Click Here to go to Bioms Medical's Home Page

"Hi Stan,

It was nice talking to you again!

BioMS has one mission: to deliver a safe and effective treatment for MS
patients and we are well on our way.

MBP8298 is based on ground-breaking research and has successfully completed phase I and II clinical trials.

Currently we are in an international phase III trial for secondary
progressive MS in Canada and Europe.

BioMS expects to commence a similar phase III trial in the US in the first half of 2007.

Recently the European Journal of Neurology published data that showed MBP8298 safely delayed disease progression in an HLA-defined subgroup of MS patients for an unprecedented 5 years. It is my hope that all MS patients can potentially benefit from this exciting research.

Please feel free to call me if you need any more information on MBP8298. I will give you any information that we are able to release to the public...immediately...so you can give it to your MS patients and their families"


Ryan Giese
Vice President Corporate Communications
BioMS Medical Corp

New MS oral treatment improves symptoms
Novartis has reported new phase II results of FTY720 that show a sustained reduction in relapses and inflammation in multiple sclerosis patients over a two year period.

New phase II data presented demonstrated that up to 77% of patients taking once-daily oral FTY720 remained free of relapses over two years. They also maintained a low rate of inflammatory disease.

New preclinical data also suggested that FTY720 may work through multiple modes of action. In addition to its anti-inflammatory effects, preclinical data suggest that FTY720 may have the potential to reduce neurodegeneration and enhance repair of the central nervous system.

FTY720, the first oral sphingosine 1-phosphate receptor (S1P-R) modulator, may represent a new approach to the treatment of MS through its unique mode of action.

In MS, inflammatory lymphocytes (T-cells) are believed to be responsible for the destruction of the protective myelin coating, which surrounds the nerves in key areas of the brain and spinal cord. This destruction hinders the ability of nerves to send electrical signals, resulting in problems with muscle movement, coordination, balance and cognition.

FTY720 binds to the sphingosine 1-phosphate receptor-1 (S1P1) on circulating lymphocytes and reversibly traps a proportion of them in the lymph nodes. As a result, FTY720 lowers the number of activated T-cells circulating in the bloodstream and central nervous system.

FTY720 has been developed by Novartis and licensed from Mitsubishi Pharma Corporation.

"Testosterone gel proven to slow symptoms of MS...in small study"....]CLICK TO READ MORE:
"In a small study, 10 men with multiple sclerosis applied this testosterone gel to their shoulders once a day for a year; the study found the gel improved their immune systems and all the patients performed better on memory tests....

Rhonda Voskuhl, M.D., of the UCLA School of Medicine, says, "What they reported is that they felt better, that they had more energy and less fatigue."

The gel improved their immune systems and all the patients performed better on memory tests.

MRI scans also showed parts of the brain, which normally decline when affected by multiple sclerosis, actually slowed."...

Symadex Can Reverse Disease in Preclinical Multiple Sclerosis Animal Model
"Xanthus Pharmaceuticals Inc., a privately-held drug development company, today presented data that Symadex(TM) reverses the clinical and pathological signs of chronic disease in an animal model for multiple sclerosis (MS). The presentation was made by Stephen J. Karlik, PhD, Professor of Diagnostic Radiology at the University of Western Ontario, London, Ontario, together with researchers from Xanthus in aposter session at the 22nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) meeting in Madrid, Spain.

Dr. Karlik used a model of experimental allergic encephalomyelitis(EAE) for the study. This same model was used by Dr. Karlik and his colleagues for published studies with natalizumab and related molecules. The study demonstrated that Symadex can reverse the clinical and pathological signs of chronic disease and that it can permit nerve remyelination. In addition, longer dosing resulted in continued benefit and the pathological changes including inflammation and vascular abnormalities were reversed. Importantly, Symadex did not affect circulating immune cell numbers, suggesting that it is not a general immunosuppressive agent....MORE

SERONO'S ORAL CLADRIBINE FOR THE TREATMENT OF MULTIPLE SCLEROSIS AWARDED FAST TRACK STATUS BY FDA

Geneva, Switzerland, September 21, 2006 - Serono (virt-x: SEO and NYSE: SRA) announced today that oral cladribine has been designated a Fast Track product by the US Food and Drug Administration (FDA). This designation covers patients with relapsing forms of multiple sclerosis.

