COLORADO SPRINGS, Colo., May 29, 2012 /PRNewswire via COMTEX/ -- Cannabis Science, Inc. (CBIS.OB), a pioneering U.S. biotech company developing pharmaceutical cannabis (marijuana) products, is pleased to provide insight on the upcoming release of its new over-the-counter skin and nutraceutical product line to be branded "Phytiva" through its newest venture Phytiva Pharmaceuticals Inc. The Company is working as fast as it can to make its cannabis-based formulations that target critical ailments more widely available through multiple regulatory body guidelines. This approach will allow the Company to release its formulations to multiple markets reaching the maximum amount of people in the shortest time frame across the nation and internationally. To support this cause Cannabis Science has been working with numerous patients who have been documenting their self-medicating treatment process using the cannabis-extracts.
The Company continues to receive a large number of inquiries about current and new product releases and operational updates on its projects in the works. The Company is in the process of updating its website to provide up-to-date timeline information on its projects, product lines, events, conferences and other important corporate and operational information for the public as released for the public.
Cannabis Science is working very closely with its previously announced FDA clinical trials consultants to guide the Company through the formal FDA new product release regulatory guidelines. The main steps required to be completed are as follows:
1. Pre-IND meeting with the FDA
*** The Company is currently in this stage and is working close with its FDA advisory group towards requesting a pre-IND meeting date. The Company has identified its initial target indication as skin cancer and will present this case to the FDA at the pre-IND meeting.
2. Application filing for IND Number
Once the Company has presented its case at the pre-IND meeting with the FDA and makes any recommended adjustments to its case study, it will then submit its formal application to the FDA for the IND number application.
3. IND Number assignment
FDA will assign an IND number for the case study once the Company has completed a successful application process. The IND number assignment will give the Company the green light to begin its clinical trials.
4. Begin clinical trials
Once the Company has successfully completed the application process and receives its IND number from the FDA it can then begin formal clinical trials to prove the product viable for general market consumption or use.
5. Successful IND product release
Working within the FDA regulatory procedures is paramount for Cannabis Science. Once it receives full approvals from the FDA on each of its target indications, it will then release its products for patients in need of the treatments for their critical ailments nationwide.
Over-the-counter Nutraceutical Product Lines
This market opportunity for the Company and the people who are looking for Cannabis Science formulations is very large and spans the nation and beyond. The Company has identified several target products to release and is finalizing a few for immediate OTC market release. Our supporters recognize that these products will help finance the company as we move forward with the FDA process.
Cannabis Science is rapidly moving to commercialize Phytiva, our new over-the-counter skin and nutraceutical product line to be available through its newest venture Phytiva Pharmaceuticals Inc. Cannabis Science formulations for these new products are finalized and we are making decisions for mass manufacturing and nationwide distribution. With several products on the roster for the Phytiva product line, the Company has made public a few: a lip balm to improve the dryness of lips and promote healing, a sunscreen with dual purposes to block the sun, promote sunburn healing and relief, and a dry skin lotion that enhance skin care for those suffering with Eczema and Psoriasis, a fourth product is a facial and body moisturizer that contains compounds with anti-aging properties that promote healthy skin and appearance.
As we develop the initial products for the Phytiva Product line, Cannabis Science is working on lateral expansion as we negotiate to acquire new and effective products and treatment processes.
State Regulated Medical Cannabis Dispensaries
The Company target initiatives in states that have approved medical marijuana programs is based on the successful results being reported by patients self-medicating using Cannabis Science approved formulations through state licensed manufacturers and distributors. The Company is working to expand availability of our formulations across the nation on a state-by-state basis as states continue to approve medical cannabis treatments.
Currently, Cannabis Science has its cannabis-based high quality extract formulations available in Pueblo and Denver, Colorado, through licensing agreements. As well, the Company has signed a licensing deal with Apothecary Genetics in California to provide the same full circle operations required under State regulated medical cannabis laws to provide California State licensed medical cannabis patients its formulations.
The Company has been receiving outstanding feed back from the current patients using its formulations for Skin Cancer as documented on the www.cannabisscience.com website.
Cannabis Science President & CEO, Dr. Robert Melamede Ph.D. and the Science
In order for one to understand the unique health benefits provided by cannabis extracts, including their ability to kill numerous cancer cell types, one must examine the role of the endocannabinoids system in maintaining and promoting human health. The endocannabinoid system formally evolved with the appearance of vertebrates, with the development of receptors that specifically bind to the lipid derived endocannabinoids. Surprisingly, the endocannabinoid system is a global, multi-scaled, homeostatic regulator of all body systems. Thus, the cardiovascular, digestive, endocrine, immune, musculoskeletal, nervous, reproductive, and tegumentary systems are all kept in dynamic balance by the endocannabinoid system through its ability to regulate mass and energy flow (the munchies). All cells can only survive by extracting what they need from their environment in order to maintain their internal organization. Cannabinoids, including those derived from the plant (phytocannabinoids), those produced by our bodies (endocannabinoids), and those synthesized by man (synthetics) can very powerfully promote the death of cancer cells by disrupting their internal organization while minimizing the ability of the environment to support them. Thus, unlike conventional pharmaceuticals and anticancer agents that typically target a single pathway (the magic bullet approach), cannabinoids impact many aspects of cellular and organismic biochemistry to kill cancers. The chemical complexity of concentrated cannabis extracts holistically decreases the probability that a cancer cell can survive while at the same time promoting general health, as evidenced by the anti-aging and health promoting properties that arise from stimulating the endocannabinoids system.
Melamede, R. Harm reduction--the cannabis paradox. Harm Reduct J 2, 17 (2005).
Sarfaraz, S., Adhami, V. M., Syed, D. N., Afaq, F. & Mukhtar, H. Cannabinoids for cancer treatment: progress and promise. Cancer Res 68, 339-342 (2008).
Massi, P., Solinas, M., Cinquina, V. & Parolaro, D. CANNABIDIOL AS POTENTIAL ANTICANCER DRUG. Br J Clin Pharmacol (2012).
Hermanson, D. J. & Marnett, L. J. Cannabinoids, endocannabinoids, and cancer. Cancer Metastasis Rev (2011).
About Cannabis Science, Inc.
Cannabis Science, Inc. is at the forefront of pharmaceutical grade medical marijuana research and development. The second formulations will address the needs of patients choosing to use concentrated cannabis extracts to treat their ailments. Eventually, all Americans will have access to a safe and effective FDA approved medicine regardless of which state they live in. To maintain that marijuana is a dangerous, addictive drug with no medical value is scientifically absurd. Cannabis medicines, with no effective lethal dose, are far safer than aspirin, acetaminophen, and most other OTC drugs that kill thousands of Americans every year.
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.