Clinigene, Pacific Biomarkers enter deal

Clinigene International, a subsidiary of Biocon and Pacific Biomarkers, a US-based limited liability company, entered into a collaborative agreement to address the specialty biomarker and high-end clinical trial laboratory needs of the global pharmaceutical and biotechnology industry.

Mr Ronald Helm, CEO of Pacific Biomarkers said this partnership with Clinigene provided them access to India, considered to be an emerging hub for drug development and contract research. He further added, “Clinigene's state-of-the-art facilities and highly qualified staff help us offer to all of our clients an economic option to conduct their biomarker and specialty clinical lab tests. We are also excited about Clinigene' s unique capabilities in cell-based assays and immunoanalytical testing services, which are of great interest to the global pharmaceutical and biotechnology community.�

“The PBI is a recognized global leader in providing specialty biomarkers and clinical diagnostic assay services to discovery and development-based life science enterprises. We are delighted that the PBI has selected Clinigene as its partner in India and we look forward to supporting it in extending and expanding its specialist service offerings,'' said Mr Peter Bains, director of research services business, Clinigene.

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Israeli firm to hold trial for schizophrenia
Indian regulatory authorities and Indian local ethics committees have given their approval to BiolineRX, an Israel-based company to commence the clinical trial of BL-1020, a first-in-class molecule, orally available GABA-enhanced anti-psychotic for the treatment of schizophrenia. The Israeli drug company said that it will soon commence clinical trial for the treatment of schizophrenia in India. BiolineRX said initiation visits at the Indian clinical research centers will be completed this month and the first patient is likely to be enrolled by December. The trial is expected to be conducted at 18 sites in India. The goal of the study is to determine the short and long-term cognitive efficacy as well as anti-psychotic efficacy, safety and tolerability of BL-1020 in schizophrenic patients over periods of six, 12 and 24 weeks.

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Quintiles launches CRO in China
Quintiles has launched Kun Tuo (koon-TOO-ah), a local contract research organization (CRO), built to service the unique needs of the Chinese biopharmaceutical industry and multinational biopharma companies operating in China. Building on Quintiles' unmatched success at the global level and experience in conducting clinical trials in China since 1997, Kun Tuo will focus on developing customized solutions to help local and global biopharma companies achieve successful registration of new medicines in China. Kun Tuo will provide a full range of services, including comprehensive clinical trial management, regulatory submission preparation, biostatistics and data management. Kun Tuo will tap Quintiles' global resources and expertise to develop customized offerings in key therapeutic areas, along with vaccines, late phase studies, medical devices and diagnostics.

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GVK, Temple Varsity collaborate
GVK Biosciences entered into a drug discovery alliance with the Moulder Center for Drug Discovery Research at Temple University. GVK will be responsible for target validation, lead identification and lead optimization of small molecules in selected therapeutic areas, including cardiovascular, metabolic, and central nervous system disorders.

The Moulder Center is a unique, fully integrated state-of-the-art drug discovery center that is used for both internal research within Temple University and for external collaborations with pharmaceutical and biotech companies and other universities. GVK will apply their integrated drug discovery expertise and technologies to identify interesting small molecules against selected targets.

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Human trials for HIV vaccine
In the first clinical trial of an injectable vaccine containing trimeric HIV envelope protein (gp140) relevant to the predominant strain of HIV in Africa, researchers from four UK academic centers and from the Infectious Disease Research Institute (IDRI) have come together to evaluate whether the vaccine is safe for use in human volunteers. The trial, which is funded by the Wellcome Trust and goes by the name MUCOVAC2, is evaluating a vaccine that contains the HIV trimeric gp140 protein CN54, representative of Clade C strains of the virus. The vaccine candidate will be formulated with an adjuvant known as GLA, developed by IDRI to enhance immune responsiveness following intramuscular injection.