Biotech Values

[jq1234]

But nonetheless they also noted in the conference call that they didn't fully describe the SAE issues in their ASH presentation because they "ran out of room" in their 12 page limit. Maybe that flies for more minor issues, or issues seen and disclosed for other trials. But for potential liver issues not seen in previous trials... ?

Where did you get these stuff they didn't disclose SAE issue in ASH? I put that portion of transcript in my previous post already. Here is further updated safety data from 16 patients (14 patients at ASH) portion of transcript - consistent with transcript I previously posted. I would like to figure out why I don't see what you saw - I agreed with some of your other points, ie explanation about stopping enrolling PV patients in ET/PV trial not clear and convincing.

In the ET study, imetelstat was initially administered weekly by intravenous infusion during an induction phase. After achieving a complete hematologic response, which occurred in a median time of approximately 6 weeks, a maintenance phase was begun in which dosing frequency was modified based on a patient's individual response profile, generally decreasing with time. The responses observed have been durable. All patients who achieved a complete hematologic response remained on therapy, including 6 for more than 1 year. I can also add that one patient has just begun year 3 on the study. The last patient enrolled in December has just begun dosing. Median time on the study is currently approximately 33 weeks.

As of the latest data cut for safety from the first 16 patients in the trial, long-term administration of imetelstat was generally well-tolerated. Of those 16 patients, 15 patients remained in the trail and no patients have discontinued due to adverse events. The majority of the non-hematologic adverse events were mild to moderate in severity, with the most frequently reported being gastrointestinal events, infections, muscular and joint pain and fatigue. Infections appear to be increased in incidence, although without a comparator arm, it is difficult to assess this accurately. Most infections were considered grade 1 to 2 or mild to moderate in severity, and all were managed easily with conventional therapies. No drug-related non-hematologic grade 4 adverse events were reported.

Neutropenia was the most frequently observed hematologic abnormality. Two patients had grade 4 neutropenia and no cases febrile neutropenia were reported. No patients with grade 4 neutropenia had a concurrent infection. One suspected thromboembolic event, which was assessed as not being related to imetelstat, has been reported. No bleeding events associated with thrombocytopenia were reported.

At least one abnormal liver function test was observed in most patients. The majority were grade 1 or 2 elevations in ALT or AST. Reversible grade 2 to 3 elevations in ALT, with grade 1 to 3 elevations in AST were observed in 4 patients within a few weeks of starting imetelstat. These abnormalities resolve and did not reoccur with ongoing imetelstat treatment. With longer dosing, grade 1 increases in alkaline phosphatase were observed in 7 patients, associated with mostly grade 1 and in some cases, grade 2, unconjugated hyperbilirubinemia in 4 of the patients. The etiology of this is unclear and is currently being further investigated.

The ET study was closed to new patients enrollment in December last year when we determined that we have sufficient number of patients to be confident of the hematologic and molecular response data that we had observed and reported at ASH. A total of 20 patients have been enrolled in the trial, which includes 18 patients with ET and 2 patients with polycythemia vera. Patients on the study may continue to receive imetelstat for up to 3 years according to the study protocol. We expect to report periodic updates from the study at future scientific meetings.

Here is their ASH presentation:

http://ir.geron.com/phoenix.zhtml?c=67323&p=irol-EventDetails&EventId=4864725