Serono’s proprietary oral formulation of cladribine for the treatment of multiple sclerosis is currently being evaluated in a multi-center, multi-national Phase III study, CLARITY (CLAdRIbine Tablets Treating MS OrallY) . It is a two-year, double-blind, placebo-controlled study involving over 1,200 patients. Patient enrollment into this pivotal trial is planned to be completed by the end of 2006.

“We are very pleased that oral cladribine has been designated a Fast Track product,” said Ernesto Bertarelli, CEO of Serono. “As a leader in multiple sclerosis, we are committed to providing new treatment options that can further improve the quality of the lives of people with this serious disease and our objective is to bring to them the first oral disease modifying treatment.”

"Thanks to decades of research, there are injectible drugs available to treat some forms of MS, but there is certainly a need for more and even better therapies to treat all forms of the disease. Having an effective oral therapy for MS would be a major step forward in improving quality of life for people with MS," said Dr. John Richert, Vice President, Research and Clinical Programs, at the National Multiple Sclerosis Society.

Fast Track programs are designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs.

Under Fast Track designation oral cladribine is eligible for Priority Review and FDA may consider for review portions of the marketing application before the New Drug Application (NDA) is completed.

About cladribine

Cladribine is a purine nucleoside analogue that interferes with the behavior and the proliferation of certain white blood cells, particularly lymphocytes, which are involved in the pathological process of multiple sclerosis. Through its differentiated mechanism of action, oral cladribine may offer an alternative option to patients with multiple sclerosis.

New Patent for MS drug: PHARMACEUTICAL COMPOSITION COMPRISING A ZINC-HYALURONATE COMPLEX
FOR THE TREATMENT OF MS

NovaDel Announces Two CNS Oral Spray Drug Candidates in its Development Pipeline; Oral Spray Formulations of Tizanidine for Spasticity [CLICK HERE - Forbes.com]NovaDel's oral spray technology may be particularly applicable to drugs for the treatment of CNS disorders where the oral sprays ability to overcome difficulty in swallowing tablets and achieving rapid onset of action could fulfill important unmet medical needs for patients," commented Jan Egberts, M.D., CEO of NovaDel. "For instance, we expect that the ease of administering Tizanidine Oral Spray will be well suited to patients suffering from spasticity, which often includes difficulty in swallowing and drugs administered via tablet represent an obstacle to treatment......

TOVAXIN: Click for Opexa Therapeutics Home Page
"Opexa Therapeutics, Inc. (OPXA) announced a number of positive steps in the Company's development including: -- Its Phase IIb study with Tovaxin(TM) for the treatment of multiple sclerosis has begun. -- Positive data from the Phase I/II trial with Tovaxin in multiple sclerosis indicate that after 12 months, patients exhibited a relapse rate reduction of more than 90%.

Initiation of animal studies at the University of Texas Medical Branch at Galveston utilizing the Company's autologous adult human stem cell regenerative medicine platform technology."

>PRESS RELEASE BY TEVA: LAQUINIMOD -The once-daily novel oral agent for relapsing remitting MS....CLICK: FULL ARTICLE

"Laquinimod Phase IIb Trial confirms efficacy and favorable safety profile and shows significant reduction in the rate of inflammatory disease activity

The once-daily novel oral agent for relapsing remitting multiple sclerosis (MS) patients met its primary end-point."

"Jerusalem, Israel and Lund, Sweden, September 5, 2006 - Teva Pharmaceutical Industries Ltd (Nasdaq: TEVA) and Active Biotech AB (ACTI.ST) today announced that a Phase IIb study designed to evaluate the safety and efficacy of laquinimod, a once-daily novel oral agent, in relapsing remitting multiple sclerosis (MS) patients, met its primary end-point.

Laquinimod treatment significantly reduced the rate of inflammatory disease activity, as measured by the cumulative number of Gadolinium enhancing lesions on brain MRI scans after 36 weeks of treatment. Laquinimod treatment also demonstrated a considerable reduction in the number of clinical relapses compared to placebo. This Phase IIb multi-center, randomized, double-blind, placebo-controlled study enrolled approximately 300 patients in 8 European countries and in Israel.

