SOUTH SAN FRANCISCO, CA–(Marketwire -05/14/12)- VistaGen Therapeutics, Inc. (OTC.BB: VSTA) (VSTA.OB), a biotechnology company applying stem cell technology for drug rescue, today issued the following letter to its stockholders and the investment community from its CEO, Shawn Singh.

To our valued Stockholders:

Since becoming a public company one year ago, we have progressed to perhaps the most exciting time in our company’s 14-year history. To arrive at this point, more than $45 million, obtained through various strategic collaborations, investments and grant awards, has been carefully employed. We believe our pluripotent stem cell technology platform, Human Clinical Trials in a Test Tube, combined with the network of strategic relationships we have announced, will allow us to secure additional capital and the large market drug rescue opportunities that can deliver value to our stockholders.

Since the beginning of the year, our team has carefully reviewed our Top 10 drug rescue opportunities and narrowed our focus to our Top 5 candidates. Now we intend to launch our initial drug rescue program and secure strategic capital necessary to support it, as well as launch our second drug rescue program by year-end. We also are working on validation of LiverSafe 3D, our bioassay system for drug rescue involving liver toxicity and drug metabolism issues, for launch during the first half of next year.

The pharmaceutical industry continues to face extremely high barriers in bringing new medicine to market. The number of drugs approved by the FDA over the past decade has dropped precipitously, by over 50%, in spite of staggering increases in resources devoted to R&D by pharmaceutical companies. Based on the progress we have made with CardioSafe 3D and our efforts to build our strategic drug rescue ecosystem of collaborators, we believe our core business model — to use our stem cell technology and strategic relationships to develop less toxic variants of drugs that have already been proven in vitro to be effective — is now more commercially promising than at any other point in our history. We believe we will be able to help major pharmaceutical companies avoid the loss of years of time and millions of dollars spent in developing new therapies that have positive efficacy data, but must be discontinued due to later discovery of unsafe toxicity levels for human heart and liver tissue.

Over the past year, we have secured additional intellectual property protection and entered into strategic relationships with leading biotech firms and academic researchers to support development of our stem technology and our drug rescue-based commercialization initiatives:

Over the next 12 months, we have an ambitious agenda to work closely with our advisors and collaborators to secure capital and achieve these transformative milestones:

Our goals are reachable, with strategic financing. We believe we have the right technology, intellectual property, development teams and specialized focus to deliver on our founding mission — “putting humans first” — bringing clinically relevant human biology to the front end of the drug development process, long before standard animal and human testing, and using better cells to make better medicine.

We would like to thank our partners, advisors, employees and each of you, our loyal stockholders, for helping support us in our efforts to deliver long-term value for you.

Sincerely,

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VistaGen CEO Issues Update Letter to Stockholders

DENVER, May 14, 2012 /PRNewswire/ — Regenerative Sciences, Inc., a company dedicated to advancing orthopedic care through non-surgical adult stem cell procedures, today announced that it has secured a $2M investment from philanthropist, visionary and businessman John C. Malone, PhD, chairman of Liberty Media Corporation. In addition to advancing Regenerative Sciences’ clinical and lab-based stem cell research, the investment will help support the national expansion of their Regenexx Physician Network.

Regenerative Sciences’ Regenexx procedures utilize a patient’s own stem cells to help repair a broad range of common injuries and degenerative conditions, including cartilage lesions, torn ligaments and tendons, osteoarthritis and bulging spinal discs. For many, the procedures offer a viable alternative to arthroscopic surgery, open-joint surgery, or joint replacement surgery. Regenexx patients experience little or no downtime from the procedures and avoid the lengthy rehabilitation period associated with most surgical procedures.

“We are proud of our accomplishments in the field of regenerative interventional orthopedics and it’s exciting that our work has drawn the attention of such a noted entrepreneur and philanthropist,” said Christopher J. Centeno, M.D., Chief Executive Officer of Regenerative Sciences. “Dr. Malone shares our vision for forging the next generation of minimally invasive regenerative treatments. This investment will not only bolster our existing stem cell research programs and make our procedures available in all regions of the U.S., but it will help us maintain a leadership role in clarifying the regulatory space for physician stem cell use.”

