• Acuity Pharmaceuticals Inc., of Philadelphia, completed the patient dosing component of its Phase II program for Cand5 in wet age-related macular degeneration. The CARE (Cand5 Anti-VEGF RNAi Evaluation) study enrolled 129 patients to evaluate the product, a small interfering RNA therapy. Results are expected by mid-year. In other news, the company began dosing patients in a pilot Phase II trial of Cand5 in patients with diabetic macular edema.

• Apoxis SA, of Lausanne, Switzerland, received orphan medicinal product designation from the FDA for its protein therapeutic APO200, which could guarantee seven years of marketing exclusivity upon product approval. APO200 is in preclinical development for the treatment of X-linked hypohidrotic ectodermal dysplasia, a rare genetic disease that prevents the body from controlling its temperature through sweating. APO200 previously was granted orphan status in Europe.

• ArQule Inc., of Woburn, Mass., dosed the first patient in a Phase I trial of ARQ 197, an orally administered small-molecule inhibitor of the c-Met receptor tyrosine kinase. The trial will include patients with multiple metastatic tumor types who are refractory to available therapy, or for whom no standard systemic therapy exists.

• Cougar Biotechnology Inc., of Los Angeles, said the FDA approved its investigational new drug application to begin a Phase I study of CB7630 (abiraterone acetate), an orally active inhibitor of the steroidal enzyme 17alpha-hydroxylase/C17,20 lyase designed to treat advanced prostate cancer. The company intends to evaluate the drug as a second-line hormonal therapy.

• Cytos Biotechnology AG, of Zurich, Switzerland, said results from a Phase II clinical dose-optimization study with CYT002-NicQb, its vaccine for nicotine addiction, showed that the drug dosed at 100 g promoted and sustained continuous abstinence from smoking from week 8 to 52 after the start of treatment in 42 percent of the participants who achieved a high antibody level upon vaccination.

• Halozyme Therapeutics Inc., of San Diego, initiated and dosed the first patient in a clinical trial of subcutaneous administration of morphine with Hylenex, a liquid, injectable formulation that includes recombinant human hyaluronidase. The study is designed to determine the time to maximal blood levels of morphine with and without Hylenex, and will enroll up to 18 patients. Hylenex was approved in December for use as an adjuvant agent to increase the absorption and dispersion of other injected drugs, for hypodermoclysis, and as an adjunct in subcutaneous urography for improving resorption of radiopaque agents. (See BioWorld Today, Dec. 6, 2005.)

• ISTA Pharmaceuticals Inc., of Irvine, Calif., released positive results from a Phase III bioequivalence study of its combination ophthalmic product containing tobramycin and prednisolone acetate for steroid-responsive inflammatory ocular conditions in which risk of bacterial infection exists. The trial achieved its primary endpoint, demonstrating bioequivalence of prednisolone between the company's product and prednisolone acetate 1 percent in both the intent-to-treat and per-protocol patient populations. ISTA plans to submit a new drug application during the first half of this year.

• Nabi Biopharmaceuticals, of Rockville, Md., said the FDA granted fast-track status to Civacir, an antibody for preventing hepatitis C virus re-infection in liver transplants. The company also reported that recent discussion with U.S. and European regulators have suggested that a proof-of-concept Phase II trial, followed by a single pivotal Phase III study, would be adequate for approval submission. Nabi is establishing an outside scientific and clinical advisory panel to work with the company on the Civacir development program.

• Pharmexa A/S, of Hoersholm, Denmark, filed an application to initiate a Phase III trial of GV1001 in Ireland, and expects further applications in other countries in the coming weeks. GV1001 is a cancer vaccine designed to target telomerase and activate the immune system's T cells to kill cancer cells. The Phase III program is expected to involve 520 patients with pancreatic cancer and evaluate the vaccine in combination with gemcitabine.

• Pro-Pharmaceuticals Inc., of Newton, Mass., said the FDA approved a request for a compassionate-use investigational new drug application to administer Davana/5-FU to treat another patient who has cholangiocarcinoma. Davana is a polysaccharide in a carbosome formation that target-delivers chemotherapy drugs to receptors found on cancer cells.

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