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"We are pleased with these results, which met the conditions specified in the study protocol for proceeding to the next stage," said Judy Chiao, M.D., Vice President, Clinical Development and Regulatory Affairs of Cyclacel. "We are grateful for the contributions of our investigators, their colleagues and patients who helped us complete the lead-in stage of this study. Although NPC is considered sensitive to radiation and chemotherapy treatments, once the disease recurs after initial chemotherapy and/or radiotherapy, the prognosis is poor despite the use of salvage chemotherapies. An unmet medical need exists for patients with recurrent and/or metastatic NPC. The results suggest that seliciclib induces prolonged stable disease and inhibits tumor growth in such patients and should be evaluated in randomized studies as a single agent and in combinations with other anti-cancer agents."
Best response by investigator assessment was:
-- 7 out of 10 NPC patients achieved stable disease (SD) including
3 with SD lasting longer than 8 months;
-- 4 patients with other cancers (malignant histiocytoma, non-small
cell lung, ovarian leiomyosarcoma and renal carcinomas) also
achieved SD.
Phase 2 Study Details
Twenty-three patients were randomized to one of two dosing schedules of seliciclib (400 mg twice a day and 800 mg once a day both for 4 consecutive days every week for 3 weekly cycles), of which 13 had solid tumors and 10 previously-treated NPC. Twenty-one patients have received prior systemic therapies including 7 who had four or more prior systemic therapies.
The data demonstrated that seliciclib could be safely administered by the oral route on two dosing schedules both for 4 days per week. Both dosing schedules were well tolerated and met the criteria for proceeding to the randomized stage of the study. The most common grade 3 or 4 adverse events were anemia, increase in ALT enzymes and hypokalemia in two patients each. Seliciclib treatment resulted in prolonged stable disease in previously-treated NPC patients suggesting seliciclib inhibits tumor growth in NPC. The data supports further clinical development of oral seliciclib in NPC as a single agent or in combination with other anti-cancer agents. The results of the trial will be submitted for publication in a peer-reviewed journal.
Study Reference
W. Yeo, et. al., "A phase II randomized study of oral seliciclib in patients with previously treated nasopharyngeal carcinoma", J Clin Oncol 27:15s, 2009 (suppl; abstr 6026).
Conference call and Webcast Information:
Cyclacel management will review the NPC data and discuss the progress of its pipeline on a conference call scheduled for Wednesday June 3rd at 4:30 p.m. Eastern. Conference call and webcast details are as follows:
U.S./Canada call: (877) 493-9121/ international call: (973) 582-2750 U.S./Canada archive: (800) 642-1687 / international archive: (706) 645-9291 Code for live and archived conference call is 12669776
Webcast: For the live and archived webcast, please visit the CorporatePresentations page on the Cyclacel website at www.cyclacel.com. The webcast will be archived for 90 days and the audio replay for 7 days.
About Seliciclib
Seliciclib is an orally available cyclin dependent kinase (CDK) inhibitor that selectively inhibits multiple enzyme targets (CDK2/E, CDK2/A, CDK7 and CDK9), that are central to the process of cell division and cell cycle control. Seliciclib has been administered to approximately 400 patients to date and is currently being evaluated in a Phase 2b randomized, double blinded study ("APPRAISE") as a single agent treatment in patients with non-small cell lung cancer (NSCLC) treated with at least two prior systemic therapies. It is also being evaluated in a randomized, Phase 2 clinical trial in patients with nasopharyngeal cancer (NPC), a disease associated with Epstein-Barr virus infection.
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. Three orally-available Cyclacel drugs are in clinical development. Sapacitabine (CYC682), a cell cycle modulating nucleoside analog, is in Phase 2 studies for the treatment of acute myeloid leukemia in the elderly, myelodysplastic syndromes and lung cancer and in Phase1 in combination with seliciclib. Seliciclib (CYC202 or R-roscovitine), a CDK (cyclin dependent kinase) inhibitor, is in Phase 2 for the treatment of lung cancer and nasopharyngeal cancer. CYC116, an Aurora kinase and VEGFR2 inhibitor, is in Phase 1 in patients with solid tumors. Cyclacel's ALIGN Pharmaceuticals subsidiary markets directly in the U.S. Xclair(R) Cream for radiation dermatitis, Numoisyn(R) Liquid and Numoisyn(R) Lozenges for xerostomia. Cyclacel's strategy is to build a diversified biopharmaceutical business focused in hematology and oncology based on a portfolio of commercial products and a development pipeline of novel drug candidates. Please visit www.cyclacel.com for additional information.
Risk Factors
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 Annual Report on Form 10-K for the year ended December 31, 2008, as supplemented by the interim quarterly reports, filed with the SEC.
The Cyclacel logo and Cyclacel(R) are trademarks of Cyclacel Pharmaceuticals, Inc. Numoisyn(R) and Xclair(R) are trademarks of Sinclair Pharma plc.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Cyclacel Pharmaceuticals, Inc.
Cyclacel Pharmaceuticals, Inc.
Investors/Media:
Corey Sohmer
(908) 517-7330
csohmer@cyclacel.com
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