Regenerative Sciences is at the forefront of regenerative orthopedic medicine within the United States and the company is bringing the future of orthopedic treatments to patient care today.

About Regenerative Sciences

Regenerative Sciences is an outgrowth of the Centeno-Schultz clinic, where we are reinventing orthopedic care for the 21st century using key biologics such as stem cells, next generation tools and devices, and unique therapeutic approaches. Our signature initiative, Interventional Orthopedics, allows doctors to treat orthopedic conditions through injection, rather than traditional invasive surgery. The Regenexx Physician Network brings together like-minded physicians from around the country to offer more patients access to our innovative procedures. For more information on Regenerative Sciences and Regenexx procedures, visit: www.regenexx.com

About John C. Malone, PhD

Dr. John C. Malone holds a bachelor’s degree in electrical engineering and economics from Yale University, where he was a Phi Beta Kappa and merit scholar. He also holds a master’s degree in industrial management and a Ph.D. in operations research from Johns Hopkins University.

Dr. Malone is Chairman of Liberty Media Corporation, a position he has held since 1990. Dr. Malone is also the Chairman of the Board of Liberty Global, Inc. (LGI), a position he has held since June, 2005. From 1996 to March 1999 when Tele-Communications, Inc. (TCI) merged with AT&T Corp., he was also Chairman and Chief Executive Officer of TCI. Previous to that, from 1973 to 1996, Dr. Malone served as President and CEO of TCI. He currently serves on the Board of Directors for CATO Institute, Expedia, Inc., Discovery Communications, Inc., and SiriusXM.

Contact:

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Regenerative Sciences Receives $2M Investment for Orthopedic Stem Cell Initiatives

DUBLIN–(BUSINESS WIRE)–

Research and Markets (http://www.researchandmarkets.com/research/lffnp7/stem_cell_research) has announced the addition of the “Stem Cell Research Products: Opportunities, Tools & Technologies 2012 (Updated)” report to their offering.

Stem cells are primitive cells found in all multi-cellular organisms that are characterized by self-renewal and the capacity to differentiate into any mature cell type. Several broad categories of stem cells exist, including embryonic stem cells, derived from blastocysts; fetal stem cells, obtained from aborted fetuses; adult stem cells, found in adult tissues; cord blood stem cells, isolated from umbilical tissue; dental stem cells, derived from deciduous teeth; cancer stem cells, which give rise to clonal populations of cells that form tumors or disperse in the body; and animal stem cells, derived from non-human sources.

In a developing embryo, stem cells can differentiate into all of the specialized embryonic tissues. In adult organisms, stem and progenitor cells act as a repair system for the body, replenishing specialized cells. Of interest to researchers is the potential for use of stem cells in regenerative medicine to treat conditions ranging from diabetes, to cardiovascular disease and neurological disorders. Additionally, the ability to use stem cells to improve drug target validation and toxicology screening is of intense interest to pharmaceutical companies. Stem cells are also being studied for their ability to improve both the understanding and treatment of birth disorders.

To facilitate research resulting from interest in these far-ranging applications, a large and growing stem cells research products market has emerged. Large companies selling stem cell research products include Life Technologies, BD Biosciences, Thermo Fisher Scientific, and Millipore, although dozens of other suppliers exist as well. Products offered by these companies include: antibodies to stem cell antigens, bead-based stem cell separation systems, stem cell protein purification and analysis tools, tools for DNA and RNA-based characterization of stem cells, stem cell culture and media reagents, stem cell specific growth factors and cytokines, tools for stem cell gene regulation, a range of stem cell services, tools for in vivo and in vitro stem cell tracking, and stem cell lines.

This report explores current market conditions and provides guidance for companies interested in developing strategically positioned stem cell product lines.

Featured elements of this report include:

– What are novel stem cells research products that can be developed?

– What stem cells types are most frequently used by research scientists?

– Which species of stem cells do scientists prefer and what are the factors driving this preference (access, pricing, funding, handling advantages)?

