Navigation Links
Cyclacel Pharmaceuticals Announces Results of Phase II Seliciclib,Combination Studies

BERKELEY HEIGHTS, N.J.--(BUSINESS WIRE)--Jun 28, 2007 - 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.

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 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 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 actua l 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 10-K and in the other reports of Cyclacel filed with the SEC.

Contact

Cyclacel Pharmaceuticals, Inc.
For Investors:
TS Communications Group, LLC
Tara Spiess, 914-921-5900
or
For Media:
Feinstein Kean Healthcare
Heather McDonald, 617-577-8110


'"/>




Related medicine technology :

1. Cyclacel Pharmaceuticals to Report Sapacitabine Phase I Study Results at the American Society of Clinical Oncology Annual Meeting
2. Cyclacel Pharmaceuticals to Present Preclinical Data on Sapacitabine and Seliciclib at AACR
3. BioSante Pharmaceuticals Announces New Findings for Potential Bird Flu Vaccine
4. Portola Pharmaceuticals Announces Positive Data from a Phase II Study of its Factor Xa Inhibitor at the XXI Congress of the International Society on Thrombosis and Haemostasis
5. Manhattan Pharmaceuticals Announces Results of Phase 2a Studies for Oral Oleoyl-estrone
6. Auxilium Pharmaceuticals to Present at the 2007 CEUT Emerging Growth Opportunities Conference
7. Sunesis Pharmaceuticals to Present at the C. E. Unterberg, Towbin Emerging Growth Conference
8. EPIX Pharmaceuticals to Present at the C.E. Unterberg, Towbin Emerging Growth Opportunities Conference
9. Pro-Pharmaceuticals Updates Progress of Clinical Trials & Davanat 505 (b)(2) Filings
10. Cosmo Pharmaceuticals Reports Positive Preliminary Phase II/III Data with Rifamycin MMX in Infectious Diarrhea
11. Portola Pharmaceuticals Announces Positive Phase II EXPERT Results and Additional Oral and Poster Presentations at the XXI Congress of the International Society on Thrombosis and Haemostasis (ISTH)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:8/11/2018)... ... August 11, 2018 , ... Award-winning ... ‘Information Matrix’ on integrative medicine. The episode will go through different integrative medicine ... , Integrative medicine involves using both conventional and complementary approaches to health care ...
(Date:8/9/2018)... ... 2018 , ... Doctor Snehal Patel is offering the residents of South Fairfax ... September 30th, applicants who are in need of full-arch restorations, but who otherwise couldn’t ... Project Smile Program. , "Our local communities have been very good to us and ...
(Date:8/7/2018)... ... , ... Braun Ambulances is honored to announce their attendance at FRI 2018. ... Dallas, Texas. Braun Ambulances will have four units on display at the conference and ... International (FRI) is the International Association of Fire Chiefs’ (IAFC) annual event; the conference ...
Breaking Medicine Technology:
(Date:8/9/2018)... , ... August 09, 2018 , ... ... certification. LegitScript is a new verification process that substance abuse providers must pass ... certified means we can reach more people to help.” , Helping people ...
(Date:8/7/2018)... Mich. (PRWEB) , ... August 07, 2018 , ... Sussex ... partnered with Blue Sky Vision. Michael Sussex, OD, founded the practice in Coldwater, and ... Sussex practices with Matt Austin, OD, to offer comprehensive eye health services for patients ...
(Date:8/3/2018)... ... August 03, 2018 , ... Yisrayl Hawkins, Pastor and Overseer at The ... and meanings from the Bible meant only to be understood in this current generation. ... been able to decode passages that he says scholars have struggled with for generations. ...
(Date:8/2/2018)... , ... August 02, 2018 , ... ... certification to recruit caregivers to participate in brain cancer caregiver and patient clinical ... with Providence Health Services of Southern California. , At the Pacific Neuroscience ...
(Date:8/2/2018)... , ... August 01, 2018 , ... Continuing their momentum ... 2018 cohort. , Founder and Chief Investment Officer of Ecliptic Capital, Mike W. Erwin, ... Sempulse. He said, “I have lived in Austin for over 30 years starting companies ...
Breaking Medicine News(10 mins):