• Advaxis Inc., of North Brunswick, N.J., has begun its randomized, single blind, placebo-controlled, Phase II trial of ADXS11-001 for the treatment of cervical intraepithelial neoplasia. The study is designed to assess the safety and efficacy of ADXS11-001 for the treatment of CIN grade 2/3 commonly known as cervical dysplasia.

• Bioheart Inc., of Sunrise, Fla., disclosed treatment with stem cell therapy on two congestive heart failure patients was performed successfully at the Hospital Angeles Tijuana, Mexico, through Bioheart's Center of Excellence program with Regenerative Medicine Institute. The therapy employed stem cells derived from the patient's own fat (adipose tissue) obtained using liposuction. Stem cells were separated from the adipose tissue utilizing the fully automated TGI 1200 Cell Isolation System. The separation process takes about an hour. No tissue pre-processing is required with this system. The recovered stem cells were injected into the patients' hearts utilizing Bioheart's MyoCath needle injection catheter.

• Centocor Inc., of Horsham, Pa., said findings were published in the New England Journal of Medicine from a first-of-its-kind comparator trial evaluating the antitumor necrosis factor-alpha biologic treatment Remicade (infliximab) in the treatment of moderately to severely active Crohn's disease in patients naive to immunomodulator and biologic therapy. Results showed that a significantly greater proportion of patients receiving Remicade achieved steroid-free remission and mucosal healing compared with patients receiving azathioprine.

• Cequent Pharmaceuticals Inc., of Cambridge, Mass., initiated a long-term (26-week) toxicology study of CEQ508, the company's lead drug candidate based on its proprietary RNAi technology. The study is designed to enable a Phase II trial slated for 2011. CEQ508 targets beta-catenin, a key oncogene implicated in the formation of colonic polyps and in the progression of polyps to colorectal cancer. The non-human primate study will evaluate safety and gene knock-down with once-daily oral administration of CEQ508. As an addition to the study, Cequent has begun dosing with the therapeutic candidate optioned by Novartis AG, of Basel, Switzerland, to enable an upcoming investigational new drug application in inflammatory bowel disease.

• Emisphere Technologies Inc., of Cedar Knolls, N.J., said that Novartis Pharma AG, of Basel, Switzerland, has initiated a second Phase I trial for an oral PTH1-34 which uses Emisphere's Eligen Technology, and is in development for the treatment of postmenopausal osteoporosis. First patient enrollment is planned in April.

• Kenta Biotech, of Berne, Switzerland, presented positive Phase IIa results with its lead drug candidate, panobacumab (KBPA101), with all patients completing the treatment for hospital-acquired pneumonia and ventilator-acquired pneumonia caused by P. aeruginosa achieving an effective clearance of pneumonia as well as a 100 percent survival rate. Panobacumab, a fully human IgM monoclonal antibody, is a first-in-class immunotherapy for these life-threatening infections. The study was presented at the 20th European Congress of Clinical Microbiology and Infectious Diseases.

• Medivation Inc., of San Francisco, and Astellas Pharma Inc., of Tokyo, said positive results from their previously reported Phase I-II trial of the triple-acting oral androgen receptor antagonist MDV3100 in men with progressive, metastatic castration-resistant prostate cancer were published in the April 15 online version of The Lancet. MDV3100 showed antitumor activity in patients with late-stage prostate cancer as evaluated by reductions in prostate specific antigen levels, radiographic findings and circulating tumor cell counts. MDV3100 is currently in Phase III development for advanced prostate cancer.

• NovaBay Pharmaceuticals Inc., of Emeryville, Calif., reported positive results of an open-label Phase IIa trial of NVC-422 in chronically catheterized patients with significant bacteriuria, or bacteria in the urine. The study showed that NVC-422 was well tolerated and reduced or eliminated certain pathogens in the urine.

• Theravance Inc., of South San Francisco, said the first patient with opioid-induced constipation has been dosed in a Phase II study with TD-1211, an orally administered peripherally selective mu opioid receptor antagonist. TD-1211 is a potent, multivalent inhibitor of the mu opioid receptor designed to alleviate gastrointestinal side effects of opioid analgesic therapy without affecting analgesia.