ReceptoPharm, Inc. - Home page
"
RPRPI-78M posseses several desirable properties:

They lack measurable toxicity but are still capable of attaching to and affecting the target site on the nerve cells. This means that patients cannot overdose.

They display no serious adverse side effects following years of investigations in humans and animals.

They are extremely stable and resistant to heat, which gives the drugs a long shelf life. The drugs' stability has been determined to be over 4 years at room temperature. This is extremely unusual for a biologic drug.

They are easy to administer.

RPI-78M can be administered orally-a first for a biologic MS drug. This will present MS patients with additional quality of life benefits by eliminating the requirement for routine injections."

NEW DRUGS...Laquinimod: experimental oral MS drug by Teva/Copaxone :
"Teva Vice President Rivka Kreitman said Teva expects to announce toward the end of this year results from a mid-stage trial of its experimental oral MS drug called Laquinimod."

Novartis: MS pill efficacy sustained for 18 months:
"Drugmaker Novartis AG said on Thursday
its experimental multiple sclerosis pill FTY720 continued to
work well after patients used it for 18 months, supporting the
case for the drug as it moves into decisive Phase III testing.
Novartis said FTY720, which would be one of the first oral
multiple sclerosis drugs on the market, showed sustained
efficacy and good tolerability after 18 months in patients with
a relapsing form of the disease.

Data from a Phase II test, to be presented at a meeting of
the American Association of Neurology, showed that patients
taking the drug who had seen their relapse rate reduced by 50
percent after six months maintained the low relapse rate during
the following 12 months....."

Serono commenced a two-year clinical trial of Mylinax involving 1200 MS patients.

(expected to file for regulatory approval in 2008)

CLICK FOR VIDEO [Opexa Therapeutics home page:
"Tovaxin is a T-cell therapeutic vaccine that parallels the concept of autologous cancer vaccines. Instead of modifying cancerous cells, Tovaxin consists of attenuated autoreactive T cells. Attenuation of these cells during the vaccine production process renders the cells non-replicating but viable and causes them to elicit an immune response when injected subcutaneously into the patient. This immune response is directed against T cells within the patient that are self-reactive with myelin. This immune response, directed against a specific subset of autoreactive T cells, greatly reduces the number of these autoreactive cells in MS patients...."

To increase the half life of IFN beta-1a

"Researchers in Israel are working on a new treatment they hope will slow down the progressive deterioration suffered by patients with multiple sclerosis and other autoimmune diseases.

The new treatment uses the body’s own cells as a vaccine against autoimmune diseases such as multiple sclerosis (MS), according to Professor Irun R. Cohen of the Weizmann Institute who invented the treatment and is leading the study.

Cohen is the director of the newly established National Institute of Biotechnology in the Negev (NIBN), associated with Ben Gurion University of the Negev in Be'er Sheva. He said Israel is an ideal place for such research “because we exist beyond the pressures for conformity that you have in the U.S.” He added that Israel is a much better atmosphere for interdisciplinary collaboration as well.

“At Weizmann I share students with physicists, chemists and mathematicians. It is easy to talk to people here; everyone is free and generous with their ideas. There is a feeling that we are a small country and we have to pull together – and we do,” he said.

Double-blind trials are being held at Hadassah Ein Kerem Hospital in Jerusalem and Sheba Multiple Sclerosis Center at Sheba Hospital, a multi-disciplinary treatment facility which treats more than 60% of Israel’s MS patients. The center, founded in 1995, offers diagnostic and treatment services through preventive and rehabilitative care.

Multiple sclerosis is caused by white blood cells that attack the central nervous system and destroy the sclera which coat the nerves that run throughout the body. As the sclera is destroyed, the body deteriorates, often leading to severe disability and sometimes death.

Professor Anat Achiron, director of the center and a former student of Cohen’s, is leading the research team at Sheba, where 47 patients have participated in the trial thus far. Some received the real vaccine and others received a placebo.

In the real treatment, patients are vaccinated with cells taken from those in the early stages of the disease and processed in a way that causes them to become inactive.

The inactive cells are then injected into the patients’ bodies in a massive dose which triggers the body’s immune system to destroy them as well as any that might appear in the future.

