• BioAlliance Pharma SA, of Paris, said that in vivo and in vitro results for its new drug candidate plasmid AMEP, which codes for an anti-invasive peptide, showed that the compound binds to cellular receptors, integrins, which are present on the endothelial cells of neovessels and on some tumoral cells. The in vitro research showed that AMEP inhibits both proliferation and invasion of endothelial cells that cause the formation of neovessels. It also inhibits the proliferation and migration of human melanoma cells. The in vivo research results were achieved with the AMEP plasmid on an invasive melanoma model using intratumoral electrotransfer. The effect of a single dose gives more than 80 percent inhibition of tumoral growth. With repeated doses, there is a 97 percent inhibition of tumoral growth and in 40 percent of cases complete and lasting regression of the tumors.

• Cytokine PharmaSciences Inc., of King of Prussia, Pa., has developed an orally active form of semapimod, its synthetic anticytokine compound. Semapimod is a potential treatment for inflammatory and autoimmune diseases including rheumatoid arthritis, Crohn's and psoriasis. The compound has been tested in clinical trials only as an intravenous infusion. Semapimod is a synthetic guanylhydrazone that inhibits the activity of various kinases.

• DUSA Pharmaceuticals Inc., of Wilmington, Mass., said it has entered into a settlement and mutual release agreement to drop its patent infringement suit against generic drug maker River's Edge Pharmaceuticals LLC. DUSA asserted that River's Edge infringed U.S. Patent No. 6,979,468 under which DUSA has marketed, distributed and sold Nicomide. Under the terms of the agreement, River's Edge acknowledges the validity and enforceability of the Nicomide patent and agreed to make a lump-sum settlement payment to DUSA for damages and will permanently cease the manufacture, distribution and sale of its nicotinamide product, NIC 750. As part of the settlement, DUSA has granted a perpetual exclusive license to River's Edge to manufacture and sell four of its products from the AVAR line, including AVAR cleanser, AVAR gel, AVAR E-emollient cream and AVAR E-green which are nonstrategic for DUSA in exchange for a royalty, including a guaranteed minimum annual royalty, for three years. DUSA will transfer its existing inventory of those products to River's Edge so that the supply of the products will not be interrupted.

• Elan Corp. plc, of Dublin, Ireland, said Johnson & Johnson Pharmaceutical Research & Development LLC, a subsidiary of Johnson & Johnson, of New Brunswick, N.J., has submitted a new drug application to the FDA for paliperidone palmitate, an investigational, once-monthly atypical antipsychotic intramuscular injection for schizophrenia and the prevention of recurrence of the symptoms of schizophrenia. Paliperidone palmitate is a long-acting injectable ester of the active ingredient in Invega and utilizes Elan's NanoCrystal Technology. Under the terms of Elan's license agreement with J&JPRD, it is eligible to receive payments for milestones and royalty payments based on sales if the product is commercialized.

• N30 Pharma, of Boulder, Colo., signed a licensing deal with Lexington, Mass.-based NitroMed Inc. covering the respiratory use of an s-nitrosothiol drug candidate. N30 is developing s-nitrosothiol therapies, which are designed to modulate airway and vascular smooth muscle tone, in diseases such as cystic fibrosis, asthma and chronic obstructive pulmonary disease. Financial terms were not disclosed.

• NanoViricides Inc., of West Haven, Conn., executed a material transfer agreement allowing scientists at the U.S. Army Medical Research Institute of Infectious Diseases to test the efficacy of several NanoViricides antiviral nanomedicines against hemorrhagic fever viruses at the Ft. Detrick, Md., BSL4 facilities. The initial focus of that joint effort will be the Ebola virus, and animal studies and in vitro testing are planned. Terms of the agreement were not disclosed.

• OpGen Inc., of Madison, Wis., said it has entered into a strategic investment and development agreement with investment firm In-Q-Tel in Wilmington, Mass. to develop and enhance new optical mapping systems. OpGen is commercializing a novel single molecule DNA analysis technology, called Optical Mapping, for rapid identification and analysis of microorganisms. The system can be used to obtain detailed genetic information with no requirement for prior sequence data, PCR, cloning or probes. The In-Q-Tel investment is linked to OpGen's recent funding round led by Stamford, Conn.-based CHL Medical Partners, Boston-based Highland Capital Partners and Menlo Park, Calif.-based Versant Ventures, with previous investor Milwaukee-based Mason Wells also participating, the firm said. (See BioWorld Today, Sept. 13, 2007.)

• Supratek Pharma Inc., of Montreal, said the FDA cleared its investigational new drug application for SP1049C for metastatic adenocarcinoma of the upper gastrointestinal tract. The IND proposes a randomized Phase III pivotal trial that will compare SP1049C plus best supportive care (BSC) vs. BSC alone for the treatment of patients with advanced adenocarcinoma of the esophagus, gastroesophageal junction and stomach who have failed adjuvant or first- or second-line chemotherapy. Supratek will initiate the trial after completion of a special protocol assessment.

• Tengion Inc., of East Norrinton, Pa., said that study data showed that subjects who received the firm's Neo-Bladder Augment, which is composed of a biodegradable scaffold and autologous urothelial and smooth muscle cells, achieved functional recovery and a regenerative tissue response that emulated the native bladder's structure, function and biofeedback. The Neo-Bladder group regained baseline bladder capacity by four months and compliance by six months. In contrast, patients who received a re-implanted native bladder, over time, became unstable, with urodynamic parameters significantly lower than baseline by nine months.

• Xenomics Inc., of New York, has granted Asuragen Inc., of Austin, Texas, co-exclusive worldwide rights to use NPM1 technology in Asuragen's molecular diagnostic products. Under the terms of the agreement, Asuragen will have the right to develop, manufacture and market products for the diagnosis, stratification and monitoring of patients with acute myeloid leukemia. Many AML patients have mutations in the nucleophosmin (NPM1) gene, which is a favorable marker for clinical outcome.