Study Evaluating REVLIMID® Combination Compared to Autologous Stem Cell Transplant with or without REVLIMID …

BOUDRY, Switzerland--(BUSINESS WIRE)--

Celgene International Srl, a wholly-owned subsidiary of Celgene Corporation (CELG), today announced data from a study comparing melphalan, prednisone and REVLIMID (lenalidomide) (MPR) with high-dose chemotherapy and tandem autologous stem cell transplant (MEL200), as well as evaluating the effect of lenalidomide maintenance in patients with newly-diagnosed multiple myeloma were presented during a June 3rd oral session at the American Society of Clinical Oncology (ASCO) 2013 Annual Meeting in Chicago, Ill.

In the study, conducted by the Gruppo Italiano Malattie EMatologiche dellAdulto (GIMEMA), and presented by lead investigator, Prof. Antonio Palumbo, Chief of the Myeloma Unit, Department of Oncology, at the University of Torino, a total of 402 patients received four 28-day courses of lenalidomide and low-dose dexamethasone at diagnosis, and then were randomly assigned to receive six cycles of MPR (n=202) or MEL200 (n=200), and to receive either continuous lenalidomide maintenance treatment or to be followed by observation.

After a median follow-up of 49 months from diagnosis, median progression-free survival (PFS), the primary endpoint of the study, was 24 months with MPR compared to 38 months with MEL200 (HR 1.69, p

In the maintenance analysis, with a median follow-up of 35 months, patients receiving lenalidomide maintenance following either regimen, had a median PFS of 37 months compared to 26 months for observation (HR 0.52, p

The most common grade 3/4 adverse events observed during the maintenance phase of the study were neutropenia (23%), cutaneous toxicity (5%), infections (4%), second primary malignancies (4%), thrombocytopenia (4%), diarrhea (3%), fatigue (3%) and anemia (2%).

These results are from an investigational study. REVLIMID is not approved for the treatment of patients with newly-diagnosed multiple myeloma.

About REVLIMID

REVLIMID is approved in combination with dexamethasone for the treatment of patients with multiple myeloma who have received at least one prior therapy, in nearly 70 countries, encompassing Europe, the Americas, the Middle-East and Asia, and in combination with dexamethasone for the treatment of patients whose disease has progressed after one therapy in Australia and New Zealand.

REVLIMID is approved in the United States, Canada, Switzerland, Australia, New Zealand and several Latin American countries, as well as Malaysia and Israel, for transfusion-dependent anaemia due to low- or intermediate-1-risk MDS associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Marketing Authorization Applications are currently being evaluated in a number of other countries.

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Study Evaluating REVLIMID® Combination Compared to Autologous Stem Cell Transplant with or without REVLIMID ...

A chat with 'Dr. Stem Cell'

In 2004, with President George W. Bush dead set against stem cell research, California just went ahead and did it. Voters made stem cell research a state constitutional right, and endorsed $3 billion in bond sales for 10 years to cement the deal. CIRM, the California Institute for Regenerative Medicine created under Proposition 71, has become a world center for stem cell research, and its president is Australian Alan Trounson, a pioneer in in vitro fertilization. As Proposition 71 approaches its 10-year anniversary, Trounson offers a prognosis.

Q: It's been almost 10 years since California funded what may be the world's biggest stem cell research program. What are you up to?

A: We are working hard to get six or seven projects to clinical trials. We have more than 70 (total) programs moving (toward) clinical trials. It's a lot of work to chaperon.

I'll give you three examples: one, linking genetics, or genomics work, to stem cells, integrating the two. We're going to create a center in California that will bring a lot of (genetics) studies and clinical work to a new level.

Secondly, we've set up a structure for banking the 3,000 cell lines from "induced pluripotent stem cells" that we turn into the equivalent of embryonic stem cells. We call them IPS cells. You take a skin cell or blood cell and convert it to the equivalent of an embryonic stem cell.

We've also taken samples from patients with complex diseases, and we're banking these so scientists can "interrogate" these diseases like heart disease, Alzheimer's, blindness. We are targeting a range of conditions autism, cerebral palsy for which we have scant understanding of causes and major drivers. This is material for long-term research studies.

What we're doing is meaningful. Somebody with cancer may have a better treatment. Parkinson's patients might be in a clinical trial around 2016, 2017.

Q: Are Californians getting enough bang for their buck?

A: I think we're way ahead of what people predicted. Nevertheless, it takes a lot of time to do this. I think we're hurrying carefully.

Q: What else?

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A chat with 'Dr. Stem Cell'

Stem Cell Orthopedic Expand Advances in Sports Medicine

Boca Raton, FL (PRWEB) May 31, 2013

The Institute of Regenerative and Molecular Orthopaedics (IRMO), world-renowned stem cell therapy experts, expand sports medicine advances with their expertise at stem cell and PRP (platelet rich plasma) therapy. As pioneers in stem cell and PRP therapy, the IRMO has introduced to the world what may be some of the biggest breakthroughs in sports medicine and beyond. This comes as good news to athletes everywhere suffering from various injures who are seeking state-of-the-art medical solutions.