Cohen has been working on the revolutionary new treatment since 1981, when he published an initial study with Avraham Bin-Nun that showed that T-cells could be adapted to help the body fight diseases they themselves cause.

T-cells, a type of lymphocyte, are blood cells which play a role in the body’s immune system. The “T” stands for thymus, the organ where T-cells complete their development.

Cohen is careful not to raise false hopes and warns that it is too soon to draw conclusions before the trials are completed and the data analyzed.

“Only when we discover who among the patients is getting the vaccine and who is getting the placebo will we be able to assess absolutely the precise influence of the vaccine,” he said, but was optimistic about the potential for success."

In Phase III trials

News - Combination Appears Safe in Relapsing-Remitting Multiple Sclerosis: Presented at AAN
" The combination of interferon beta 1-a (Avonex) and azathioprine for use in multiple sclerosis (MS) patients is safe and well tolerated and potentially effective, according to preliminary results presented here at the 58th Annual Meeting of the American Academy of Neurology (AAN).

Jeffrey I. Greenstein, MD, director, Multiple Sclerosis Institute, Philadelphia, Pennsylvania, United States, and colleagues assessed the safety of the addition of azathioprine to intramuscular interferon beta 1-a in patients who were incompletely responsive to intramuscular interferon beta-1a and to determine if the combination would improve both clinical and magnetic resonance imaging (MRI) outcomes.

Dr. Greenstein presented the results of the 12-month, open-label safety study on April 4th.

The study enrolled 12 patients with relapsing-remitting MS who had experienced at least 1 relapse in the prior 12 months while on interferon beta-1a alone. None of the 12 subjects had interferon neutralising antibodies. They received a combination of a 30-mcg intramuscular injection of interferon beta-1a plus 150 mg azathioprine orally each week.

"Although the currently approved therapies for the treatment of MS have proven efficacy in relapse reduction, and some of them slow disease progression, it is estimated that 50% to 70% of patients on monotherapy will experience ongoing disease activity," Dr. Greenstein observed. "Combination therapy, particularly the use of agents with different modes of action, may improve outcomes."

Interferon-beta therapy has pleiotropic immunomodulatory, anti-inflammatory, and antiviral effects. Potential effects in MS include reduction of matrix metalloproteinase activity, inhibition of proliferation, and enhanced secretion of interleukin-10, he said.

Azathioprine reduces cellular and humoral immunity by inducing T-cell apoptosis and inhibits T-cell/APC conjugation, producing immunosuppression.

Both agents have shown reductions in relapse rates in MS, he added.

In the trial, safety evaluations were performed at baseline and months 1, 2, 3, 6, 9, and 12.

Three subjects withdrew from the study because of nonadherence, limb fracture, and treatment-induced nausea. No significant haematologic or hepatic toxicity occurred.

At the 12-month evaluation, results showed that the annualised relapse rate was significantly decreased from baseline following treatment (1.4-0.3, P <.001). In addition, the number of gadolinium-positive lesions decreased from a mean of 3.3 to 0.5 (P <.0625).

Neither the Expanded Disability Status Score (EDSS) nor the Multiple Sclerosis Functional Composite or its components were significantly affected by combination therapy (P =.280; P =.190, respectively).

Dr. Greenstein said that larger trials of longer duration are needed to confirm the efficacy of the combination.

"Overall, the combination appears safe and well tolerated in patients with relapsing-remitting MS and potentially effective, with a significant effect on relapse rate and trends towards magnetic resonance imaging and disease improvement on both EDSS and MRI measures after treatment," Dr. Greenstein concluded.

The study was supported by Biogen Idec, Inc."

Tulane University News Release
"High-tech methods of vaccine delivery may make needles a thing of the past, if a Tulane University team succeeds in using nanotechnology that allows the absorption of vaccines through the skin. Tulane is slated to receive $2.3 million from the National Institutes of Health over four years for research into technology that will allow vaccines to cross directly through the skin barrier.

"Vaccine applications using nanotechnology have the potential to increase overall immunity, be more stable, last longer between production and use, and lower the costs of vaccination programs," says principal investigator John Clements, Chair of the Department of Microbiology and Immunology. Coinvestigators include Lucy Freytag and Louise Lawson from the Department of Microbiology and Immunology; Kyrkiakos Papadopoulos, Yunfeng Lu and Vijay John from the Chemical and Biomolecular Engineering Department and Scott Grayson from the Department of Chemistry.

