-mentioned trials, IntraDose is also being evaluated in Phase II studies in primary and metastatic liver disease. MPI 5020, a locally injected gel designed to enhance the cytotoxic effects of radiation therapy, is in a Phase I/II trial in recurrent and metastatic breast cancer. Matrix has recently acquired FMdC, a potent nucleoside analog and inhibitor of the enzyme ribonucleotide reductase that has completed Phase I studies in numerous types of solid tumors.
This press release contains, in addition to historical statements, forward looking statements relating to the Company's plans to complete IntraDose clinical trials currently enrolling patients and to use these and other studies to seek marketing approval of IntraDose. Such statements are subject to risks and uncertainties including but not limited to the potential for delays in filing an NDA or the potential that the clinical data will not be adequate to submit an NDA. Note also that the granting of fast track status does not imply greater or lesser chance of ultimate product approval. Additional risk factors are listed in the Company's most recent filings with the Securities and Exchange Commission, including Form 10-Q for the quarter ended Sept. 30, 1998.
Note to Editors: Previous Matrix news releases are available on the World Wide Web at www.businesswire.com/cnn/matx.htm. Also visit the Matrix web site at www.matx.com.
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CONTACT: Matrix Pharmaceutical, Inc.
Peter Dworkin, 510/494-7750
KEYWORD: CALIFORNIA
INDUSTRY KEYWORD: BIOTECHNOLOGY PHARMACEUTICAL MEDICINE PRODUCT
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