• AB Science SA, of Paris, said Phase II results published in BMC Neurology showed that masitinib, an oral tyrosine kinase inhibitor, has potential therapeutic benefits in patients with progressive forms of multiple sclerosis. Results showed that for the primary endpoint of Multiple Sclerosis Functional Composite score, 32 percent of patients treated with masitinib were responders compared to 0 percent in the placebo group. Responses were seen in the third month and were more or less sustained over the study's 18-month duration.

• Astex Pharmaceuticals Inc., of Dublin, Calif., said Janssen Pharmaceutica NV, a unit of New Brunswick, N.J.-based Johnson & Johnson, received clearance to start a Phase I trial of a fibroblast growth factor receptor (FGFR) kinase inhibitor from the companies' 2008 FGFR collaboration, triggering a £3.5 million (US$5.4 million) milestone payment. Astex also is eligible to receive further milestones during clinical development and royalties on commercialization of products derived from the collaboration. (See BioWorld Today, June 10, 2008.)

• Azaya Therapeutics Inc., of San Antonio, Texas, said final results from the Phase I study of its cancer drug, ATI-1123 (liposomal docetaxel), showed 79 percent of heavily pretreated patients received benefit from the compound. The 29 patients enrolled in the study suffered from a variety of solid tumors, including cervical, gastric, melanoma, lung, ovarian, pancreatic, prostate, thyroid and uterine cancers. The study was designed to determine the maximum tolerated dose, dose-limiting toxicities and pharmacokinetics of ATI-1123. In addition, the study sought to observe initial evidence of antitumor activity and to establish the recommended dose of ATI-1123 for Phase II studies.

• Immunomedics Inc., of Morris Plains, N.J., reported initial findings from combining epratuzumab, its humanized anti-CD22 antibody labeled with the radioisotope yttrium-90 (90Y), and veltuzumab, its humanized anti-CD20 antibody, in relapsed aggressive non-Hodgkin's lymphoma (NHL). The approach involves radioimmunotherapy with 90Y-epratuzumab combined with immunotherapy using unlabeled veltuzumab. Thirteen patients with various types of aggressive NHL who failed one or more prior standard therapies are enrolled in the Phase I/II study to receive four weekly treatments of veltuzumab at 200 mg/m2, with indium-111-epratuzumab for imaging and pharmacokinetics on week two and 90Y-epratuzumab at planned dose levels on weeks three and four. Half of the first 10 patients showed an overall objective response rate, with one diffuse large B-cell lymphoma (DLBCL) patient having a complete response that persisted at nine months. Three patients with transformed follicular NHL and one DLBCL patient were partial responders, and three patients with mantle cell lymphoma had disease stabilization as their best response. The combination treatment was well tolerated. Separately, Immunomedics provided updates from studies involving two bispecific antibodies created by the company's protein conjugation method, known as Dock-and-Lock, at the Society of Nuclear Medicine meeting in Miami Beach, Fla. A Phase I study of pretargeted radioimmunotherapy (PRIT) in patients with advanced colorectal cancer (CRC) assessing safety, dosimetry tumor targeting and therapeutic potential of TF2, a DNL-bispecific antibody that binds to the carcinoembryonic antigen and the peptide IMP288, showed rapid tumor localization of radio-labeled IMP288 in CRC patients within one hour following injection of the peptide. In a preclinical study of the other DNL-created bispecific antibody, TF12, which has two binding arms targeting the TROP-2 antigen, treatment with one cycle of PRIT in a mouse model of human prostate cancer improved median survival from 82 days to 121 days, which could be extended to more than 160 days when animals were treated with an additional cycle of the pretargeted therapy. After 150 days, 70 percent of the mice treated with two cycles of PRIT were still alive, while none in the control groups survived. The pretargeting studies were conducted by Immunomedics' collaborators at Radboud University Nijmegen Medical Center in Nijmegen, the Netherlands.

• Oncolytics Biotech Inc., of Calgary, Alberta, said a paper published in Science Translational Medicine showed that intravenous administration of Reolysin in patients with metastatic colorectal cancer prior to surgical resection of liver metastases could still specifically target and infect metastatic liver tumors in 90 percent of the patients, even though they had preexisting immunity to the virus. The researchers were able to determine that reovirus was able to evade those neutralizing effects of the immune system by binding to specific blood cells that would in turn deliver the virus to the tumor. The open-label trial involved administration of Reolysin to 10 patients.

• Sylentis SA, of Madrid, Spain, a subsidiary of Grupo Zeltia SA, received authorization from Spanish and Estonian regulatory agencies to begin Phase II trials with RNAi therapeutic SYL040012 in ocular hypertension associated with glaucoma. The placebo-controlled, blind trial will evaluate the effect of a range of doses on 80 patients enrolled at sites in Spain, Estonia and Germany. Phase I findings, presented in March at the Seventh Conference of the Spanish Society for Glaucoma, indicated the molecule was safe and well tolerated.