TotipotentRX & ThermoGenesis Case Study Demonstrates Autologous Stem Cell Product Safely Treats Primary Heart Attack …

LOS ANGELES and RANCHO CORDOVA, Calif., Oct. 14, 2013 (GLOBE NEWSWIRE) -- TotipotentRX Corporation and ThermoGenesis Corp. (KOOL), reported yesterday at the annual meeting of the American Association of Blood Banks in Denver, Colorado, a study confirming TotipotentRX's ground-breaking acute myocardial infarction ("AMI") combination product utilizing ThermoGenesis' point-of-care cell processing technology for an autologous bone marrow derived stem cell therapy can be delivered safely in 60 minutes.

Mr. Ken Harris, Study Director and Chief Executive Officer of TotipotentRX, presented a case study and physician feedback confirming that the Company's Acute Myocardial Infarction Rapid Stem Cell Therapy ("AMIRST") protocol utilizing autologous bone marrow derived stem cells achieved its primary safety and secondary efficacy endpoints by improving the patient's Left Ventricular Ejection Fraction ("LVEF") from 35% to 60.3% in 24 months while preventing further infarct scarring and undesirable remodeling. Low LVEF and heart remodeling are two key contributors in AMI patients advancing to heart failure.

Dr. Ashok Seth, Chairman - Cardiac Sciences, and Dr. Vinay Sanghi, both of Fortis Healthcare, conducted the clinical case study which shows the AMIRST treatment safely delivered to a single male patient an effective dose of autologous selected stem cells in a single intracoronary heart catheterization procedure. The Company believes this is the first integrated combination product treatment, consisting of a combination of devices and biologics, to be evaluated in a larger follow-up study.

The combination product and procedure developed by TotipotentRX (patent pending) incorporating ThermoGenesis' cell processing technology, is known as the AMIRST protocol. The AMIRST protocol is performed by a cardiac interventional physician in less than 60 minutes to treat acute ST-elevated myocardial infarction in patients having an LVEF below 40%. This fully integrated treatment includes:

Dr. Vinay Sanghi, Clinical Investigator and treating physician on this case, said "conducting a fully-integrated point-of-care treatment on a patient with an acute ST-elevated myocardial infarction using the AMIRST protocol was straightforward and very exciting as a practicing interventional cardiologist. The safety and positive clinical benefits demonstrated in this single patient case study are very encouraging as we begin the double-blinded AMIRST study which should provide statistically significant insights".

Mr. Harris noted, "this case study affirmed that our integrated combination product has appropriately considered the essential devices, diagnostics, cell formulation, and directions for use ensuring the AMIRST treatment meets the objectives of providing a safe, effective, rapid, bedside therapy for treating low ejection fraction after a primary myocardial infarction." He continued, "we are enthusiastically looking forward to the randomized placebo controlled Phase Ib study in the coming few months. We envision this product, if approved, will improve the quality of life and mortality rates of low LVEF patients."

"We are very pleased with the initial results of this study using our combination product," said Mr. Matthew Plavan, Chief Executive Officer of ThermoGenesis. "In addition to the positive safety and efficacy data, we are particularly encouraged by the potential durability of the treatment, given this patient's LVEF exceeded 60% two years post treatment. Based upon the AMI population and those that meet the criteria for an approved AMIRST therapy, we estimate the addressable U.S. market for our combination product to exceed $500 million per year."

This study will be advanced to a double blinded placebo-controlled randomized Phase Ib clinical trial of 30 patients (NCT01536106) in the first quarter of 2014.

About Acute Myocardial Infarction

Cardiovascular disease ("CVD") is the number one cause of morbidity and mortality worldwide. An estimated 17.3 million people died from CVDs in 2008, representing 30% of all global deaths. Of these deaths 7.3 million were due to coronary heart disease and 6.2 million from stroke. In the progression of CVDs, plaque lesions develop in arteries that result in a narrowing of vessels, and in severe cases the vulnerable plaque breaks open and creates a blockage of blood flow to vital organs in the heart or brain. In the case of the heart, this is classified as a myocardial infarction. LVEF is one of the key indications of mortality rates post myocardial infarction with a reduced LVEF being a risk factor for both sudden and non-sudden death, with the odds ratio for 1 year mortality after myocardial infarction at 9.48 (High Rate) for patients with an LVEF 30% compared to patients with LVEF > 50%, 2.94% (Moderate Rate) for patients with LVEF 30-40%, whereas the risk is not significantly increased (low rate) in patients with LVEF 40-50%. The specific patient highlighted in this announcement was in the moderate risk category.

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TotipotentRX & ThermoGenesis Case Study Demonstrates Autologous Stem Cell Product Safely Treats Primary Heart Attack ...

