Drug Criteria & Outcomes: In the Pipeline 

• Connetics Corp. has completed enrollment in its Phase III clinical trial for Actiza, a formulation of 1% clindamycin delivered in Connetics’ proprietary foam delivery system, for the treatment of acne.

• Adolor Corp. has completed enrollment in its Phase III clinical trial studying the use of the company’s product candidate, alvimopan, for the management of postoperative ileus.

• Medarex has initiated a Phase I clinical trial of MDX-010, a fully human anti-CTLA-4 antibody, for patients infected with HIV, the causative agent of AIDS.

• SuperGen has announced that a Phase II clinical study of the investigational anticancer agent decitabine (Dacogen) for injection, in combination with imatinib mesylate (Gleevec) capsules, has been initiated in patients with chronic myelogenous leukemia.

• Therapeutics has received fast track designation from the U.S. Food and Drug Administration (FDA) for CT-2103 (Xyotax), its polyglutamate paclitaxel, for the treatment of advanced non-small cell lung cancer in patients with a poor performance status.

• Exelixis has initiated the Phase I first-in-man safety trial for its proprietary small molecule anticancer compound XL784.

• Titan Pharmaceuticals has initiated clinical testing of Probuphine, a novel treatment for opiate addiction. Probuphine is a proprietary product in development by Titan that delivers buprenorphine, an approved opiate addiction treatment, for an extended period.

• Nuvelo has commenced dosing in a Phase II trial with its lead product candidate, alfimeprase, for the treatment of acute peripheral arterial occlusion.

• Myriad Genetics has opened enrollment for patients in its Phase II trial of its drug, R-flurbiprofen (MPC-7869), in the treatment of mild-to-moderate Alzheimer’s disease.

• Immtech International has initiated patient enrollment of an expanded Phase IIa human clinical trial of its oral drug candidate DB289 to treat malaria.

• Millennium has initiated a Phase II clinical trial with bortezomib (Velcade) for injection in patients with relapsed or refractory mantle cell lymphoma.

• Aton Pharma has begun enrollment in a Phase I clinical trial of SAHA, an inhibitor of histone deacetylase, in patients with advanced leukemias.

• Celgene Corp. has initiated a clinical trial of dexmethylphenidate hydrochloride extended-release capsules (Focalin) LA in adults with attention deficit disorder/attention deficit hyperactivity disorder.

• Pharmos Corp. has begun U.S. enrollment in its Phase III study of dexanabinol for traumatic brain injury.

• Millennium Pharmaceuticals and Xenova Group, plc have initiated a Phase I clinical trial of MLN944 (also known as XR5944), a novel DNA-targeting agent under investigation for the treatment of advanced cancers.

• Pain Therapeutics has initiated a Phase III clinical study with Oxytrex, the company’s investigational new drug to treat chronic, severe low-back pain.

• Pharmaceuticals has initiated a multicenter, randomized, controlled Phase IIb clinical trial with its anticancer drug Pivanex in the treatment of advanced nonsmall cell lung cancer. The study will evaluate the safety and efficacy of Pivanex plus docetaxel, vs. docetaxel alone.

• SuperGen and Cancer Research UK have initiated a Phase I/II clinical study of decitabine (Dacogen), in combination with carboplatin, in cancer patients with advanced solid tumors.

• Genta has announced that the FDA has designated oblimersen sodium (Genasense) as a fast track product for the treatment of patients with chronic lymphocytic leukemia

• AtheroGenics has begun enrollment of patients in its ARISE Phase III clinical trial of AGI-1067, an oral anti-inflammatory agent targeting atherosclerosis.