In the News

Cyclacel Reports Phase I Sapacitabine Data in Patients with Advanced (2º) Leukemias and Myelodysplastic Syndromes at 2007 ASCO Annual Meeting

February 6, 2007

Dose-limiting toxicity on the 7-day schedule was gastrointestinal which included abdominal pain, diarrhea, small bowel obstruction and neutropenic colitis. One patient treated at the MTD died of complications from neutropenic colitis. Non-hematological toxicities were mostly mild to moderate. The best response from the 7-day schedule was complete remission without platelet recovery in 2 patients with refractory AML (n=2), complete remission in 1 patient with refractory AML leukemia cutis (n=1), and completion remission in 1 patient with refractory MDS (n=1).

In addition, 11 patients (AML, n=9; MDS, n=2) had more than 50% decrease in bone marrow blasts including 7 patients who had a reduction in bone marrow blasts to 5% or less.

About Sapacitabine

Sapacitabine appears to act through a dual mechanism. It interferes with DNA synthesis by causing single-strand DNA breaks and also induces arrest of cell cycle progression at G2/M-Phase. Both sapacitabine and CNDAC, its major metabolite or a substance into which the drugs converts after ingestion by patients, have demonstrated potent anti-tumor activity in preclinical studies.

In addition, in a mouse model of liver metastasis, sapacitabine was shown to be superior in terms of delaying the onset and growth of liver metastasis to either gemcitabine (Gemzar(R); Lilly) or 5-FU, two widely used nucleoside analogs. Gemcitabine is indicated for the palliative treatment of breast, lung, pancreatic and ovarian cancer, but it has not been reported to be active in leukemias or MDS.

A Phase II study of sapacitabine in patients with advanced cutaneous T cell lymphoma started in the first half of 2007. A second Phase II trial in hematological cancers is planned to begin later this year along with a third Phase II trial in patients with non-small cell lung cancer. Sapacitabine is part of a deep pipeline of small molecule drugs designed to target and stop uncontrolled cell division.

Cyclacel's other development programs include seliciclib, a CDK (cyclin dependent kinase) inhibitor in Phase IIb clinical trials for non-small cell lung cancer, and CYC116, an aurora kinase inhibitor in IND-directed development.

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.

Two Cyclacel drugs are in Phase II trials: sapacitabine (CYC682), an orally-available, cell cycle modulating nucleoside analog, for the treatment of cutaneous T-cell lymphoma (CTCL) and seliciclib (CYC202), an orally-available CDK (cyclin dependent kinase) inhibitor, for the treatment of lung cancer.

Sapacitabine is also in Phase I trials in patients with hematological 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 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.