CYCC Cyclacel Phase3 Medikament gegen AML Leukämie etc

nhod .665 !

yes
sieht bullish aus

sehr dünner ask
konnte in der letzen stunde abgehen heute

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outcome positive for CYCC

http://www.minyanville.com/businessmarkets/articles/astex-pharmaceuticals-dacogen-eisai-johnson-2526/2/9/2012/id/39319


The negative vote, which was expected, is a setback for the drug’s developer Astex Pharmaceuticals (ASTX) and its partners Eisai of Japan and Johnson & Johnson (JNJ). Eisai sells the drug in North America, while J&J markets the product overseas. Astex receives royalties from sales.

Today’s vote also is being watched by Celgene (CELG) and small-cap biotech Cyclacel Pharmaceuticals (CYCC), two companies developing their own treatments for AML, a cancer that starts in bone marrow. The cancer cells grow rapidly and replace a person’s healthy blood cells. The disease usually strikes people over age 60.

AML is a tricky disease to treat. Pfizer (PFE) pulled an approved drug off the market in 2010 over questions about safety and effectiveness. That same year, Seattle Genetics (SGEN) said it scrapped development of its own drug after the treatment failed in a human trial. In 2009, Sanofi’s (SNY) Genzyme failed to win FDA approval of a therapy.

Dacogen is approved to treat myelodysplastic syndrome, a disease that can lead to AML. A study of Dacogen for treating AML failed to show that the drug helped people live longer than those who received low doses of chemotherapy.

So it was interesting that the FDA convened an advisory panel to discuss the drug rather than just reject the application for a new use. But it appears that the agency folks are struggling with simply rejecting a drug that potentially treats a serious unmet need. Indeed, some doctors on the panel struggled on the question of Dacogen’s benefits as they expressed desire for better treatment. Dacogen already is being prescribed by some doctors to treat AML even though the drug isn’t approved for that use.

“The study failed to meet the primary endpoint, which according to FDA guidance means it isn't sufficient for approval,” says biotech industry consultant Michael Becker, who advises Cyclacel. “However, AML represents a disease with limited treatment options, which is why the (FDA) panel is debating the merits of Dacogen.”



Read more: http://www.minyanville.com/businessmarkets/articles/astex-pharmaceuticals-dacogen-eisai-johnson-2526/2/9/2012/id/39319#ixzz1lv4Riaoq

HEUTE MORGEN BIG NEWS:

Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (Cyclacel or the Company), announced today new topline response data from an ongoing, multicenter, Phase 2 randomized trial of oral sapacitabine capsules, a novel nucleoside analogue, in older patients with myelodysplastic syndromes (MDS) after treatment failure of hypomethylating agents, such as azacitidine and/or decitabine. Eight patients responded with 2 complete remissions (CR), 2 complete remissions with incomplete platelet count recovery (CRp) and 4 major hematological improvements of platelet counts or neutrophils. More than 50% of the patients are still alive and longer follow-up is needed to assess 1-year survival and overall survival.

"MDS patients have poor outcome after treatment failures of front-line hypomethylating agents.The interim response data indicates that sapacitabine is active in this patient population," said Hagop Kantarjian, M.D., Chairman & Professor, Department of Leukemia, The University of Texas MD Anderson Cancer Center and principal investigator for the study."Front line treatment of MDS with hypomethylating agents results in a CR rate ranging from 5.6% to 17%.It is encouraging to observe CRs in MDS patients treated with sapacitabine as a single agent after failures of hypomethylating agents."

"We are encouraged by these interim results with sapacitabine as a second line treatment of older patients with myelodysplastic syndromes (MDS)," said Judy H. Chiao, M.D., Cyclacel's Vice President, Clinical Development & Regulatory Affairs. "We plan to initiate discussions with the FDA regarding potential registration pathways in MDS patients after treatment failure of hypomethylating agents.We are also looking forward to continue enrollment in 'SEAMLESS', our pivotal Phase 3 study of sapacitabine in elderly patients with acute myeloid leukemia (AML).Sapacitabine may emerge as the first oral drug that could address the unmet medical need in both AML and MDS patients."

Interim Data from Ongoing Phase 2 Study in Patients with MDS

The study randomized 61 patients aged 60 years or older with IPSS score 2 or higher risk MDS to receive sapacitabine every 4 weeks on one of the 3 dosing schedules: 200 mg twice daily for 7 days, 300 mg once daily for 7 days, or 100 mg once daily for 5 days per week for 2 weeks.Among 56 patients who have had at least 30 days of follow-up, the thirty-day mortality from all causes is 5.4%.Eight patients responded with 2 complete remissions (CR), 2 complete remissions with incomplete platelet count recovery (CRp) and 4 major hematological improvements of platelet counts or neutrophils.Responses occurred on all 3 dosing schedules.More than 50% of the patients are still alive and longer follow-up is needed to assess 1-year survival and overall survival.

MDS Phase 2 Study Objective & Previously Reported Interim Data

The study uses a selection design with the objective of identifying a dosing schedule which produces a better 1-year survival rate in the event that all three dosing schedules are active. Updated results will be reported at an upcoming medical conference.

At the 2010 annual meeting of the American Society of Hematology Cyclacel reported interim data from three schedules of sapacitabine administered as single-agent treatment over a 4-week cycle in 61 patients with IPSS intermediate - 2 or higher risk MDS after treatment failure of hypomethylating agents: 200 mg twice daily for 7 days, 300 mg twice daily for 7 days, or 400 mg twice daily for 3 days per week for 2 weeks.The primary endpoint of 1-year survival was achieved in 29%, 30% and 35% of the patients respectively among the 3 schedules tested.Median overall survival was 217, 232 and 236 days respectively. Two patients achieved a CR.The mortality rate from all causes within 30 days of randomization was 6.6%.

About Myelodysplastic Syndromes (MDS)

MDS is a family of clonal myeloid neoplasms, or malignancies of the blood, caused by the failure of blood cells in the bone marrow to develop into mature cells.Patients with MDS typically suffer from bone marrow failure and cytopenias, or reduced counts of platelets, red and white blood cells.The exact incidence and prevalence of MDS are unknown because it can go undiagnosed and a national survey canvassing both hospitals and office practitioners has not been completed.Some estimates place MDS incidence at 15,000 to 20,000 new cases each year in the US alone with some authors estimating incidence as high as 46,000.Literature evidence suggests that there is a rising incidence of MDS as the age of the population increases with the majority of patients aged above 60 years.

Most patients with high risk disease, as defined by IPSS or the International Prognostic Scoring System,1 die from their disease within one year of diagnosis with reported mean survival rates of six to nine months.Patients with high IPSS scores, such as intermediate-2 and high risk, have a high probability of experiencing transformation of their MDS into acute myeloid leukemia (AML), an aggressive form of blood cancer with typically poor survival.

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