OxThera: Pivotal Study Is Being Conducted With Oxabact(TM) For The Treatment Of Primary Hyperoxaluria

OxThera announced that all 42 patients have been enrolled in their pivotal phase II/III study using Oxabact™ for the treatment of Primary Hyperoxaluria. Results from this multicenter study will be presented during Q4 of 2008 and be used to file for licensure in EU, US and the rest of the world.

Primary Hyperoxaluria is a rare genetic disease in which excessive oxalate is produced by the liver and excreted in the urine by the kidneys. High levels of urinary oxalate cause kidney stones and/or calcification of the kidney which could lead to kidney failure and in many cases premature death. OxThera estimates that there are about 2000 patients with Primary Hyperoxaluria in EU and US combined.

Oxabact™ consists of a unique intestinal bacterium, Oxalobacter formigenes, naturally colonizing the intestinal tract of most humans with the purpose to degrade oxalate. Previous studies with Oxabact™ have already shown a significant effect in lowering urinary oxalate which in turn leads to a decreased risk of kidney damage. Oxabact™ has been designated orphan drug status in both EU and the US.

The 28 week pivotal study is a randomized, double-blind, placebo-controlled, multi-center study being conducted at eight Primary Hyperoxaluria referral sites in the Netherlands, France, UK, Germany and US.

“Primary Hyperoxaluria is a very serious disease often leading to early kidney failure and in particular systemic oxalate deposition with all its complications including death with no effective medical therapy currently available. For majority of patients the only real option today is a combined liver-kidney transplantation which is available to a very limited number of patients worldwide. Therefore, the Primary Hyperoxaluria community has great hopes that Oxabact™ will offer a new treatment opportunity. A confirmation of earlier study results with Oxabact™ will reflect scientific breakthrough and a new chapter in the treatment of this rare and severe disease”, says Prof. Bernd Hoppe, University Hospital in Cologne, Germany.

Jon Heimer, CEO and President of OxThera comments: “After several years of intensive research on Oxalobacter formigenes and Oxabact™, a significant milestone is met with the inclusion of all patients in this pivotal study. A successful outcome will put us in a position to file for licensure and making the product available to treating physicians and patients during 2009 which is very exciting”.

Short facts about OxThera

OxThera is a biotechnology company active in the development of products for the treatment of metabolic disorders resulting from excess levels of oxalate from endogenous and exogenous sources. Currently, OxThera has two products in its pipeline, Oxabact™ for the treatment of primary hyperoxaluria, and Oxazyme™, for the prevention of recurring calcium-oxalate kidney stones due to secondary hyperoxaluria.

Oxalate is a metabolic end product in humans. It is endogenously produced by the liver and also derived by absorption from the diet. The majority of oxalate is eliminated from the body through the kidneys and a small percentage is eliminated through the GI-tract. Oxalate forms a calcium-oxalate salt which is insoluble at physiological pH and its accumulation can result in serious renal conditions. Consistent high levels of urinary oxalate are known as “hyperoxaluria”, which can result in recurrent kidney stones and renal complications. Hyperoxaluria is currently classified as:

- Primary hyperoxaluria types I and II are rare genetic diseases resulting from overproduction of oxalate in the liver (PH I) or in all body cells (PH II); urinary oxalate excretion is usually greater than 100 mg/day (normal level

JCI Online Early Table Of Contents: Oct. 9, 2008

VASCULAR BIOLOGY: A real-time view of blood flow through the pancreas

A team of researchers at Vanderbilt University, Nashville, has developed a new microscopy approach that enabled them to image, in real time, the flow of blood in mouse pancreatic islets of Langerhans.

The pancreatic islets of Langerhans have a central role in regulating the amount of glucose in the blood. Beta cells are found in the center of the islets and produce insulin, which decreases levels of glucose in the blood. They are surrounded by non-beta cells, which produce a number of other hormones, including glucagon, which increases levels of glucose in the blood. The team of researchers, led by David Piston and Alvin Powers, was able to reconstruct the in vivo 3D architecture of mouse islets and observe real-time blood flow. Two main blood-flow patterns were observed: inner-to outer, in which blood first contacted the beta-cells and then the non-beta cells, and top-to-bottom, in which blood moved from one side of the islet to the other regardless of cell type. These data have important implications for our understanding of how blood glucose levels are regulated by the cells in the pancreatic islets of Langerhans. In addition, the authors hope that this approach can be used to study blood flow in the other organs.

