>>Cyclacel Pharmaceuticals Announces Results of Phase II Seliciclib Combination Studies
Thursday June 28, 4:06 pm ET
BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP) announced today the results from two Phase II non-randomized studies of seliciclib fixed dose combinations. In one study seliciclib was given in combination with gemcitabine and cisplatin and in another with docetaxel in patients with advanced non-small cell lung cancer (NSCLC).
The primary objectives of the studies were to assess the safety and efficacy of the two combinations. In the first study, 45 patients with advanced NSCLC, who were previously untreated or treated with no more than one prior chemotherapy, were enrolled and treated with the combination of seliciclib plus gemcitabine and cisplatin. Seliciclib was administered twice daily (b.i.d.) by mouth for 4 days every week. Gemcitabine was administered once a week for two weeks followed by one week of rest. Cisplatin was administered once every three weeks. Patients were entered into 3 seliciclib cohorts dosed at 400 mg b.i.d. (n=3), 800 mg b.i.d. (n=36) and 1200 mg b.i.d. (n=6). In the second study, 7 patients with advanced NSCLC who have had one prior chemotherapy were enrolled and treated with the combination of seliciclib plus docetaxel. Seliciclib was administered at 1600 mg b.i.d. for 3 days every 3 weeks. Docetaxel was administered once every three weeks. The combination study with docetaxel was discontinued early due to slow accrual.
The best response by investigator assessment consisted of 9 patients with partial response and 21 with stable disease in patients treated with the combination of seliciclib plus gemcitabine/cisplatin and 2 with partial response and 1 with stable disease in the combination of seliciclib plus docetaxel. The major dose-limiting toxicities were nausea, vomiting, fatigue, hypokalemia and elevation in liver enzymes which were primarily attributed to seliciclib. There were no unexpected toxicities.
"The results of these combination studies demonstrated that seliciclib could be safely combined with gemcitabine/cisplatin or docetaxel with evidence of anti-tumor activity. However the contribution of seliciclib to the anti-tumor activity of the combinations could not be adequately evaluated in a non-randomized study. To assess the anti-tumor activity of seliciclib as a single agent, we are currently conducting a double-blinded, randomized, Phase II study of single agent seliciclib versus best supportive care in patients with advanced NSCLC who have had at least two prior systemic therapies (the APPRAISE study). In addition, we are currently planning a randomized Phase II study of single agent seliciclib in patients with previously treated nasopharyngeal cancer (NPC)", commented Dr. Judy Chiao, Vice President of Clinical Development and Regulatory Affairs of Cyclacel.<<
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Not sure what to make of this, as I don't know the expected outcomes in these chemo regimes. The company doesn't seem too excited about these results. Not sure if that's because they are middling, or the company is just unusually restrained in its wording of PRs. Gotta go soon, so not much time research this.
Stock is not moving after hours.
Is anyone else watching?
Cheers, Tuck |
