On 4/28/09, Dendreon (NASDAQ:DNDN) announced that its experimental cancer vaccine Provenge extended the life of patients with advanced prostate cancer by a median of 4.1 months, which is one month longer than the only other treatment option, Taxotere. On 9/24/09, DNDN announced plans to file an amendment to its existing BLA seeking FDA approval in mid-November for Provenge with a possible decision by the Agency likely to occur around mid-2010. The Company will have the manufacturing capacity to generate possible sales of $60-125 million during 2H10 until full capacity is achieved in late 2011.
On 9/24/09, Chelsea Therapeutics (NASDAQ:CHTP) announced top-line results from Study 302, the first of its two Phase 3 trials of Droxidopa for the treatment of symptomatic neurogenic orthostatic hypotension (NOH). While Study 302 demonstrated that Droxidopa showed a strong symptomatic benefit during the open-label dose titration and run-in phase of the trial, a preliminary review of the data indicates it did not demonstrate a statistically significant improvement relative to placebo, as measured by the mean score of Item 1 (dizziness or light-headedness) of the Orthostatic Hypotension Symptom Assessment (OHSA) during the double-blind phase of trial, the study's primary endpoint. Droxidopa was safe and well tolerated, with no significant related adverse events reported.
Another Phase 3 trial, Study 301, was previously reviewed by the U.S. Food and Drug Administration (FDA) and awarded a Special Protocol Assessment (NYSE:SPA) in February 2008. In addition to the SPA, the FDA has awarded Chelsea Fast Track designation for its pivotal program in NOH.
On 9/24/09, Cephalon (NASDAQ:CEPH) announced that the FDA granted a priority (six-month) review for its supplemental New Drug Application (sNDA) for NUVIGIL (armodafinil) Tablets [C-IV], which was filed in June of this year. The FDA decision on approval of NUVIGIL as a treatment for improving wakefulness in patients with excessive sleepiness associated with jet lag disorder due to eastbound travel is expected by 12/29/09 and there is currently no FDA-approved treatment for this indication.
On 9/24/09, OraSure Technologies (NASDAQ:OSUR) announced that it has been awarded a 36-month contract for its OraQuick ADVANCE(R) Rapid HIV-1/2 Antibody Test with Premier Purchasing Partners, L.P., that is effective 11/1/09 and provides Premier's more than 2,200 member hospitals with pre-negotiated pricing and terms for the purchase of OraSure’s test, which is the first and only FDA-approved and CLIA-waived rapid point-of-care test that can detect antibodies to both HIV-1 and HIV-2 in 20 minutes, using oral fluid, finger-stick or venipuncture whole blood or plasma specimens.
Additionally, the OraQuick ADVANCE(R) test is the only rapid HIV test offered through Premier's ASCEND(TM) (Accelerated Supply Chain Endeavor) program, a group purchasing program designed to help participants achieve and sustain rapid improvements in supply chain performance. Currently, more than 90 participants representing approximately $2.7 billion in supply chain purchasing volume and close to 24,000 hospital beds are collaborating to share best practices in supply chain efficiency as a part of the program.
On 9/24/09, Genzyme (GENZ) announced that its randomized Phase 3 clinical trial investigating Campath (alemtuzumab) in combination with Fludara (fludarabine phosphate) in relapsed or refractory chronic lymphocytic leukemia (CLL) patients met its primary endpoint by demonstrating a significant improvement in progression free survival (PFS). Study results from this interim analysis are expected to be submitted to the American Society of Hematology meeting held in December.
GENZ stated that, pending approval, the FluCAM dosing regimen used in the Phase 3 trial will extend the use of Campath by giving physicians an important alternative treatment regimen for their patients with progressive disease. In the CAM314 trial, patients in the FluCAM arm had lower total exposure to Campath and Fludara when dosed in combination, as compared to the labeled, single-agent dosing regimen of each drug for the treatment of CLL.
Based on the study’s positive findings, Genzyme intends to seek regulatory approval in the United States, European Union, and other countries to further broaden the Campath label to include the use of this combination regimen. If the expanded label is granted, Campath, marketed as MabCampath® in Europe, would be the first humanized monoclonal antibody approved as both a single agent and in combination therapy for the treatment of CLL.
In collaboration with NIH scientists, Dr. Kovach / Lixte Biotech (LIXT.OB) have a new publication (Cell Cycle 8:20, 1-4; October 15, 2009) which is entitled, “Enhancement of cancer chemotherapy by simultaneously altering cell cycle progression and DNA-damage defenses through global modification of the serine/threonine phospho-proteome.” To summarize, Lixte’s lead compound has demonstrated positive preclinical results and has the potential to greatly enhance the cancer killing effects as part of combination treatment with chemotherapy drugs that target DNA as their mode of action such as temozolomide and doxorubicin. Lixte’s lead compound has a counter-intuitive mode of action that involves speeding up the cell cycle / DNA replication process of cancer cells despite the presence of chemo-induced DNA damage.
These cancer cells would otherwise lie dormant and repair the DNA damage caused by drugs such as Temodar, but in combination with Lixte’s compound, the cancer cells speed through the cell cycle / replication process to their demise. The authors of this article conclude that (1) the absence of toxicity in preclinical / animal model studies suggests that specific mutations in the signaling pathways regulating the cell cycle in cancer cells make them more vulnerable to this mode of action as compared to normal cells and (2) the mode of action of Lixte’s compound (global modulation of the serine-threonine phospho-proteome) may represent a general method of enhancing the anti-cancer effects of cytotoxic chemotherapy drugs by exploiting molecular defects in cell cycle regulation for targeted killing of cancer cells.
As a follow-up to my article earlier this week, Cytori's (NASDAQ:CYTX) Cardiac Celution: Encouraging Interim Results, a 31-page PDF is now available at the BioMedReports.com research section in the medical / scientific reports section for a presentation earlier this week by Dr. Francisco Fernandez-Aviles (who kindly sent me the file today) at the 21st Annual Transcatheter Cardiovascular Therapeutics (TCT) scientific symposium in San Francisco in a session entitled, “Update on Adipose Cells for Chronic Ischemia.”
Disclosure: Long CYTX.
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