According to Clements the research will draw from the wide range of expertise at Tulane, from developing complex particles smaller than atoms to take vaccines across the skin, to novel ways to watch the delivery process using newly acquired high powered microscopy tools at Tulane, to cell and small animal studies and even further to primate studies."

Multiple Sclerosis Society Website - Welcome to the MS Society - Stem Cell Q&A
""The MS Society has been asked about recent developments for stem cell treatments to MS that have become available for sale."

REBIF: NEW FORMULA: "....less incidence of inflammation at the site of injections"..."formulation developed fewer antibodies -- immune system proteins that might attack the medicine -- a favorable finding that typically suggests a drug will work longer."
"The company said late-stage trials of the new formulation showed a "substantial improvement in overall tolerability... including less incidence of inflammation at the site of injections."Serono said the trials also showed that patients taking the new formulation developed fewer antibodies -- immune system proteins that might attack the medicine -- a favorable finding that typically suggests a drug will work longer." [more : Reuters]

Bayhill Therapeutics Doses Patients With MS in a Phase II Trial and Raises an Additional $15.8 Million as an Extension to its Series B Financing: "Bayhill Therapeutics Inc. has begun dosing patients with BHT-3009, the company's experimental drug candidate, in a Phase II company sponsored trial for multiple sclerosis. The Phase II study is a multi-center, double-blind, placebo-controlled evaluation with an MRI endpoint. In a related development, current investors indicated strong support for Bayhill's antigen-specific tolerance platform by raising an additional $15.8 million in private equity. The company has now closed its Series B round totaling $51.2 million. "

"A Jekyll And Hyde Of Cytokines: IL-25 Both Promotes And Limits Inflammatory Diseases: U of Penn reseachers demonstrate how a signaling protein both prevents and promotes rampant inflammation by the immune system.":

CLICK:
"A drug commonly prescribed for Alzheimer's patients may also be helpful to people with MS. A memory test is the kind of neuro-psychological test used to evaluate Alzheimer's patients. But, Donna Sauer has MS, not Alzheimer's.'I was unable to recall simple details, dates, appointments I had,' said Sauer. 'I'm a school teacher, as you know, and um, I was not able to remember certain sentences that I would have to write on the board.....Therefore, because of the similarities between multiple sclerosis and Alzheimer's, physicians at Stonybrook University Hospital thought they would try using the popular Alzheimer's drug, Aricept, on patients with MS....'"

"CHROMOS TO MANUFACTURE MS DRUG CANDIDATE FOR TOXICOLOGY STUDIES AND CLINICAL TRIAL USING ACE SYSTEM"
Press Release: The manufacture and testing of a monoclonal antibody (CHR-1103) that may be helpful in controlling acute exacerbations in MS

Lilly Ventures Helps Fund Clinical Trial For MS :
"California-based Bayhill Therapeutics, Inc. has received an additional $15.8 million in funding from several groups including Lilly Ventures for a clinical trial for the treatment of MS"

NEW DRUGS: Tovaxin - "PharmaFrontiers Completes $23 Million Financing"
:"The proceeds will be used primarily to fund PharmaFrontiers' Phase
IIb trial with Tovaxin(TM) for the treatment of MS.
"

Martha Crowninshield: Her goal: Put MS out of business
"Martha Crowninshield brokered high-stakes business deals all the time as a venture capitalist. But never before had she been involved in a deal with a payoff that could help millions of people worldwide. Crowninshield is a major player in a landmark effort to search the human genome for genes that put people at risk for multiple sclerosis.

Crowninshield, a former partner at the investment firm Boston Ventures, is banking on the project. She, like an estimated 2.5 million people worldwide, has MS,

She believes the team effort, which involves scientists from all over the world, eventually will lead to improved treatments and maybe something better. In 2002, Crowninshield learned about the International Multiple Sclerosis Genetics Consortium. After researching the project, she put $1 million of her own money into the project. "I wanted to be able to say I believe in this," she says. She also helped the scientists involved put together a business plan, which was crucial in selling the project to private investors as well as the National Institutes of Health and the National Multiple Sclerosis Society.