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Research and Markets: Stem Cell Research Products: Opportunities, Tools & Technologies 2012 (Updated)

LEUVEN, BELGIUM–(Marketwire -05/15/12)- TiGenix NV (TIG) a leader in the field of cell therapy, today gave a business update and announced the financial results for the first quarter ending March 31, 2012.

Business highlights

Financial highlights

“In the first quarter 2012 we continued to aggressively push our commercial efforts forward,” said Eduardo Bravo, CEO of TiGenix. “As a result sales of ChondroCelect are developing in line with the improved traction we observed in the second part of last year. At the same time we are moving ahead of schedule with most of our clinical adipose stem cell programs. We closed the quarter with almost EUR 17 million cash on hand, which is sufficient to execute on our business plan and reach key inflection points.”

Business update

ChondroCelect sales increase continues apaceThe Company reports net sales growth for the quarter of 123% compared with the same period of last year, and of 62% compared to Q4, 2011, a positive trend reflecting the uptake in Belgium, where we benefit from national reimbursement. In the Netherlands one of the leading private healthcare insurance companies has made treatment with ChondroCelect compulsory for its insured, and no longer reimburses non-ATMP treatments. Similarly, one of the large private insurers in the UK has expressed its intention to routinely reimburse ChondroCelect going forward. Discussions to obtain full national reimbursement keep advancing in the Netherlands, France, Spain and Germany.

Positive outcome of ChondroCelect compassionate use program published in leading journalPositive outcome data from the ChondroCelect compassionate use program (CUP), involving 43 orthopedic centers in 7 European countries, treating 370 patients with ChondroCelect over the span of four years, were published in advance online in Cartilage, the official journal of the International Cartilage Repair Society. The data show that the implantation of ChondroCelect results in a positive benefit/risk ratio when used in an unselected, heterogeneous population, irrespective of the follow-up period, lesion size and type of lesion treated. In addition, the CUP study significantly expands the data set used to obtain approval for ChondroCelect from the European Medicines Agency in 2009, increasing eight-fold, from 43 to 334, the number of patients with long-term follow up data. To date almost 700 patients have been treated with ChondroCelect.

ADMIRE-CD Phase III trial (Cx601) in complex perianal fistula on schedule The ADMIRE-CD (Adipose Derived Mesenchymal stem cells for Induction of REmission in perianal fistulizing Crohn’s Disease) Phase III protocol was submitted to Ethics Committees or Health Authorities in all 8 participating countries, and to date approvals have been received in four of those countries already.

Cx611 Phase IIa in RA passes last safety hurdleOn April 17, upon review of the safety data of the first three patients of the third cohort of the company’s Phase IIa clinical trial in rheumatoid arthritis (Cx611), TiGenix received the go-ahead from the independent Safety Monitoring Board to recruit and dose the remaining patients of this cohort. This fact is of major importance. In RA it ensures that the product will not be held back by any dose-limiting factors and that we will be able to move forward with the optimal treatment dose. Of almost equal importance is that, if required, we can expand the dosing range in other indications that we are exploring as well. With 6 months of follow-up, the current RA trial in 53 patients is expected to report meaningful results in H1 2013.

Last patient treated in Cx621 Phase I clinical trialAll 10 healthy volunteers have been recruited and treated in the Phase I study of Cx621. Cx621 investigates the safety and feasibility of intra-lymphatic administration of stem cells. Intra-lymphatic administration of (all) stem cells is patented by TiGenix. The final report of this trial will be available at the end of June.

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TiGenix Reports Business & Financial Results for the First Quarter 2012

JERUSALEM–(BUSINESS WIRE)–

Gamida Cell announced today that it has closed an internal E financing round of $10 million. All major shareholders participated.

The financing will be used to support the global commercialization of the companys lead cell therapy product, StemEx, in development as an alternative therapeutic treatment for patients with blood cancers, such as leukemia and lymphoma, who can be cured by bone marrow transplantation but do not have a matched bone marrow donor. The company is currently seeking a strategic partner to join in the global commercialization of StemEx.

The financing will also support the continued development of the companys pipeline of products, primarily the NiCord clinical trial for sickle cell disease and thalassemia.

