PRAECIS PHARMACEUTICALS INCORPORATED Presents Preclinical Data on PPI-2458
September 21 2005 - 8:44AM
Business Wire
PRAECIS PHARMACEUTICALS INCORPORATED (NASDAQ: PRCS) today announced
that it presented preclinical data on its investigational compound,
PPI-2458, at the Cambridge Healthtech Institute's Inaugural
Targeted Cancer Therapies Conference being held in Cambridge,
Massachusetts. The Company's presentation, entitled "Inhibitors of
Methionine Aminopeptidase-2 (MetAP-2) in the Treatment of
Non-Hodgkin's Lymphoma," was delivered by William Westlin, Ph.D.,
Vice President, Preclinical Research. A copy of the presentation is
available on the Company's website at http://www.praecis.com, under
"Investors." The Company believes PPI-2458 represents a potentially
new and important addition to the growing list of therapeutics
aimed at specific molecular oncology targets. PPI-2458 is a novel,
proprietary molecule belonging to the fumagillin class of compounds
that specifically targets the MetAP-2 enzyme. This class of
compounds has been shown to prevent both abnormal cell growth and
the formation of new blood vessels (known as angiogenesis), which
contribute to the growth of aberrant tissues in diseases such as
cancer and rheumatoid arthritis. Clinical development with previous
fumagillin derivatives has been limited by their toxicity profile.
In preclinical studies to date, PPI-2458 has demonstrated the
potent pharmacologic activity of this class of compounds while
displaying an improved pharmacokinetic and toxicity profile. In
preclinical studies conducted separately by PRAECIS and the
National Cancer Institute, using both cellular and animal models,
PPI-2458 demonstrated significant anti-tumor activity against
several varied cancer cell lines. Preclinical data presented today
demonstrates that PPI-2458's potent inhibition of MetAP-2 presents
the potential for use as a new therapy for non-Hodgkin's lymphoma
(NHL). MetAP-2 is highly expressed in human germinal center B
cells. The neoplastic counterparts of these cells are the cell
types observed in certain NHL subtypes, such as diffuse large B
cell lymphoma and follicular lymphoma. PPI-2458 has been shown to
reduce the formation of germinal centers in lymphoid tissues in
vivo, have direct anti-proliferative activity on NHL cells in vitro
and inhibit the growth of NHL tumors in a preclinical model in
vivo. The anti-tumor activity of PPI-2458 was dose-dependent in
this preclinical in vivo model and directly correlated with the
level of molecular target MetAP-2 enzyme inhibition in tumor
tissue, as measured by a proprietary, pharmacodynamic assay
developed by PRAECIS. Additionally, the activity of PPI-2458 in
this preclinical model was synergistic with several
chemotherapeutic agents that are routinely used in combination in
NHL patients. The Company believes these and other preclinical
results provide the non-clinical rationale for clinical
investigation of PPI-2458 in patients with certain cancerous
tumors. PRAECIS has initiated a Phase 1 clinical study of PPI-2458
in patients with non-Hodgkin's lymphoma or solid tumors. The study
is designed to assess the safety and tolerability of orally
administered PPI-2458. As a secondary endpoint, the study will
assess the pharmacodynamic activity of PPI-2458. Additional
information about the Company's clinical trial for PPI-2458 can be
accessed on the Internet at www.clinicaltrials.gov. In addition to
the ongoing clinical trial in cancer patients, the Company
continues to conduct preclinical evaluations of the use of this
compound for treating certain inflammatory and autoimmune
disorders, including rheumatoid arthritis. About PRAECIS PRAECIS
PHARMACEUTICALS INCORPORATED is a biopharmaceutical company focused
on the discovery, development and commercialization of innovative
therapies that either address unmet medical needs or offer
improvements over existing therapies. PRAECIS has a novel MetAP-2
inhibitor in clinical development for non-Hodgkin's lymphoma and
solid tumors, as well as an innovative drug discovery technology,
Direct Select(TM), which enables the generation and practical use
of ultra-large libraries for the discovery of orally active
compounds for drug development. PRAECIS is also seeking approval to
market Plenaxis(R) in Germany. This news release contains
forward-looking statements regarding the Company's continued
clinical development of PPI-2458. These statements are based on the
Company's current beliefs and expectations as to future outcomes
and are not guarantees of future events or performance. Such
statements are subject to numerous factors and uncertainties. These
include, but are not limited to, the timing and content of
decisions made by the FDA, unexpected results in ongoing and future
preclinical or clinical trials and related analyses, and the need
for additional research and testing, including those required as a
result of unanticipated determinations by the FDA, as well as the
risks set forth from time to time in the Company's filings with the
Securities and Exchange Commission, including but not limited to
the risks discussed in the Company's Quarterly Report on Form 10-Q
for the quarter ended June 30, 2005. The Company undertakes no
obligation to update any forward-looking statement made in this
press release to reflect new information, events or circumstances
after the date of this release.
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