Xanthus Life Sciences Initiates Phase 2 Clinical Trial With Symadex In Women With Metastatic Breast Cancer

CAMBRIDGE, Mass., Jan. 3 /PRNewswire/ -- 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 women with metastatic breast cancer following anthracycline and taxane failure.

“Even though significant advances have been made in the treatment of early breast cancer, treatment options for advanced breast cancer are still limited and metastatic breast cancer is almost always fatal,” stated Robert L. Capizzi, M.D., Senior Vice President and Chief Medical Officer at Xanthus. “We are particularly enthusiastic about Symadex in the treatment of metastatic breast cancer because prior studies suggest that its activity will not be affected by acquired resistance to the commonly-used first-line therapies. We also believe that the potential reduction in cardio- and hemato-toxicities associated with Symadex will be beneficial to this very sick patient population.”

“The initiation of this study is an important milestone for our Company as it marks Xanthus’ second oncology candidate to enter Phase 2 clinical trials this year. In 2006, we plan to initiate a second Phase 2 study with Symadex in patients with metastatic colorectal cancer, and expect to broaden our clinical pipeline by entering the clinic with our third oncology candidate, Clomet(TM),” noted Richard T. Dean, Ph.D., President and CEO of Xanthus.

About the Phase 2 Metastatic Breast Cancer Trial

The trial is an open-label, multi-center European study of Symadex expected to enroll 49 patients with metastatic breast cancer who relapsed following prior treatment with an anthracycline and taxane regimen. Patients will be treated with Symadex via intravenous administration weekly for three weeks followed by a week of rest for a minimum of two four-week cycles. After completing two cycles, patients with stable disease will continue for two further cycles. Responding patients will continue for additional cycles with tumor assessments every eight weeks 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.

About Symadex(TM)

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., Novantrone(R) (mitoxantrone)), but with reduced cardio- and hemato-toxicities known to be associated with these active drugs. Additionally, in previous preclinical studies, Symadex has shown early evidence of both oral activity and efficacy in various models of acquired drug resistance. The Company intends to develop Symadex in several 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.

Contacts:

Kari Watson, MacDougall Biomedical Communications, Inc. - kwatson@macbiocom.com or (508) 647-0209

John A. McCarthy, Jr., Senior Vice President & CFO, Xanthus Life Sciences, Inc. - john.mccarthy@xanthus.com or (617) 225-0522, x 125

Xanthus Life Sciences, Inc.

CONTACT: Kari Watson of MacDougall Biomedical Communications, Inc., +1-508-647-0209, kwatson@macbiocom.com; or John A. McCarthy, Jr., Senior VicePresident & CFO of Xanthus Life Sciences, Inc., +1-617-225-0522, ext. 125,john.mccarthy@xanthus.com

MORE ON THIS TOPIC