• BioBalance Corp., of New York, won clearance from the FDA to start trials with its biotherapeutic agent, Probactrix, as a prescription drug for pouchitis, a debilitating complication that can develop following corrective surgical treatment of ulcerative colitis, in which an ileal reservoir, or pouch, is constructed to enable normal bowel movements after removal of the diseased colon. The Phase I/II study will enroll about 63 antibiotic-dependent pouchitis patients to demonstrate the ability of a prescription formulation of Probactrix to maintain symptomatic response of pouchitis symptoms after antibiotic withdrawal.

• Exelixis Inc., of South San Francisco, started a Phase II program with XL784 against proteinuria, a marker for renal damage. The primary endpoint is reduction in proteinuria, and secondary endpoints will evaluate changes in renal function and cardiovascular effects. XL784 is a potent small-molecule inhibitor of the ADAM-10 metalloprotease enzyme, which plays a role in blood vessel formation and cell proliferation that can cause renal fibrosis and impairment.

• Idenix Pharmaceuticals Inc., of Cambridge, Mass., offered data showing that telbivudine, its oral, once-daily nucleoside analogue, provided significantly greater antiviral and clinical efficacy in Chinese patients with chronic hepatitis B virus after one year of treatment when compared with a current standard of care, lamivudine. Data from a Phase III registration trial were offered at International Liver Congress in Shanghai, China, and the results, along with Idenix’s international Phase III GLOBE study - the largest trial ever against chronic HBV - were included in a recent regulatory submission to Chinese health authorities. The study is an ongoing trial comparing two years of treatment with telbivudine or lamivudine in 332 Chinese adults with HBV. Most were HBeAg-positive (n=290) although HBeAg-negative patients also participated (n=42). After one year, telbivudine displayed significantly greater antiviral and clinical efficacy compared with lamivudine, significantly reducing virus levels by 6.22 log10, or more than 1 million-fold, compared with 5.4 log10 for lamivudine (p<0.001). In addition, undetectable virus levels were achieved by significantly more telbivudine-treated patients compared with lamivudine-treated patients (70 and 43 percent, respectively; p< 0.001). Several months ago, Idenix and the U.S. arm of partner Novartis Pharma AG, of Basel, Switzerland (Idenix’s majority owner), submitted the new drug application to the FDA for telbivudine against HBV. Idenix’s stock (NASDAQ:IDIX) closed Monday at $14.20, down 37 cents.

• Immtech Pharmaceuticals Inc., of Vernon Hills, Ill., initiated a pivotal Phase III trial of its oral drug, pafuramidine maleate (DB289), to treat HIV/AIDS patients with pneumocystis pneumonia. The trial, which will be conducted under a special protocol assessment, is expected to enroll about 270 HIV/AIDS patients with confirmed PCP to assess the safety, tolerability and efficacy of pafuramidine vs. TMP-SMX, the standard of care, following a 22-day treatment period. Immtech also has an ongoing pivotal trial of DB289 in African sleeping sickness. That trial started enrolling patients in August, following an SPA in June. DB289 also is in testing as a potential treatment for malaria. (See BioWorld Today, June 17, 2005.)

• Molecular Insight Pharmaceuticals Inc., of Cambridge, Mass., started a Phase II trial to develop a reference database of normal Zemiva images of the heart using SPECT imaging. The normative trial is part of the firm's ongoing clinical program to develop Zemiva (iodofiltic acid I 123) for the diagnosis of cardiac ischemia in chest pain patients in the emergency department setting. The normative trial is designed to include about 120 patients at 12 centers in North America, and is expected to finish in about six months.

• PDL BioPharma Inc., of Fremont, Calif., initiated a trial to evaluate visilizumab, a monoclonal antibody designed to target and block the action of T cells, in patients with severe ulcerative colitis that no longer respond to standard therapies. The aim of the trial will be to significantly reduce the symptoms of UC, and potentially delay the need for colectomy.

• SciClone Pharmaceuticals Inc., of San Mateo, Calif., offered data from its Phase II trial with Zadaxin (thymalfasin) plus trans-arterial chemoembolization (TACE) against hepatocellular carcinoma, or primary liver cancer. At the plenary session Shanghai-Hong Kong International Liver Congress, lead investigator Robert Gish detailed the results first reported in late 2005, which showed a median survival of 994 days for the 12 patients who received the combo treatment vs. a median survival of only 399 days for the 13 patients who only received TACE.