Cyclacel Reports Phase I Sapacitabine Study Results at 18th EORTC-NCI-AACR Molecular Targets and Cancer Therapeutics Meeting.

SHORT HILLS, N.J. -- Cyclacel Pharmaceuticals, Inc. (Nasdaq: CYCC) announced today preliminary results from a Phase I clinical trial of sapacitabine (CYC682), a novel orally available nucleoside analog. The results, presented as a poster at the 18th EORTC-NCI-AACR1 symposium on "Molecular Targets and Cancer Therapeutics" in Prague, Czech Republic, demonstrated that the compound could be safely administered to patients with refractory solid tumors or lymphomas and might be active in several tumor types. The trial is part of a Phase I program that included three additional Phase I studies: two in patients with incurable solid tumors and one in patients with advanced leukemias and myelodysplastic syndromes.

The current study was conducted at the Institute for Drug Development, Cancer Therapy and Research Center (CTRC) in San Antonio, Texas and Fox Chase Cancer Center in Philadelphia, Pennsylvania. The primary objective of the study was to evaluate the safety profile of sapacitabine administered twice daily for 14 consecutive days or 7 consecutive days every 21 days. Of the 37 treated patients, 28 received the drug twice daily for 14 days and 9 received the drug twice daily for 7 days. The dose-limiting toxicity was reversible myelosuppression. One patient treated at the maximum tolerated dose died of candida sepsis in the setting of grade 4 neutropenia and thrombocytopenia. Non-hematological toxicities were mostly mild to moderate. The best response by investigator assessment was stable disease in 13 patients with non-small cell lung cancer (n=5), breast cancer (n=2), ovarian cancer (n=2), colorectal cancer (n=1), adenocarcinoma of unknown primary (n=1), gastrointestinal stroma tumor (n=1), and parotid acinar carcinoma (n=1).

Anthony Tolcher, MD, Director of Clinical Research, CTRC and lead author of the poster noted, "Sapacitabine is a novel oral anti-cancer drug that can be administered safely on an outpatient basis. The observations of stable disease in a variety of tumor types warrant further study of this drug in Phase II trials."

Judy Chiao, MD, Cyclacel's Vice President, Clinical Development and Regulatory Affairs, said, "This trial expands sapacitabine safety data from previous Phase I trials in patients with solid tumors. The observation of stable disease in 5 patients with non-small cell lung cancer (NSCLC) is encouraging. Together with the finding of stable disease in 3 NSCLC patients from a previous Phase I trial conducted at The Johns Hopkins Oncology Center, these data suggest that sapacitabine may have promising single agent activity in NSCLC. Collectively, these results provide a strong foundation for designing future Phase II studies of sapacitabine administered as a single agent or in combination with other anti-cancer agents."

Abstract no: 463

About sapacitabine

Sapacitabine is an oral nucleoside analog prodrug that acts through a dual mechanism that is unique among nucleoside analogs. The compound interferes with DNA synthesis by causing single-strand DNA breaks and induces arrest of cell cycle progression. Both sapacitabine and its major metabolite have demonstrated potent anti-tumor activity in preclinical studies. In addition to three Phase I studies in patients with solid tumors and lymphomas, sapacitabine is currently being evaluated in a Phase I clinical trial in patients with advanced leukemias or myelodysplastic syndromes (MDS).

About Cyclacel Pharmaceuticals, Inc.

Cyclacel is a clinical-stage 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 cyclin dependent kinase inhibitor, in Phase II clinical trials for the treatment of lung cancer. Sapacitabine (CYC682) is an orally available, cell cycle modulating nucleoside analog in Phase I clinical trials for the treatment of cancer. CYC116 is an orally available, Aurora kinase inhibitor in IND-directed preclinical development. Several additional programs are at an earlier stage.

Note: The Cyclacel logo and Cyclacel[R] are trademarks of Cyclacel Pharmaceuticals, Inc.

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 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.

1 EORTC [European Organisation for Research and Treatment of Cancer]; NCI [National Cancer Institute]; AACR [American Association for Cancer Research]