The Institute of Regenerative and Molecular Orthopaedics is one of the few orthopedic practices in the world that utilizes stem cell and PRP therapy with orthopedic surgery. Headed by Dr. Joseph Purita, the world-renowned stem cell treatment pioneer, the IRMO has been making waves in the sports medicine community for years with their groundbreaking procedures. Dr. Purita has treated thousands of patients from around the world with tremendous success.

Dr. Purita and his staff use stem cell and PRP therapy to treat conditions ranging from basic tennis elbow problems, to degenerative arthritis afflicting major joints and more.

The injection of stem cells for its advanced rejuvenation and repair qualities is still in limited use in sports medicine. For years, stem cell extraction was extremely expensive and minimal. Only relatively recently has new technologies and techniques allowed for the acquisition of a persons own stem cells to be achieved inexpensively through simple procedures.

Similarly, platelet rich plasma therapy has only recently become a viable treatment. Platelets, though occurring naturally in relatively small numbers, perform crucial functions responsible for the bodys repair processes. Over the last 15 years, scientists have discovered its effectiveness when concentrated, and thus PRP therapy was born.

The sports medicine community has been increasingly interested in, and influenced by, the work coming out of The Institute of Regenerative and Molecular Orthopaedics. Dr. Joseph Purita and his staff have been featured in major publications around the country, including the New York Times, ESPN Magazine and more. Most notably, Dr. Purita has recently garnered the attention of the entire sports medicine community with his exceptional work with New York Yankees pitcher, Bartolo Colon.

The Institute of Regenerative and Molecular Orthopaedics has led the way in viable stem cell and PRP therapy treatments. Dr. Purita and his staff have devised new techniques that are registered as their own intellectual property. In addition, Dr. Purita gives lectures around the world on the latest uses of PRP and stem cell injection therapy for sports injuries.

As PRP stem cell therapy continues to shape the sports medicine community, The Institute of Regenerative and Molecular Orthopaedics will continue to lead the way in innovation and state-of-the-art orthopedic practices. Dr. Purita and his group run one of the few stem cell facilities in the world staffed by seasoned board certified orthopedic surgeons. Their mission is to continue serving their patients with the latest tools available and to significantly advance the understanding and applications of stem cell and PRP therapy well into the future.

About Stem Cell Orthopedic

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Stem Cell Orthopedic Expand Advances in Sports Medicine

Grant funds cardiac stem cell research for Duchenne muscular dystrophy-related heart disease

Public release date: 30-May-2013 [ | E-mail | Share ]

Contact: Sally Stewart sally.stewart@cshs.org 310-248-6566 Cedars-Sinai Medical Center

LOS ANGELES May 30, 2013 Newport Beach-based nonprofit Coalition Duchenne has awarded a $150,000 grant to a Cedars-Sinai Heart Institute team investigating whether an experimental cardiac stem cell treatment could be used to treat Duchenne muscular dystrophy patients who have developed heart disease.

Coalition Duchenne is led by Catherine Jayasuriya, a mother whose 20-year-old son, Dusty Brandom, has cardiomyopathy associated with Duchenne muscular dystrophy. She was inspired to underwrite cardiac stem cell research at Cedars-Sinai after reading about a successful clinical trial led by Eduardo Marbn, MD, PhD, director of the Cedars-Sinai Heart Institute and the Mark S. Siegel Family Professor.

The experimental stem cell therapy, developed by Marbn, is the only treatment shown in clinical trials to regenerate healthy heart muscle. In the clinical trial, patients underwent biopsies during which doctors removed a piece of heart muscle about the size of half a raisin. The heart tissue was then used to grow specialized heart stem cells, which then were injected back into the patient's heart. Results published in The Lancet showed that patients experienced an average 50 percent reduction in muscle damaged by heart attack.

"I immediately sensed the potential for applying this rapidly evolving treatment to Duchenne," said Jayasuriya. "I made it my personal quest to help get this kind of therapy for Duchenne patients."

Jayasuriya's commitment was further cemented when she discovered that Ron Victor, MD, associate director of the Cedars-Sinai Heart Institute, has been working with Duchenne patients as part of his investigation of the cardiac benefits of sildenafil (Viagra) and tadalafil (Cialis).

"We know that boys with Duchenne are born with a small scar in the base of their heart," said Victor, the Burns and Allen Chair in Cardiology Research at the Cedars-Sinai Heart Institute. "The damage to hearts in boys with Duchenne increases over time. If we can use stem cells to slow or stop heart damage, it could help stall progression of the disease."

