• Curis Inc., of Lexington, Mass., treated the first patient in a Phase I trial of CUDC-101, a small-molecule inhibitor of EGFR, HER2 and histone deacetylase, in combination with radiation and cisplatin in human papillomavirus-negative locally advanced head and neck cancer patients. The primary objective is to establish safety, tolerability and maximum-tolerated dose, while secondary objectives will evaluate the efficacy of the therapy combination, assess the pharmacokinetics of CUDC-101 and evaluate tumor markers for response associated with the combination. About 15 to 25 patients will be enrolled.

• Inhibikase Therapeutics Inc., of Atlanta, received FDA clearance to start a Phase II trial of IkT-001, a host-directed kinase inhibitor aimed at clearing JC polyomavirus (JCV) infection, the causative agent of progressive multifocal leukoencephalopathy. The four-week study will enroll 48 multiple sclerosis patients on Tysabri (natalizumab, Biogen Idec Inc.) and will monitor safety and pharmacokinetic profile and also determine potential antiviral effect as measured by the suppression of urinary excretion of JCV.

• Marshall Edwards Inc., of San Diego, said the FDA cleared its investigational new drug application for ME-143 (formerly NV-143), an NADH oxidase inhibitor for cancer. The biotech plans to initiate a Phase I trial of intravenous ME-143 next month. Shares of Marshall Edwards (NASDAQ:MSHL) jumped 53 cents, or 38.4 percent, to close at $1.91 Tuesday.

• NexBio Inc., of San Diego, reported top-line Phase II data showing DAS181 (Fludase) significantly reduced influenza viral loads. The double-blind, placebo-controlled, NIH-funded, 297-patient study showed once-daily treatment for three days with 10-mg DAS181 resulted in a significant reduction of viral load when compared to placebo over the first 24 hours (p < 0.002), first 48 hours (p < 0.009) and from day one to day five (p < 0.008). DAS181 was well tolerated.

• Optimer Pharmaceuticals Inc., of San Diego, said a subgroup analysis of patients with Clostridium difficile-associated diarrhea (CDAD) receiving concomitant systemic antibiotics in two Phase III trials found that, in those patients, Dificid (fidaxomicin) achieved a significantly higher initial clinical cure rate and higher rate of global cure when compared to vancomycin. Data published in Clinical Infectious Diseases showed that patients taking Dificid while on concomitant antibiotics demonstrated a 90 percent clinical rate vs. 79.4 percent in the vancomycin group (p = 0.04). Regardless of concomitant use, Dificid was statistically superior to oral vancomycin in global cure rate. The drug, which gained approval for CDAD in late May, met the primary endpoint in the full Phase III trial populations, showing noninferiority to vancomycin, and the drug's label cites superiority over vancomycin in sustained clinical response. (See BioWorld Today, May 31, 2011, and June 1, 2011.)

• Titan Pharmaceuticals Inc., of South San Francisco, reported additional results from its Phase III confirmatory study of Probuphine in opioid dependence, which confirmed the drug's noninferiority to Suboxone (buprenorphine/naloxone). Probuphine treatment resulted in a significant improvement in the global severity of opioid dependence (p = 0.0003) and overall patient improvement vs. placebo (p = 0.0002), as assessed by clinicians. Titan reported top-line data last month and expects to file a new drug application by the end of this year. (See BioWorld Today, July 12, 2011.)