Healthcare Industry News: myelodysplastic syndromes
News Release - April 30, 2007
Cyclacel Pharmaceuticals Begins Phase II Study of Oral Sapacitabine in Patients with Advanced Cutaneous T-Cell LymphomaBERKELEY HEIGHTS, N.J.--(HSMN NewsFeed)--Cyclacel Pharmaceuticals, Inc. (Nasdaq: CYCC ; Nasdaq: CYCCP ) announced today that the company has initiated a multicenter randomized Phase II clinical trial of sapacitabine (CYC682), an orally available nucleoside analog, in patients with advanced cutaneous T-cell lymphoma (CTCL). The study is the first of several Phase II clinical trials the company plans to begin this year to evaluate sapacitabine's potential in hematological and solid tumors.
The multicenter study is led by Dr. Madeleine Duvic, Professor & Deputy Chairman of the Department of Dermatology at The University of Texas M. D. Anderson Cancer Center (UTMDACC) in Houston, Texas. The primary objective of the study is to evaluate the tolerability and response rate of high-dose and low-dose regimens in patients with CTCL who have had progressive, recurrent, or persistent disease on or following two systemic therapies. The study uses a selection design with the objective of choosing an optimal dose in the event that both doses are active. Secondary objectives are to assess response duration, time to response, time to progression and relief of pruritus or itching.
"Nucleoside analogs, such as gemcitabine, have significant activity in CTCL" said Dr. Duvic. "We are interested in evaluating sapacitabine because of its unique mechanisms of action and the possibility that it may be an active drug in CTCL that can be orally administered. Although there are several treatment options for CTCL, the responses to these treatments are not durable and there is a need for new effective therapies."
"The opening of this study marks the initiation of the Phase II program of sapacitabine," said Spiro Rombotis, President and Chief Executive Officer of Cyclacel. "The sapacitabine program is part of Cyclacel's strategy to develop a portfolio of drugs that affect the cell cycle. Cyclacel's other development-stage programs include seliciclib, an orally-available CDK (cyclin dependent kinase) inhibitor in Phase II clinical trials for non-small cell lung cancer, and CYC116, an orally-available Aurora kinase and VEGFR2 inhibitor, at the IND stage."
Sapacitabine appears to act through a dual mechanism that is unique among nucleoside analogs. It interferes with DNA synthesis by causing single-strand DNA breaks and induces arrest of the cell division cycle at G2 phase. Both sapacitabine and its major metabolite, CNDAC, have demonstrated potent anti-tumor activity in preclinical studies. In a liver metastatic mouse model, sapacitabine was shown to be superior to gemcitabine or 5-FU, two widely used nucleoside analogs, in delaying the onset and growth of liver metastasis.
The study follows four Phase I trials in which sapacitabine has been given as a single agent to approximately 150 patients: three in patients with incurable solid tumors and one in patients with advanced leukemias or myelodysplastic syndromes.
Cutaneous T-cell lymphoma, or CTCL, is a cancer of a type of white blood cell called T-lymphocytes. The most common types of CTCL are mycosis fungoides and Sezary syndrome. In mycosis fungoides, cancerous T-cell lymphocytes affect the skin. In Sezary syndrome, cancerous T-cell lymphocytes affect the skin and peripheral blood. CTCL patients suffer from disfiguring skin lesions and severe itching or pruritus. CTCL affects an estimated 20,000 patients in the United States, typically developing the disease after the age of 50. Approximately 1,500 new cases are reported each year.
About Cyclacel Pharmaceuticals, Inc.
Cyclacel is a biopharmaceutical company dedicated to the discovery, development and commercialization of novel, mechanism-targeted drugs to treat human cancers and other serious disorders. The Company is currently evaluating seliciclib (CYC202), an orally-available CDK (cyclin dependent kinase) inhibitor, in Phase IIb clinical trials for the treatment of lung cancer. Sapacitabine (CYC682), an orally-available, cell cycle modulating nucleoside analog, is in Phase II trials for the treatment of cutaneous T-cell lymphoma (CTCL) and Phase I trials in patients with hematologic malignancies. CYC116, an orally-available, Aurora kinase and VEGFR2 inhibitor, is at the IND stage. Several additional programs are at an earlier stage.
Please visit http://www.cyclacel.com/cyc/investors/news/pressreleases for additional information.
Note: The Cyclacel logo and CyclacelŽ are trademarks of Cyclacel Pharmaceuticals, Inc.
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety, and intended utilization of Cyclacel's product candidates, the conduct and results of future clinical trials, plans regarding regulatory filings, future research and clinical trials and plans regarding partnering activities. Factors that may cause actual results to differ materially include the risk that product candidates that appeared promising in early research and clinical trials do not demonstrate safety and/or efficacy in larger-scale or later clinical trials, the risk that Cyclacel will not obtain approval to market its products, the risks associated with reliance on outside financing to meet capital requirements, and the risks associated with reliance on collaborative partners for further clinical trials, development and commercialization of product candidates. You are urged to consider statements that include the words "may," "will," "would," "could," "should," "believes," "estimates," "projects," "potential," "expects," "plans," "anticipates," "intends," "continues," "forecast," "designed," "goal," or the negative of those words or other comparable words to be uncertain and forward-looking. These factors and others are more fully discussed under "Risk Factors" in the registration statement on Forms S-3 (File No. 333-134945) and S-4 (File No. 333-131225) and in the other reports of Cyclacel filed with the SEC.
Source: Cyclacel Pharmaceuticals
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