The first step in the study is to examine the effect of injecting cardiac stem cells into the hearts of mice with Duchenne. If the data is positive, the experimental treatment could be rapidly approved for use in humans with Duchenne because of cardiac stem cell treatments have been approved for other patient populations, including those with advanced heart disease.

"Each year, 20,000 boys are born with Duchenne," Jayasuriya said, who founded Coalition Duchenne in 2010 to raise global awareness for Duchenne muscular dystrophy, fund research and find a cure for Duchenne. "Many do not live into their 20s and we lose many to cardiac issues. We need to focus on changing the course of the disease. We hope that working with cardiac stem cells is one way we will eventually change that outcome."

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Grant funds cardiac stem cell research for Duchenne muscular dystrophy-related heart disease

Sen. Mike Carrell dies in Seattle at age 69

OLYMPIA, Wash.

Sen. Mike Carrell, who received a stem cell transplant last month for a blood condition, died Wednesday from complications related to his treatment. He was 69.

Senate Republican Leader Mark Schoesler said Carrell died at a Seattle hospital of lung complications from his ongoing treatment of stem cell transplants from his brother and chemotherapy. Schoesler said that Carrell died in his sleep with his wife, Charlotte, nearby.

Earlier this year, the Lakewood Republican was diagnosed with myelodysplastic syndrome, also known as pre-leukemia. The chronic disease affects blood-forming stem cells.

In a statement, Schoesler said Carrell was a "kind, warm and gracious man, with a great sense of humor and strong convictions."

"His commitment to his community was always evident in his work, and you always knew exactly where you stood with him," Schoesler wrote. "At the same time, he worked every day he was at the Capitol to reach across the aisle in a bipartisan manner and to get results for his constituents and this state. "

Carrell, a retired math and science teacher, served 10 years in the House before first being elected to the Senate in 2004. He's been re-elected to the Senate twice, most recently in November. This past legislative session, he was chairman of the Senate Human Services and Corrections Committee, but was out the latter half of the legislative session because of health issues.

An update written Tuesday on a website put together by friends raising money for his medical costs indicated a turn in his condition, saying that he had trouble fighting off fevers and nausea and was in grave condition.

Carrell is survived by his wife, their three sons and five grandchildren.

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Sen. Mike Carrell dies in Seattle at age 69

Arizona Pain Stem Cell Institute Opens, Now Offering Multiple Research Projects for Back and Neck Pain and Extremity …

Phoenix, Arizona (PRWEB) May 30, 2013

The leading pain management clinics in Phoenix, Arizona Pain Specialists, is now offering multiple regenerative medicine treatment options at the new Arizona Pain Stem Cell Institute. The stem cell injection studies are partially industry subsidized, therefore, patients can expect procedures to cost 40% less than usual. For more information and scheduling call (602) 507-6550.

The Arizona Pain Stem Cell Institute has multiple ongoing clinical research studies evaluating amniotic derived, stem cell rich injections for spinal and extremity arthritis. In addition, the Institute offers bone marrow derived stem cell injections as well, along with platelet rich plasma therapy.

For inclusion in the research projects, patients must be at least 18 years of age and be able to achieve multiple follow up visits. The cost of treatment is not completely covered by the industry and Institute subsidies. There are additional inclusion criteria, so a screening visit is necessary.

All treatments are administered by Board Certified or Eligible pain management doctors who are also Fellowship trained. The injections are outpatient, and the studies are non-randomized so all participants will receive the regenerative treatments. The procedures are all performed at the Scottsdale location of Arizona Pain.

"What the Institute is doing is very exciting. By offering multiple types of regenerative medicine treatments with stem cell injections, they are on the cutting edge of research and being able to see which option works best. It's exactly what Arizona Pain does best, offer the latest treatment options in a continual attempt to maximize successful outcomes," said David Greene, CEO of the Arizona Pain Network.

For more information on the treatments offered by the Arizona Pain Stem Cell Institute and to schedule, call (602) 507-6550.

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Arizona Pain Stem Cell Institute Opens, Now Offering Multiple Research Projects for Back and Neck Pain and Extremity ...

NeoStem Announces Presentations at 2nd Baltic Stem Cell Meeting and Session to Feature VSEL(TM) Technology

NEW YORK, May 30, 2013 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), a leader in the emerging cellular therapy market, today announced that Company management will make two presentations at the 2nd Baltic Stem Cell Meeting, running from Friday, May 31 to Sunday, June 2, 2013, and that the conference will feature a session with multiple researchers from around the world discussing advances using very small embryonic-like stem cells (VSELs(TM) Technology).

