• BioTime Inc., of Emeryville, Calif., organized a new subsidiary, Embryome Sciences Inc., to focus on the regenerative medicine field known as "embryomics." The subsidiary's plan is to market products and services to companies and academic researchers in that field, with three types of research products to be launched in the next two years: a database providing the first detailed map of the embryome, growth and differentiation factors that can induce embryonic stem cells to become specific cell types and a line of purification tools for quality control uses.

• Cleveland BioLabs Inc., of Buffalo, N.Y., reported results showing its CBLB612 demonstrated much stronger efficacy as a stimulator and mobilize of hematopoietic stem cells (HSCs) in peripheral blood compared to G-CSF in mice. Each product was administered both as a single agent and in combination with AMD3100, a clinical-stage stem cell mobilize developed by AnorMed Inc. (later acquired by Cambridge, Mass.-based Genzyme Corp.) Data from the preclinical study also showed that a single injection of CBLB612 given in combination with the current standard methodology for stem cell donor isolation - four daily injections of G-CSF followed by one injection of AMD3100 - yielded eight to 10 times higher concentrations of short-term and long-term HSCs in peripheral blood, respectively, compared to standard protocol. A single administration of CBLB612 in combination with AMD3100 yielded twice as many mobilized HSCs compared to the standard regimen.

• Cytori Therapeutics Inc., of San Diego, received 510(k) clearance from the FDA for its Autologous Fat Transfer (AFT) system, which is designed to harvest, filter and re-inject a patient's fatty tissue during a surgical procedure. The company is also developing its Celution system, a device that is approved in Europe for harvesting and purifying stem and regenerative cells from fatty tissue for delivery back into the patient. Shares of Cytori (NASDAQ:CYTX) rose 42 cents, or 8 percent, to close at $5.59 on Wednesday.

• Geron Corp., of Menlo Park, Calif., said partner Merck & Co Inc., of Whitehouse Station, N.J., has filed an investigational new drug application with the FDA for a cancer vaccine candidate that targets telomerase, triggering a $4 million milestone payment to Geron. Merck is developing the vaccine under a July, 2005 agreement giving it exclusive worldwide rights to nondendritic cell based vaccines targeting telomerase. Separately, Geron is enrolling patients with acute myelogenous leukemia in a Phase I/II study of its own telomerase vaccine candidate, GRNVAC1, which delivers the telomerase antigen using autologous dendritic cells.

• ImmuneWorks LLC, of Indianapolis, received a $1.5 million grant from the Indiana 21st Century Research and Technology Fund to support certain preclinical and Phase I trial activities. The company will use those funds to complete preclinical development of its lead product for idiopathic pulmonary fibrosis, with an investigational new drug application submission expected in 2008. Funding also will provide partial support for a first clinical trial.

• Inovio Biomedical Corp., of San Diego, will receive a $2 million milestone payment from Merck & Co. Inc., of Whitehouse Station, N.J., resulting from the filing of a second investigational new drug application for a DNA-based vaccine using Inovio's MedPulser DNA Delivery System. This is the second investigational DNA-based vaccine Merck has advanced into clinical studies using Inovio's technology.

• Insmed, of Richmond, Va., received a $2,087,325 grant from the Muscular Dystrophy Association to support development of Iplex, which is moving Phase III testing for treatment of myotonic muscular dystrophy. Insmed decided to initiate the trial based on results from an ongoing open-label, dose-escalation trial of Iplex in MMD. To date, up to 70 percent of patients tested have reported improvements in one or more symptoms associated with the disorder. Patients undergoing a standardized six-minute walk test improved their walking distance. The funding is expected to cover a substantial portion of the external costs associated with the 24-week late-stage study.

• Pro-Pharmaceuticals Inc., of Newton, Mass., entered a research collaboration with the University of Massachusetts Lowell to evaluate Davanat in combination with chemotherapy drugs. Davanat is a new chemical entity based on mannose and galactose and is designed to deliver encapsulated chemotherapy in a way that may allow for increased potency and decreased toxicity. The approach is in Phase II trials in colorectal and biliary cancer. Terms of the deal were not disclosed.

• QLT Inc., of Vancouver, British Columbia, engaged Goldman, Sachs & Co. to serve as its financial advisor and assist in the evaluation of strategic alternatives to maximize shareholder value. QLT announced last month that it would cease investing in new products and would consider the sale of some or all of its assets. (See BioWorld Today, Nov. 29, 2007.)

• Regulus Therapeutics LLC, of Carlsbad, Calif., said research performed in collaboration with Duke University scientists shows that a virally derived microRNA mimics the gene expression control by an endogenous host microRNA that previously has been implicated in human cancer. Study data suggest that the viral microRNA, which is encoded by the Kaposi's sarcoma-associated herpesvirus, might represent the first example of an oncomir, a viral microRNA oncogene. Those results were published in Nature. Regulus is a joint venture between Cambridge, Mass.-based Alnylam Pharmaceuticals Inc. and Carlsbad, Calif.-based Isis Pharmaceuticals Inc. aimed at developing and commercializing microRNA-based drugs.

• Xanthus Pharmaceuticals Inc., of Cambridge, Mass., presented preclinical data demonstrating that Symadex (C-1311) attenuated acute disease in a model designed to replicate multiple sclerosis (MS) and prevented chronic disease by reversing perivascular inflammation, myelitis and demyelination. The drug also increased spinal cord remyelination. Xanthus is evaluating Symadex in a Phase II breast cancer trial and plans to begin a clinical proof-of-concept trial in autoimmune disease in 2008. The drug is an imidazoacridinone and has been shown to inhibit FLT3 kinases. The data were presented at a meeting of the Multiple Sclerosis Society of Canada in Banff, Alberta.

No Comments