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PRAECIS PHARMACEUTICALS INCORPORATED Presents Preclinical Data on PPI-2458.


WALTHAM, Mass. -- PRAECIS PHARMACEUTICALS INCORPORATED (NASDAQ NASDAQ
 in full National Association of Securities Dealers Automated Quotations

U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on
: PRCS PRCS Palestine Red Crescent Society
PRCS Permit Required Confined Space
PRCS Primary Reaction Control System
PRCS Senior Chief Parachute Rigger (Naval Rating)
PRCS Pseudorandom Chip Stream
PRCS Project Revision Control System
) 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 methionine (mĕthī`ənēn), organic compound, one of the 20 amino acids commonly found in animal proteins. Only the L-stereoisomer appears in mammalian protein.  Aminopeptidase-2 (MetAP-2) in the Treatment of Non-Hodgkin's Lymphoma non-Hodg·kin's lymphoma
n.
Any of various malignant lymphomas characterized by the absence of Reed-Sternberg cells.


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 Blood vessels

Tubular channels for blood transport, of which there are three principal types: arteries, capillaries, and veins. Only the larger arteries and veins in the body bear distinct names.
 (known as angiogenesis angiogenesis /an·gio·gen·e·sis/ (-jen´e-sis) vasculogenesis; development of blood vessels either in the embryo or in the form of neovascularization or revascularization.

an·gi·o·gen·e·sis
n.
), which contribute to the growth of aberrant tissues in diseases such as cancer and rheumatoid arthritis rheumatoid arthritis

Chronic, progressive autoimmune disease causing connective-tissue inflammation, mostly in synovial joints. It can occur at any age, is more common in women, and has an unpredictable course.
. Clinical development with previous fumagillin derivatives has been limited by their toxicity profile. In preclinical studies preclinical studies,
n.pl a term used to describe research done before a clinical study. May be laboratory or epidemiologic research.
 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 NHL Non-Hodgkin's lymphoma, see there ). MetAP-2 is highly expressed in human germinal center B cells. The neoplastic neoplastic /neo·plas·tic/ (ne?o-plas´tik)
1. pertaining to a neoplasm.

2. pertaining to neoplasia.


neoplastic

pertaining to neoplasia or a neoplasm.
 counterparts of these cells are the cell types observed in certain NHL subtypes, such as diffuse large B cell lymphoma Diffuse large B-cell lymphoma is a type of aggressive Non-Hodgkin Lymphoma. It accounts for approximately 40% of NHL in adulthood[1] References

1. ^ [1] Pathobiology of the aggressive and highly aggressive non-Hodgkin's lymphomas
 and follicular lymphoma follicular lymphoma
n.
See nodular lymphoma.


follicular lymphoma Follicle center lymphoma A heterogeneous group of NHLs arising in follicular center cells, which comprises 50% of all NHLs in adults–US,
. 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 FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
, 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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Publication:Business Wire
Date:Sep 21, 2005
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