Xanthus Life Sciences Initiates A Phase 2 Study Of Xanafide In Combination With Ara-C For Treatment Of Secondary AML

CAMBRIDGE, Mass., Oct. 20 /PRNewswire/ -- Xanthus Life Sciences today announced the commencement of a Phase 2 study of Xanafide(TM) (amonafide malate) in combination with cytosine arabinoside (ara-C) for the treatment of patients with secondary acute myeloid leukemia (AML).

"Currently, there are no approved therapies specifically indicated for secondary AML, a disease that responds infrequently and only briefly to standard therapies," said Robert L. Capizzi, M.D., Xanthus' Chief Medical Officer. "We are extremely encouraged by the 46% response rate achieved in the Phase 1 trial of amonafide and ara-C in patients with AML, together with the acceptable safety profile, given that the vast majority of enrollees in this phase 2 trial are likely to be elderly, with high-risk AML."

About the Phase 2 study

The Phase 2 study will be conducted at multiple centers in North America and is expected to enroll up to 60 patients with secondary AML (patients with antecedent myelodysplastic syndrome or prior exposure to leukemogenic therapy). Patients will receive a daily dose of Xanafide for five days in combination with a standard dose of ara-C as a continuous infusion for 7 days. The primary endpoint of the study is the rate of complete remission, and secondary endpoints include duration of remission and overall survival.

About Xanafide(TM)

Xanafide (amonafide malate) is an ATP-independent topoisomerase 2 inhibitor. In a Phase 1 study, amonafide and ara-C in patients with poor-risk AML demonstrated a clinical response rate of 46% (12/26), with 38% (10/26) achieving complete remission and two patients achieving near-complete remission. The median duration of remission was five months, with two patients remaining disease-free for over two years and over 5 years following post remission therapy. Results of this Phase 1 study were presented at the 2005 ASCO annual meeting.

About Xanthus

Xanthus is an oncology drug development company. Xanthus' small molecule candidates are Xanafide(TM), Symadex(TM) and Clomet(TM) which are advancing in clinical and preclinical development for multiple cancer indications. Each of these product candidates was in-licensed based on significant clinical and/ or preclinical data supporting safety and activity. Xanthus also has proprietary technology to individualize patient dosing, which it believes may help improve the performance of certain drugs in development, and facilitate the life cycle management of certain marketed products, without limiting patient populations or markets.

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.

CONTACT: Richard T. Dean, Ph.D., Chief Executive Officer of Xanthus LifeSciences, +1-617-225-0522; or Kari Watson of MacDougall BiomedicalCommunications, Inc., for Xanthus Life Sciences, +1-508-647-0209,kwatson@macbiocom.com

Web site: http://www.xanthus.com//