Initial production of CS-TATI-1 will be performed in Colorado under C-GMP conditions evaluated by the FDA for initial human studies to treat HIV associated Kaposi Sarcoma
August 13, 2012
COLORADO SPRINGS, Colo.--(BUSINESS WIRE)--Cannabis Science (CBIS), a pioneering U.S. Biotech Company developing pharmaceutical to meet global public health challenges is pleased to announce the initiation of GMP development plan for CS-TATI-1 with the initial production of CS-TATI-1 to be performed in Colorado under C-GMP conditions evaluated by the FDA for initial human studies to treat HIV associated Kaposi Sarcoma.
CBIS CS-TATI-1 is a preclinical development program intended to address the presentation of KSHV transactivation by HIV TAT. The codependent relation of the TAT’s expression at the HIV LTR and the upregulation of Nf-KB dependent expression of Kaposi Sarcoma is well defined in peer reviewed publications.
Kaposi Sarcoma is a type of cancerous tumor of connective tissue. Kaposi Sarcoma produces nodules or patches that can affect the skin, mouth, nose, eye, lungs, liver, stomach, intestine, lymph nodes, and various other sites. Kaposi Sarcoma affected approximately one-third of all AIDS patients in resource poor settings on a global scale were the efforts of the global fund for AIDS, TB, and Malaria and the Presidents Emergency Program for AIDS relief is focused. Instances of Kaposi Sarcoma are also on the rise in drug resistant patient populations in the United States and Europe. Other countries, particularly those in Africa, have a high rate of Kaposi Sarcoma. Also, about twenty percent of AIDS patients who do not take antiretroviral drugs have Kaposi Sarcoma.
“Our analysis of utilizing an endosome based transdermal delivery of CS-TATI-1 in our initial studies will be optimal for addressing regulatory compliance concerns and meet the need of patients who are in need of effective localized delivery of the clinical activity of Cannabis Science’s flagship therapeutic agent,” said Dr Robert Melamede, President & CEO of Cannabis Science Inc.
Initial vendor bid solicitation is being managed by corporate leadership as CBIS develops an executive team to facilitate scale of production over the next quarter, as CBIS pursues federal sponsorship of initial studies in publically funded clinical trial programs.
CS-TATI-1 is in preclinical development intended to target HIV TAT, which is an important target for developing new HIV drugs, which are urgently needed. While there are currently 30 antiretroviral drugs on the market, increasing drug resistance to and toxicity from long term use of all existing medications. There is a high demand and need for new treatments to treat HIV drug resistance patients.
There are approximately 1.2 million people living with HIV in the United States and 34 million worldwide. In fiscal year 2012, the Federal Government spent $27,700,000,000 on HIV/AIDS, the largest component being services and treatment for people living with HIV/AIDS in the United States at a cost of $15,600,000,000. The average lifetime cost of HIV treatment is estimated to be $367,134 per person. Pharmaceutical sales to treat HIV equal $10.6 billion annually.
About Cannabis Science, Inc.
Cannabis Science, Inc. is at the forefront of cannabinoid research and development for unmet medical needs. The Company works with leading experts in HIV drug development, medicinal characterization, and clinical research to develop, produce, and commercialize Phytocannabinoid-based pharmaceutical products.
Cannabis Science is currently working with CBR International to develop a Pre-IND Application to the FDA that focuses on the use of CS-S/BCC-1 and CS-TATI-1 topical cannabis-based preparations for the treatment of basal and squamous cell carcinomas.
Forward Looking Statements
This Press Release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. A statement containing works such as "anticipate," "seek," intend," "believe," "plan," "estimate," "expect," "project," "plan," or similar phrases may be deemed "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Some or all of the events or results anticipated by these forward-looking statements may not occur. Factors that could cause or contribute to such differences include the future U.S. and global economies, the impact of competition, and the Company's reliance on existing regulations regarding the use and development of cannabis-based drugs. Cannabis Science, Inc. does not undertake any duty nor does it intend to update the results of these forward-looking statements.
Cannabis Science, Inc.
Dr. Robert J. Melamede
President & CEO
VP Investor Relations