I see a huge market for Cannabis Science with their Swine Flu H1N1 treatment fast track status. I see this as a potentially nice trade right now trading around 1.14. Strong Buy Option for CBIS. The FDA rarely gives out fast track statuses for approval so this is another good trade right now and price right for those on a tight budget. This could be a huge payoff for a long trade option. We will have to see.
I have also included information about Acadia Pharmaaceuticals. They released Clinical Trial data last Friday for Acadia's pivotal Phase III trial of pimavanserin. There have been impressive gains in the past two days over the Parkinson's Disease Psychosis medication Pimavanserin. On a side note I love the wilderness and included some pictures of Maine's Acadia National Park and Lighthouse. Enjoy.
07/27/09 Cannabis Science to Apply to the FDA
Cannabis 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 -- (MARKET WIRE) -- 07/27/09 -- 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.
Here is another article from the Wall Street Journal on Cannabis Science
07/23/09 Today's Wall Street Journal Reports on Cannabis
Today's Wall Street Journal Reports on Cannabis Science Inc. in Article on Booming Medical Cannabis Industry; Indicates Great Demand for Products From a Patient Oriented Company
SAN FRANCISCO, CA -- (MARKET WIRE) -- 07/23/09 -- Cannabis Science Inc. (OTCBB: CBIS), an emerging pharmaceutical cannabis company, is pleased that today's Wall Street Journal article on the booming medical cannabis industry in California notes the role of Cannabis Science Inc.
Commenting on why Cannabis Science was mentioned in the article, Richard Cowan, chief financial officer of Cannabis Science Inc., said, "Although the company is beginning the FDA approval process for its products, we believe that the inclusion of Cannabis Science Inc. in an article about the struggle to get medical cannabis to patients is further evidence that we are a patient oriented company, whose business strategy does not depend on a continuation of marijuana prohibition."
Although the company is not involved in the state's gray market, the article notes, "A pot activist named Richard Cowan has opened what he envisions as an investment bank for pot-related businesses, called General Marijuana (General Marijuana.com). Mr. Cowan is also chief financial officer of Cannabis Science Inc., which is trying to market a pot lozenge for nonsmokers." Please click http://online.wsj.com/article/SB124829403893673335.html to read the article in full.
Cannabis Science CEO, Dr. Robert J. Melamede, observed, "This article is further demonstration of the huge need for FDA approved medical cannabis products."
Earlier this week, Cannabis Science reported that Dr. Melamede had spoken at a hearing in Denver in opposition to an attempt to undermine a voter-approved constitutional amendment that would have made it much more difficult for patients to get affordable medical marijuana.
Another strong trade right now is Acadia Pharmaceutical. Stock Ticker: ACAD.
This article can be found at BioMedReports at the following link:
Acadia shares soar ahead of late-stage trial results
Written by Staff and Wire Reports
Saturday, 25 July 2009 08:37
(Reuters) - Acadia Pharmaceuticals Inc (NASDAQ:ACAD) shares rose as much as 44 percent to a year-high on Friday, amid speculation of an imminent release of data from a late-stage trial of its experimental drug for psychosis brought on by Parkinson's disease.
Shares of the company closed at $3.41 Friday on Nasdaq. They had earlier touched a high of $3.75.
"The speculation appears to be related to results that are due in this quarter for Acadia's pivotal Phase III trial of pimavanserin," Jon Najarian, a founder of Web information site optionMonster.com, said.
The company declined to comment on the stock movement and reiterated that it would release the late-stage data in the third quarter.
Acadia is co-developing pimavanserin, which is currently being studied in two late-stage trials, with a unit of Biovail Corp (NYSE:BVF) for the treatment of Parkinson's disease psychosis (PDP).
In the options market, Acadia attracted a flurry of trading in the stock's call options, which give the right to buy the underlying shares at a fixed price within a specified time period.
In all, about 15,000 calls and 1,635 puts traded, on combined daily volume 19 times the norm, according to option analytics firm Trade Alert.
(Reporting by Doris Frankel in Chicago and Anand Basu in Bangalore; Editing by Anthony Kurian)
This is a previous article discussing Acadia's partnership with Biovail on the Parkinson's Disease Psychosis medication. It can be found at the following link:
ACADIA Pharmaceuticals and Biovail Announce Completion of Enrollment in First Pivotal Phase III Trial with Pimavanserin in Patients with Parkinson’s Disease PsychosisMay 6, 2009 8:00 AM ET advertisement
Article tools E-mail this article Print-friendly version Discuss this articleStocks mentioned in this articleACADIA Pharmaceuticals Inc (ACAD) Stock Quote, Chart, News, Add to WatchlistBiovail Corp (BVF) Stock Quote, Chart, News, Add to WatchlistRecent investing newsBP Q2 profit up 71 pct from Q1, halved on the yearBP Q2 profit halved by oil fall, beats forecastCanon profits plunge 86 percent in 2QCall Buying Rises in Western DigitalFrank wants tougher rules for Wall Street pay
All Business Wire newsACADIA Pharmaceuticals Inc. ACAD and Biovail Corporation BVF (TSX:BVF), today announced the completion of enrollment in the first pivotal Phase III clinical trial of pimavanserin in patients with Parkinson’s disease psychosis (PDP). Top-line results from this trial are expected to be announced by the end of the third quarter of 2009.
The Phase III trial is a multi-center, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of pimavanserin in patients with PDP. A total of 298 patients were enrolled in the trial and randomized to one of three study arms, including two different doses of pimavanserin (10 mg or 40 mg daily) and one placebo arm. Patients receive oral doses of either pimavanserin or placebo once daily for six weeks in addition to stable doses of their existing dopamine replacement therapy.
Patient enrollment in the second pivotal Phase III clinical trial of pimavanserin in PDP is ongoing. The primary endpoint of each of the Phase III trials is antipsychotic efficacy as measured using the Scale for the Assessment of Positive Symptoms, or SAPS. Motoric tolerability is an important secondary endpoint in the Phase III trials and is measured using the Unified Parkinson’s Disease Rating Scale, or UPDRS (Parts II and III).
Pimavanserin is a 5-HT2A receptor inverse agonist in Phase III development as a treatment for Parkinson’s disease psychosis. This new chemical entity, which was discovered by ACADIA, is a small molecule that can be taken orally as a tablet once-a-day. ACADIA and Biovail Laboratories International SRL, a subsidiary of Biovail, have formed a collaboration to co-develop and commercialize pimavanserin for neurological and psychiatric indications in the United States and Canada. ACADIA retains rights to pimavanserin in the rest of the world.
About Parkinson’s Disease Psychosis (PDP)
According to the National Parkinson Foundation, over 1.5 million people in the United States suffer from Parkinson’s disease. Up to 40 percent of patients with Parkinson’s disease may develop psychotic symptoms, commonly consisting of visual hallucinations and delusions. Currently there is no therapy in the United States approved to treat PDP. The development of psychosis in patients with Parkinson’s disease is associated with increased caregiver burden, nursing home placement, and increased mortality.