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BiomedReports: FDA Calendar's Cancer Drug Updates for Allos (NASDAQ:ALTH), Biovest (OTC:BVTI), Celldex (NASDAQ:CLDX) and CuraGen (NASDAQ:CRGN)
Mon. June 01, 2009; Posted: 05:05 AM
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Pasadena, CA, Jun 01, 2009 (M2 PRESSWIRE via COMTEX) -- CRGN | Quote | Chart | News | PowerRating -- There are new updates to BioMedReports.com's database of FDA and Clinical Trial Calendars.
Below are brief summary updates to the site's database of over 200 entries included in the FDA and Clinical Trial Calendars. The FDA Calendar includes companies with pending new drug, biological agent, or medical device new product decisions at the FDA sorted by their PDUFA decision deadline dates while the Clinical Trial Calendar encompasses pending clinical trial results:
Allos Therapeutics (NASDAQ:ALTH): On 30/05/09 , ALTH updated data from the Company's pivotal Phase 2 PROPEL study of pralatrexate in patients with relapsed or refractory peripheral T-cell lymphoma (PTCL). The overall response rate for pralatrexate as evaluated by central independent oncology review using International Workshop Criteria (IWC) was 28% (30 of 109 evaluable patients) with a median duration of response of 9.4 months, or 287 days. Of the 30 patients who responded to pralatraxate, 21 patients (70%) did so after cycle one of therapy. Median overall survival was 14.7 months, with 57% of responders surviving 12 months or more. The most common Grade 3/4 adverse events were thrombocytopenia, mucositis, neutropenia, and anemia.
Biovest (OTC:BVTI): On 31/05/09, BVTI announced that an eight year pivotal, randomized, multi-center, double-blind, controlled Phase 3 clinical study has shown that BiovaxID (personalized therapeutic anti-cancer vaccine) significantly prolonged disease-free survival in follicular non-Hodgkin's lymphoma.
On 29/05/09, Celldex (NASDAQ:CLDX) announced its proposed acquisition (expected to close during 3Q09) of CuraGen (NASDAQ:CRGN), which adds to Celldex's clinical development program a number of important milestones anticipated over the next 12-18 months including:
(1) Phase 2 CDX-110 ACT II and ACTIVATE data in GBM,
(2) Phase 2 CR011 breast cancer and melanoma data,
(3) Phase 1 CDX-1307 combination data in epithelial cancers,
(4) Phase 2 ACT III study of CDX-110 in GBM; design of randomized study in GBM,
(5) Phase 2 CR011 studies in breast cancer and melanoma; determine next steps for CR011 development in breast cancer and melanoma,
(6) Phase 1 CDX-1307 novel combination,
(7) Phase 2 CDX-1307 randomized study in bladder cancer
(8) Phase 1/2 CDX-1401 study in multiple solid tumors.
The companies stated in a press release that data from the 40 evaluable patients in ACTIVATE and ACT II trials continue to suggest that vaccination with CDX-110 may be able to improve time to tumor recurrence and overall survival when used in patients with newly-diagnosed GBM. These data also continue to suggest that tolerability and side effects associated with CDX-110 are minimal.
A full, detailed report on the developments and how they affect other FDA decisions and approvals is available at:
Biotech investors interested in seeing the complete database of clinical trials and upcoming FDA decisions can access that information here:
Disclosure: No positions.
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