Xanthus announces Phase 1 results for P2045 - a targeted agent for nonsmall cell lung cancer
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- Category: Proteins and Peptides
- Published on Tuesday, 05 June 2007 04:00
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CAMBRIDGE, MA, USA | June 3, 2007 | Xanthus Pharmaceuticals, Inc. today announced the presentationof 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 ScheringAG. The presentation was made in a poster session at the 43rd Annual Meeting of the American Society ofClinical Oncology (ASCO). In the study, a single dose of P2045 was well tolerated and patient survivalwas encouraging.
The Phase 1 dose-escalation study of P2045, an agent that specifically targets tumors that over-expresssomatostatin receptors (SSTR) such as lung cancer, follows two earlier Phase 1 studies conducted bySchering AG that confirmed the candidate’s targeted activity to lung cancer. Researchers evaluated thesafety of the compound in combination with Rhenium-188. In this study, eight patients with advancedlung cancer received single doses of 30 mCi/m2, 60 mCi/m2 or 90 mCi/m2 of the Rhenium-188/P2045combination. While no radiographic responses were seen, five of the eight patients had stable disease ateight weeks, all of whom entered the trial with progressive disease. Additionally, median event freesurvival was 3.1 months and median overall survival was 11.5 months. No symptomatic or laboratorydose-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 stabledisease following treatment with P2045,” said Martin J. Edelman, M.D., Professor of Medicine at theMaryland Greenebaum Cancer Center and lead investigator for the study. “These are encouraging resultsfor an early clinical trial, especially given that these patients had progressed after prior therapies andreceived only a single dose of P2045.”
“We believe that this study confirms Xanthus’ expectations about the targeted mechanism of action andtherapeutic 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 clinicaldevelopment 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 Re188somatostatis analogue P2045.”
About P2045P2045 is a small peptide of 11 amino acids that specifically targets tumors over-expressing somatostatinreceptors (SSTR) such as lung cancers, neuroendocrine cancers and some breast cancers. P2045, whencombined with the radioisotope, Rhenium-188, is designed to deliver a dose of radiation to SSTRexpressingtumors, thereby eradicating the tumor or inhibiting its growth. The Company plans to developP2045 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-moleculetherapeutic candidates through a management team whose accomplished track record encompasses allaspects of drug development, from discovery through regulatory approval and commercialization.Xanthus is applying its expertise to advance its current pipeline to address significant unmet medicalneeds 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 ofrisks and uncertainties. For this purpose, any statements contained herein that are not statements ofhistorical fact may be deemed to be forward-looking statements. Without limiting the foregoing, thewords, "believes," "anticipates," "plans," "expects," "estimates," "intends," "should," "could,""will," "may," and similar expressions are intended to identify forward-looking statements. There area number of important factors that could cause Xanthus’ actual results to differ materially from thoseindicated by such forward-looking statements, including risks as to whether results obtained in earlyclinical studies or in preclinical studies such as the studies referred to above will be indicative of resultsobtained in future preclinical studies or clinical trials or warrant clinical trials; whether productsbased on Xanthus’ technology will advance through the clinical trial process and receive approvalfrom 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; andwhether the patents and patent applications owned or licensed by Xanthus, such as the patents andpatent applications licensed from Johns Hopkins University, will protect the Company’s technologyand prevent others from infringing it. Xanthus disclaims any intention or obligation to update anyforward-looking statements.
SOURCE: Xanthus Pharmaceuticals, Inc.