TITLE: Real-time, multidimensional in vivo imaging to investigate blood flow in mouse pancreatic islets

David W. Piston
Vanderbilt University, Nashville, Tennessee, USA.

Alvin C. Powers
Vanderbilt University, Nashville, Tennessee, USA.

View the PDF of this article at: https://www.the-jci/article.php?id=36209

BONE BIOLOGY: The protein NFATc1: a master controller of bone destruction

The most common disease caused by excessive bone destruction is osteoporosis. However, regional bone loss is observed in several inflammatory conditions, including cherubism and rheumatoid arthritis. Laurie Glimcher and colleagues, at Harvard School of Public Health, Boston, have now provided new insight into the molecular control of bone degradation in mice during growth and disease, thereby uncovering a potential new therapeutic target for these diseases.

In the study, mice in which expression of the protein NFATc1 was eliminated at 10 days old developed osteopetrosis (a condition in which the bones are harder and denser than normal). This was associated with a decrease in the number of cells that destroy bone (osteoclasts). Further analysis revealed that NFATc1 regulated expression of numerous genes required for osteoclast generation. Additional experiments showed that elimination of NFATc1 in a mouse model of cherubism prevented bone loss, although it did not lessen the associated inflammation. The authors therefore conclude that NFATc1 is necessary for generating osteoclasts in growing and adult mice and might be a new therapeutic target for bone loss associated with inflammatory conditions such as cherubism.

TITLE: NFATc1 in mice represses osteoprotegrin during osteoclastogenesis and dissociates systemic osteopenia from inflammation in cherubism

Laurie H. Glimcher
Harvard School of Public Health, Boston, Massachusetts, USA.

View the PDF of this article at: https://www.the-jci/article.php?id=35711

MUSCLE BIOLOGY: Slow, slow, quick, quick, slow: molecular insight into muscle fiber composition

Muscles are made of two different types of fibers: fast-twitch fibers, which contract quickly and powerfully, tire easily, and are suited to physical exercise such as weight lifting and sprinting; and slow-twitch fibers, which can contract for long periods of time, generate less power, and are suited to endurance events. The relative amount of each type of fiber in a muscle can change over time, allowing a muscle to adapt to changing physical demands. New insight into the molecules that control the relative amount of slow- and fast-twitch fibers in the muscles of mice has now been provided by a team of researchers at the University of Heidelberg, Germany, and the University of Texas Southwestern Medical Center, Dallas.

The researchers, led by Norbert Frey and Eric Olson, found that mice lacking the protein calsarcin-2, which is expressed exclusively by fast-twitch muscle, have substantially reduced body weight, reduced amounts of fast-twitch muscle, and increased ability to run long distances. Consistent with the improved performance in distance running, muscles of the calsarcin-2-deficient mice showed a switch toward slow-twitch fibers. Further analysis revealed a molecular mechanism for this change in the fiber-type composition of the muscles: increased activity of the calcineurin/NFAT signaling pathway, which is known to promote the formation of slow-twitch fibers. The authors therefore conclude that calsarcin-2 modulates mouse exercise performance by dampening calcineurin/NFAT signaling and thereby reducing the formation of slow-twitch muscle fibers.

TITLE: Calsarcin-2 deficiency increases exercise capacity in mice through calcineurin/NFAT activation

Norbert Frey
University of Heidelberg, Heidelberg, Germany.

Eric N. Olson
University of Texas Southwestern Medical Center, Dallas, Texas, USA.

View the PDF of this article at: https://www.the-jci/article.php?id=36277

TRANSPLANTATION: Engineering Tregs to see transplants and stop rejection

Immune cells known as Tregs are regulatory cells that dampen immune responses and prevent the immune system attacking the body’s own tissues. It has been suggested that it might be possible to generate Tregs specifically to dampen immune responses that cause rejection of transplanted organs from donors not genetically identical to the transplant recipient. Mouse Tregs able to suppress rejection of hearts transplanted between genetically disparate donors and recipients have now been generated by Robert Lechler and colleagues, at King’s College London, United Kingdom.