So far, the team has raised $15 million — just $5 million short of the money required for a massive five-year gene hunt for MS..."

" Dr. Samuel David (Research Institute of the McGill University Health
Centre) will test a potential new treatment for MS":

NEW DRUGS: Teriflunomide Reduces Active Lesions in MS Patients:
"Treatment with teriflunomide, an oral dihydro-orotate dehydrogenase inhibitor, reduces disease activity with a trend towards fewer relapses in patients with MS according to the results of a phase II trial conducted by North American and European investigators.

Lead researcher Dr. Paul W. O'Connor told Reuters Health: 'These findings are exciting in that they move us one step further to developing something that all MS patients on therapy want: an effective oral treatment.'
All current MS drugs require administration by injection. However, teriflunomide, which can be given orally, has shown promise in animal models of autoimmune disease, Dr. O'Connor of St. Michael's Hospital, Toronto and colleagues note in the March 28th issue of Neurology....."

Incyte Press release: oral CCR2 antagonist:
"..Continued advancement of a lead follow on oral CCR2 antagonist, INCB8696, which we expect to advance into clinical development later this year. We intend to develop INCB8696 as a treatment for MS...."

ORAL DRUGS/REBIF : "Sales of Rebif, which is facing increasing competition and a future switch to more convenient oral forms of MS therapy, rose 17.7 percent worldwide to $327.0 million, benefiting from a weak year-ago figure.":

Antisense Therapeutics reported that the Ethics Committee of the University of Essen in Germany has approved the company's application to restart the phase IIa trial of its antisense compound, ATL1102, for patients with relapsing remitting MS
[PDF of Antisense Therapeutics news release]

AVANIR Announces Neurodex Phase III Trial Results Published in Annals of Neurology

MultiCell Announces Online Availability of Video Presentation of MS Drug Candidates
"The streaming video shows a presentation by MultiCell President Dr. Stephen Chang at a recent meeting of the Southern California Investment Association (SCIA) Conference. "

MORE
" Building on this achievement, the series will progress into the next phase, focused on compound optimization and advancement of the program towards development"

Stem Cell Innovations Files Patents Relating to Production of Human Motor Neurons and Progenitors; Cells May Be Useful in Therapies for ALS, Parkinson's, MS and Other Neurodegenerative Diseases - [Forbes]

BioMS Medical expands pivotal MS trial into The Netherlands:

"BioMS Medical Corp (TSX: MS - News), a leading
developer in the treatment of multiple sclerosis (MS), today announced it has
received approval to start patient enrolment in The Netherlands for its
pivotal phase II/III clinical trial of MBP8298, a proprietary synthetic
peptide for the treatment of secondary progressive multiple sclerosis (SPMS).
Approval was received from the Competent Authority in The Netherlands, CCMO
(Central Committee on Research Involving Human Subjects)."

"Schering's interest is in "autoimmune disease, of which multiple sclerosis is an important part," Speechly said. It plans to develop CRA-028129 initially for multiple sclerosis, adding to an existing Phase III program exploring high-dose interferon beta-1b and a Phase II program for alemtuzumab in MS."

Phase III Trial of Oral Cladribine Begins in the US:
"Serono announced that recruitment in the U.S. is beginning for the Phase III CLARITY study (CLAdRIbine Tablets in Treating MS OrallY Study) of oral cladribine for the treatment of patients with relapsing forms of multiple sclerosis (MS). This multi-national study was successfully initiated outside the U.S. in 2005, and will now expand to include 17 clinical trial sites in the U.S. The study is one of the largest MS trials ever conducted, and enrollment is on track to be completed in 2006.

Oral cladribine is a proprietary oral tablet formulation of cladribine that is being studied in an effort to demonstrate possible benefits as a treatment for patients with relapsing forms of MS. 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 MS. Through its differentiated mechanism of action, cladribine tablets may offer an effective new option to patients with MS.

"We all are looking forward to the day when there is an FDA approved oral therapy that can affect the underlying disease process in MS," said Dr. John Richert vice president research and clinical programs at the National MS Society. "Clinical studies, such as CLARITY, are an important part of the process leading to the development of these new medications....."