BrainStorm Partners With Dana-Farber for NurOwn(TM) Production in Phase II ALS Clinical Trial

NEW YORK, NY and PETACH TIKVAH, ISRAEL--(Marketwired - Apr 8, 2013) - BrainStorm Cell Therapeutics (OTCQB: BCLI), a leading developer of adult stem cell technologies for neurodegenerative diseases, announced today that Dana-Farber Cancer Institute ("Dana-Farber") has entered into an agreement to provide cGMP-compliant clean room facilities for production of BrainStorm's NurOwn stem cell candidate during its upcoming Phase II ALS trial in the USA. The Company's Phase II trial, to be launched in the second half of 2013 pending FDA approval, will be conducted at Massachusetts General Hospital ("MGH"), the University of Massachusetts ("UMass") Hospital and the Mayo Clinic. The Connell and O'Reilly Cell Manipulation Core Facility at Dana-Farber will produce NurOwn for the MGH and UMass Hospital clinical sites.

"We are pleased to begin this work that could be of great value to ALS patients," said Dr. Jerome Ritz, Director of the Connell and O'Reilly Cell Manipulation Core Facility at Dana-Farber and Professor of Medicine at Harvard Medical School. "This is exactly the kind of service that the facility was set up to provide. We appreciate the opportunity to work closely with BrainStorm and colleagues at MGH and UMass to advance cell therapy solutions for difficult diseases."

"Today's announcement brings us another step closer to developing a potentially effective treatment option for patients with ALS," said Alon Natanson, Chief Executive Officer of BrainStorm. "With plans in place at leading institutions like MGH, UMass, Mayo Clinic and Dana-Farber, we believe the company is well positioned to conduct our next Phase II trial at the highest clinical standards and with maximum efficiency."

Results of a Phase I/II clinical study of BrainStorm's NurOwn technology in patients with ALS were recently presented at the 65th Annual Meeting of the American Academy of Neurology. The data demonstrated a significantly slower decline in overall clinical and respiratory function, as measured by the ALS Functional Rating Score (ALSFRS-R) and Forced Vital Capacity (FVC) score respectively, in the six patients that received an intrathecal injection of the cells in the six months following treatment, as compared to the three months preceding treatment.

About NurOwnNurOwn is an autologous, adult stem cell therapy technology that differentiates bone marrow-derived mesenchymal stem cells into specialized, neuron-supporting cells. These neuron-supporting cells (known as "MSC-NTF" cells) secrete neurotrophic, or nerve-growth, factors for PROTECTION of existing motor neurons, PROMOTION of motor neuron growth, and RE-ESTABLISHMENT of nerve-muscle interaction. The ability to differentiate mesenchymal stem cells into MSC-NTF cells, and confirmation of their activity and potency before transplantation, makes NurOwn a first-of-its-kind approach for treating neurodegenerative diseases. More information about NurOwn can be found at http://brainstorm-cell.com/index.php/science-a-technology/-nurown.

About BrainStorm Cell Therapeutics, Inc.

BrainStorm Cell Therapeutics Inc. is a biotechnology company engaged in the development of first-of-its-kind adult stem cell therapies derived from autologous bone marrow cells for the treatment of neurodegenerative diseases. The Company holds the rights to develop and commercialize its NurOwn technology through an exclusive, worldwide licensing agreement with Ramot, the technology transfer company of Tel Aviv University. For more information, visit the company's website at http://www.brainstorm-cell.com.

Safe Harbor Statement - Statements in this announcement other than historical data and information constitute "forward-looking statements" and involve risks and uncertainties that could cause BrainStorm Cell Therapeutics Inc.'s actual results to differ materially from those stated or implied by such forward-looking statements. Terms and phrases such as "may", "should", "would", "could", "will", "expect", "likely", "believe", "plan", "estimate", "predict", "potential", and similar terms and phrases are intended to identify these forward-looking statements. The potential risks and uncertainties include, without limitation, risks associated with BrainStorm's limited operating history, history of losses; minimal working capital, dependence on its license to Ramot's technology; ability to adequately protect the technology; dependence on key executives and on its scientific consultants; ability to obtain required regulatory approvals; and other factors detailed in BrainStorm's annual report on Form 10-K and quarterly reports on Form 10-Q available at http://www.sec.gov. These factors should be considered carefully, and readers should not place undue reliance on BrainStorm's forward-looking statements. The forward-looking statements contained in this press release are based on the beliefs, expectations and opinions of management as of the date of this press release. We do not assume any obligation to update forward-looking statements to reflect actual results or assumptions if circumstances or management's beliefs, expectations or opinions should change, unless otherwise required by law. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.