Tregs that directly recognized one of the main targets on the heart transplant of the destructive immune response were obtained from the intended recipient mice. These cells were then engineered so that they also indirectly recognized this target. When infused into the recipient mice, Tregs able to both directly and indirectly recognize the main target of the destructive immune response were better at preventing rejection of heart grafts than Tregs able to only directly recognize this target. The authors therefore suggest that it might be possible to engineer Tregs to be clinically useful in transplantation settings.

TITLE: Conferring indirect allospecificity on CD4+CD25+ Tregs by TCR gene transfer favors transplantation tolerance in mice

Robert Lechler
King’s College London, London, United Kingdom.

View the PDF of this article at: https://www.the-jci/article.php?id=33185

ONCOLOGY: Of cancer and metabolic disease: a role for the protein S6K1 in distinguishing between the two

Beta-cells in the pancreatic islets of Langerhans are dysfunctional in individuals with diabetes, and the molecules that control their growth and function are therefore potential therapeutic targets. While determining the role of the protein Akt1 in regulating the growth and function of mouse pancreatic beta-cells, Mario Pende and colleagues, at INSERM U845, France, generated data that might have more of an impact on anticancer therapy.

In the study, although mice engineered to overexpress a constitutively active form of Akt1 in their pancreatic beta-cells showed improved beta-cell function (because the cells were enlarged), a substantial number of the mice developed insulinomas (a rare form of pancreatic cancer) later in life and died. Further analysis revealed that the signaling protein S6K1 was required for constitutively activated Akt to cause insulinoma formation but not required for it to increase pancreatic beta-cell size. These data have implications for the development of strategies to modify pancreatic beta-cell size and function while minimizing cancer risks as well as suggesting that S6K1 might be a useful therapeutic target for individuals with some forms of cancer.

TITLE: Constitutively active Akt1 expression in mouse pancreas requires S6 kinase 1 for insulinoma formation

Mario Pende
INSERM U845, Paris, France.

View the PDF of this article at: https://www.the-jci/article.php?id=35237


Source: Karen Honey

Journal of Clinical Investigation

View drug information on Glucagon.

Brain Development Goes Off Track As Vulnerable Individuals Develop Schizophrenia

Two new research studies published in Biological Psychiatry point to progressive abnormalities in brain development that emerge as vulnerable individuals develop schizophrenia.

The first of these papers studied individuals with a deletion of a small section of chromosome 22. This genetic deletion often results in the development of abnormalities in the structure of the heart and of the face, a condition called velocardiofacial syndrome (VCFS; also known as 22q11.2 deletion syndrome). Up to 32% of people with VCFS develop psychotic disorders including schizophrenia, which occurs in 1% of the general population.

Using magnetic resonance imaging (MRI), Dr. Wendy Kates and her colleagues showed that during adolescence, progressive deficits in the volume of the temporal cortex gray matter were predictive of developing psychosis.

“Our findings suggest that in VCFS, brain changes during mid-adolescence, particularly in the temporal lobe, predict early signs of psychosis,” said Dr. Kates. “This suggests that it may be possible, eventually, to develop a screening tool that would identify those VCFS-affected youth who are at the highest risk for schizophrenia.”

In another paper, Dr. Andrew McIntosh and colleagues report a similar pattern among adolescents and young adults who were followed over a 10 year period. All of the young people were well at the beginning of the study, but some were at high genetic risk of developing schizophrenia due to having family members with schizophrenia.

“The participants were examined repeatedly by a psychiatrist and with structural brain scans to see if there were changes in brain structure in people who later became unwell,” explained Dr. McIntosh. “At the end of the study, we found that there were accelerated reductions in the volume of particular brain structures in the people at high risk, and additional reductions in the volume of the frontal lobes in those people who later developed schizophrenia.”

These two studies highlight the existence of progressive changes in brain structure related to the emergence of symptoms among individuals at risk for developing schizophrenia.

“These studies cannot define the specific changes at the cellular level and thus, we are limited in our capacity to make precise predictions based on these MRI data,” commented Dr. John Krystal, Editor of Biological Psychiatry. “However, the findings suggest that schizophrenia is not simply a ‘scar’ but rather an ongoing brain process that might need to reach an as yet unclear stage where symptoms emerge. That being the case, there is hope that someday one might develop treatments that block this ‘disease process’ as we have been able to do for some other heritable brain diseases.”

Source: Elsevier, AlphaGalileo Foundation.