The conference focuses on innovative applications of stem cells in multiple areas, the clinical application of umbilical cord blood in regenerative medicine, news and updates on VSEL(TM) Technology, stem cell mobilization and homing, novel directions in hematopoietic transplants, stem cells and cancer, stem cells and aging, and more. Dr. Robin L. Smith, Chairman and CEO of NeoStem, will chair a panel and give a talk titled "From the bench to the clinic: Considerations in cell therapy development." Dr. Denis O. Rodgerson, Director of Stem Cell Science of NeoStem, will speak on "Generation of skeletal structures by human very small embryonic-like (VSEL) stem cells."

The conference will also feature some of the researchers from the United States, Europe and Asia who have expanded on the initial studies of VSEL(TM) Technology carried out by Dr. Mariusz Ratajczak, including:

"The research being presented by these scientists both enhances our understanding of the potential of VSELs as the ultimate cell for regenerative therapy and provides further validation of the capabilities of these cells," said Dr. Robin L. Smith, Chairman and CEO of NeoStem. "We are happy to see research into VSEL(TM) Technology by a growing number of scientists who are not affiliated with NeoStem and we welcome the interest of the scientific community in these extraordinary cells."

NeoStem is pursuing a development program relating to its VSEL(TM) Technology in selected clinical applications and markets based on unmet medical need, target patient population size, regulatory strategy, and overall commercial market. Through both grant funding and NeoStem's own funding, the Company is exploring the potential of VSEL(TM) Technology in the treatment of periodontitis, healing complex skin and soft tissue wounds, corneal regeneration and repair, age-related macular degeneration, nerve regeneration and acute radiation syndrome in a parallel but staggered timeline. NeoStem anticipates that a single clinical manufacturing process will be developed for these indications, collectively, and that the major pacing item will be the generation of preclinical data to support the filing of an investigational new drug application (IND) for a Phase 1 clinical trial, the first of which it expects to be in periodontitis.

The event takes place at the Radisson SAS Hotel, Szczecin, Poland and is organized by Pomeranian Medical University.

About NeoStem, Inc.

NeoStem, Inc. ("NeoStem" or the "Company") is a leader in the emerging cellular therapy industry. Our business model includes the development of novel proprietary cell therapy products as well as operating a contract development and manufacturing organization providing services to others in the regenerative medicine industry. The combination of a therapeutic development business and revenue-generating service provider business provides the Company with capabilities for cost effective in-house product development and immediate revenue and cash flow generation.

For more information, please visit: http://www.neostem.com.

About VSEL(TM) Technology

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NeoStem Announces Presentations at 2nd Baltic Stem Cell Meeting and Session to Feature VSEL(TM) Technology

International Stem Cell Corporation Initiates IND-Enabling Study in Parkinson's Disease Program

CARLSBAD, CA--(Marketwired - May 30, 2013) - International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) a California-based biotechnology company developing novel stem cell based therapies, announced today the initiation of its IND-enabling pharmacology and toxicology non-human primate studies, under the direction of Yale School of Medicine Professor D. Eugene Redmond Jr. MD, the internationally recognized neurosurgeon and a leader in the use of stem cells for the treatment of Parkinson's disease.

The studies will use non-human primates with moderate to severe Parkinson's disease symptoms to assess the safety and functional efficacy of ISCO's proprietary stem cell-derived neuronal cells. The endpoints of these multi-dose studies include determining cell fate, biodistribution and primate behavioral evaluations using a standardized rating scale to assess potential extrapyramidal side effects associated with the cell engraftment. The first, interim results are expected in Q4 of 2013 with the final results available in Q2 of 2014.

Leading the studies will be Prof. Redmond, a recognized expert in the use of transplanted neural cells to treat parkinsonism in primates and the development of effective replacement strategies using stem cell derived neurons. In his career of over 25 years, Prof. Redmond has made many significant contributions in the field of cellular repair in the nervous system for Parkinson's disease. His accomplishments include establishing one of the first preclinical models for Parkinson's disease in primates, the first successful transplantation of fetal tissue into the brain of a primate and one of the first clinical studies of fetal tissue in Parkinson's patients.

"Building on the results from the successful primate and rodent studies we reported earlier this year, we expect these formal studies to be the final step allowing ISCO to file an IND for Parkinson's disease," said Dr. Ruslan Semechkin, Vice President of Research and Development. "As one of the leaders in this field, it's tremendously exciting for ISCO to have such an experienced and influential clinical scientist as Prof. Redmond to direct this research. His clinical experience will be invaluable as we prepare both our IND submission to the FDA and the subsequent phase I clinical trial," Dr. Semechkin continues.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO's core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs) hence avoiding ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at http://www.internationalstemcell.com.

Forward-looking StatementsStatements pertaining to anticipated developments, the potential benefits of research programs and products, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates,") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company's business, particularly those mentioned in the cautionary statements found in the company's Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

To receive ongoing corporate communications via email, visit: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

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International Stem Cell Corporation Initiates IND-Enabling Study in Parkinson's Disease Program