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BrainStorm Partners With Dana-Farber for NurOwn(TM) Production in Phase II ALS Clinical Trial

Stem Cell Treatment Heals Ailing Dogs

A couple of years ago, Brad Perry's dogs started having joint problems. Cowboy, the golden retriever, developed a severe case of arthritis, while Mr. Jones, the mutt, tore the ligaments in both of his knees during some overenthusiastic play.

"It was so sad. They wouldn't even come to the door to greet me they were in so much pain. It just broke my heart," recalled Perry, a tractor-trailer driver from Alexandria, Ky.

Perry gave the dogs all sorts of medications, but nothing worked, and he knew such medications could result in kidney and liver damage. The dogs' suffering became so great, Perry considered putting the pets down. But late last year he heard about a veterinarian in his area who performed stem cell therapy on dogs to regenerate and repair their joints and figured it was worth a try.

Cowboy underwent the procedure first. Mr. Jones followed a few months later. Perry said that within 10 days of receiving treatment the dogs were like puppies again, chasing his kids, running around in the park and swimming in the lake.

The treatment Perry's dogs received was developed by MediVet America of Lexington, Ky., one of several companies that sell equipment and training to veterinary clinics around the world. MediVet has more than a thousand clinics. Participating vets have performed more than 10,000 stem cell procedures about 7,000 of them in the past 12 months.

An operation like the one Cowboy and Mr. Jones underwent takes several hours. To start, the vet harvests a few tablespoons of fat cells from the pet's abdomen or shoulder, then spins the cells in a centrifuge to separate out the stem cells that are naturally present in fat. Next, the cells are mixed with special enzymes to "digest" any residual fat and connective tissue, and are then "activated" by mixing them with "plasma rich platelets" extracted from the animal's blood cells. The mixture is stimulated under a LED light for 20 minutes or so to further concentrate the stem cells. Finally, the newly awakened cells are injected back into the damaged joint.

Jeremy Delk, MediVet's chief executive officer, said that the therapy works because stem cells are the only cells in the body that have the ability to transform themselves into other types of specialized cells -- such as cartilage -- making them a potent tool for repairing damaged and deteriorating joints. There are 50 to 1,000 times more stem cells in the fat than bone marrow, a source that was more consistently used in animal and human -- stem cell therapy until the fat method started becoming more popular.

"As we age, humans and animals alike, our stem cells are starting to die off so we have fewer. What we are able to do with these techniques is isolate the cells in very large numbers, wake them up and put them back into the area that needs help," he explained.

While still largely unavailable to their owners, stem cell therapy from fat cells has been offered to our furry friends for several years. With fewer regulatory hoops to jump through in veterinary medicine and no contentious religious debates, experimental procedures are often tested and perfected on animals decades before they're green-lighted for use on humans.

One of the things veterinarians and owners alike praise about the procedure is it can be completed in one day, and all at the vet's office. Stem cells can also be banked for future injection so the animal does not have to endure extraction again.

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Stem Cell Treatment Heals Ailing Dogs

Arthritis Stem Cell Treatment for Dogs Leads Pack

A couple of years ago, Brad Perry's dogs started having joint problems. Cowboy, the golden retriever, developed a severe case of arthritis, while Mr. Jones, the mutt, tore the ligaments in both of his knees during some overenthusiastic play.

"It was so sad. They wouldn't even come to the door to greet me they were in so much pain. It just broke my heart," recalled Perry, a tractor-trailer driver from Alexandria, Ky.

Perry gave the dogs all sorts of medications, but nothing worked, and he knew such medications could result in kidney and liver damage. The dogs' suffering became so great, Perry considered putting the pets down. But late last year he heard about a veterinarian in his area who performed stem cell therapy on dogs to regenerate and repair their joints and figured it was worth a try.

Cowboy underwent the procedure first. Mr. Jones followed a few months later. Perry said that within 10 days of receiving treatment the dogs were like puppies again, chasing his kids, running around in the park and swimming in the lake.