Scientists Demonstrate Feasibility Of Preventing Malaria Parasite From Becoming Sexually Mature

Discovery could help to control the spread of drug resistance

Researchers have demonstrated the possibility of preventing the human malaria parasite, Plasmodium falciparum, which is responsible for more than a million malaria deaths a year, from becoming sexually mature.

The discovery could have implications for controlling the spread of drug resistance, which is a major public health problem and which hinders the control of malaria.

The life cycle of Plasmodium falciparum is complex, and it is not yet known what triggers the production of parasite gametes or sex cells. These sexual forms of the parasite do not contribute to malaria symptoms, but are essential for transmission of malaria between humans via the bite of a mosquito.

A team based at the London School of Hygiene & Tropical Medicine, working with a colleague from the Wellcome Trust Sanger Institute in Cambridge, identified a parasite enzyme that is instrumental in triggering the emergence of mature gametes within the mosquito. Their findings are published today in the journal PLoS Biology.

Dr. David A Baker, a Reader in Parasite Molecular Biology at the London School of Hygiene & Tropical Medicine and senior author of the study, comments: ‘The enzyme we have discovered, a protein kinasea, is essential for the development of malaria parasite gametes. Working with genetically modified parasites, in combination with inhibitors of this enzyme, we have demonstrated that it is feasible to block the sexual stage of the life cycle of the malaria parasite.

He adds: ‘This has exciting implications in terms of improving how we go about tackling malaria. If a drug can be developed that targets this stage of the life cycle, and combined with a curative drug, it would be an important new approach for controlling malaria transmission and the spread of drug resistance’.

Keppel Street

Dialysis Patients Urged To Prepare For Gustav – Fresenius Medical Care Gives Disaster Tips For Anyone On Dialysis

With Tropical Storm Gustav projected to hit the Gulf Coast as a hurricane next week, Fresenius Medical Care North America, operator of the nation’s leading network of dialysis facilities, encourages all dialysis patients in the area to begin preparing now for the storm.

Also, with three months left in the hurricane season, Fresenius reminds anyone on dialysis who lives in hurricane-prone areas to be prepared for a storm.

About 26 million people in the United States have kidney disease, according to the National Kidney Foundation, and more than 360,000 of them are on dialysis. These patients represent one of the most vulnerable segments of the population during a natural disaster. They typically need dialysis every two days; when storms disrupt electrical power or make routine travel to treatments impractical, any substantial delay in dialysis care can be life-threatening.

Fresenius Medical Care offers Five Disaster Preparedness Tips for Dialysis Patients:

1. Keep your emergency phone numbers handy.

– Patient Disaster Hotline: 1 (800) 626-1297. During a large disaster, the hotline is activated and staffed by Fresenius Medical Care dialysis service specialists who can answer questions and direct all dialysis patients and their families to the nearest open clinic during an emergency.

2. Carry your up-to-date personal information with you at all times (ID, medication and allergy lists, insurance, emergency contact information, type of dialysis treatment).

3. Talk to your doctor and family about your evacuation plan – what you should do and where you should go if a disaster strikes. Keep track of local weather forecasts.

4. Create a disaster kit with emergency supplies and at least one extra three-day supply of medicines. Many patients find it convenient to keep medicines and medical supplies in an easy-to-carry fanny pack or backpack.

5. Store a three-day supply of food based on your emergency meal plan. Begin this special diet plan as soon as a disaster is predicted or occurs and remain on it until you receive dialysis treatment. Limit fluid intake to two cups per 24 hours and avoid fresh fruit or vegetables.

About Fresenius Medical Care North America

Fresenius Medical Care North America is a subsidiary of Fresenius Medical Care AG & Co. KGaA, the world’s largest integrated provider of products and services for individuals undergoing dialysis because of chronic kidney failure, a condition that affects more than 1,600,000 individuals worldwide. Through its network of 2,297 dialysis clinics in North America, Europe, Latin America, Asia-Pacific and Africa, Fresenius Medical Care provides dialysis treatment to approximately 177,059 patients around the globe. Fresenius Medical Care is also the world’s leading provider of dialysis products such as hemodialysis machines, dialyzers and related disposable products. Fresenius Medical Care is listed on the Frankfurt Stock Exchange (FME, FME3) and the New York Stock Exchange (FMS, FMS-p).

For more information about Fresenius Medical Care’s U.S. network of more than 1,650 dialysis facilities, visit the Company’s website at www.ultracare-dialysis. For more information about Fresenius Medical Care, visit the Company’s websites: www.fmcna or www.fmc-ag.