Stem Cell Treatment for Pets | Roger A. Mauer DVM on Channel 8 News | Las Vegas – Video

Stem Cell Treatment for Pets | Roger A. Mauer DVM on Channel 8 News | Las Vegas
http://veterinary-stemcell.com Dr. Mauer is very excited to be offering Stem Cell Therapy. This innovative and affordable treatment has been making news all ...

By: Roger Mauer

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Stem Cell Treatment for Pets | Roger A. Mauer DVM on Channel 8 News | Las Vegas - Video

donga.com[English donga]

Seoul St. Mary`s Hospital performs 5,000th hematopoietic stem cell transplantation OCTOBER 11, 2013 05:40 Seoul St. Mary`s Hospital performs 5,000th hematopoietic stem cell transplantation . OCTOBER 11, 2013 05:40. . The Seoul St. Mary`s Hospital on Thursday became Asia`s first medical institution to perform 5,000 transplants of hematopoietic stem cells. Hematopoietic stem cell transplantation is a treatment involving the infusion of blood-forming stem cells into patients of blood tumors such as leukemia, malignant lymphoma and multiple myeloma.

The Seoul St. Mary`s Hospital has reached the milestone 30 years after it performed Korea`s first successful transplantation of hematopoietic stem cells between two brothers in 1983. In the number of such hematopoietic stem cell transplantations, the hospital ranks sixth in the world and first in Asia. In transplantations of allergenic hematopoietic stem cell transplantation, the hospital ranks the fourth in the world. It is also the country`s first hospital to successfully perform autologous hematopoietic stem cell transplantation, umbilical cord blood transplantation and nonmyeloablative stem cell transplantation.

The hospital`s 5,000th patient who underwent the hematopoietic stem cell transplant is an 18-year-old leukemic girl, who received bone marrows from her younger brother.

"An analysis shows that we are one of the best performers in the world, as the rate is 10 to 30 percent higher than in the United States, as the survival rate of our 5,000 transplantation surgeries is 20 to 30 percent higher than U.S. hospitals," said Dr. Lee Jong-wook, head of the hospital`s hematopoietic stem cell transplantation center. "There is no need to go overseas for leukemia treatments."

The Seoul St. Mary`s Hospital has reached the milestone 30 years after it performed Korea`s first successful transplantation of hematopoietic stem cells between two brothers in 1983. In the number of such hematopoietic stem cell transplantations, the hospital ranks sixth in the world and first in Asia. In transplantations of allergenic hematopoietic stem cell transplantation, the hospital ranks the fourth in the world. It is also the country`s first hospital to successfully perform autologous hematopoietic stem cell transplantation, umbilical cord blood transplantation and nonmyeloablative stem cell transplantation.

The hospital`s 5,000th patient who underwent the hematopoietic stem cell transplant is an 18-year-old leukemic girl, who received bone marrows from her younger brother.

"An analysis shows that we are one of the best performers in the world, as the rate is 10 to 30 percent higher than in the United States, as the survival rate of our 5,000 transplantation surgeries is 20 to 30 percent higher than U.S. hospitals," said Dr. Lee Jong-wook, head of the hospital`s hematopoietic stem cell transplantation center. "There is no need to go overseas for leukemia treatments."

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Rocker's stem cell transplant hope

Jim Keays and Russell Morris Source: Supplied

AUSTRALIAN rock legend Jim Keays has narrowly survived acute renal failure after a radical stem cell transplant he hopes will save his life.

Keays was diagnosed with multiple myeloma - a cancer of the blood's plasma cells - six years ago and has been battling the disease since.

Myeloma often attacks the kidneys and Keays had chemotherapy and was put on dialysis after seeing his kidney function drop to 5 per cent.

Early this year he had a transplant using stem cells harvested from his own blood.

But in radical, and still experimental, surgery, he recently received stem cells from an unknown donor - a man who does not even share Keays' blood group.

"There is a global register of stem cells donors, and the doctors told me they had found a reasonable match on it," the former Master's Apprentices' frontman explained.

All Keays, who turned 67 last month, knows of the donor is that he is 28 and from New Jersey.

When doctors explained the treatment Keays was told it was his "last roll of the dice".

"The alternative was to die," said Keays.

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Rocker's stem cell transplant hope

MESOBLAST ACQUIRES OSIRIS' CULTURE EXPANDED STEM CELL THERAPEUTIC BUSINESS

MELBOURNE, Australia and NEW YORK, Oct. 10, 2013 (GLOBE NEWSWIRE) -- Regenerative medicine company Mesoblast Limited (ASX:MSB) (MBLTY) today announced the acquisition of the entire culture-expanded mesenchymal stem cell (MSC) business of Osiris Therapeutics (OSIR) by the Mesoblast Group.

"The many commercial and strategic benefits of this transaction firm Mesoblast's leadership position in the global regenerative medicine industry," said Mesoblast Chief Executive Officer Professor Silviu Itescu.

