Hot Trades Cannabis Science and Acadia Pharmaceuticals

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:

http://biomedreports.com/articles/most-popular/2441-acadia-shares-soar-ahead-of-late-stage-trial-results.html

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:

http://news.moneycentral.msn.com/ticker/article.aspx?Feed=BW&Date=20090506&ID=9873079&Symbol=US:ACAD

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).

About Pimavanserin

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.

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Okay so this is news for Schering. Diosynth Biotechnology will probably be in line for some part of this. Anyways, Clinical Trial News for Ensure trial. Merck and Schering have recently been asked by the SEC for more merger information.



Schering-Plough Announces Phase II and III Data for Corifollitropin Alfa
Friday, 03 July 2009
Schering-Plough Corp., (NYSE: SGP) has announced results from the Phase III ENGAGE clinical trial demonstrating that a single injection of corifollitropin alfa, first in the class of sustained follicle stimulants, achieved similar efficacy to recombinant follicle stimulating hormone (rFSH) given once daily for seven days. The ENGAGE data was presented along with data from the Phase III ENSURE trial and the Phase II REALIZE trial at the 25th annual meeting of the European Society of Human Reproduction and Embryology (ESHRE) in Amsterdam, The Netherlands.
"The burden of fertility treatment is a major challenge for women experiencing difficulty conceiving," said Thomas Koestler, executive vice president and president, Schering-Plough Research Institute. "Schering-Plough is committed to making fertility treatments easier, and these results demonstrate that corifollitropin alfa in combination with a GnRH antagonist may be an effective treatment that can reduce the number of injections and the length of treatment protocols."

ENGAGE is the largest double-blind fertility agent trial ever performed. The ongoing pregnancy rate, the primary endpoint of the ENGAGE non-inferiority trial, obtained in the 150 mcg corifollitropin alfa treatment arm (38.9 percent per started cycle) was similar to that achieved in patients receiving a daily dose of 200 IU rFSH (follitropin beta) for seven days (38.1 percent per started cycle).(1) ENGAGE also demonstrated that a single injection of 150 mcg corifollitropin alfa achieved similar oocyte and embryo quality compared to a daily dose of 200 IU rFSH given for one week.(2) Further sub-analyses of the ENGAGE trial showed a single injection of 150 mcg corifollitropin alfa, compared to the daily rFSH treatment arm, achieved consistently high pregnancy outcomes regardless of fertilization procedure (in-vitro fertilization (IVF) or intracytoplasmic sperm injection (ICSI), number of embryos transferred (single or double), or day of embryo transfer (day three or five), confirming the robustness of the main efficacy outcome.(1)

An additional sub-analysis of the ENGAGE data demonstrated that endogenous luteinizing hormone (LH) levels do not affect ongoing pregnancy rates in women undergoing controlled ovarian stimulation (COS) with a standardized rFSH / gonadotropin-releasing hormone (GnRH) antagonist protocol.(3)

An analysis compared data from the ENGAGE trial to data from the ENSURE trial. The ENSURE trial used a similar protocol to ENGAGE with identical patient inclusion criteria but different body weight categories. It showed that exposure and ovarian response were similar after a single-dose of 100 mcg corifollitropin alfa in patients weighing 60 kg or less, as compared to 150 mcg corifollitropin alfa in patients weighing more than 60 kg.(4) Additional data from the ENSURE trial show that in patients weighing 60 kg or less, a single dose of 100 mcg corifollitropin alfa resulted in significantly more oocytes and an equally short duration of treatment as those receiving 150 IU rFSH daily during the first week of stimulation.(5)

Data was also presented from the Phase II REALIZE study, a 50 patient, open-label uncontrolled pilot study. In this study, a single dose of 100 mcg or 150 mcg corifollitropin alfa in a long GnRH agonist protocol was able to support multifollicular development during the first week of ovarian stimulation.(6)

About ENGAGE
ENGAGE was a non-inferiority trial designed to compare corifollitropin alfa 150 mcg to 200 IU rFSH (follitropin beta). A total of 1,506 patients (greater than 60 kg) at 34 IVF clinics in North America and Europe were randomized to receive either corifollitropin alfa 150 mcg or a daily dose of 200 IU rFSH, followed by rFSH (maximum 200 IU/day) from stimulation day eight onward, when required. Starting on stimulation day five, all patients received 0.25 mg gonadotropin-releasing hormone (GnRH) antagonist until triggering of final oocyte maturation by human chorionic gonadotropin (hCG). The primary endpoint was the ongoing pregnancy rate assessed at ten weeks or more after embryo transfer. The number of oocytes retrieved was the co-primary endpoint. The incidence of ovarian hyperstimulation syndrome (OHSS) was similar between both groups, 7.0 percent in the corifollitropin alfa group (1.9 percent severe) and 6.3 percent in the follitropin beta group (1.3 percent severe).(1)

