• Genta Inc., of Berkeley Heights, N.J., and Emisphere Technologies Inc., of Tarrytown, N.Y., submitted an investigational new drug exemption to the FDA for G4544. The product is a new tablet formulation designed to enable oral absorption of the active ingredient contained in Ganite (gallium nitrate injection), a drug marketed by Genta for treating cancer-related hypercalcemia that is resistant to hydration. The IND proposes a Phase I clinical trial to examine initial safety and pharmacokinetics in human subjects.

• ImmunoGen Inc., of Cambridge, Mass., initiated a Phase II trial to evaluate huC242-DM4 for the treatment of stomach cancer. The study is the first Phase II trial of huC242-DM4, an antibody designed to bind to the CanAg antigen and deliver the company's DM4 cell-killing agent. The single-agent study is designed to assess activity - as measured by objective responses - and tolerability in up to 40 patients who have metastatic or locally advanced gastric or gastroesophageal cancer and have failed front-line chemotherapy.

• Iomai Corp., of Gaithersburg, Md., said its patch-based vaccine for enterotoxigenic E. coli bacteria conferred statistically significant protection from travelers' diarrhea vs. placebo, particularly for more severe cases, according to interim data from a double-blind Phase II field study. Vaccinated travelers were 75 percent less likely to suffer moderate or severe diarrhea from any cause (p<0.01) and 84 percent less likely to be afflicted by severe diarrhea (p<0.05), Iomai said. No vaccine-related serious adverse events were reported. In addition to the protective effects, investigators found that the frequency and duration of diarrhea in vaccinated subjects who did contract disease was significantly lower than in their unvaccinated peers. The Trek field study followed 170 subjects, 111 of whom received a placebo and 59 who received two doses of Iomai's patch-based vaccine before traveling to Mexico or Guatemala. The company intends to launch a Phase III program for the vaccine in 2008.

• MedImmune Inc., a Gaithersburg, Md., unit of AstraZeneca plc, initiated a Phase IIa trial of its MEDI-528 monoclonal antibody targeting interleukin-9, in adults with mild, persistent asthma. The placebo-controlled, dose-escalation study is designed to evaluate the safety and tolerability of multiple doses of the antibody. An ongoing Phase IIa study of MEDI-528 is evaluating the efficacy of a single intravenous dose and its effect on disease mechanisms in adults with atopic asthma. A third Phase IIa study is planned in atopic asthma. MedImmune licensed MEDI-528 from Genaera Corp., of Plymouth Meeting, Pa., in 2001. (See BioWorld Today, April 23, 2001.)

• OncoGenex Technologies Inc., of Vancouver, British Columbia, enrolled the first patient in an open-label, dose-escalation, multicenter Phase I study evaluating OGX-427 in patients with breast, ovarian, bladder, prostate or lung cancer. OGX-427 is designed to block production of heat shock protein 27, a cell-survival protein that inhibits apoptotic cell death through multiple pathways. The study, which will enroll up to 54 patients with cancers known to overexpress Hsp27, will evaluate the safety, pharmacokinetics and biological activity of the second-generation antisense agent alone and in combination with docetaxel. The study in the U.S. and Canada will be conducted in patients who have either failed or refused to take other therapies.

• Rheoscience A/S, of Copenhagen, Denmark, and Dr. Reddy's Laboratories, of Hyderabad, India, said the first patient has been dosed in a Phase III study of balaglitazone (DRF2593-307), an insulin sensitizer that acts as a partial PPAR (peroxisome proliferator-activated receptor) gamma agonist. The study is the first in a series of planned Phase III trials that will investigate the safety and efficacy of balaglitazone as an oral antidiabetic drug. The six-month, double-blind, randomized, placebo-controlled trial in Type II diabetes patients will compare the drug to Actos (pioglitazone) as an add-on to stable insulin treatment. The primary clinical endpoint is to show a noninferior glucose-lowering effect.