The evaluation of the safety and side-effect data confirmed the favourable safety profile that was seen in earlier phase II clinical trials. The majority of the patients who participated in the study are currently continuing treatment with laquinimod in an ongoing, blinded extension study.

"The study results with once daily oral laquinimod are very encouraging and further demonstrate our ongoing commitment to developing new classes of therapies for MS, including oral therapies, to treat the disease, as well as to improve the patients' quality of life," said Israel Makov, President and CEO of Teva Pharmaceutical Industries Ltd.

"As of today, nearly 400 patients have received laquinimod in various clinical trials over the last years. The data from the completed studies together with preclinical documentation, confirm laquinimod's efficacy and favorable safety profile in MS patients," said Sven Andr'asson, President and CEO of Active Biotech AB.

The positive result of the clinical trial triggers a milestone payment to Active Biotech.

Further details about the study will be given at Teva's Innovative R&D Day in New York City on September 26th, 2006. A complete presentation of the Phase IIb data will be given at upcoming relevant scientific meetings.

Teva is discussing laquinimod's development plan with regulatory authorities in order to accelerate the clinical program into Phase III.

About Laquinimod:
Laquinimod is a novel once-daily, orally administered immunomodulatory compound developed as a disease modifying treatment for multiple sclerosis (MS). Active Biotech developed laquinimod and licensed it to Teva Pharmaceutical Industries Ltd. in June 2004 ....[MORE]"

A possible advance in fight against MS by Researchers at Children's Hospital Boston, the pediatric teaching hospital for Harvard Medical School...CLICK FOR FULL ARTICLE:
"...The experiments, described Wednesday in the Journal of Neuroscience, showed that nicotinamide a form of vitamin B3, or niacin not only protected the animals' nerve fibers from degeneration and fatty insulating tissues loss, it also protected nerve fibers that have already lost insulation from degrading further.
'We hope our work will initiate a clinical trial, and that nicotinamide could be used in real patients,' said Dr. Shinjiro Kaneko, a research fellow at Children's who led the study. 'In the early phase of MS, anti-inflammatory drugs may work, but long-term, you need to protect against axonal (nerve fiber) damage.'

On a scale of 1 to 5 (with 1 being only mild weakness in the tail; 4, paralysis in all four limbs, and 5, death from the disease), mice receiving the highest doses of daily nicotinamide injections under the skin had scores of 1 or 2, while mice not getting the vitamin had scores of 3 or 4.
Nicotinamide significantly reduced neurological symptoms even when treatment was delayed for 10 days after the onset of disease in the mice, raising hopes that it can be effective in.... the later stages of MS in people. "

Genzyme Corp. said its Campath drug was more effective in treating multiple sclerosis than Serono SA's Rebif, the second-best selling MS treatment worldwide [MORE... Bloomberg.com:]

MS patients had 75 percent fewer symptom relapses after two years of treatment with Campath than with Rebif, Cambridge, Massachusetts-based Genzyme said today in releasing interim results of a 334-patient study. The Genzyme-sponsored trial was suspended a year ago after a patient died from abnormal bleeding.

The results suggest that Campath may be an effective option for treating MS, a debilitating neurological disorder that affects more than 2.5 million people worldwide, analysts said. A plan by Genzyme to reduce the bleeding risk may help persuade regulators to allow a larger patient study needed to win U.S. regulatory approval, the company said

``Patients and physicians are willing to take on a certain amount of risk when you have new opportunities to combat this debilitating disease,'' Aaron Reames, an analyst with A.G. Edwards in Boston said today in an interview. ``This is definitely positive data.''

The U.S. Food and Drug Administration in June approved Biogen Idec Inc.' Tysabri MS drug, which had been withdrawn more than a year ago because of a fatal side effect. The FDA allowed Tysabri back on the market after the company set up procedures designed to have doctors closely monitor patients. Biogen's Avonex is the world's top-selling MS medicine.

Safety Data

Shares of Genzyme, based in Cambridge, Massachusetts, gained $1.80, or 2.7 percent, to $68.35 in Nasdaq Stock Market composite trading. They had fallen 6 percent this year before today. Serono fell 8 Swiss francs to 871.5 francs in Zurich.

Safety data from the trial will be presented later this month at the meeting of the European Committee for Treatment and Research in MS in Madrid. Final results from the three-year trial are due in a year from now.

