• 4SC AG, of Planegg-Martinsreid, Germany, said that it has treated its first patient in a Phase I (TOPAS) trial of 4SC-202 for advanced hematological indications including acute myeloid leukemia, acute lymphocytic leukemia, chronic lymphocytic leukemia, multiple myeloma, myelodysplastic syndrome and lymphoma. The single-arm, open-label, dose-escalation trial will evaluate doses from 25 mg to 400 mg daily for 14 days in a 21-day treatment cycle for safety, tolerability and pharmacokinetics. Its secondary objective will be to observe any antitumor activity, duration of response and progression-free survival. The trial will also measure certain biomarkers.

• Beech Tree Labs Inc., of Providence, R.I., began a Phase I/IIa trial of UISH001 for urinary incontinence. The trial is placebo-controlled and will enroll 60 patients. In a previous study, the product showed efficacy in treating urge, stress and mixed incontinence.

• Genzyme Corp., of Cambridge, Mass., a subsidiary of Sanofi-Aventis Group, reported additional five-year data from its Phase II multiple sclerosis trial showing that nearly two-thirds of alemtuzumab-treated patients remained free of clinically active disease as much as four years after most patients received their last course of treatment. Five-year findings also showed that an estimated 72 percent of patients receiving alemtuzumab were relapse-free compared to 41 percent of patients taking Rebif (interferon beta-1a, Merck Serono SA) and an estimated 87 percent of patients in the alemtuzumab group were free of sustained accumulation of disability vs. 62 percent in the Rebif group. Those data were presented at the American Academy of Neurology meeting in Hawaii.

• InSite Vision Inc., of Alameda, Calif., said it received eight minor recommendations from the FDA regarding its proposed special protocol assessment for a Phase III trial of AzaSite Plus (ISV-502) and DexaSite (ISV-305) in patients with blepharitis.

• Novo Nordisk A/S, of Bagsvaerd, Denmark, presented data showing that regardless of baseline A1C, once-daily glucagon-like peptide-1 agonist Victoza (liraglutide) consistently helped more patients achieve blood sugar control than other commonly used Type II diabetes therapies. The number of patients achieving the AACE target A1C of less than or equal to 6.5 percent showed the drug's benefit across all baseline categories. Data were presented at the American Association of Clinical Endocrinologists meeting in San Diego.

• Pfizer Inc., of New York, reported data from an open-label extension study of its pivotal Phase II/III trial of tafamidis for transthyretin familial amyloid polyneuropathy that showed slowing of disease progression sustained for 30 months. In the original 18 month Phase II/III study, 128 patients received 20 mg of tafamidis or placebo. That study missed its primary endpoints of improvement in neuropathy impairment score-lower limb (NIS-LL) and quality of life. It did show statistical significance in a secondary endpoint of reducing attrition due to liver transplantation. In the extension study, patients treated with tafamidis for 30 months had less neurologic deterioration than patients who began tafamidis 18 months later, with 55.9 percent preservation of function by the NIS-LL. Results will be presented at the 63rd Annual Meeting of the American Academy of Neurology.

• PharmaMar, of Madrid, Spain, included its first patient in a Phase II trial of Yondelis for advanced breast cancer. Between 40 and 100 patients who have received at least two previous lines of treatment will be enrolled and divided into groups according to their levels of the protein XPG. Results will be evaluated based on the number of patients who have not progressed within the first four months after treatment.

• PharmAthene Inc., of Annapolis, Md., completed dosing in a Phase I trial of Valortim, a human monoclonal antibody for inhalational anthrax. The randomized, placebo-controlled, double-blind trial will evaluate escalating doses of intravenously administered Valortim in 28 healthy male and female volunteers between 18 and 60. Infusion has been completed and PharmAthene said that no adverse reactions related to infusion have been observed.

• Pluristem Therapeutics Inc., of Haifa, Israel, said that its open-label, dose-escalation, Phase I trial of cell therapy PLX-PAD showed that the treatment is safe, improves quality of life and may be effective in reducing amputations for patients with critical limb ischemia. Out of 27 patients treated with PLX-PAD, there was only one amputation, representing a 75 percent reduction in the rate of amputation compared to historical data. Pluristem plans to further test PLX-PAD for intermittent claudation and CLI.

• Proteon Therapeutics Inc., of Waltham, Mass., started enrollment in a Phase II study of lead product PRT-201, a recombinant human elastase, in chronic kidney disease patients undergoing surgery for arteriovenous fistula creation in preparation for hemodialysis. Results of the trial will be provided to Basel, Switzerland-based Novartis AG under the firms' 2009 option agreement. (See BioWorld Today, March 6, 2009.)

• Precision Therapeutics Inc., of Pittsburgh, said a trial in non-small-cell lung cancer showed that 35 percent of patients' specimens in vitro are resistant to three standard platinum-based therapies, and 28 percent showed a uniquely variable response. The results suggested that ChemoFx chemoresponse testing may help guide selection of platinum-based therapy.

• S*BIO Pte. Ltd., of Singapore, said it dosed the first 10 patients in a Phase II study of JAK2 inhibitor SB1518 in advanced lymphoid malignancies. The study is designed primarily to test efficacy and safety of the drug, with secondary objectives measuring duration of response and progression-free survival. Up to 87 patients will be enrolled. SB1518 is part of S*BIO's development collaboration and option deal with Onyx Pharmaceuticals Inc., of Emeryville, Calif. (See BioWorld Today, Jan. 8, 2009.)

• Teva Pharmaceutical Industries Ltd., of Jerusalem, reported preliminary data from its 688-patient Coptimize study, showing that multiple sclerosis patients who switched to Copaxone (glatiramer acetate) from other approved disease-modifying therapies experienced a reduction of 61 percent (p < 0.0001). Switching to Copaxone also halted the progression of disability of patients in the trial. Preliminary data from the QualiCop study indicated a significant improvement of cognitive function and depressive symptoms over 24 months in patients receiving Copaxone. Those data were presented at the American Academy of Neurology meeting in Hawaii.