Mr. Reuven Krupik, chairman of the board of Gamida Cell said, The investors were unanimous in their decision to reinvest, understanding the importance of bringing StemEx to market as well as maintaining the companys leadership role in the stem cell industry. Gamida Cell is a game changer.

The international, multi-center, pivotal registration, Phase III clinical trial of StemEx completed enrollment in February 2012. Clinical outcome is expected in Q4/2012. The market launch of StemEx is planned for 2013. StemEx is likely to be the first allogeneic stem cell product in the market. StemEx is being developed by the Gamida Cell-TEVA joint venture.

Dr. Yael Margolin, president and chief executive officer of Gamida Cell said, With the continued support of our shareholders and the analysis of the clinical results of the StemEx trial just around the corner, we are now focused on submitting the BLA.

StemEx is a graft of an expanded population of stem/progenitor cells, derived from part of a single unit of umbilical cord blood and transplanted by IV administration along with the remaining, non-manipulated cells from the same unit. Competing products in development use two units. As the average cost of a cord blood unit in the U.S. is $40K, StemEx is expected to be a significantly less expensive treatment option. StemEx is also expected to be available in the market several years before any of the competing products.

About Gamida Cell

Gamida Cell is a world leader in stem cell population expansion technologies and stem cell therapy products for transplantation and regenerative medicine. The companys pipeline of stem cell therapy products are in development to treat a wide range of conditions including blood cancers, solid tumors, non-malignant hematological diseases such as hemoglobinopathies, neutropenia and acute radiation syndrome, autoimmune diseases and metabolic diseases as well as conditions that can be helped by regenerative medicine. Gamida Cells therapeutic candidates contain populations of adult stem cells, selected from non-controversial sources such as umbilical cord blood, bone marrow and peripheral blood, which are expanded in culture. Gamida Cells current shareholders include: Elbit Imaging, Clal Biotechnology Industries, Israel Healthcare Venture, Teva Pharmaceutical Industries, Amgen, Denali Ventures and Auriga Ventures. For more information, please visit: www.gamida-cell.com.

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Gamida Cell Closes $10 Million E Financing Round Earmarked to Support the Global Commercialization of the Company’s …

MADISON, Wis., May 15, 2012 /PRNewswire/ — Novelos Therapeutics, Inc. (NVLT.OB), a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer, today announced that it has successfully completed the first cohort in a U.S. multi-center Phase 1b dose-escalation trial of its cancer-targeted molecular radiotherapeutic compound I-131-CLR1404 (HOT) in cancer patients with advanced solid tumors. The first two-patient cohort was successfully dosed with approximately 20 mCi of HOT, triggering enrollment into the second cohort at approximately 40 mCi. Details of the trial design are available on www.clinicaltrials.gov ID: NCT01495663, or at www.novelos.com in the ‘Clinical Trials’ section. Glenn Liu, M.D., University of Wisconsin Carbone Cancer Center, is the trial’s principal investigator. Detailed trial results are expected to be presented at a scientific venue at a later date.

“Patients with advanced solid tumors need safer and more effective therapies,” said Dr. Liu. “Based on animal data, results from a completed Phase 1a dosimetry trial, and now initial data from this Phase 1b trial, HOT appears to deliver radiation directly and selectively to cancerous tumors. Data from the first cohort indicates HOT was well-tolerated, without any grade 3 or 4 toxicities, enabling enrollment of the first patient in the second cohort. HOT uptake in cancerous tumors persisted for at least 21 days. One patient with advanced prostate cancer remains on trial at two months following treatment with HOT, while another patient with advanced colorectal cancer has completed the trial.”

“We are pleased with HOT’s safety profile and selective cancerous tumor uptake and retention in this first cohort at a dose of approximately 20 mCi,” said Kim Hawkins, Vice President of Clinical Development of Novelos. “We now look forward to evaluating HOT at approximately 40 mCi in cancer patients with advanced solid tumors, as per the trial protocol. We also look forward to adding two additional clinical investigators to the trial, Joanne Mortimer, M.D., at the City of Hope and Michael Pishvaian, M.D., Ph.D., at Georgetown University.”