The treatment Perry's dogs received was developed by MediVet America of Lexington, Ky., one of several companies that sell equipment and training to veterinary clinics around the world. MediVet has more than a thousand clinics. Participating vets have performed more than 10,000 stem cell procedures about 7,000 of them in the past 12 months.

An operation like the one Cowboy and Mr. Jones underwent takes several hours. To start, the vet harvests a few tablespoons of fat cells from the pet's abdomen or shoulder, then spins the cells in a centrifuge to separate out the stem cells that are naturally present in fat. Next, the cells are mixed with special enzymes to "digest" any residual fat and connective tissue, and are then "activated" by mixing them with "plasma rich platelets" extracted from the animal's blood cells. The mixture is stimulated under a LED light for 20 minutes or so to further concentrate the stem cells. Finally, the newly awakened cells are injected back into the damaged joint.

Jeremy Delk, MediVet's chief executive officer, said that the therapy works because stem cells are the only cells in the body that have the ability to transform themselves into other types of specialized cells -- such as cartilage -- making them a potent tool for repairing damaged and deteriorating joints. There are 50 to 1,000 times more stem cells in the fat than bone marrow, a source that was more consistently used in animal and human -- stem cell therapy until the fat method started becoming more popular.

"As we age, humans and animals alike, our stem cells are starting to die off so we have fewer. What we are able to do with these techniques is isolate the cells in very large numbers, wake them up and put them back into the area that needs help," he explained.

While still largely unavailable to their owners, stem cell therapy from fat cells has been offered to our furry friends for several years. With fewer regulatory hoops to jump through in veterinary medicine and no contentious religious debates, experimental procedures are often tested and perfected on animals decades before they're green-lighted for use on humans.

One of the things veterinarians and owners alike praise about the procedure is it can be completed in one day, and all at the vet's office. Stem cells can also be banked for future injection so the animal does not have to endure extraction again.

Read the rest here:
Arthritis Stem Cell Treatment for Dogs Leads Pack

Meta-Analysis of VELCADE® (bortezomib)-Based Induction Therapy Followed by Stem – Cell Transplantation Showed …

CAMBRIDGE, Mass.--(BUSINESS WIRE)--

Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502) today announced data from a meta-analysis of VELCADE-based regimens compared to non-VELCADE-based regimens as induction therapy prior to autologous stem cell transplant (ASCT) in patients with previously untreated multiple myeloma (MM). These data were reported in an oral presentation at the 14th International Myeloma Workshop (IMW) held April 3-7, 2013 in Kyoto, Japan.

The median progression-free survival (PFS) was significantly higher with VELCADE-based induction therapy compared to non-VELCADE-based: 35.9 months compared to 28.6 percent respectively (p

This meta-analysis demonstrated that VELCADE-based induction therapy improved progression-free survival and overall survival in multiple myeloma patients who underwent autologous transplantation, said Karen Ferrante, M.D., Chief Medical Officer, Millennium. With data from more than 1,500 patients, this meta-analysis underscores the extensive body of evidence, both in clinical trials and real-world experience, that exists for VELCADE.

Bortezomib-based versus non-bortezomib-based induction prior to ASCT in multiple myeloma: meta-analysis of phase 3 trials (Abstract #O-11)

The primary objectives of this analysis were to compare the post-transplant CR+nCR rates and PFS of VELCADE-based induction therapy (administered IV, twice weekly) with non-VELCADE-based induction in previously untreated patients with MM undergoing ASCT. Secondary endpoints included overall response rate (ORR) and overall survival (OS). This meta-analysis of three phase 3 studies included 1,572 patients. Results, which were presented by Pieter Sonneveld, M.D., Dept. of Hematology, Erasmus Medical Center, Rotterdam, the Netherlands, showed:

Patient-level data from three large phase 3 studies were pooled in a thorough integrated analysis of efficacy and safety. Data from a fourth study was included in a larger meta-analysis; however patient-level data was not available due to legal restrictions and is not included in the data reported here with the exception of the OS. The VELCADE-based regimens included VELCADE (Vc) plus dexamethasone (dex), Vc plus doxorubicin plus dex and Vc plus thalidomide (T) plus dex. Non-Vc-based regimens included vincristine plus doxorubicin plus dex, and T plus dex.