MS robs people of muscle coordination and balance, and can lead to damaged vision and paralysis. The disease is caused when the body's immune system attacks myelin, the coating on nerve fibers. In severe MS, people have permanent symptoms, including partial or complete paralysis.

The Campath study compared the drug to Rebif in patients with a form of the disease, called relapsing/remitting MS, in which a flare-up of symptoms is followed by remission.

Genzyme said today it requested a meeting with the FDA to present the data and to address the next steps in the drug's development. The company has already received scientific advice from the European Medicines Agency for moving forward into the last of three stages of human tests needed for regulatory approval.....MORE

CAMPATH (alemtuzumab) Editorial by the UK Multiple Sclerosis Society
The (UK) Multiple Sclerosis Society has welcomed the interim results of a phase II trial of Campath (alemtuzumab).

They show that people with MS taking the drug at both high and low doses experienced at least a 75% reduction in the risk of a relapse, compared with those taking Rebif (interferon beta-1a), after more than two years of follow-up. They also experienced at least a 65% reduction in the risk of progression of clinically significant disability.

Simon Gillespie, Chief Executive of the Society, said: ‘These are preliminary but very encouraging results, especially as they demonstrate a significant improvement on currently available therapies. With the appropriate risk management measures in place, we look forward to the completion of this phase of trialling and the important phase III trial.’

The phase II clinical trial was set up to compare the safety and efficacy of Campath (administered intravenously as a course of injections once a year) with Rebif (administered three times per week by subcutaneous injection). 334 people with early active relapsing remitting MS are taking part.

Dosing of Campath in this clinical trial was stopped in September 2005 after three people were diagnosed with immune thrombocytopenic purpura (ITP), a recognised and treatable condition in which low blood platelet counts can lead to abnormal bleeding. An initial case of ITP was fatal. However, five subsequent cases have been successfully treated. Genzyme has since created a comprehensive risk management plan to help physicians and people participating in the trial detect ITP early and minimise the risks of complications.

Other reported side effects of Campath include headache, rash, and fever, temporary worsening of MS symptoms and marginally increased risk of infections. Previous studies have reported around a 30% risk of developing an overactive thyroid, or Graves’ disease, which is a completely treatable condition, but may have serious eye effects in a minority of people. However, Genzyme reports that incidents of all thyroid-related adverse events, including Graves’ disease, were less than expected.

Genzyme is expected to initiate a phase III clinical trial with Campath early in 2007.


What is Campath?

Campath® (alemtuzumab) is a humanized monoclonal antibody, that is licensed for the treatment of chronic lymphatic leukaemia. It is thought to have an anti-inflammatory effect in MS. It binds to a specific target on the surface of immune cells and then depletes these cells. Campath has a prolonged action and therefore administration of one dose a year (or even after a longer interval) may be sufficient.

Tovaxin: New drug in the pipeline

New MS Drug: MBP8298...BioMS Medical Press Release: Pivotal MS Trial expanded.....FULL STORY

"BioMS Medical Expands Pivotal Multiple Sclerosis Trial into Spain and Germany

Edmonton, Alberta - BioMS Medical Corp (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced it has received approval from the Spanish Agency for Medicines and Healthcare Products (SAMHP) in Spain and from the Federal Institute for Medicines and Medical Products in Germany to start patient enrolment for its pivotal phase II/III clinical trial of MBP8298, a proprietary synthetic peptide for the treatment of secondary progressive multiple sclerosis (SPMS).

Pivotal Phase II/III Multiple Sclerosis Trial

BioMS Medical is currently enrolling patients across Canada , the U.K. , Sweden , Denmark and The Netherlands in its pivotal phase II/III clinical trial evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study enrolling approximately 553 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study. To date the trial has successfully passed five safety reviews by its independent Data Safety Monitoring Board."

Click the link in the headline to read more about BioMS Medical Corp.

Oral Fingolimod May Reduce Disease Activity in Relapsing MS [UPDATE #1]CLICK FOR MORE
[The New England Journal of Medicine 2006;1124-1140, 1088-1091]
"Results of a proof-of-concept randomized trial of fingolimod, an oral immune-modulating drug, show that treatment reduced the number of gadolinium-enhancing lesions on MRI as well as relapse-related clinical end points in patients with relapsing multiple sclerosis (MS).

