Oncology Drug Activity

Phase III

• In a Phase III multicenter, randomized, open-label trial comparing injectable degarelix with leuprolide, 610 prostate cancer patients were randomized to a starting dose of degarelix 240 mg for one month, followed by monthly maintenance doses of 80 mg (n=207) or 160 mg (n=202), or leuprolide 7.5 mg/month (n=201). Suppression of testosterone to castrate levels occurred significantly faster in patients receiving degarelix than in those receiving leuprolide. The study was evaluating Firmagon from Ferring Pharmaceuticals, randomized to Lupron Depot from TAP Pharmaceuticals. Clinicaltrials.gov identifier is NCT00928434.

•In a large Phase III clinical trial, Tasigna® (nilotinib) 200 mg capsules demonstrated greater efficacy over Gleevec® (imatinib mesylate) tablets in the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Both drugs are marketed by Novartis. Clinicaltrials.gov identifier for this trial is NCT00802841.

Phase II

• GlaxoSmithKline announced updated long-term survival data from two Phase II studies of BEXXAR® (tositumomab and iodine I-131 tositumomab) used in either patients with previously untreated cancer of the immune system (follicular lymphoma) or in patients with cancer of the lymphocytes (non-Hodgkin's lymphoma, NHL) that no longer responded to rituximab. The first study demonstrated that, among 76 patients with previously untreated follicular lymphoma, the 10-year overall survival rate was 83% and the 10-year progression-free survival rate was 38%. The second study of NHL patients experienced an overall median survival of 6.7 years. Clinicaltrials.gov identifier is NCT00996996.

• Ohr Pharmaceutical Inc. announced interim data from its Phase II clinical trial of OHR/AVR118 demonstrating the drug safely and effectively restores strength and vitality to patients suffering with cachexia, a severe wasting disorder that affects late stage cancer patients. The company anticipates it will complete the Phase II clinical trial and report the data by fall 2010. It will then request FDA approval to commence a definitive Phase III randomized, blinded clinical trial. Clinicaltrials.gov identifier is NCT00765466.

Phase I/II

• Onyx Pharmaceuticals' interim results from a Phase Ib/II 006 study, demonstrated that carfilzomib, when administered with the standard therapies lenalidomide (Revlimid®, marketed by Celgene) and low dose dexamethasone, is active and well-tolerated in patients with relapsed and/or refractory multiple myeloma. The Clinicaltrials.gov identifier for this trial is NCT00603447. A large, randomized international Phase III clinical trial studying the combination of lenalidomide and low dose dexamethasone with or without carfilzomib is planned for 2010.

Phase I

• Ambit Biosciences Corporation announced preliminary results from its open-label, dose-escalation study of its lead product candidate, AC220, in acute myeloid leukemia (AML). AC220 is a novel, orally available, small molecule that was expressly optimized as an FMS-like tyrosine kinase-3 (FLT3) inhibitor for the treatment of AML. The overall study population had a median survival time of 14 weeks. In 2010, Ambit plans to commence several clinical studies with AC220, including a registration study in AML. The Clinicaltrials.gov identifier for this trial is NCT00989261

SPA/Orphan Drug/FastTrack Designations

• Keryx Pharmaceuticals that it has been granted a Special Protocol Assessment (SPA) from the FDA for the Phase III study of perifosine in multiple myeloma. Additionally, the FDA has granted perifosine Orphan Drug and Fast Track designations in this indication. The company planned to begin the Phase III trial by end of 2009. The Division of Hematologic Neoplasia, Dana-Farber Cancer Institute was stated to be launching the trial.

Business News

• GSK Oncology, the Oncology R&D Unit of GSK, and US Oncology have entered into a research alliance agreement. The agreement calls for US Oncology scientists and oncologists to provide patient-oriented insight to the clinical researchers at GSK. US Oncology professionals will also be critiquing and participating in the design of future clinical trials.

• The chemotherapy drug Folotyn, approved by the FDA in September 2009 for a rare cancer, is receiving attention for its high price, the New York Times reported in early December. The price is approximately $30,000 a month. Folotyn, manufactured by Allos Therapeutics, is the first approved drug for peripheral T-cell lymphoma, an aggressive blood cancer diagnosed in 5,600 U.S. patients a year. Because Folotyn works by shrinking tumors, the company maintains patients would receive the drug for a short time, making the total cost of Folotyn less than other drugs with lower monthly prices. These drugs would include, for example, Erbitux for colon cancer at $10,000 a month and Avastin at $8,800/month for lung cancer.

• The Lung Cancer Clinical Trial Call to Action campaign was launched in November by a group of patient advocacy organizations to match lung cancer patients with currently recruiting clinical trials. The campaign is supported by Boehringer Ingelheim, Amgen, AstraZeneca, Genentech BioOncology, and Pfizer Oncology. The participating advocacy groups are Lung Cancer Alliance, CancerCare's lungCANCER.org, Uniting Against Lung Cancer, National Lung Cancer Partnership, LUNGevity and the Respiratory Health Association of Chicago. The service provider for the matching capability is EmergingMed.

• The Baylor Charles A. Sammons Cancer Cancer Center has become a full member of the Southwest Oncology Group or SWOG. Baylor joined SWOG to provide important clinical trials to its patients, as well to improve the level of its research.

• CEL-SCI has retained the services of an unnamed international CRO that specializes in late stage oncology trials to run its upcoming Phase III clinical trial in advanced primary head and neck cancers with its lead product candidate Multikane.® The trial will enroll up to 800 patients worldwide to assess overall survival when used in conjunction with standard of care treatment.