• Acacia Pharma Ltd., of Cambridge, UK, started a Phase I trial of APD515, an optimized oromucosal formulation of a marketed drug for treating xerostomia in advanced cancer patients. The ascending-dose study will enroll healthy volunteers who will receive the drug topically to the lining of the mouth. Volunteers also will take the drug orally to compare blood levels between the two administrations.

• Allon Therapeutics Inc., of Vancouver, British Columbia, started a pivotal Phase II/III trial of davunetide in progressive supranuclear palsy. The company secured a special protocol assessment earlier this week. (See BioWorld Today, Jan. 5, 2011.)

• Altheus Therapeutics Inc., of Oklahoma City, completed two Phase I trials testing Zoenasa rectal suspension in adults with left-sided, or distal, ulcerative colitis. No serious adverse reactions were experienced, and the company is planning to move into Phase II.

• Athersys Inc., of Cleveland, completed patient enrollment of the single-dose arm of a study involving administration of MultiStem to patients being treated for leukemia or other blood-borne cancers. The study involves administration of a single or multiple doses of MultiStem, an allogeneic cell therapy product, to patients following radiation therapy and a donor-derived hematopoietic stem cell transplant. Patients receiving such transplants are typically at risk for graft-vs.-host disease, as well as other complications. Initial results of safety information from the single dose arm of the trial are expected to be announced following the completion of patient evaluation periods and subsequent analysis of data.

• Cell Medica, of London, signed an exclusive license agreement and research collaboration with the Center for Cell and Gene Therapy, Baylor College of Medicine, of Houston, for the commercialization of a cell-based treatment for cancers associated with the oncogenic Epstein Barr virus. Financial terms were not disclosed.

• CeNeRx BioPharma Inc., of Research Triangle Park, N.C., initiated a Phase II trial of its new formulation of TriRima, an antidepressant in development as a monotherapy for treatment-resistant depression. TriRima is a reversible and selective inhibitor of monoamine oxidase A. It's designed to achieve the efficacy of the older MAO inhibitor class while reducing or eliminating the risk of common food-associated effects. The Phase II is a double-blind, placebo-controlled study that will enroll 360 patients.

• Esperion Therapeutics Inc., of Plymouth, Mich., started a Phase II study to test the role of ETC-1002, a small molecule designed to inhibit fatty acid and cholesterol synthesis, in lipid regulation (LDL-C and triglycerides.) The 12-week study will enroll 176 patients with hypercholesterolemia with or without high triglycerides.

• Generex Biotechnology Corp., of Worcester, Mass, together with its wholly owned immunotherapeutic vaccines subsidiary, Antigen Express Inc., and RXi Pharmaceuticals Corp., also of Worcester, obtained positive early research data from their collaboration to explore the use of RXi's RNAi technology to develop vaccine formulations for active immunotherapy. Initial results from the alliance demonstrated success in using RXi's self-delivering rxRNA (sd-rxRNA) compounds to silence genes up to 80 percent in hemopoietic cells. The ability to knock down expression of certain genes in isolated hemopoietic-derived cancer cells (ex vivo) has the potential to convert them into specific immune-stimulants and opens the possibility for development of a new class of anticancer therapeutic vaccines.

• Lexicon Pharmaceuticals Inc., of The Woodlands, Texas, reported Phase II data showing that a solid oral-dose formulation of LX4211, a dual inhibitor of sodium-glucose co-transporters 1 and 2, significantly increased total GLP-1, active GLP-1 and PYY, all mediators of glycemic and appetite control. Single doses of LX4211 produced rapid and significant improvement in post-prandial glucose and fasting plasma glucose, consistent with results seen in a previous study. Lexicon plans to move the tablet formulation into a Phase IIb study in the second quarter. The company's shares (NASDAQ:LXRX) shot up 45.8 percent, or 69 cents, to close Thursday at $2.20.

• LifeCycle Pharma A/S, of Horsholm, Denmark, reported positive top-line results from a Phase II trial of 58 patients comparing LCP-Tacro tablets administered once daily vs. Prograf (tacrolimus, Astellas Pharma US Inc.) capsules administered twice daily in de novo liver transplant patients for one year. The data confirmed the previous positive experience with LCP-Tacro in stable kidney and liver transplant patients and supported comparability of LCP's extended-release tablet formulation of tacrolimus when compared to twice-daily Prograf capsules.

The Multiple Myeloma Research Foundation, of Norwalk, Conn., awarded $1 million to each of three Boston-area biotech companies through its 2010 Biotech Investment Awards program: Constellation Pharmaceuticals Inc. and Epizyme Inc., both of Cambridge, Mass., and Karyopharm Therapeutics Inc., of Newton, Mass.

• Pharmasset Inc., of Princeton, N.J., reported positive data from interim analyses of two of its programs: the HCV genotype 2 or 3 (GT2/3) arm of the PSI-7977 Phase IIb trial and the 14-day PSI-938 monotherapy cohort of the dual nucleotide study. Twenty five treatment-naive patients with HCV GT2/3 patients were enrolled in the open-label arm; 24/25 patients completed 12 weeks of PSI-7977 400 mg QD with Peg-IFN/RBV. A preliminary analysis of all data available at the end of 12 weeks of dosing revealed no serious adverse events and no discontinuations due to adverse events. PSI-7977 with Peg-IFN/RBV resulted in rapid viral suppression, with all HCV GT2 or three patients (n = 24) achieving both a rapid virologic response and remaining below the limit of detection through the end of treatment at week 12.

• Salix Pharmaceuticals Ltd., of Raleigh, N.C., said The New England Journal of Medicine published results from TARGET 1 and TARGET 2, the company's two pivotal Phase III efficacy and safety studies of Xifaxan (rifaximin) 550-mg tablets for the treatment of irritable bowel syndrome (IBS)without constipation. The studies showed it demonstrated a statistically significant improvement for the adequate relief of global IBS symptoms, IBS-related bloating, abdominal pain and stool consistency following a 14-day course of therapy.

Paris-based Sanofi-Aventis Group and its wholly owned subsidiary, BiPar Sciences, of South San Francisco, announced that The New England Journal of Medicine published the final Phase II data for iniparib (BSI-201) demonstrating significant clinical benefit in women with metastatic triple negative breast cancer (mTNBC) when iniparib was administered in combination with chemotherapy agents gemcitabine/carboplatin. Although not a prespecified endpoint, overall survival also was significantly increased in women who received iniparib.

• Spectrum Pharmaceuticals Inc., of Irvine, Calif., said the first patient was dosed in Japan in a Phase I study of apaziquone in bladder cancer sponsored by Asian partner Nippon Kayaku Ltd., of Tokyo. The study is designed to enroll up to six patients and will determine the safety and pharmacokinetics of an immediate instillation of apaziquone in the bladder following transurethral resection of bladder tumor, followed by six weekly instillations starting at week four.