Key Findings

The ongoing pregnancy rate in the 150 mcg corifollitropin alfa treatment arm (38.9 percent per started cycle) was similar to that achieved in patients receiving daily 200 IU rFSH (follitropin beta) (38.1 percent per started cycle).(1)
Corifollitropin alfa achieved similar efficacy regardless of fertilization procedure; number of embryos transferred; or day of embryo transfer;(1)
The mean number of oocytes retrieved per attempt was 13.7 (+/-8.2) for the corifollitropin alfa group and 12.5 (+/-6.7) for the rFSH group.(2)
The mean number of good quality embryos obtained at day 3 and day 5 was 4.6 (+/-4.3) and 2.6 (+/-3.3) in the corifollitropin alfa group, respectively and 4.4 (+/-3.9) and 2.6 (+/-3.1) in the rFSH group, respectively.(2)
About ENSURE
The ENSURE trial is a multinational (Europe/Asia), double-blind, randomized trial; 396 patients weighing 60 kg or less were randomized in a 2:1 ratio to treatment with either a single dose of 100 mcg corifollitropin alfa or daily 150 IU rFSH (follitropin beta) followed by daily follitropin beta (maximum 200 IU/day) from stimulation day eight onwards when required, to reach the criterion for human chorionic gonadotropin (hCG) administration (at least three follicles 17 mm or greater). Starting on stimulation day five all patients received 0.25 mg gonadotropin-releasing hormone (GnRH) antagonist until induction of final oocyte maturation by hCG. About 34-36 hours after induction of final oocyte maturation, oocyte pick up followed by IVF or ICSI was performed. At embryo transfer, three or five days after oocyte pick up, a maximum of two embryos were transferred. The primary endpoint of the ENSURE trial was the number of oocytes retrieved and the predefined equivalence margin was -3 and +5 oocytes for the 95 percent confidence interval (CI) of the difference. The incidence of moderate and severe OHSS was 3.4 percent in the corifollitropin alfa treatment arm versus 1.6 percent in the rFSH treatment group.(5)

Key Findings

The mean (SD) number of oocytes retrieved per started cycle in the corifollitropin alfa group was 13.3 (+/-7.3) versus 10.6 (+/-5.9) in the reference group.(5)
Following a single injection of corifollitropin alfa, patients required on average another two days of further stimulation with rFSH to reach the criterion to administer hCG. This was equal to the average duration of stimulation of nine days of the reference group treated with daily rFSH.(5)
About REALIZE
In this single-center, open-label, uncontrolled, pilot study, 50 women undergoing ovarian stimulation prior to IVF or ICSI were down-regulated with daily injections of 0.1 mg of GnRH agonist (starting on cycle day 21). Ovarian stimulation was started with a single dose of corifollitropin alfa (100 mcg or 150 mcg) followed by daily rFSH (follitropin beta) from stimulation day eight until the day of triggering oocyte maturation. Final oocyte maturation was induced by administration of hCG as soon as three follicles 17 mm or greater were present. Vaginal progesterone was administered for luteal phase support. Patients with proven poor response were excluded from participation. The main endpoint of this trial was ovarian response. The observed number of follicles, serum estradiol levels and number of oocytes indicated a relatively high ovarian response. Corifollitropin alfa was well tolerated and there were no serious adverse events or cases of OHSS.(6)

Key Findings

Both the 100 mcg and 150 mcg dose groups recruited a large number of follicles 11 mm or greater with mean (SD) values of 17.5 (+/-5.5) and 18.3 (+/-6.4), respectively on the day of hCG and median serum estradiol levels of 10,019 and 10,221 pmol/L, respectively.(6)
The mean (SD) number of oocytes retrieved per started cycle was 15.4 (+/-6.7) in the 100 mcg dose group and 17.8 (+/-5.1) in the 150 mcg dose group.(6)
About corifollitropin alfa
Corifollitropin alfa is an investigational product being developed as a potential treatment in Controlled Ovarian Stimulation (COS) for the development of multiple follicles in women participating in an Assisted Reproductive Technology (ART) program. Corifollitropin alfa is designed as a sustained follicle stimulant (SFS) with the same pharmacodynamic profile as rFSH, but with a markedly prolonged duration of FSH activity. Due to its ability to initiate and sustain multiple follicular growth for an entire week, a single subcutaneous injection of the recommended dose of corifollitropin alfa may replace the first seven injections of rFSH preparation in a COS treatment cycle. The corifollitropin alfa regimen is being developed in a GnRH antagonist protocol. Corifollitropin alfa was filed in the European Union in late 2008.

