Cannabis Science Issues Guidance on Its Progress Toward FDA Investigative New Drug Applications For Clinical Trials and Proposed Dividend Payout for Current Shareholders to Receive a New Class of Common Stock
COLORADO SPRINGS, Colo., Oct. 12 /PRNewswire/ — Cannabis Science, Inc. (OTC Bulletin Board: CBIS), a pioneering US biotech company developing pharmaceutical cannabis products, is pleased to announce guidance on its product development and FDA Investigative New Drug Applications for its cannabis clinical trials. The Company is also pleased to announce the proposed dividend payout to current shareholders for a new class of common shares is under review by counsel, and the Company expects to announce the date of shareholder record, the proposed share ratio payments, and attached financing options within the next few days.
Cannabis Science Inc. President & CEO, Dr. Robert Melamede Ph.D., commented, “We are at the beginning stages of our growth curve right now. This is the most exciting time yet for us all in our short history, we see the proposed dividend payout with the proposed new class of common shares as a way to multiply, reward, and increase our investor options and participation. Our operational structure has been increased dramatically by the ever-increasing amount of partnership opportunities. We have seen some impressive results worldwide from cannabis patients, whether they are using medical cannabis in what is considered informal trials or for personal edification. Absurdly, this vast trove of clinical experience has been dismissed as ‘anecdotal.’ At some point that willful blindness is not only unscientific, it is simply dishonest. However, it has created a great opportunity for us. Cannabis Science is in the strategic planning phase with respect to the enormous amount of positive research and data collection coming from all of this ‘real world’ experience of thousands of Colorado patients. Consequently, we are forming a well-qualified team of physicians, and this data will be compounded through our RockBrook agreements and later used with respect to the FDA applications and clinical trials. At this point our focus remains on submitting our initial Investigative New Drug Applications to FDA, so we are weighing the options and expect to announce a decision in the near future.”
Cannabis Science is implementing its pharmaceutical grade cannabis product development and quality control standardizations through its licensed commercialization developer RockBrook Inc. and is currently negotiating its laboratory quality control standardizations with another group. This will be a large contribution to the body of evidence presented as part of our Investigative New Drug Applications to the FDA for the critical ailments, which we will be pursuing through the FDA regulatory process.
Cannabis Science Inc. Lab Director, Christopher Stubbs, remarked, “The Cannabis Science Lab Division has been compiling pharmaceutical guidance for The Company and its affiliates with respect to horticulture standards and practices, good manufacturing compliance, health and safety profiling of medical cannabis and formulated products, as well as FDA guidance for our long-term goals. We’ve also been busy generating new scientific partnerships and collaborations in order to meet our needs. As has always been the case, our ultimate aim is to bring multiple levels of cannabis treatment to market, with proper case documentation and organization of viable clinical trials that utilize FDA regulatory guidance and operations transparency. This provides a strong scientific basis for internal use, as well as industry dissemination. With respect to both patient treatment and dosing – utilizing well-characterized, standardized products – the Cannabis Science horticultural method and product formulation model is being implemented in the State of Colorado. Our entry into other medical cannabis states through licensing agreements or partnerships will follow suit in a timely manner, as many organizations will benefit from the application research we have been engaged in.”
The following is a prioritized list of potential FDA Investigative New Drug Indications that Cannabis Science is researching:
Pain Management – Cannabis use in pain management has long been documented clinically and anecdotally. A recent Canadian Medical Association publication showed “Our results support the claim that smoked cannabis reduces pain, improves mood and helps sleep”(Ware et al 2010).
The medical cannabis dispensary model has provided a wealth of observational data, with pain patients reporting improved pain management as well as increases in overall quality of life after beginning cannabis therapy. Cannabis Science licensee RockBrook, Inc. works with one of the leading pain management doctors in the State of Colorado, which has led to the selection of a standardized cannabis strain and appropriate methods of ingestion for these patients. This strain and its formulated products will be available for dispensary sale in the next quarter. Because pain management is often associated with Post Traumatic Stress Disorder (PTSD, see below), it is likely that both indications will be targeted with this same formulation in the new drug application.
Last year, MarketResearch.com reported that the “global pain management market generated $46.4 billion sales in 2007, a 12.5% increase over 2006. The most prevalent forms of neuropathic pain in the seven major markets were neuralgia/fibromyalgia and lower back pain, with 16.3m and 15.9m cases respectively during 2008.”
