Therapeutic Discovery Program initiated in the Netherlands, executed along U.S. guidelines for regulatory submission
Cannabis Science, Inc. (CBIS) announced the initiation of preclinical development characterization of CS-TATI-I following the execution of contractual retention of vendor labs located in the Amsterdam Life Science Cluster.
Under the direction of Richard Ogden, PhD, Chief Scientific Officer, and Christopher Meenan, MBA, MS, Executive Vice President of Product Manufacturing and Development, Cannabis Science, has begun initial preclinical pharmacological characterization, including pharmacokinetics, pharmacodynamics, concentration analysis, chemical structure characterization, and in vitro and in vivo extrapolation (IVIVE), as well as other essential studies that will be performed by contract manufacturing organizations utilizing proprietary strains of cannabinoids possessing properties characterized by peer reviewed literature indicating clinical attributes including inhibition of the genomic expression of HIV-associated Kaposi’s Sarcoma (KS).
In conjunction with maturing Collaborative Research and Development Agreements (CRADAs) under review by academic centers associated with Members of the Company’s Scientific Advisory Board, the data from these unprecedented investigations will allow for reproducible data on medicinal characteristics, pharmacogenetics and biology of the endocannabinoid activity in virologic oncology for submission to regulatory authorities in the U.S. and Europe under the supervision of Ron Sekura, PhD, Executive Vice President of Regulatory Affairs, Cannabis Science.
Robert Melamede, PhD, CEO of Cannabis Science, said, “The past 12 months, characterized by presentations at the XIX International AIDS Conference, ASA Medical Cannabis conference and other scientific meetings, and appointments of Dr. Richard Ogden and Dr. Ron Sekura and other prestigious members of the Company’s Scientific Advisory Board, has prepared us to initiate preclinical characterization studies that will provide Cannabis Science with the pathway to our first-in-class, first-in-man studies of CS-TATI-I. By establishing a corporate presence with the Amsterdam Life Science Cluster, the Company is able to aggressively move forward with the research necessary to progress to human trials.”
“Initial studies will be followed by investigation of full exposure response curves, enzyme expression, QSAR analysis, in vitro-in vivo extrapolation, optimization of release rates and full exposure response curves, among others,” said Roscoe M. Moore, Jr., DVM, PhD, MPH, Chair of the Company’s Scientific Advisory Board. “We are exploring further optimization of semisolid topical and transdermal drug product physiochemical composition, physical performance and delivery of CS-TATI-I via validated methods and procedures in preparation for Phase I trials through the use of electroporation, product quality testing, product performance evaluation and topical dose control dispensement.”
Cannabis Science plans to announce the results of these studies at significant conference venues, including HIV DART 2013, 27th International Conference on Antiviral Research (ICAR), 15th International Workshop on the Clinical Pharmacology of HIV Therapy and International Symposium on HIV and Emerging Infectious Diseases (ISHEID 2014).
Peer-reviewed studies validate Cannabis Science’s approach to commercializing the antiviral potential of cannabinoid-based therapeutics as a viable target for addressing the Kaposi’s Sarcoma-associated herpesvirus (KSHV) and HIV Tat inhibition. A study published in 2012 by researchers from Harvard Medical School found that cannabidiol (CBD) inhibits the growth of and induces programmed cell death in KSHV in endothelial cells (Maor 2012). Studies published in 2011 and 2012 in the Journal of Neuroimmune Pharmacology, PLoS ONE, and Journal of Pharmacology and Experimental Therapeutics found that cannabinoids inhibit macrophage migration to HIV TAT.
A meeting by the Cannabis Science Scientific Advisory Board planned for May to be held immediately prior to the Institut Pasteur HIV meeting from May 21-23, 2013 in Paris, France, will examine the results of these initial studies for dissemination to leading publically sponsored clinical research programs to guide the design of Phase I studies.
About Kaposi’s Sarcoma (KS)
KS is a form of cancer that develops typically from exposure to the HHV8 virus, a type of Herpes simplex virus. HHV8 can lay dormant in the body and develop when and if the immune system is dramatically weakened. KS arises from the cells that line lymph or blood vessels. KS lesions can occur internally in lymph nodes and visceral organs, externally on various parts of the body or both internally and externally. There are distinct types of KS: epidemic HIV-associated KS and endemic KS.
Cannabis Science’s research of CS-TATI-I will be targeted to newly diagnosed patients infected with drug resistant virus, treatment-experienced patients with drug-resistant HIV strains, and those intolerant of currently available therapies. Cannabis Science will be pursuing a wide range of Federal Research Programs such as RO1s, PO1s and SBIRs, which exist to support preclinical development of target validation and proof of concept studies. These studies will be implemented through collaborations with leading scientific institutions. Cannabis Science will also be pursuing other clinical research collaborations including the AIDS Clinical Trials Groups (ACTG), the Canadian AIDS Trial Network (CATN) and the European AIDS Trial Network (EATN).
Cannabis Science is currently working to develop preclinical investigations of CS-S/BCC-1 treatment of basal and squamous cell carcinomas. The Company has begun preclinical investigations, which are being initiated in Europe for squamous and basal cell carcinomas and Kaposi’s sarcoma based on inhibition of carcinogenicity utilizing cannabinoids that have been demonstrated in recent studies to significantly affect tumor necrosis.
About Cannabis Science, Inc.
Cannabis Science, Inc. is conducting cannabinoid-based therapeutic research and development to address neglected pandemic oncological manifestations of pandemic infectious diseases in human health. The Company works with leading experts in HIV drug development, medicinal characterization, and clinical research to develop, produce, and commercialize other therapeutic approaches to antiviral and antibacterial innovation. Cannabis Science is currently working with CBR International to develop a Pre-IND Application to the FDA that focuses on the use of CS-TATI-I topical cannabinoid-based preparations for the treatment of Kaposi’s Sarcoma, basal and squamous cell carcinomas and HIV Tat inhibition.