'Our results show that oral fingolimod may be a treatment option for relapsing multiple sclerosis,' the researchers, with first author Ludwig Kappos, MD, from the University Hospital, Basel, Switzerland, conclude in their report. 'Before these findings can be considered clinically directive, the benefits and risks of fingolimod need to be further evaluated in larger-scale, longer-term clinical studies."

Genentech and Biogen Idec Announce Positive Results From a Phase 2 Trial of Rituxan in Relapsing-Remitting Ms
"Genentech, Inc. and Biogen Idec, Inc. announced today that a phase 2 study of Rituxan(R) (Rituximab) for relapsing-remitting multiple sclerosis (RRMS) met its primary endpoint. The study of 104 patients showed a statistically significant reduction in the total number of gadolinium enhancing T1 lesions observed on serial MRI scans of the brain at weeks 12, 16, 20, and 24 in the Rituxan-treated group compared to placebo. Genentech and Biogen Idec will continue to analyze the study results and will submit the data for presentation at an upcoming medical meeting.

This phase 2 randomized, double-blind, parallel-group, placebo-controlled, multi-center study was designed to evaluate safety and efficacy of Rituxan in adults with RRMS. A total of 104 patients at 48 sites in the U.S. and Canada were randomized to receive either a single treatment course of Rituxan or placebo. Gadolinium-enhancing lesions visible by MRI scans were assessed at 12, 16, 20 and 24 weeks. Patients will continue to be followed for 48 weeks.

"These initial results exceeded our expectations," said Hal Barron, MD, Genentech senior vice president, development and chief medical officer. "Showing a significant benefit at 24 weeks in this small phase 2 trial supports our hypothesis that selective B-cell targeted therapy may play an important role in the treatment of MS."

"Biogen Idec is committed to offering multiple options for people living with MS, a devastating disease. We are very encouraged by these data and look forward to learning more about the potential of Rituxan as a therapy to treat MS," said Alfred Sandrock, MD, PhD, senior vice president, neurology research and development, Biogen Idec.

Rates of overall adverse events and serious adverse events were comparable between the two treatment groups. Serious infectious adverse events occurring in Rituxan-treated patients included gastroenteritis and bronchitis. The overall rates of infection were comparable among the two treatment groups with an increase in the rates of nasopharyngitis, upper respiratory tract infections, urinary tract infections, and sinusitis in the Rituxan-treated patients. There were more first infusion-related reactions with Rituxan, the majority of which were mild to moderate and were generally reversible with medical intervention. The companies continue to monitor the long-term safety of Rituxan treatment.

Rituxan Safety Profile in Oncology and Autoimmune Diseases

The safety profile of Rituxan has been established in more than 960,000 patient exposures over a period of eight years.

In general, the adverse events observed in patients with RA, an autoimmune disease, were similar in type to those seen in patients with non-Hodgkin's lymphoma (NHL). The most common adverse events observed in patients treated with Rituxan for RA in clinical trials were infusion reactions and infections. No significant change in average immunoglobulin levels was observed in Rituxan-treated patients in clinical trials. There was no increase in hematologic malignancies, demyelinating events, or risk of opportunistic infections (including tuberculosis) in Rituxan-treated patients over 24 weeks of treatment. Although 5 percent of Rituxan-treated patients developed human anti-chimeric antibodies (HACA), this was not associated with loss of clinical response or additional safety observations.

The majority of patients experience infusion-related symptoms with their first Rituxan infusion. These symptoms include but are not limited to: flu-like illness, fever, chills/rigors, nausea, urticaria, headache, bronchospasm, angioedema, hypotension and hypoxia. These symptoms vary in severity and generally are reversible with medical intervention....."

NEW MS DRUG IN PIPELINE: STANFORD UNIVERSITY APPLIES FOR PATENT
"Method of treating rheumatoid arthritis and MS ...: "Applicant The Board of Trustees of the Leland Stanford Junior University...Inventor(s) Godfrey, Wayne
Engleman, Edgar G.....Abstract The invention provides ligands and fragments
thereof to a receptor on the surface of activated CD4+T-cells. An
exemplary ligand is designated ACT-4-L-h-1. Preferred fragments include
purified extracellular domains of ligands. The invention also provides
humanized and human antibodies to the ligand. The invention further provides
methods of using the ligand and the antibodies in treatment of diseases and
conditions of the immune system. The invention also provides methods of
monitoring activated CD4+T-cells using the ligands or fragments
thereof. If you would like to purchase a copy of this patent, please call MicroPatent at 800-648-6787."

