• Cytori Therapeutics Inc., of San Diego, said longer-term follow-up data from an investigator-sponsored Japanese breast reconstruction study showed no significant loss of breast tissue thickness from one month to a mean follow-up of 12 months and a patient satisfaction of 79 percent. The study involved the use of adipose tissue-derived stem and regenerative cells, processed using Cytori's Celution 600 System, to reconstruct breast tissue following partial mastectomy. Data were presented at the Japan-Korea Congress of Plastic and Reconstructive Surgery in Okinawa, Japan.
• ImClone Systems Inc., of New York, enrolled the first patient in a disease-directed Phase II trial of IMC-1121B, an anti-VEGFR-2 antibody, in patients with advanced hepatocellular carcinoma who have not received prior chemotherapy or other systemic therapies. That study will involve a total of 40 patients who will receive IMC-1121B every two weeks by intravenous infusion, with the primary objective of progression-free survival.
• ISTA Pharmaceuticals Inc., of Irvine, Calif., said results from a 60-patient study testing Xibrom (bromfenac ophthalmic solution) in combination with Lucentis (ranibizumab, Genentech Inc.) in age-related macular degeneration showed that patients receiving Xibrom required 1.6+/-0.69 injections of Lucentis during the six-month study period vs. 4.5+/-0.41 injections for patients getting Lucentis alone. Those receiving only Lucentis received significantly more (2.83 times) injections than those getting combo treatment. While there was a numerical trend in favor of the combo group on improvement in visual acuity, it did not achieve statistical significance. ISTA said it intends to start additional studies to confirm those findings. Xibrom is a topical non-steroidal anti-inflammatory compound approved for treating ocular inflammation and pain.
• Kiadis Pharma BV, of Amsterdam, said the FDA approved its investigational new drug application for a Phase III trial of Reviroc, which is designed to eliminate cancer cells from an autologous graft in bone marrow transplantation for end-stage blood cancer patients. The company expects to start the study upon completion of a special protocol assessment. Reviroc previously demonstrated positive results in a Phase II trial, showing that it effectively eliminated cancer from autologous bone marrow grafts and demonstrated an encouraging overall survival following transplantation in non-Hodgkin's lymphoma patients.