• 4SC AG, of Planegg-Martinsried, Germany, said the European Medicines Agency recommended orphan designation for resminostat in Hodgkin lymphoma. Resminostat, an oral pan-histone deacetylase inhibitor, previously demonstrated a 33.3 percent overall response rate in a Phase II study in third-line, relapsed/refractory Hodgkin lymphoma patients.

• Achillion Pharmaceuticals Inc., of New Haven, Conn., reported that ACH-3102, a second-generation NS5A inhibitor, demonstrated potent activity against hepatitis C genotypes 1-6 in preclinical studies. It also showed excellent activity against the genotype 1a subtype and known mutant variants of genotype 1. Achillion plans to advance ACH-3102 into clinical trials and is anticipating trial results near year-end on its first-generation NS5A inhibitor, ACH-2928. Achillion said its pipeline, which also includes protease inhibitors, has the potential to deliver multiple combinations for an interferon-free hepatitis C treatment. (See BioWorld Today, June 23, 2011.)

• Agenix Ltd., of Brisbane, Australia, said it signed two new agreements with strategic partners in China. Agenix's China subsidiary inked an agreement with China's Institute of Pharmacology and Toxicology of the Academy of Military Medical Sciences to complete toxicology tests for hepatitis B compound AGX-1009 ahead of the expected start of clinical trials in China next year. It also signed a memorandum of understanding with the Institute of Medicinal Biotechnology of the Chinese Academy of Medical Sciences in Beijing covering development of future drug candidates, sharing intellectual property, production, marketing, distribution and access to IMB's national research and regulatory expertise. Financial terms were not disclosed.

• Cylene Pharmaceuticals Inc., of San Diego, moved its leukemia, lymphoma and myeloma candidate, CX-5461, forward in preclinical development. The drug is a p53 activator designed to avoid the DNA-damaging side effects of other p53-activating drugs by selectively inhibiting RNA Polymerase I.

• Helix BioPharma Corp., of Aurora, Ontario, said it filed its complete response to the clinical hold issues raised by the FDA relating to a pending an investigational new drug application for a Phase II/III trial of topical interferon alpha-2b in low-grade cervical lesions. Assuming regulatory approval is granted, the company said it will need additional funding and a strategic partner before moving ahead. Alpha-2b is the company's most advanced product in development incorporating its Biphasix drug delivery technology.

• Micromet Inc., of Rockville, Md., announced a clinical development plan for U.S. registration of blinatumomab in relapsed and refractory acute lymphoblastic leukemia, based on advice from the FDA in a Type C meeting. The company will begin two clinical trials later this quarter.

• NeuroVive Pharmaceutical AB, of Lund, Sweden, and to-BBB Technologies BV, of Leiden, the Netherlands, said they were awarded a €1 million (US$1.38 million)grant through the Eureka Eurostars program for joint development of therapies for stroke and other acute neurological conditions. Funding will support preclinical development of a treatment combining NeuroVive's cyclosporine A for treating neurological damage with to-BBB's G-Technology to enhance delivery of the drug across the blood-brain barrier. In separate news, NeuroVive said it signed a research collaboration with UK-based contract research organization Selcia Ltd. to develop medicines and drug compounds targeting mitochondrial physiology and pathophysiology. The two firms will jointly invest in the deal to combine Selcia's expertise in medicinal and analytical chemistry with NeuroVive's R&D programs in mitochondrial medicine. Financial terms were not disclosed.

• PharmAthene Inc., of Annapolis, Md., said it filed its legal brief in response to New York-based SIGA Technologies Inc.'s motion for re-argument. Last month, the court awarded PharmAthene 50 percent of net profits over 10 years from all sales of SIGA's ST-246 and related products after SIGA receives the first $40 million in net profits. SIGA is arguing that the court erred in its application of the law, while PharmAthene's brief outlines specific examples supporting the use of a constructive trust as an appropriate equitable remedy. (See BioWorld Today, Sept. 23, 2011.)

• Sangamo BioSciences Inc., of Richmond, Calif., said a preclinical study demonstrated the highly specific, functional correction of the alpha 1-antitrypsin gene defect in patient-derived induced pluripotent stem cells (iPSCs) using zinc finger nucleases (ZFN). The study, published in the Oct. 12, 2011, online issue of Nature, highlighted the potential of combining human iPSCs with ZFN-driven gene correction to generate differentiated cell-based therapies. The in vitro mouse study showed that Sangamo's platform can generate novel ZFP therapeutic options for diseases that have a well-defined genetic cause, the company said.

• The Beijing Centers for Disease Control and Prevention (CDC) chose Sinovac Biotech Ltd., of Beijing, as one of four manufacturers supplying seasonal influenza vaccine to citizens of Beijing for the fourth time. The Beijing CDC expects to order 2 million doses for its 2011 vaccination campaign.

• Stockholders in Synageva BioPharma Corp., of Lexington, Mass., and Trimeris Inc., of Durham, N.C., will meet Nov. 2 to consider matters related to a proposed merger between the companies. The boards of both companies have recommended approval of the merger. (See BioWorld Today, June 14, 2011.)

• Uluru Inc., of Addison, Texas, signed a binding letter of intent with Melmed Holdings AG, of Switzerland, to license Altrazeal, a product for diabetic foot ulcers. Melmed will pay a licensing fee plus 25 percent interest in the Altrazeal marketing subsidiary. Uluru will supply Altrazeal at 30 percent of the European sales price and will receive royalties on sales within the European territory.