Corifollitropin alfa Important Safety Information
The most frequently reported adverse drug reactions during treatment with corifollitropin alfa in clinical trials are Ovarian Hyperstimulation Syndrome (OHSS), pelvic pain and discomfort, headache, nausea, fatigue and breast complaints (including tenderness). They are reported with an incidence between 1% and 6%.

About Infertility
Infertility is a disease or condition that impairs the body's ability to perform the basic function of reproduction.(7) It is often diagnosed after a couple has not conceived after one year of unprotected, well-timed intercourse.(8) Women over the age of 35 are encouraged to seek diagnosis and treatment for infertility following six months of unprotected intercourse.(9) Around 15 percent of couples of reproductive age have a fertility problem.(8)

There are many causes of infertility including problems with the production of sperm or eggs, with the fallopian tubes or the uterus, endometriosis, frequent miscarriage, as well as hormonal and autoimmune (antibody) disorders in both men and women.(8)

With infertile couples, the source of infertility lies with the male in 40 percent of cases and 40 percent with the female. The remaining 20 percent is either a joint problem or unknown, because the cause has not been identified. There are a variety of treatments available for infertility; these include surgery, hormone treatments, insemination, IVF and natural treatments, among others.(8)

About Schering-Plough
Schering-Plough is an innovation-driven, science-centered global health care company. Through its own biopharmaceutical research and collaborations with partners, Schering-Plough creates therapies that help save and improve lives around the world. The company applies its research-and-development platform to human prescription, animal health and consumer health care products. Schering-Plough's vision is to "Earn Trust, Every Day" with the doctors, patients, customers and other stakeholders served by its colleagues around the world. The company is based in Kenilworth, N.J., and its Web site is www.schering-plough.com.

1. Fernandez-Sanchez M et al, Equally high ongoing pregnancy rates with corifollitropin alfa and recombinant FSH irrespective of variations in ART procedures. Oral presentation at 25th European Society of Human Reproduction and Embryology (ESHRE) on June 29, 2009. Abstract no. O-005
2. Behr B, et al Corifollitropin alfa versus recombinant FSH treatment in controlled ovarian stimulation: equal efficacy in terms of oocyte and embryo quality. Oral presentation at 25th European Society of Human Reproduction and Embryology (ESHRE) on June 29, 2009. Abstract no O-003
3. Doody K et al, Puregon reference-'Success rates of a fixed rFSH/GnRH antagonist protocol are not affected by enodgenous LH levels. Oral presentation at 25th European Society of Human Reproduction and Embryology (ESHRE) on July 1, 2009. Abstract no. O-255
4. Ledger W et al, Two doses of corifollitropin alfa allow for similar exposure and ovarian response in patients weighing less than or equal to 60 kg and > 60 kg. Oral presentation at 25th European Society of Human Reproduction and Embryology (ESHRE) on July 1, 2009. Abstract no. O-282
5. Hillensjo T et al, Corifollitropin alfa versus recombinant FSH in a GnRH antagonist protocol for controlled ovarian stimulation in women weighing 60 kg or less. Oral presentation at 25th European Society of Human Reproduction and Embryology (ESHRE) on June 29, 2009. Abstract no. O-004
6. Fatemi HM et al, The first pilot study with corifollitropin alfa in a long GnRH agonist protocol indicates the development of a large cohort of follicles during the first week of ovarian stimulation. Oral presentation at 25th European Society of Human Reproduction and Embryology (ESHRE) on July 1, 2009. Abstract no. O-283
7. Frequently Asked Questions About Infertility. American Society for Reproductive Medicine Web site. http://www.asrm.org/Patients/faqs.html. Accessed May 14, 2009
8. http://www.icsi.ws/about_infertility. Accessed May 14, 2009
9. Frequently Asked Questions; Questions about Infertility. Centre for Fertility and Reproductive Medicine. http://www.csmc.edu/3830.html. Accessed May 14, 2009