New Active Compound Identified In Treatment Of Malaria

Malaria is caused by Plasmodium parasites and it is the female Anopheles mosquito that acts as a vector for these malarial parasites in to the human body.

Each year, 200 to 400 million people are infected in the underdeveloped and developing regions of the planet, causing the death of between 2 to 3 million of their inhabitans, most of which are children below 5 years of age. Several therapeutic agents that efficiently fight the disease already exist, but nevertheless; there is still a need to develop new antimalarial drugs to increase the therapeutic arsenal against the disease and to help prevent the different strains of already resistant Plasmodium parasites from acquiring further resistance to antimalarial drugs.

The Universidad AutГіnoma de Barcelona and the Universidad Complutense de Madrid have patented a new active compound for the treatment of malaria.

The researchers have also identified the gene where this compound inhibits the growth of the parasite, since it has a crucial role in its cycle inside the erythrocytes. The new compound is a non digestive protease inhibitor that does not allow the growth or development of the Plasmodium parasite inside the erythrocytes. This active compound, even considering its peptide origin, is expected to improve the activity and bioavailability of the drugs.

The identification of specific targets essential for the development of the parasite is an effective tool to facilitate the development of new drugs that cure infections by parasites resistant to current antimalarial drugs. The target identified, is a single gene with a very specific role for the parasite, and that is conserved and shared among all the species of plasmodium, which potentially implies a low probability for acquiring resistance. Also, the human host has several homologous genes to this target gene, but with different properties to the parasitic one, which is the possible reason for nearly non existent toxic effects of the new active compound in the mice used to test the drug, lending an additional advantage to this patented compound.

C/ AlcalГЎ 30-32, 3ВЄplanta

Iowa Cigarette Tax Increase Would Fund Universal Access To Care

Democratic lawmakers in Iowa are proposing a plan to fund universal access to health care in the state with a $1-per-pack increase in the state cigarette tax, the Des Moines Register reports. The plan would create a bipartisan commission to develop ways to make health insurance more affordable for small businesses and working families. The plan also would increase access to safety-net programs, such as community clinics that serve low-income, disabled and elderly residents. State Sen. Jack Hatch (D) and state Rep. Ro Foege (D) said that the cigarette tax increase would generate an estimated $134 million in annual revenue to fund health programs. Incoming Gov. Chet Culver (D) has proposed increasing the current 36-cents-per-pack cigarette tax. Legislative hearings on the plan are scheduled for next week (Roos, Des Moines Register, 1/11).

“Reprinted with permission from kaisernetwork. You can view the entire Kaiser Daily Health Policy Report, search the archives, or sign up for email delivery at kaisernetwork/dailyreports/healthpolicy. The Kaiser Daily Health Policy Report is published for kaisernetwork, a free service of The Henry J. Kaiser Family Foundation . © 2005 Advisory Board Company and Kaiser Family Foundation. All rights reserved.

Has Exercise Treatment A Role In Improving Mood Swings?

A paper that is published in the current issue of Psychotherapy and Psychosomatics analyzes the role of exercise treatment in mood swings.

Outcomes are frequently suboptimal for patients with bipolar disorder who are treated with pharmacotherapy alone. Adjunct exercise has the potential to substantially improve acute and long-term outcomes, although how exercise would improve the course of bipolar disorder needs to be elucidated. The Authors of this study propose that exercise may improve mood and functioning by increasing neurogenesis and reducing allostatic load. In this paper, they review data suggesting that exercise increases levels of brain-derived neurotrophic factor, which in turn increases neurogenesis and decreases allostatic load. Exercise as a psychosocial adjunct for bipolar disorder should be assessed with rigorous randomized clinical trials.

Source: Psychotherapy and Psychosomatics

Eliquis (Apixaban) Better Treatment Option For Stroke Prevention, Study Reveals

The main results of a Phase 3 clinical trial known as ARISTOTLE and conducted by Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) were announced at the end of August and the study reveals a better treatment option for stroke prevention.

The results were published in The New England Journal of Medicine.

They compared Eliquis (apixaban) to warfarin for the prevention of stroke or systemic embolism in 18,201 patients with atrial fibrillation and at least one risk factor for stroke. In the ARISTOTLE trial, Eliquis as compared with warfarin significantly reduced the risk of stroke or systemic embolism by 21 percent, major bleeding by 31 percent, and mortality by 11 percent.

