• Expression Genetics Inc., of Huntsville, Ala., started a Phase Ia study of its lead candidate, EGEN-001, in combination with standard chemotherapy in patients with recurrent epithelial ovarian cancer. The product, formulated using the company's TheraPlas delivery technology, is composed of interleukin-12 gene expression plasmid and a biocompatible delivery polymer and is designed to increase the local concentration of IL-12. The trial is expected to enroll up to 30 patients. EGEN-001 has orphan drug status in the U.S.

• Kinex Pharmaceuticals LLC, of Buffalo, N.Y., said the FDA cleared its investigational new drug, KX2-391, to begin Phase I trials in September in patients with lymphoma or solid tumors. KX2-391 is an oral drug designed to inhibit the Src kinase, a key regulator of tumor growth, tumor vascularization and metastasis. In preclinical models, the compound demonstrated an ability to inhibit the growth of both primary tumors and metastasis, and showed activity against a range of human tumor cells, including cells that are resistant to existing cancer therapies.

• Oncolytics Biotech Inc., of Calgary, Alberta, in collaboration with the Cancer Therapy & Research Center Institute for Drug Development, enrolled the first two patients in a Phase II study to test Reolysin in various types of sarcomas that have metastasized to the lung. Reolysin, a human reovirus, is designed to target cancer cells without being harmful to normal cells. The study, which will enroll up to 52 patients, has the primary objective of measuring tumor responses and the duration of those responses, and of describing any evidence of antitumor activity.

• Samaritan Pharmaceuticals Inc., of Las Vegas, reported positive preliminary results from a Phase IIb monotherapy trial of the oral HIV entry inhibitor SP-01A, which is being developed as an adjunct treatment for HIV drug resistance. The double-blind, placebo-controlled study in 43 treatment-experienced HIV patients showed a reduction in the amount of viral infection in the blood of those taking SP-01A, with a dose-dependent relationship in effect on viral load, the company said. The monotherapy trial was run per the request of the FDA, following Samaritan's submission of the product to the FDA as an adjunctive therapy. Samaritan said it and SP-01A partner Pharmaplaz Ltd., of Athlone, Ireland, plan to submit finalized data to the FDA and the European Medicines Agency.

• Tercica Inc., of Brisbane, Calif., completed patient enrollment in its MS301 Phase IIIb trial, a study evaluating the current formulation of Increlex (mecasermin [rDNA origin] injection) in children of short stature with primary insulin-like growth factor-1 deficiency. The product already is approved in the U.S. for treating severe primary IGFD. Children in the multicenter, open-label trial will be treated with Increlex for one year. The primary endpoint is height velocity. Data from the MS301 trial are expected to be available in the second half of 2008. If the data are positive, Tercica said it expects to submit a supplemental new drug application by year-end 2008. The company said approval would allow it to promote in a market estimated at five times that of severe primary IGFD.

• Wyeth Pharmaceuticals, of Collegeville, Pa., and Progenics Pharmaceuticals Inc., of Tarrytown, N.Y., said positive activity was seen in the higher dose from a Phase I trial of a new oral formulation of methylnaltrexone. The product is a peripherally acting mu-opioid receptor antagonist being developed for treating opioid-induced constipation. The double-blind, randomized, crossover study was conducted in subjects receiving methadone. A substantial majority of patients experienced a bowel movement after receiving the higher of two doses, the companies said. An earlier study from an initial formulation of oral methylnaltrexone did not exhibit sufficient activity in patients for further development. The companies said they will initiate an additional Phase I trial in the coming weeks to further optimize the new oral formulation.