Weekly Pharma Recap
Alright Pharma Investors time for the weekly pharma recap. This week we’ll be going over CYCC, AEZS, SQNM, KERX, JAV, MYRX, ACHN, NVLT, ADLS, ARRY and CHTP
Cyclacel (CYCC):
Cyclacel said they held a meeting with the FDA to discuss a Phase III trial design for their AML drug Sapacitabine. This is good news for Cyclacel because it means the company is taking the approval process seriously, but investors should be aware that there are other competitor AML products vying for approval. I like the fact that the company is setting up its trial via the FDA’s Special Protocol Assessment Process (SPA), because it allows the FDA to work with the company to set up endpoints and safety assessments that are good enough to get approval if met.
Generex (GNBT):
Generex put out some new results this week from their Phase II study of an immunotherapeutic vaccine that is being developed by its subsidiary Antigen Express. The vaccine, AE37, is designed to prevent breast cancer recurrence with the primary endpoint being the rate of relapsed to those not receiving the vaccine. The data released today showed that only half the number of patients in the treatment arm compared to non-treatment group had a relapse. The company also has a promising Diabetic treatment called Oral-Lyn, the product is an alternative insulin delivery system that allows for buccal dosing for diabetic patients.
Vion Pharma (VION):
Vion filed for bankruptcy this week. In a previous post (here) I outlined some thoughts I have on the subject because I think bankruptcy could have been avoided in this case. One of the troubling aspects to this bankruptcy is that the company is developing a promising AML drug Onrigin which is set to undergo a Phase III randomized trial. The company is in talks with the FDA to set the trial up under the FDA’s Special Protocol Assessment process which would allow the FDA to work closely with the company to set endpoints and safety points for the drug. If the drug met those endpoints then the likelihood of approval would be much much greater. I never like to see promising drug companies go through bankruptcies because it slows the clinical trial process down drastically. Sometimes companies are forced to sell of good drug candidates in order to survive. cont’d on next page
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