Oncolytics was supposed to have interim results before the end of 2012, but like with the head and neck trial, that timeline came and went without any news. Then, the timeline was pushed to the first half of 2013. Then the company issued a useless update from a different study in lung cancer in February and quickly raised money. This week, Coffey, speaking at RBC, said pancreatic cancer data might be ready for release in the second half of the year.
My story Wednesday on the
Duchenne muscular dystophy patients hospitalized
following treatment with Glaxo's drisapersen generated a lot of Twitter chatter.
"Do you read the GSK AE [adverse event] news as positive for AA [accelerated approval] chances?"
He's referring to Sarepta Therapeutics and its DMD drug eteplirsen. Does Sarepta have a better chance of convincing FDA to accept an accelerated approval filing for eteplirsen given what appears to be more significant toxicity associated with Glaxo's drisapersen?
I don't think so, mainly because FDA will make its decision on accelerated approval based on the strength of the eteplirsen clinical data and the unmet medical need in DMD,
on drisapersen's side effect profile. Those are separate issues.
Sarepta benefits if eteplirsen's safety profile is cleaner than Glaxo's drisapersen. Given a choice between the drugs (and assuming similar efficacy), doctors and DMD patients are more likely to choose eteplirsen over drisapersen.
"Is there are time frame for the full $GSK data to be released? Is this game over for them?"
I'll take the latter question first. No, these patient hospitalizations do not mean the end of drisapersen, and my story Wednesday in no way suggested that Glaxo was giving up on the drug, nor should it. Remember, a drug's toxicity must always be weighed against efficacy and the severity of the disease. Patients at risk for hospitalization due to severe thrombocytopenia would be unacceptable for a drug treating stomach ulcers, but not so for DMD where the outcome is death.
But then, even in a disease as fatal as DMD, patients will prefer safer drugs over those that cause severe side effects. The disclosure of patient hospitalizations in drisapersen patients is important because Glaxo and its partner Prosensa had been telling investors that the drug's side effects were mild and transient. Well, clearly that's not true if some patients, even a relatively small number, are forced into the hospital.
Investors won't be able to fully assess the toxicity profile of drisapersen until more data is released. Glaxo has committed to announcing results from a randomized phase II study in the third quarter, followed by data from the larger phase III study in the fourth quarter.
Hopefully, before we see these drisapersen data, Sarepta will have an answer from FDA on the eteplirsen accelerated approval filing.
If you have the time or inclination, read Appeering's curation of an
epic, 100 tweet-plus debate
over the newsworthiness of my Glaxo-drisapersen story.
-- Reported by Adam Feuerstein in Boston.