“We intend to combine the data from this trial with calculation of effective doses for HOT based on quantitative positron emission tomography (PET) tumor imaging data using I-124-CLR1404 (LIGHT), our small-molecule cancer-targeted PET imaging agent,” said Harry Palmin, President and CEO of Novelos. “Together, we believe these data will enable us to commence HOT Phase 2 proof-of-concept trials in the first quarter of 2013 in cancer patients that have significant unmet medical need.”

About HOTHOT (iodine-131 radiolabeled CLR1404) is a small-molecule, broad-spectrum, cancer-targeted molecular radiotherapeutic that we believe has first-in-class potential. HOT is comprised of a small, non-pharmacological quantity of CLR1404 (COLD) acting as a cancer-targeted delivery and retention vehicle and incorporating a cytotoxic (cell-killing) dose of radiotherapy (in the form of iodine-131, a radioisotope that is already in common use to treat thyroid and other cancer types). The ongoing Phase 1b dose-escalation trial is aimed at determining the Maximum Tolerated Dose of HOT. We expect to initiate HOT Phase 2 efficacy trials as a monotherapy for solid tumors with significant unmet medical need as soon as a minimal efficacious dose is established, subject to additional funding. We may determine such an effective dose upon calculating it from ongoing PET imaging trials in cancer patients with LIGHT (since PET imaging is quantitative, enabling determination of tumor radiation exposure at a given dose level) or seeing a tumor response in the Phase 1b trial. Preclinical experiments in vitro (in cell culture) and in more than a dozen in vivo (in animals) models have demonstrated selective killing of cancer cells along with a benign safety profile. In view of HOT’s selective uptake and retention in a wide range of solid tumors and in cancer stem cells, its single-agent efficacy in animal models and its non-specific mechanism of cancer-killing (radiation), we are first developing HOT as a monotherapy for solid tumors with significant unmet medical need.

About Novelos Therapeutics, Inc.We are a pharmaceutical company developing novel drugs for the treatment and diagnosis of cancer. Our three cancer-targeted compounds are selectively taken up and retained in cancer cells, including cancer stem cells, versus normal cells. Thus, our therapeutic compounds appear to directly kill cancer cells while minimizing harm to normal cells. This offers the potential for a paradigm shift in cancer therapy by providing efficacy versus all three major drivers of mortality in cancer: primary tumors, metastases and stem cell-based relapse. I-124-CLR1404 (LIGHT) is a small-molecule cancer-targeted PET imaging agent. We believe LIGHT has first-in-class potential and Phase 1-2 clinical trials are ongoing. I-131-CLR1404 (HOT) is a small-molecule, broad-spectrum, cancer-targeted molecular radiotherapeutic that delivers cytotoxic radiation directly and selectively to cancer cells and cancer stem cells. We believe HOT also has first-in-class potential. HOT Phase 1b dose-escalation trial is ongoing and we expect HOT to enter Phase 2 trials in the first quarter of 2013 as a monotherapy for solid tumors with significant unmet medical need, subject to additional funding. CLR1404 (COLD), a pre-clinical cancer-targeted non-radioactive chemotherapy, works primarily through Akt inhibition. Together, we believe our compounds are able to “find, treat and follow” cancer anywhere in the body in a novel, effective and highly selective way. For additional information please visit www.novelos.com

INVESTOR CONTACTSJ. Patrick Genn, Vice President of IR

Anne Marie Fields, Senior Vice President

Novelos Therapeutics, Inc.

LHA

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Novelos Therapeutics Successfully Completes First Cohort In Phase 1b Solid Tumor Trial With I-131-CLR1404 (HOT) Cancer …

SEBASTIAN Toby, a 6-year-old golden retriever, loves to run and play catch. And Oreo, a 12-year-old border collie mix, also is a bundle of energy.

Movement for both dogs got easier about a month ago when they received a revolutionary stem cell treatment at the Highlands Animal Hospital.

Veterinarian Marcus Kramer performed the successful transplant procedures, which were developed by Kentucky-based MediVet-America.

Both dogs had been in significant pain with a restricted range of motion, as shown on X-rays.

“It’s made a big difference,” said Kramer. “The really amazing thing is that they both healed so quickly. Both dogs had problems with their hips and were suffering from osteoarthritis. Just 30-days later, they are able to walk and run again.”