The benefits derived from acquiring the approved and late-phase MSC products include:

"Importantly, in 2014 we plan to have active products in Phase 3 clinical trials in all four core major therapeutic areas of focus: cardiovascular medicine (congestive heart failure), inflammatory/immune diseases (Crohn's disease), orthopedics (spinal fusion and intervertebral disc repair) and oncology (acute Graft versus Host Disease, and cord blood expansion in bone marrow transplantation)."

Existing cash reserves are sufficient to meet current and new product development plans. Cost savings and other synergies are expected across personnel, capital expenditure, and manufacturing, and as a result there will only be a modest increase in operating cash burn.

Strategic and Financial Benefits of the Transaction

Significant new and early potential revenue stream with the acquisition of Prochymal(R), the world's first approved stem cell therapeutic and the only stem cell therapeutic designated by the United States Food and Drug Administration (FDA) as both an Orphan Drug and Fast Track product. Prochymal(R) has already received conditional approval in Canada and New Zealand for the treatment of children with acute GvHD, and is available in the United States under an Expanded Access Program for treatment of acute GvHD in both children and adults.

A broadening of Mesoblast's Phase 3-ready products in two new indications:

Crohn's disease - a major driver for the transaction was Mesoblast's evaluation of the ongoing, 330-patient, Phase 3 trial in patients with Crohn's disease who have failed other biologic agents. Following an interim analysis for futility after 207 patients were enrolled, the best performing Prochymal dose (based on the primary endpoint of disease remission) was selected to complete the study.

Acute GvHD - the promising Phase 3 data in adults with GvHD at high risk of death due to liver or gut complications was another major driver for the transaction, and Mesoblast intends to seek approval from the FDA for this indication.

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MESOBLAST ACQUIRES OSIRIS' CULTURE EXPANDED STEM CELL THERAPEUTIC BUSINESS

Mesoblast jumps on stem cell asset purchase

Shares in stem cells group Mesoblast have surged back to their highest level in two months on news it is to spend up to $100 million buying a suite of patents in the US which have the potential to deliver revenues sooner than expected.

Earlier today, it disclosed details of the purchase of a clutch of assets from US-based Osiris Therapeutic for an initial $US20 million in cash, although the final price could reach $US100 million depending on progress in developing the acquired products, with provision for future royalty payments as well.

The purchase brings with it two products already in their final stage of clinical trials with approvals for launch in Canada and New Zealand, and with the potential to win clearance for launch in the key US market within two years.

These are substantially derisked, Mesoblast chief executive, Professor Silviu Itescu said of the two advanced products, an agent for treating some Crohns disease cases along with a treatment for some graft versus host disease cases resulting from stem cell transplants.

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In afternoon trading, the shares were up 5.1 per cent at $5.76.

Like Mesoblast, Osiris has been developing therapeutic products that use so-called mesenchymal stem cells which can help body tissue heal large wounds, repair cartilage and muscle tissue.

Osiris has been producing these stem cells in the US since 1999, and also has a joint venture in Japan.

The US companys product is already approved for use in selected bone marrow cases involving children in the US, Canada and New Zealand.

The purchase gives Mesoblast access to two products in phase 3 trials - a treatment for Crohns disease and for selected bone marrow cases involving adults as well, it said.

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Mesoblast jumps on stem cell asset purchase

Mesoblast Rises on Plan to Buy Stem-Cell Business: Sydney Mover

Mesoblast Ltd. (MSB) climbed the most in eight months in Sydney trading after agreeing to buy a stem-cell business of Osiris Therapeutics Inc. (OSIR) for as much as $100 million to gain new treatments.

The maker of stem-cell therapies rose as much as 11 percent, the largest advance since Feb. 7, and was up 6.2 percent to A$5.82 as of 11:47 a.m. in Sydney trading.

Mesoblast will buy the mesenchymal stem-cell unit of Osiris, including Prochymal, a treatment for acute graft versus host disease, Columbia, Maryland-based Osiris said in a statement. The price tag includes as much as $50 million in payments if certain trial and regulatory milestones are met, and Osiris may also receive royalties on sales of certain products, Melbourne-based Mesoblast said in a separate statement today.

Prochymal has received conditional approval in Canada and New Zealand for use in children with acute graft versus host disease, and is available under an access program in the U.S. for treating both children and adults, according to Osiriss statement. The illness is a complication that can occur after a stem-cell or bone-marrow transplant in which the newly transplanted donor cells attack the transplant recipients body, according to Medline Plus.

To contact the reporter on this story: Lena Lee in Singapore at llee42@bloomberg.net

To contact the editor responsible for this story: Jason Gale at j.gale@bloomberg.net

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Mesoblast Rises on Plan to Buy Stem-Cell Business: Sydney Mover

Mesoblast's US patents deal lifts shares

Silviu Itescu.

