Healthcare Industry News: oxaliplatin
News Release - January 17, 2006
Xanthus Initiates Phase 2 Clinical Trial with Symadex in Patients with Metastatic Colorectal CancerCAMBRIDGE, Mass., Jan. 17 (HSMN NewsFeed) -- Xanthus Life Sciences, Inc., a privately-held oncology drug development company, today announced that it has begun dosing patients in a Phase 2 clinical trial with Symadex(TM) (C-1311) in patients with metastatic colorectal cancer who relapsed following prior treatment with an oxaliplatin and/or an Irinotecan regimen.
"Metastatic colorectal cancer remains an essentially incurable disease that is characterized by serious morbidity. We believe there is still a great need for additional effective second- and third-line novel agents with different mechanisms of action that might complement existing therapies," stated Robert L. Capizzi, M.D., Senior Vice President and Chief Medical Officer at Xanthus. "We believe that Symadex has particularly strong potential in this cancer type given that the drug has demonstrated superior anti-tumor activity in vitro when compared to three approved agents that are widely used for treating human colorectal cancer."
"This study is Xanthus' third Phase 2 clinical trial initiated in the last three months. These studies are important milestones for our company as our clinical strategy is to rapidly advance multiple, well-characterized, small- molecule oncology drug candidates that both meet unmet medical needs and improve on existing therapies," noted Richard T. Dean, Ph.D., President and CEO of Xanthus.
About the Phase 2 Metastatic Colorectal Cancer Trial
The trial is an open-label, multi-center European study of Symadex expected to enroll approximately 49 patients with metastatic colorectal cancer following oxaliplatin and/or Irinotecan failure. Patients will receive weekly intravenous infusions of Symadex for three weeks, followed by a week of rest for a total of four cycles. Responding patients will continue for additional cycles with regular tumor assessments until progressive disease or death. The primary objective of the study is overall response rate (including patients with complete responses and partial responses). Secondary objectives of the study include, time-to-progression, duration-of-response and overall survival, as well as determination of toxicity and pharmacokinetic characteristics for Symadex.
Symadex (formerly C-1311) is a next-generation investigational anticancer drug that has shown a potentially novel, targeted mechanism of action in preclinical studies. Symadex was developed to deliver efficacy comparable to anthracyclines (e.g., doxorubicin) and anthracenediones (e.g., NovantroneŽ (mitoxantrone)), but with reduced cardio-, and other non-hematological toxicities as well as hemato-toxicities known to be associated with these active drugs. Additionally, in previous Phase 1 and preclinical studies, Symadex has shown evidence of oral activity. The Company intends to test Symadex in multiple tumor indications. Xanthus is also exploring the use of Symadex for the treatment of a number of autoimmune diseases, such as Multiple Sclerosis, where early preclinical data has shown encouraging signs of activity. Xanthus licensed intellectual property related to Symadex from BTG International, Ltd.
About Xanthus Life Sciences, Inc.
Xanthus Life Sciences, Inc. is developing a portfolio of novel, clinical- stage, small-molecule oncology drugs through a management team whose accomplished track record encompasses all aspects of drug development, from discovery through regulatory approval and commercialization. The Company is applying its expertise both to advance its current pipeline and expand it into indications of unmet medical need beyond oncology.
Xanthus is headquartered in Cambridge, Massachusetts with an additional facility in Montreal, Quebec. More information is available at http://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 clinical trials or warrant additional 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 patent and patent applications owned or licensed by Xanthus 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 Life Sciences
Issuer of this News Release is solely responsible for its
Please address inquiries directly to the issuing company.