• Abraxis BioScience Inc., of San Diego, announced that data from a Phase I trial showed clinical benefit of Abraxane for Injectable Suspension (paclitaxel protein-bound particles for injectable suspension) (albumin-bound) in combination with Gemzar (gemcitabine) in more than 70 percent of advanced pancreatic patients. Of the original 20 patients enrolled at the nab-paclitaxel 100-mg/m2 dose, 17 had levels of CA 19-9 that could be evaluated. CA 19-9 levels dropped more than 20 percent in 82 percent of patients and reductions in CA 19-9 of more than 70 percent were observed in 64 percent of patients. Side effects were considered tolerable. Based on the results, Abraxis said it plans to conduct additional safety and efficacy studies in patients with first- and second-line pancreatic cancer.

• Amkor Pharmaceuticals Inc., of Seattle, a subsidiary of Neurotech Pharmaceuticals Co. Ltd., said data from a Phase I study in 95 healthy volunteers demonstrated that neu2000KL, a moderate N-methyl d-aspartate (NMDA) receptor antagonist and antioxidant, can be safety administered and is well tolerated at doses of up to 6,000 mg, and the company said those results are more than sufficient to support advancement into Phase II studies in ischemic stroke and sudden cardiac arrest.

• Chemokine Therapeutics Corp., of Vancouver, British Columbia, said a poster was presented at the American Association for Cancer Research annual meeting showing positive results for CTCE-9908 in breast cancer. CTCE-9908 is a peptide analogue of the chemokine SDF-1, and an antagonist of its receptor, CXCR4. CTCE-9908 treatment by itself had an effect on reducing the tumor size in the breast and consistently reduced the number of metastases in the lungs by about one-half. Also, adding CTCE-9908 to chemotherapy further inhibited the primary tumor compared to chemotherapy alone and supplementing CTCE-9908 to an anti-angiogenic drug, similar to the cancer drug Avastin, further increased the efficacy of that therapy.

• Cytheris SA, of Paris, started a Phase I trial of CYT107, its interleukin-7 candidate, in post-transplant patients with T-cell depleted bone marrow or peripheral blood stem cell transplants. The primary objective is to determine the safety and recommended dose in recipients of an HLA-matched related or unrelated ex vivo T-cell-depleted bone marrow or peripheral blood stem cell transplant after initial engraftment and hematopoietic reconstitution.

• ESBATech AG, of Zurich, Switzerland, has begun Phase I clinical development of its lead candidate, ESBA105, in ophthalmology. The study is designed to evaluate the safety, tolerability and pharmacokinetic profile of ESBA105, when delivered topically via eye drops in healthy volunteers. ESBA105 is a single-chain antibody fragment directed against TNF-alpha. It is being developed initially for ophthalmic indications. In previously reported in vivo, preclinical studies, ESBA105 achieved high therapeutic concentrations in all ocular tissues, when delivered topically via eye drops.

• Lixte Biotechnology Holdings, of East Setauket, N.Y., said that its collaborators from the Surgical Neurology Branch of the National Institute of Neurological Disorders and Stroke reported that its Lixte's lead compound LB-1 has anticancer activity against human glioblastoma multiforme cells in a mouse model of cancer. The company and institute are continuing to develop LB-1 and analogues of the compound for the treatment of human brain cancers.

• Micromet Inc., of Bethesda, Md., started a Phase I trial of its BiTE antibody MT110 in patients with lung and gastrointestinal cancers. MT110 is designed to work by targeting the epithelial cell adhesion molecule, which is highly expressed on multiple cancer types.

• Poniard Pharmaceuticals Inc., of South San Francisco, announced final efficacy results from its Phase II clinical trial of picoplatin confirming interim results showing a survival benefit in patients with recurrent small-cell lung cancer who have failed prior platinum-containing first-line chemotherapy or who have progressed within six months of first-line therapy. The median overall survival rate was 27 weeks and both the efficacy and the safety profile of picoplatin compared favorably with current medical treatments, which include palliative best supportive care. Best supportive care has been shown previously to have a median overall survival of 14 weeks. The most common side effects were hematologic, including thrombocytopenia, anemia and neutropenia. No Grade 3 or 4 neurotoxicity or nephrotoxicity and no treatment-related deaths occurred.

• PTC Therapeutics Inc., of South Plainfield, N.J., started a pivotal trial of PTC124 in patients with Duchenne's/Becker muscular dystrophy due to a nonsense mutation. The primary objective is to demonstrate the efficacy of PTC124 as measured by improvements in walking ability during a six-minute walk test. Other outcome measures include activity at home, muscle and heart function, strength, cognitive ability, muscle integrity and muscle dystrophin expression. Safety parameters, compliance and PTC124 blood levels also will be monitored.

• Romark Laboratories, of Tampa, Fla., announced that data from studies of nitazoxanide in chronic hepatitis C virus infection are being presented at the annual meeting of the European Association for the Study of the Liver in Milan, Italy, this week. Among the findings was that final 24-week post-treatment sustained virologic response (SVR) rates for the company's STEALTH C-1 trial showed combination therapy with nitazoxanide plus standard of care resulted in a SVR24 rate of 79 percent, compared with 50 percent for those treated with standard of care without nitazoxanide. When nitazoxanide was combined with peginterferon alone, the observed SVR24 rate in that group was 61 percent. In 24 treatment-experienced patients, the addition of nitazoxanide to SOC for 36 weeks resulted in a 25 percent rate of SVR, compared with 8 percent when nitazoxanide was combined with peginterferon alone.

• Vertex Pharmaceuticals Inc., of Cambridge, Mass., announced data from two large Phase IIb clinical trials evaluating the investigational hepatitis C virus (HCV) protease inhibitor telaprevir (VX-950), dosed in combination with pegylated interferon (peg-IFN) and ribavirin (RBV) in treatment-naive, genotype 1-infected HCV patients. Final results from the PROVE 1 trial and further interim analysis from PROVE 2 showed consistently higher SVR rates and antiviral response in the 24-week telaprevir arms, with 61 percent of patients in PROVE 1 and 68 percent in PROVE 2 achieving SVR, compared with 41 percent of patients in the PROVE 1 control arm and 48 percent of patients in the PROVE 2 control arm having undetectable HCV RNA at 12 weeks post-treatment. The data will be presented at the annual meeting of the European Association for the Study of the Liver in Milan, Italy.