About VELCADE VELCADE is co-developed by Millennium and Janssen Pharmaceutical Companies. Millennium is responsible for commercialization of VELCADE in the U.S.; Janssen Pharmaceutical Companies are responsible for commercialization in Europe and the rest of the world. Takeda Pharmaceutical Company Limited and Janssen Pharmaceutical K.K. co-promote VELCADE in Japan. VELCADE is approved in more than 90 countries and has been used to treat more than 400,000 patients worldwide.

Important Safety Information VELCADE (bortezomib) is approved for the treatment of patients with multiple myeloma. VELCADE is also approved for the treatment of patients with mantle cell lymphoma who have already received at least one prior treatment.

Patients should not receive VELCADE if they are allergic to bortezomib, boron or mannitol. VELCADE should not be administered intrathecally. Women should avoid becoming pregnant or breastfeeding while taking VELCADE. Patients with diabetes may require close monitoring and adjustment of their medication.

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Meta-Analysis of VELCADE® (bortezomib)-Based Induction Therapy Followed by Stem - Cell Transplantation Showed ...

State medical board revokes license of stem cell doctor Zannos Grekos

DEERFIELD BEACH _ The Florida Board of Medicine revoked the license of Dr. Zannos Grekos on Friday, accepting a judges finding that he committed medical malpractice in performing an unproven stem cell therapy on a patient who later died.

The medical boards vote was unanimous and without discussion.

The Bonita Springs cardiologist and his attorney said they will appeal to a state appellate court.

While we are disappointed, we are not totally surprised, said Richard Ozelie, Grekos attorney.

Ozelie said the board was predisposed to accepting the findings of an administrative law judge. The board rejected more than a dozen objections he raised about the judges findings, and Ozelie described the proceeding Friday as an exercise in futility.

Grekos had developed a following among patients with debilitating conditions, such as heart and lung failure, with his stem cell therapy. It involved sending a sample of the patients blood to Israel for cultivating the stem cells and sending it to the Dominican Republic. The patient would travel to the Dominican Republic and Grekos partner would inject the stem cells into the patients damaged heart muscle, lungs or circulatory system.

Grekos, 47, who didnt address the panel Friday, showed no reaction to the boards decision.

The decision comes three years after the April 4, 2010, death of Domenica Fitzgerald, a 69-year-old woman who went to Grekos for his stem cell treatment.

She suffered from numbness and tingling in her legs as a side-effect from chemotherapy for breast cancer treatment earlier. She was hoping the stem cell therapy could help.

She suffered a stroke after the treatment, was hospitalized and was taken off life support. The state Department of Health restricted Grekos license in 2011 and told him not to do anything with stem cells. He violated that order in March 2012 and did a similar procedure with another patient, who also died. The state then suspended Grekos license.

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State medical board revokes license of stem cell doctor Zannos Grekos

Creation of adult stem cell center at KU Med sent to Brownback for consideration

By SCOTT ROTHSCHILD, The Lawrence Journal-World

The creation of an adult stem cell research and treatment center at Kansas University Medical Center requires only the signature of Gov. Sam Brownback, who has indicated he supports the venture.

The House and Senate on Friday sent the legislation to Brownback even though KU Med didnt ask for the measure, and there is no funding in the proposal to start what would be called the Midwest Stem Cell Therapy Center.

The proposal was championed by abortion opponents who say that adult stem cell research has the potential to establish new cures and therapies.

The bill would prohibit the center from using embryonic stem cells or cells taken from aborted fetal tissue. Abortion opponents oppose human embryonic stem cell research because it involves the destruction of the embryo.

But opponents of the bill said the startup of a research center requires a lengthy planning process that brings experts together before approaching the Legislature.

The Legislature has no business inserting itself into this sort of operation at the Medical Center, said Sen. Laura Kelly, D-Topeka. We have no qualifications to do this.

Kelly also said the advisory board set up for the center would have too many political appointees.

Under the proposal, KU would appoint a director of the center who would be responsible for oversight of patient treatment and research. The center would require $1.1 million to renovate a lab and hire staff and $750,000 annually after that, according to a state fiscal note. But the funding has not been provided by the Legislature.

Supporters of the bill said KU could solicit grants, gifts and contributions.

Continued here:
Creation of adult stem cell center at KU Med sent to Brownback for consideration