Sapacitabine in RMDS......final published data very soon. "unprecedented results" $850M -$1Bmarket
Cyclacel Reports Updated Phase 2 Survival Data of Sapacitabine for MDS
Nearly Doubles Expected Median Survival of Older Patients With MDS Who Failed Front-Line Therapies
BERKELEY HEIGHTS, N.J., April 30, 2013 (GLOBE NEWSWIRE) -- Cyclacel Pharmaceuticals, Inc. (Nasdaq:CYCC) (Nasdaq:CYCCP) (Cyclacel or the Company), announced updated median overall survival data from an ongoing, multicenter, Phase 2 randomized trial of oral sapacitabine capsules, the Company's lead product candidate, in older patients with intermediate-2 or high-risk myelodysplastic syndromes (MDS) after treatment failure of front-line hypomethylating agents, such as azacitidine (Vidaza®) and/or decitabine (Dacogen®). Median overall survival to date for all 63 patients treated is approximately 9 months. Median overall survival for each of the three randomization schedules is approximately 10 months for Arm G, 10 months for Arm H and 8 months for Arm I. The 30-day mortality for all patients is 5%.
"The updated survival data from this study in MDS patients after treatment failures of hypomethylating agents continue to be impressive based on our experience," said Guillermo Garcia-Manero, M.D., Chief of the Section of Myelodysplastic Syndromes and Professor, Department of Leukemia, The University of Texas MD Anderson Cancer Center and an investigator for the study. "Sapacitabine's oral administration and low 30-day mortality suggest that it may become a new treatment standard for older patients with MDS."
"There is a dearth of treatment options for MDS patients after failing front-line therapies. The updated survival data with sapacitabine as a single agent in MDS confirm our previous experience with the drug," said Hagop Kantarjian, M.D., Chairman & Professor, Department of Leukemia, The University of Texas MD Anderson Cancer Center and principal investigator for the study. "Median survival for patients with intermediate-2 or high-risk MDS following treatment failures of hypomethylating agents is 4.3 to 5.6 months. We urgently need new therapeutics for these patients with the potential of controlling the disease and offering high quality of life."
life; think we all agree rmds has great potential. The current known data is being touted as unprecedented. Is the final mature data going to really tell us anything different?
Also, are the results blinded? Could Spiro be reviewing data/results and marketing them to a potential partner? My view of the results is they will be consistent with previously published RMDS data which is a known.
The wait to get to the data, then to schedule FDA dialog, then to initiate a phase 3 study... probably won't get off the ground until late 2014. Maybe another SPA.
Expectation is data good enough to justify a phase 3. That leads equivalently to overhang as much as it does a positive. As until Spiro partners, financing for RMDS phase 3 will be the question. Everyone knows Spiro knows how to dilute, everyone wonders if he knows how to partner.
Value, the data that we know comes from April 2013. The final published data will be refined data instead of raw verbal data. In addition, the median times between HMA failure and initiation of Sapacitabine therapy will be highlighted. This is a highly significant metric because it leaves significant MS improvement "on the table" over and above the already stellar reported numbers. In addition, I believe we will see some "long livers" at the end of the curve (perhaps 15-20%) which also would be unprecedented in this population. It's a biggy......
"Unprecedented results" from Spiro's quote in JMP conference . No other agent has comparable data in this population. These results are also understated because of the long median times between HMA failure and initiation of Sapacitabine therapy. It should be noted that these are "single agent results".