 ChemDiv-iDialog Partnership
In October 2007 iDialog had a series of proprietary compounds that were showing anti-viral activity. This is when iDialog made a decision to enter into collaboration with ChemDiv to move compounds though drug discovery process and into pre-clinical and clinical stages. ChemDiv successfully maintains the integrated R&D program for iDialog having moved it from early discovery to clinic in 26 months.
As a result, the novel small molecule is currently in a clinical stage of development. It is an orally-bioavailable inhibitor of hepatitis C virus (HCV) that blocks early stage of viral infection. Vadim Bichko, Ph.D, ChemDiv’s Vice President of Virology, stated: "We are very encouraged by the safety, potency, PK profile, and novel molecular mechanism of action, exhibited by iDialog's HCV inhibitor in the preclinical studies. We are quite excited by the ability of ID-12 to prevent spread of viral infection through cell-cell contact, which makes it superior to the neutralizing antibodies and other viral entry inhibitors. This mechanism of action is complimentary to that of other classes of HCV inhibitors currently on the market, or in late stage clinical development. Thus, ID-12 is a potentially important component of therapeutic cocktails for chronic hepatitis C.”
In September 2009 pre-clinical stage was completed and the drug candidate received regulatory approval shortly after that. Phase 1A was initiated in January 2010 and is expected to be completed in the second quarter of 2010. By conducting these clinical studies in Russia, the program takes advantage of a notably large pool of recently diagnosed patients potentially eligible for enrollment (due to regular screening for viral diseases in Russia). Moreover, the fraction of naïve treatment patients is higher than in Western European countries or the United States. ChemDiv’s approach resulted in rapid and cost-effective advance of iDialog’s clinical HCV candidates.
About iDialog
iDialog was established in 2006 as an innovative biopharma start up. It received over USD$3M of seed investment from Torrey Pines Investment in 2007 and subsequently won the research partnership award of over USD$3 from the Russian Federal Agency of Science and Innovation for development of novel anti-infective agents to match unmet needs in Russia. iDialog conducted and continues the broad program to discover novel therapies for Tuberculosis, hepatitis C and Influenza, in partnership with Moscow State University and other academic organizations. In 2008 iDialog established the R&D collaboration with ChemDiv's Chemical Diversity Research Institute for discovery and development of novel small molecule anti-infective agents, which is extended to 2011.
Roche-Viriom-ChemDiv Collaboration
  Viriom, Russia and Hoffman La Roche Ltd., Switzerland, signed a collaboration agreement for research and development of innovative medicines for HIV, and ChemDiv was chosen by Viriom as a strategic partner to carry out pre-clinical and clinical development of this program.
Due to changes in corporate strategy, Roche was looking for a partner to take over its internal HIV program and had a couple of very promising compounds in the pipeline that showed good potential to become best-in-class drugs. ChemDiv stepped forward with an innovative solution for Roche and proposed to form a partnership and consolidate Roche’s HIV assets in a start up biotech company Viriom to be able to move forward the compounds. ChemDiv offered its services and expertise in preclinical research and clinical development to help advance the program in the most time- and cost-efficient way.
In a press statement, Vadim Bichko, ChemDiv’s VP of Virology, noted: “These HIV inhibitors have shown excellent antiviral properties in vitro, good bioavailability, PK and safety profiles, as well as a high genetic barrier to resistance.”
In this one-of-a- kind deal, Roche made a bold decision, which helped the company advance the innovative HIV program with an experienced and reliable partner and at a fraction of the costs typically associated with such development. For Roche, it also opened new opportunities as well as strategic access to the emerging Russian pharmaceutical market.
Roche’s promising HIV program was not abandoned and ChemDiv had successfully completed all pre-clinical studies and had submitted the preclinical data package with the Russian regulatory agencies. Viriom is planning to initiate clinical studies in the middle of second quarter of 2010.
About Viriom
Viriom is an innovative company, established in 2009 at the ChemRar High Tech Center for development of targeted drugs to treat HIV / AIDS. Viriom plans to conduct scientific research in Russia using the experience and knowledge of the Russian scientists. The company is partnering – among others - with Chemical Diversity Research Institute on preclinical studies of molecules, "Drug Technologies" on development of complete dosage forms, and the Moscow Center for HIV/AIDS Prevention.
www.viriom.com
ChemDiv - Avineuro Partnership
ChemDiv Inc. and Avineuro Pharmaceuticals Inc. move ahead a productive relationship in the area of neurological and psychiatric disorders. With a number of compounds in early development, Avineuro was seeking to advance these compounds through pre-clinical and early clinical stages in order to generate maximally informative data package for further development and potential pharma partnering in the shortest amount of time. Full package of pre-clinical work required for 4 regulatory submissions for development candidates in Alzheimer's Disease, Anxiety and Scizophrenia were completed and approved at an optimal cost point within 1 to 1,5 years from initiation to dosing in first volunteers. Next phase of safety studies included certain patient population in agreement with recommendations of Ethical Committee. Safety studies were accomplished within 2 to 4 months for all drug candidates. Proof of Concept studies were executed for 2 out of 4 molecules within 2 years from initiation of the service research programs. All clinical and pre-clinical data generated by ChemDiv in its Research Institute in Russia were used for an IND package.
By contracting with ChemDiv, Avineuro worked with an expert scientific and project management group overseeing all aspects of pre-clinical and early clinical development. Normally, a company will contract out to multiple vendors for chemistry formulation; scale up of investigational product, pre-clinical studies and clinical studies. ChemDiv has completed fully integrated drug development programs from target to Proof of Concept. ChemDiv's consistency in project management and data quality along the development of a compound has been very helpful in further Avineuro's partnering effort.
About Avineuro Pharmaceuticals, Inc.
Avineuro Pharmaceuticals, Inc. discovers and develops novel small molecules for unmet medical needs in neurology and psychiatry. Founded in August 2008 and headquartered in San Diego, California, Avineuro is managed by seasoned professionals experienced in drug discovery and development. By acquiring lead compounds through collaborations and partnerships, Avineuro plans to develop novel products and extend the reach of marketed compounds for indications with a significant commercial potential. Avineuro emphasizes a rational approach that combines modern medicinal chemistry with streamlined pre-clinical and clinical development studies, thus allowing a fast transition to proof-of-concept product candidates.
 Back to Clinical Development
|
Clinical Development 