Post Traumatic Stress Disorder (PTSD) – Recent peer-reviewed literature, as well as practical applications in foreign markets such as Israel, show that medical cannabis can be extremely effective in the clinical treatment of PTSD and associated symptoms. Cannabis Science has also received clear input from veterans in Colorado that this treatment is safe and effective. Cannabis Science and its colleagues have been assembling a petition to the Colorado Department of Health and Environment to gain acceptance for medical cannabis use for PTSD under the state regulations. Furthermore, The Company is in the planning phase with the CBR International Group, to complete the New Drug Application based on CBIS proprietary methodologies and formulations to treat PTSD safely and effectively. Because the extent of the PTSD problem has only recently been recognized, it is impossible to quantify the market at this point, but it is expected to be very large and its importance transcends whatever the initial estimates may be.
Cancer- Beyond the well known palliative options that cannabis provides for patients suffering from cancer and the side-effects of the standard treatments, there has been a worldwide explosion of scientific studies demonstrating the ability of cannabinoids to kill cancer cells in animals and tissue culture. Additionally, patients have initiated personal experimentation in medical marijuana states. Currently, CBIS is aware of multiple patients involved in a cannabis treatment regimen implemented by the www.PhoenixTearsFoundation.com to reduce the likely hood of cancer progression, improve quality of life through increased sleep and nutrition intake, and possibly spur remission.
It is clear that a standardized, well-profiled, and safe cannabis extract must be used for the treatment of this disease. Our goal is to coordinate clinical partnerships and patient care with our standardized product line in Colorado, and to gather data that supports the use of cannabis extracts for this indication before pursuing a new drug application. Cannabis Science has been actively working with other organizations to meet this need not only on the dispensary level, but also with respect pursuing FDA approval. Cancer drugs tend to be hugely expensive, so it is a multibillion-dollar market, but is not clear how the current market size could be extrapolated into any valuation of cannabis products, which would cost far less.
Influenza- Several cannabinoids have been shown to possess anti-inflammatory properties that could be beneficial in a variety of disease states, including many pro-inflammatory influenza strains such as the avian flu (H1N5). The secondary effects of influenza infection in susceptible populations can be the cause of eventual death from inflammation-induced Adult Respiratory Distress Syndrome (ARDS). In fact, several peer-reviewed publications have focused on the modulation of pulmonary inflammation by cannabinoids in numerous organs after mice were inoculated with highly inflammatory influenza strains (Buchweitz et al 2007). Bringing a drug to market that safely and effectively mitigates these inflammatory consequences could drastically reduce the annual death rates associated with influenza. Cannabis Science is researching possible formulations to achieve this goal in humans.
Asthma- Affecting nearly 300 million people worldwide, its incidence has been on the rise. Historically, cannabis was routinely used for treating asthma. Its bronchial dilating properties are well documented. Modern medical marijuana users have rediscovered its effectiveness for treating this illness. Cannabis Science is currently in the early stage of development with cannabis-based based products to address this need. Local observational trials in Colorado will further guide product development in the near future. Lead Discovery of the UK estimates that the “asthma treatment market is a $15 billion market, driven by an increasing prevalence and yet without a treatment to cure this debilitating disease.”
Chief Financial Officer Richard Cowan stated, “These much needed treatments for very serious health problems, such as cancer, AIDS, chronic pain, PTSD and many others, offer us the opportunity to grow this company into the major cannabis pharmaceutical firm it should be. The Cannabis Science business model – as a bridge between the medical marijuana world and pharmaceutical development — is unique, and places it in an excellent position to rise above the absurd stigmas and serious questions about medical cannabis. We will do this by leading the development of FDA approved cannabis-based pharmaceuticals, which will available through pharmacies nationwide. Several of these drugs have potential ‘block-buster’ status, a multibillion market. In the meantime, the significant revenue streams possible through intrastate over-the-counter dispensary markets provide us with multiple opportunities for growth.”
About Cannabis Science, Inc.
Cannabis Science, Inc. is at the forefront of pharmaceutical grade 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.
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. Cannabis Science Inc. Dr. Robert J. Melamede Mark J. Friedman President & CEO Investor Relations firstname.lastname@example.org email@example.com www.cannabisscience.com www.cannabisscience.com 1-888-889-0888 1-877-431-CBIS (2247)
SOURCE Cannabis Science, Inc.