PRAECIS PHARMACEUTICALS
INCORPORATED Announces Submission of
Investigational New Drug Application
Wednesday April 16, 7:02 am ET
WALTHAM, Mass.--(BUSINESS WIRE)--April 16, 2003--PRAECIS PHARMACEUTICALS
INCORPORATED (NASDAQ: PRCS - News) today announced the submission to the
United States Food and Drug Administration (FDA) of an Investigational New Drug
application (IND) to initiate a Phase I clinical study of PPI-2458, the Company's drug
candidate for the treatment of non-Hodgkin's lymphoma. PPI-2458 is a novel,
proprietary molecule based on the fumagillin class of compounds that have been
shown to prevent both abnormal cell growth and the formation of new blood vessels
(known as anti-angiogenesis), which contribute to aberrant tissue growth. In the
proposed study, the Company will evaluate an oral formulation of PPI-2458 in
non-Hodgkin's lymphoma patients who are no longer deriving benefits from other
therapies. Following submission, the FDA has 30 days to review and provide feedback
on the Company's IND. Assuming that the FDA accepts the IND and has no comments
or requests, the Company expects to initiate its Phase I clinical trial during the second
half of 2003.
"We are very pleased that we have taken this important step toward moving PPI-2458,
our third compound from internal research and discovery efforts, forward into human
clinical trials," said Malcolm L. Gefter, Ph.D., Chairman and Chief Executive Officer
of PRAECIS. "This event comes on the heels of the resubmission of our New Drug
Application for our first compound, Plenaxis(TM), for the treatment of advanced prostate
cancer, for which we are awaiting FDA action. PPI-2458 has demonstrated potent
preclinical anti-cancer activity across a broad range of tumor cell lines at the National Cancer
Institute, as well as in animal models of cancer here at PRAECIS. This compound could
well represent an important new class of therapy in the fight against non-Hodgkin's
lymphoma."
The Company also announced that United States Patent No. 6,548,477 was issued on
April 15, 2003 covering a family of fumagillin analogs, including PPI-2458.
Non-Hodgkin's lymphoma is a cancerous condition which is characterized by abnormal
growth of the cells which comprise lymph nodes. Lymph nodes are found throughout
the body and are a major part of the body's immune system. According to the American
Cancer Society, approximately 53,400 Americans will be diagnosed with non-Hodgkin's
lymphoma in 2003. Approximately 85% of non-Hodgkin's lymphomas are B-cell
lymphomas. Current treatments for B-cell non-Hodgkin's lymphoma include radiation
treatment, chemotherapy and treatment with specific monoclonal antibodies depending
on the type and stage of disease.
In addition to non-Hodgkin's lymphoma, the Company also intends to continue
evaluating the potential utility of PPI-2458 for treating other cancers, as well as
rheumatoid arthritis. <snip> |