Adult animal stem cell technology uses the pet’s own regenerative healing power to treat dogs, cats and horses suffering from arthritis, hip dysplasia and tendon, ligament and cartilage injuries. Under anesthesia, Kramer removed about 40 grams of fat from each dog and separated the stem cells from the fat. He then activated the stem cells under an LED light, and injected them back into the dogs.

Stem cell therapy allows an animal to get off pain and anti-inflammatory drugs, Kramer said. MediVet-America’s therapy is done entirely at the animal hospital in about three hours, and costs about $1,800 for dogs and $2,400 for horses. That compares to thousands of dollars that pet owners could expect to pay for medication over a pet’s lifetime.

Erica Kent, a spokesman for MediVet-America, said using the LED light is integral to the patented-process, because the light helps to awaken stem cells and makes them more active. The three-color light stimulates millions of dormant cells to initiate repair from the moment the cells are injected into the animal’s body, according to the MediVet-America website.

The company is also offering a program that allows pet owners to bank stem cells when animals are younger to use if their pet develops illnesses like arthritis in old age.

STEM CELL THERAPY

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Sebastian veterinarian performs stem cell treatment for pets

The advocates of proposition 19, the bill that tried to legalize cannabis in California, must be turning cartwheels at the news coming out of University of California, San Diego School of Medicine. It’s especially ironic coming just a few weeks after the Federal raid and almost complete shutdown of Oaksterdam University, the privately run school in Oakland, California that teaches students how to grow and harvest the much derided herb.

A clinic trial of 30 adult patients suffering from Multiple Sclerosis appears to have demonstrated its ability to reduce spasticity and pain, when compared to a placebo.

Multiple Sclerosis is a degenerative disease that affects the lining of the nerve fibers and reduces their ability to transmit properly, a little like an electrical cable with worn insulation. It can also cause ulceration on the brain. Like Parkinson’s and Alzheimer’s it’s a slow and degenerative disease, without a cure, thus the best hope for doctors is finding treatments that reduce symptoms and slow the progression.

The findings of principal investigator Jody Corey-Bloom, MD, PhD, professor of neurosciences and director of the Multiple Sclerosis Center at UC San Diego, and her colleagues will be published in Canadian Medical Association Journal this month.

In short, the trial was conducted by dividing the group in two parts, one half smoked placebo cannabis for three days, while the remaining half had the real thing. The scientists then swapped over the supply so the placebo group smoked the real thing and visa versa. The researchers didn’t mention whether or not anyone cheating by scoring their own supplies on top.

There have been previous studies that looked into the possibility of treating neurological conditions with cannabis, but they mainly focused on oral treatments, presumably because smoking was considered unhealthy. However, with a recent report showing that cannabis smokers are not affected nearly as badly as tobacco smokers, which has been attributed to its anti inflammatory properties, and taking into account that most people enjoy smoking cannabis far more than they do eating it, this new study makes more sense. There were also reports amongst the pot smoking community that cannabis was seen to relieve symptoms.

Researchers used what is known as the Ashford scale to better assess the intensity of muscle tone by grading resistance in range of motion and rigidity. The secondary study of pain levels was measured using a visual analogue scale. Physical performance was assessed by sending the patients on a timed walk, and they were also questioned about their “highness” to assess cognitive function.

Although cannabis is generally well tolerated, researchers noted the need for more wide ranging studies over longer time periods. They also commented on the reduced cognitive function on concentration and attention span, and postulate the idea of using lower doses to assess if the same medical results can be achieved with less side effects.

This is the fifth cannabis study in a row from University of California Center for Medicinal Cannabis Research to show positive results in treating neuropathic pain. We can only hope that the Feds are not planning to raid the facility for promoting an illegal drug, as they did in Oakland.

Igor Grant, MD, director of the CMCR, which provided funding for the study concluded:

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Marijuana May Relieve Multiple Sclerosis Symptoms

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AquaHab Physical Therapy Case Study Demonstrates Benefits of Aquatic Therapy for Patients with Multiple Sclerosis

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Marijuana May Help Relieve MS Patients' Symptoms