Shares in stem cell group Mesoblast surged to two-month highs on its decision on Friday to outlay up to $US100 million to buy a suite of patents in the US that hold the potential to deliver revenues sooner than expected.

In a deal with US-based Osiris Therapeutic for an initial $US20 million in cash, along with further future payments, Mesoblast is to gain access to two products in their final stage of clinical trials which already hold approvals for sale in Canada and New Zealand, and with the potential to win clearance for launch in the key US market within two years.

''These are substantially derisked,'' Mesoblast chief executive Silviu Itescu said of the two advanced products, an agent for treating some Crohn's disease cases along with a treatment for bone marrow cases resulting from stem cell transplants.

Mesoblast shares closed up 4.7 per cent on Friday at $5.74.

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Like Mesoblast, Osiris has been developing therapeutic products that use so-called mesenchymal stem cells that can help body tissue heal large wounds and repair cartilage and muscle tissue.

Osiris has been producing these stem cells in the US since 1999, and also has a joint venture in Japan.

The acquisition consolidates Mesoblast's position in the regenerative therapies sector, while providing additional growth options, Professor Itescu said.

The acquisition includes approved products in several countries and will ''more than double our portfolio of granted patent families encompassing all mesenchymal lineage stem cells'', he said. The products will bring forward Mesoblast's projected revenues and provide earlier launch opportunities for products, he said.

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Mesoblast's US patents deal lifts shares

Mesoblast to aquire further stem cell assets

Shares in stem cells group Mesoblast have surged back to their highest level in two months on news it is to spend up to $100 million buying a suite of patents in the US which have the potential to deliver revenues sooner than expected.

Earlier today, it disclosed details of the purchase of a clutch of assets from US-based Osiris Therapeutic for an initial $US20 million in cash, although the final price could reach $US100 million depending on progress in developing the acquired products, with provision for future royalty payments as well.

The purchase brings with it two products already in their final stage of clinical trials with approvals for launch in Canada and New Zealand, and with the potential to win clearance for launch in the key US market within two years.

These are substantially derisked, Mesoblast chief executive, Professor Silviu Itescu said of the two advanced products, an agent for treating some Crohns disease cases along with a treatment for some graft versus host disease cases resulting from stem cell transplants.

Advertisement

In afternoon trading, the shares were up 5.1 per cent at $5.76.

Like Mesoblast, Osiris has been developing therapeutic products that use so-called mesenchymal stem cells which can help body tissue heal large wounds, repair cartilage and muscle tissue.

Osiris has been producing these stem cells in the US since 1999, and also has a joint venture in Japan.

The US companys product is already approved for use in selected bone marrow cases involving children in the US, Canada and New Zealand.

The purchase gives Mesoblast access to two products in phase 3 trials - a treatment for Crohns disease and for selected bone marrow cases involving adults as well, it said.

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Mesoblast to aquire further stem cell assets

Stem cell meeting focuses on business

LA JOLLA Stem cell science is at last moving into clinical trials. But delivering its results to patients will require huge investments by drug and biotech companies, and health insurers must decide on how to reimburse for such therapy.

Just how thats going to happen is part of the Stem Cell Meeting on the Mesa, which begins Monday and ends Wednesday. The annual conference, which began as a scientific symposium, has extended into business matters as research get closer to patient treatments.

The meeting in La Jolla includes scientific updates on stem cell research and presentations from more than 50 companies and research institutes, seeking investment or offering their science skills.

The business push into whats called regenerative medicine takes place as the United States is adopting a new health care system. Biotech executives speaking at the conference said their job is to document the benefits in restoring patient health and replacing less effective and more costly alternatives.

Regenerative medicine aims to do what until very recently has been impossible: regrow lost tissues or organs and reverse degenerative diseases such as Parkinsons. The need for such treatments is becoming greater as baby boomers reach retirement age, and thousands of young veterans struggle with disabling injuries.

The field faces the same business challenges as any new area of medicine, said Perry Karsen, executive vice president of Celgene Corp. The biotech giant is based in Summit, N.J., and has an office in San Diego.

Its a new area of science. Its very similar to what we saw with monoclonal antibodies 20-25 years ago, Karsen said.

Monoclonal antibody drugs represent one of biotechs biggest success stories. They include drugs such as Humira, for autoimmune diseases, which brought in $9.3 billion in 2012. But many early attempts to develop monoclonal drugs failed spectacularly. Making these drugs work well took years of persistence.

Regenerative medicine is that next wave of innovation in the industry, and it has the same inherent risks as any new technology, Karsen said.

Celgene is investing in regenerative medicine because it will transform how health care is practiced, Karsen said, declining to say how much the company is spending.

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Stem cell meeting focuses on business