Alright Pharma Investors time for the Daily Pharma Watch, and don’t forget to sign up to get the Daily Pharma Watch delivered to your email every morning, so you have the latest analysis to make the best investment decisions! Sign up to the right, don’t worry no spam- I promise!
Sunesis (SNSSS):
Sunesis’ shares are flying high this morning after the company formally announced the results from their REVEAL-1 study for voreloxin in patients with Elderly AML that respond poorly to standard chemotherapy. In my last post (here) I drew a comparison of the study’s results and compared them to other drugs that are vying for similar indications. The REVEAL-1 study consisted of 3 different dosing arms that all received voreloxin. What the company clarified this morning is what dosing regimen they thought they would use in upcoming Phase III trials, in Dosing Regimen A the drug produced an Overall Response rate of 41%, but had a 30 day mortality rate of 17%. However, in Dosing Regimen C, which gives the patients a different dosing schedule, the Overall Response Rate was 38% and had a much lower 30 day mortality rate of 7%. The company said in the press release that Dosing Regimen C looks like the strongest regimen at this point. If the results at the end of the trial are as good as they look now then expect Sunesis to run a full Phase III trial for the drug.
The company also announced data from a clinical trial of voreloxin with cytarabine in relapsed/refractory AML patients. The drug also performed strongly in this indication as well, achieving a 31% Overall Response Rate and giving an estimated overall survival rate of 7.8 months. Press Release Here
Cell Therapeutics (CTIC):
Today, Cell announced some data from lab studies testing Pixantrone’s cardiotoxicity levels. The company said that Pixantrone showed marked reduction in cardiac cell toxicity compared to other anthracyclines. However, these tests were not on actual patients. What the company did was use techniques in a lab to gauge possible cardiotoxicity properties of the drug. In theory, Pixantrone shouldn’t cause as much cardiac toxicity, that is after all what the drug was designed to do, however during the EXTEND clinical trial there was a higher incidence of serious cardiac disorders in patients treated with pixantrone than among patients who received comparator agents (6/68 or 8.8% vs. 3/67 or 4.5%). This will surely be the focal issue when the company meets with the FDA to discuss the approval of Pixantrone because the efficacy data seems to be strong.
Twitter
