Healthcare Industry News:  NSCLC 

Biopharmaceuticals Oncology

 News Release - June 3, 2007

Xanthus Announces Phase 1 Results for P2045 - a Targeted Agent for Non-Small Cell Lung Cancer

Phase 1 Data Presented at ASCO Meeting

CAMBRIDGE, Mass.--(HSMN NewsFeed)--Xanthus Pharmaceuticals, Inc. today announced the presentation of Phase 1 data from a study of P2045 conducted by Bayer Schering Pharma AG (formerly Schering AG) in patients with advanced lung cancer. The Company holds an exclusive license to P2045 from Schering AG. The presentation was made in a poster session at the 43rd Annual Meeting of the American Society of Clinical Oncology (ASCO). In the study, a single dose of P2045 was well tolerated and patient survival was encouraging.

The Phase 1 dose-escalation study of P2045, an agent that specifically targets tumors that over-express somatostatin receptors (SSTR) such as lung cancer, follows two earlier Phase 1 studies conducted by Schering AG that confirmed the candidate's targeted activity to lung cancer. Researchers evaluated the safety of the compound in combination with Rhenium-188. In this study, eight patients with advanced lung cancer received single doses of 30 mCi/m2, 60 mCi/m2 or 90 mCi/m2 of the Rhenium-188/P2045 combination. While no radiographic responses were seen, five of the eight patients had stable disease at eight weeks, all of whom entered the trial with progressive disease. Additionally, median event free survival was 3.1 months and median overall survival was 11.5 months. No symptomatic or laboratory dose-limiting toxicities were observed, and P2045 with Rhenium-188 was generally well tolerated.

"We observed that several patients who came into this study with progressive lung cancer achieved stable disease following treatment with P2045," said Martin J. Edelman, M.D., Professor of Medicine at the Maryland Greenebaum Cancer Center and lead investigator for the study. "These are encouraging results for an early clinical trial, especially given that these patients had progressed after prior therapies and received only a single dose of P2045."

"We believe that this study confirms Xanthus' expectations about the targeted mechanism of action and therapeutic potential for P2045, which were based on prior work with the candidate," said Richard T. Dean, Ph.D., Chief Executive Officer of Xanthus. "We look forward to continuing the clinical development of this novel compound."

These data were presented on Sunday, June 3, 2007 from 8:00am until 12:00pm in an abstract titled, "Targeted radiopharmaceutical therapy for advanced lung cancer: Phase 1 trial of rhenium Re188 somatostatis analogue P2045."

About P2045

P2045 is a small peptide of 11 amino acids that specifically targets tumors over-expressing somatostatin receptors (SSTR) such as lung cancers, neuroendocrine cancers and some breast cancers. P2045, when combined with the radioisotope, Rhenium-188, is designed to deliver a dose of radiation to SSTR-expressing tumors, thereby eradicating the tumor or inhibiting its growth. The Company plans to develop P2045 for intravenous administration to patients with advanced lung cancer - non-small cell lung cancer (NSCLC) or small cell lung cancer (SCLC).

About Xanthus Pharmaceuticals, Inc.

Xanthus Pharmaceuticals, Inc. is developing a portfolio of novel, clinical-stage, small-molecule therapeutic candidates through a management team whose accomplished track record encompasses all aspects of drug development, from discovery through regulatory approval and commercialization. Xanthus is applying its expertise to advance its current pipeline to address significant unmet medical needs in oncology and autoimmune diseases.

Xanthus is headquartered in Cambridge, Massachusetts with an additional facility in Montreal, Quebec. More information is available at www.xanthus.com.

This press release contains forward-looking statements concerning Xanthus that involve a number of risks and uncertainties. For this purpose, any statements contained herein that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the foregoing, the words, "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could," "will," "may," and similar expressions are intended to identify forward-looking statements. There are a number of important factors that could cause Xanthus' actual results to differ materially from those indicated by such forward-looking statements, including risks as to whether results obtained in early clinical studies or in preclinical studies such as the studies referred to above will be indicative of results obtained in future preclinical studies or clinical trials or warrant clinical trials; whether products based on Xanthus' technology will advance through the clinical trial process and receive approval from the United States Food and Drug Administration or equivalent foreign regulatory agencies; whether the company will have the cash resources to develop and commercialize its products; and whether the patents and patent applications owned or licensed by Xanthus, such as the patents and patent applications licensed from Johns Hopkins University, will protect the Company's technology and prevent others from infringing it. Xanthus disclaims any intention or obligation to update any forward-looking statements.


Source: Xanthus Pharmaceuticals

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