SOURCE: Cannabis Science, Inc. / marketwire.com
Jul 27, 2009 13:23 ETCannabis Science to Apply to the FDA to Utilize Their Fast Track Procedures to Help Speed the Approval of Its Cannabinoid Medicines in Treatment of H1N1 Swine Flu as AP Report Predicts Swine Flu Could Hit up to 40 Percent in the USA
SAN FRANCISCO, CA--(Marketwire - July 27, 2009) - Cannabis Science, Inc. (OTCBB: CBIS), an emerging pharmaceutical cannabis company, is pleased to report that it is moving as fast as possible to assist in the fight against the threat of a deadly influenza pandemic. In conjunction with its recent re-organization, the Company has begun discussions with the FDA as its program moves forward to provide FDA approved solutions for several critical illnesses.
H1N1 Swine Flu:
According to the CDC (http://www.cdc.gov/flu/avian/) the Avian flu (H5N1) has a 63% mortality rate. Unfortunately, the Swine flu, while causing death at a much lower rate than the Avian flu, appears to also result in death via a similar mechanism. The common cause of death with these strains is organ failure, especially as seen in the lungs with the development of Adult Respiratory Distress Syndrome (ARDS). ARDS is caused by an excess immune-generated inflammatory response that leads to apoptosis (cell death) and subsequently to organ failure. The Company's approach will mimic how the human body uses endocannabinoids (cannabinoids that occur naturally in the body) to regulate immune activity and cell survival, by regulating inflammatory biochemistry. Excessive inflammatory responses are associated with numerous disease states including autoimmune diseases, neurological imbalances, and cardiovascular disease. Phytocannabinoids provide a natural means to supplement illness-specific endocannabinoid deficiencies.
Cannabis Science H1N1 Swine Flu Formulation:
We now know that the endocannabinoid system plays a critical role in maintaining human health. The human body produces Endocannabinoids on demand when they are needed. They help restore homeostasis (biochemical balance). The Cannabis plant produces Phytocannabinoids. When the human body has endocannabinoid deficiencies, it cannot effectively restore the healthy biochemical state needed to counter a particular illness. Phytocannabinoids from the Cannabis plant can replace the deficient endocannabinoid activity in the human body to restore a health-promoting level of cannabinoid activity. Cannabis Science will test its cannabis extract lozenge with FDA guidance and oversight to determine if it will reduce ARDS-associated deaths from both the Avian and Swine influenza infections.
Dr. Robert Melamede, Ph.D., Cannabis Science, Inc., President and CEO, believes there is enormous potential value for cannabinoids to naturally reduce excessive inflammatory immune responses, and the Cannabis Science lozenge formulation could reduce the mortality rate and allow infected individuals to develop a strong natural immunity upon recovery. Dr. Melamede is the former Chairman (ret) of the Biology Department at the University of Colorado (Colorado Springs.)
Dr. Melamede added, "Again, we recommend, based on sound scientific principles, that medical marijuana users should switch to edibles if they come down with an influenza infection. We believe that the irritation associated with the pulmonary route, when a person has an influenza infection, may lead to unnecessary deaths. In contrast, oral administration may prevent many deaths. We hope that due to the magnitude of this pandemic threat, that the FDA will fast track our proposal."
FDA's three rapid special drug release programs:
Fast Track, Accelerated Approval and Priority Review are approaches that are intended to make therapeutically important drugs available at an earlier time. They do not compromise the standards for the safety and effectiveness of the drugs that become available through this process. These revitalized FDA drug review approaches have yielded tangible results in bringing safe and effective drugs to patients with serious diseases more quickly. For example, since 1996, 68 drugs for cancer therapies have received priority review and approval. The FDA reviewed Gleevec, a treatment for chronic myeloid leukemia, in four months. Shortened review times have also brought promising treatments to patients with HIV/AIDS more quickly. Kaletra for the treatment of HIV/AIDS was reviewed and approved in 3.5 months. Pegasys, a combination product for the treatment of Hepatitis C, was approved for marketing in 4 months.
Fast Track, Accelerated Approval, and Priority Review have evolved over time. The FDA has been vigilant in assuring that reducing the time necessary for drug development has not compromised the safety and effectiveness of drugs for patients with serious diseases. The median time required to review a priority review drug was reduced from 13.9 months to 6.7 months.
About Cannabis Science, Inc.
Cannabis Science, Inc. is at the forefront of medical marijuana research and development. The Company works with world authorities on phytocannabinoid science targeting critical illnesses, and adheres to scientific methodologies to develop, produce, and commercialize phytocannabinoid-based pharmaceutical products. In sum, we are dedicated to the creation of cannabis-based medicines, both with and without psychoactive properties, to treat disease and the symptoms of disease, as well as for general health maintenance.
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.