FDA Calendar Updates: Cell Therapeutics, OncoGenex Pharma

Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of over 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

On 6/24/09, Cell Therapeutics (CTIC) announced that it has completed the submission of the New Drug Application (NDA) to the FDA for pixantrone to treat relapsed or refractory, aggressive non-Hodgkin's lymphoma (NHL). CTIC requested a six-month priority review, which if granted by the Agency would result in a possible FDA decision during 4Q09. On 5/5/09, CTIC announced that pixantrone is available on a named-patient basis for use in Europe to treat patients with aggressive NHL that has either relapsed or is refractory to standard treatment options. The FDA typically responds in about 60 days on whether the Agency will accept the NDA filing, rule on the status of the priority review request, and issue a PDUFA action date for the NDA.

On 6/24/09, OncoGenex Pharma (OGXI) announced an agreement with the FDA through the special protocol assessment process (SPA) for an amendment to the design of a Phase 3 registration trial of OGX-011, its lead product candidate targeting castrate resistant prostate cancer. The FDA has agreed on modifications to the study population of a previously reviewed Phase 3 trial featuring survival as the primary endpoint. The study population has been modified to evaluate patients receiving first-line chemotherapy, rather than those receiving second-line chemotherapy. OGXI stated that it will proceed with two Phase 3 trials subject to the receipt of additional funding, including one for first-line and one for the second-line treatment of advanced prostate cancer.

On 5/30/09, OGXI, announced the final results of a Randomized Phase 2 Trial which indicated a survival benefit in patients treated with OGX-011 in combination with docetaxel compared to docetaxel alone (the current standard care for patients with advanced prostate cancer). The median overall survival in patients with advanced metastatic prostate cancer who were treated with OGX-011 plus docetaxel in a randomized Phase 2 trial was 23.8 months compared to 16.9 months for patients treated with docetaxel alone -- a 6.9 month observed survival advantage for the OGX-011 arm. The unadjusted hazard ratio (HR), a measure used to compare the death rates between treatment groups, was 0.61, representing a 39% lower rate of death for patients treated with OGX-011.Study investigators concluded that OGX-011 treatment was well tolerated in combination with docetaxel.

Disclosure: No positions.