Mr. Pheroze Khan, Managing Director, Bristol Myers Squibb India, said:

“We know high-risk patients with Atrial Fibrillation continue to have events, and we know oral anticoagulant is effective. The results from ARISTOTLE trial demonstrated that apixaban as compared with warfarin significantly reduces the risk of stroke, major bleeding and mortality.”

Lead investigator, Dr. Christopher B. Granger, professor of medicine, Duke Clinical Research Institute, Duke University Medical Center, Durham, N.C., said:

“The risk for stroke in patients with atrial fibrillation is a major public health concern in an aging population. We are therefore encouraged by the outcome of the ARISTOTLE trial, which showed that apixaban, as compared with warfarin, significantly reduced the risk of stroke or systemic embolism, major bleeding, and mortality.”

The study was conducted at 1,034 centers in 39 countries, and coordinated by the Duke Clinical Research Institute, Durham, N.C., and Uppsala Clinical Research Institute, Uppsala, Sweden.

A class of agents are being studied or their potency to prevent and treat blood clots. Eliquis, a new oral direct Factor Xa inhibitor, is part of a class of agents being studied for their potential to prevent and treat blood clots.

Atrial fibrillation (AF) is the most commonly sustained cardiac rhythm disorder and is associated with mortality from stroke and thromboembolism not only in the western world but in India as well.

The healthcare burden of a higher AF patient population combined with the increasing presence of other risk factors causing stroke, such as hypertension, diabetes, ischemic heart disease and advanced age in India is higher, compared to the western world. India has its own challenges on top with inadequate screening, evaluation, and management strategies for stroke prevention in AF patients.

Oral anticoagulants are recommended for treatment of AF patients, who have a risk of thromboembolism running at a rate of 17-18% a year, however the current standard treatment using warfarin is now some 50+ years old and requires specified therapeutic (INR) monitoring because of bleeding risk. Apixaban thus has potential to become a new paradigm for treatment of Atrial fibrillation patients.

Rupert Shepherd BSc.

View drug information on Warfarin Sodium tablets.

Cannabis Science Officially Begins Its First Pre-IND FDA Application Process For Post Traumatic Stress Disorder (PTSD)

Cannabis Science Inc. (NASD OTCBB: CBIS), a pharmaceutical cannabis company in the US, is pleased to announce that it now has the results of its survey of more than 1,300 individuals with PTSD, including a large cohort of veterans. The survey was conducted by Cannabis Science Advisory Board member Dr. Mitch Earleywine PhD. of the State University of New York (Albany).

The Company has reported several prospective drugs for FDA clinical trials. Based on extensive studies and this survey, the Company now has the substantiated data to for its first application for a PTSD drug for FDA clinical trials. The Company will now sign a pre-negotiated contract with a group of FDA specialists based in Colorado to handle the Company’s first FDA filings.

Dr. Earleywine explained, “Veterans reported that cannabis helped nearly all symptoms of PTSD, with special emphasis on three important components: sleep disturbance, irritability, and disturbing memories. PTSD is notorious for leading to difficulty falling and staying asleep. This insomnia can make other mental and physical symptoms worse. The import of the cannabinoids in sleep is well established, so the idea that it should aid this aspect of PTSD is no surprise. Irritability in PTSD is quite common. It can precede incidents of domestic violence, aggressive driving, and other troublesome behaviors that frequently occur in the disorder. The disturbing memories often include alarming, rapid thoughts as well as distressing images that are difficult to shake. These can be particularly resistant to treatment with other approaches, but respondents reported that medical cannabis helped minimize these experiences dramatically.”

Dr. Robert Melamede, PhD., Cannabis Science Inc. President and CEO added, “This survey demonstrates a huge advantage over conventional pharmaceutical research companies that Cannabis Science enjoys. As a patient-oriented company we know that real people with real problems are getting real relief from cannabis. We are now in a position to contract with experts in the FDA processes to use this data to apply for Investigative New Drug status for our products, which we will be announcing soon. Also, it is important to note that insomnia is a very widespread problem in the general population, especially senior citizens, so the need for cannabis based medicines for sleep is not confined to people with PTSD. In fact, it is a multi-billion dollar a year market.”

Cannabis Science, Inc.