• Abeille Pharmaceuticals Inc., of Princeton, N.J., started a Phase I pharmacokinetic study of AB-1001, a transdermal patch for chemotherapy-induced nausea and vomiting. The drug is designed to deliver a 5HT3-antagonist through the skin for a continuous period of up to five days. The open-label, randomized, crossover trial is being conducted in healthy volunteers and should be completed within three months.

• ActivBiotics Inc., of Lexington, Mass., was granted fast-track designation by the FDA for rifalazil for the symptomatic treatment of peripheral arterial disease. Rifalazil, a bactericidal anti-chlamydial agent, has the potential to eliminate a possible underlying cause of PAD that may be related to infection with Chlamydia pneumonia. The company has initiated enrollment in a Phase III study.

• GemacBio, of Bordeaux, France, said 22-patient Phase IIa data of its molecule for multiple sclerosis determined that the product had a safety profile that could allow for long-term treatment. The molecule comprises several molecules occurring in the human body grafted together using a patented process, and is active in three areas: anti-inflammatory, immunomodulating and neuroprotecting.

• ImmunoGen Inc., of Cambridge, Mass., was informed by South San Francisco-based Genentech Inc. that the trastuzumab-DM1 investigational new drug application submitted to the FDA has become effective. The event triggers a $2 million milestone payment to ImmunoGen. The product comprises ImmunoGen's cell-killing agent, DM1, linked to Genentech's therapeutic antibody, trastuzumab, which targets overexpression of the HER2 protein.

• Isis Pharmaceuticals Inc., of Carlsbad, Calif., said Indianapolis-based Eli Lilly and Co. has initiated clinical trials of LY2275796 in cancer patients. The product is a second-generation antisense drug that targets eukaryotic initiation factor-4E, a protein involved in the translation of key growth and survival factors that contribute to tumor progression and the spread of cancers. Lilly will pay Isis $750,000 for the start of the Phase I program.

• Metabasis Therapeutics Inc., of San Diego, said partner Sankyo Co. Ltd., of Tokyo, initiated a Phase IIb trial designed to evaluate CS-917 to treat patients with Type II diabetes. Patients will receive CS-917, placebo or an active comparator for three months. CS-917 is an orally active inhibitor of FBPase, an enzyme that regulates production of glucose in the liver.

• Neuren Pharmaceuticals Ltd., of North Sydney, Australia, said it is on schedule to move into a Phase III efficacy trial for its lead molecule, Glypromate, in the fourth quarter. The company expects to complete the current Phase IIa trial in March or April. The FDA had allowed it to forgo a Phase IIb trial if it met certain preclinical requirements, such as additional toxicology studies and other tests.

• TheraQuest Biosciences, of Blue Bell, Pa., said the FDA granted orphan drug designation for the company's high concentration Capsaicin for the management of postherpetic neuralgia. TheraQuest is seeking a pharmaceutical partner. The company's high-concentration Capsaicin is intended to provide long-lasting pain relief.

• TopoTarget A/S, of Copenhagen, Denmark, and CuraGen Corp., of Branford, Conn., started treating patients in a new Phase II study of their histone deacetylase inhibitor, PXD101. The study will enroll 25 patients initially and another 70 following demonstration of activity. It will evaluate the anticancer agent in cutaneous T-cell, peripheral T-cell and other T-cell lymphomas of the non-Hodgkin's type. Preliminary results are expected by mid-2007.

• Vical Inc., of San Diego, said enrollment has opened in its Phase II trial of a DNA vaccine against cytomegalovirus. The trial will be conducted at leading U.S. transplant centers in donors and patients undergoing stem cell transplants. Vical's CMV vaccine has orphan drug designation in the U.S. for at-risk stem cell transplant and solid-organ transplant populations. The company has been awarded $4.1 million in funding for the program under three National Institutes of Health grants.

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