NovaDel Announces Two CNS Oral Spray Drug Candidates in its Development Pipeline; Oral Spray Formulations of Tizanidine for Spasticity ... - Forbes.comNovaDel's oral spray technology may be particularly applicable to drugs for the treatment of CNS disorders where the oral sprays ability to overcome difficulty in swallowing tablets and achieving rapid onset of action could fulfill important unmet medical needs for patients," commented Jan Egberts, M.D., CEO of NovaDel. "For instance, we expect that the ease of administering Tizanidine Oral Spray will be well suited to patients suffering from spasticity, which often includes difficulty in swallowing and drugs administered via tablet represent an obstacle to treatment......

NEW MS MED IN EUROPE: "Sativex, the cannabis-derived product could be finally set for approval after a delay of around two years.
:
UK regulator, the MHRA, rejected the drug in December 2004, calling for a second clinical trial to prove its efficacy, which the company has now conducted, and which, it believes, proves that Sativex works. The company is seeking to treat multiple sclerosis spasticity, but hopes to eventually gain licences to treat peripheral neuropathic pain, MS neuropathic pain and cancer pain as well. GW Pharmaceuticals has filed Sativex for approval through the decentralised procedure for licences in just four European countries, the UK, Denmark, Spain and the Netherlands......"

MBP8298....BioMS Medical Press Release: Pivotal Multiple Sclerosis Trial of MBP8298 expanded...

"BioMS Medical Expands Pivotal Multiple Sclerosis Trial into Spain and Germany

Edmonton, Alberta , September 7, 2006 - BioMS Medical Corp (TSX: MS), a leading developer in the treatment of multiple sclerosis (MS), today announced it has received approval from the Spanish Agency for Medicines and Healthcare Products (SAMHP) in Spain and from the Federal Institute for Medicines and Medical Products in Germany to start patient enrolment for its pivotal phase II/III clinical trial of MBP8298, a proprietary synthetic peptide for the treatment of secondary progressive multiple sclerosis (SPMS).

Pivotal Phase II/III Multiple Sclerosis Trial

BioMS Medical is currently enrolling patients across Canada , the U.K. , Sweden , Denmark and The Netherlands in its pivotal phase II/III clinical trial evaluating MBP8298 for the treatment of secondary progressive multiple sclerosis (SPMS). The trial is a randomized, double-blind study enrolling approximately 553 patients who will be administered either MBP8298 or placebo intravenously every six months for a period of two years. The primary clinical endpoint for the trial is defined as a statistically and clinically significant increase in the time to progression of the disease as measured by the Expanded Disability Status Scale (EDSS), in patients with HLA-DR2 and/or HLA-DR4 immune response genes. Time to disease progression in patients with other HLA-DR types will be assessed separately as an exploratory arm of the same study. To date the trial has successfully passed five safety reviews by its independent Data Safety Monitoring Board.

About BioMS Medical Corp.
BioMS Medical is a biotechnology company engaged in the development and commercialization of novel therapeutic technologies. BioMS Medical’s lead technology, MBP8298, is for the treatment of multiple sclerosis and is currently in a pivotal phase II/III clinical trial across Canada and Europe. For further information please visit our website at www.biomsmedical.com.

This news release may contain certain forward-looking statements that reflect the current views and/or expectations of BioMS Medical with respect to its performance, business and future events.

NEW MS MED IN EUROPE: "Sativex, the cannabis-derived product could be finally set for approval after a delay of around two years.
:
UK regulator, the MHRA, rejected the drug in December 2004, calling for a second clinical trial to prove its efficacy, which the company has now conducted, and which, it believes, proves that Sativex works. The company is seeking to treat multiple sclerosis spasticity, but hopes to eventually gain licences to treat peripheral neuropathic pain, MS neuropathic pain and cancer pain as well. GW Pharmaceuticals has filed Sativex for approval through the decentralised procedure for licences in just four European countries, the UK, Denmark, Spain and the Netherlands......"