LA BioMed's Dr. Patricia Dickson researching treatments for neurodegenerative disorders

Public release date: 30-May-2012 [ | E-mail | Share ]

Contact: Diana Soltesz diana@dsmmedia.com 818-592-6747 Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA BioMed)

LOS ANGELES (May 30, 2012) Patricia Dickson, M.D., principal investigator at The Los Angeles Biomedical Research Institute at Harbor-UCLA Medical Center (LA BioMed), is co-principal investigator of a project that was just awarded a $5.5 million grant from the California Institute for Regenerative Medicine (CIRM). The goal of the project is to develop a stem cell based therapy for the treatment of mucopolysaccharidosis I (MPS I), a fatal pediatric lysosomal storage disease that causes neurodegeneration as well as defects in other major organ systems. Dr. Dickson is working with lead investigator Philip H. Schwartz, Ph.D., senior scientist at the CHOC Children's Research Institute and managing director of the facility's National Human Neural Stem Cell Resource.

For nearly a decade, Dr. Dickson's research at LA BioMed has focused on enzyme replacement therapy for mucopolysaccharidosis, a group of metabolic disorders caused by the absence or malfunctioning of enzymes needed to break down molecules - called glycosaminoglycans - which help build bone, cartilage, connective tissue and other essential parts of the body. As part of this study, she and her colleagues will begin with proof-of-principle experiments for MPS I.

"Dr. Dickson has been at the forefront of mucopolysaccharidosis research for many years, working tirelessly to help develop therapies for MPS I," said David I. Meyer, Ph.D., president and CEO of LA BioMed. "We congratulate her on her continued success, and for her role in this project which could be an important breakthrough for children suffering from neurodegenerative disorders."

"The unique aspect of this research is that it uses a single donor for the transplantation of stem cells into the body and the brain, which allows the best treatment for both physical and neurological disease and avoids rejection of neural stem cell grafts by the host immune system," said Dr. Dickson. "Pediatric neurodegenerative diseases are generally neglected in stem cell research, but stand the greatest chance of success. The high probability of success, along with the need to alleviate suffering in children, is why we believe the first applications of stem cell therapies should be for these kids."

Dr. Schwartz, Dr. Dickson and project collaborators are working to address two critical issues in the development of a therapeutic candidate based on stem cells: that early intervention is not only required but is indeed possible in this patient population, and that the concept of immune tolerance is also required, where the immune system is trained to attack only real threats in the body but not the body's own cells or tissues.

To date, there is still a significant unmet medical need to better impact and prevent the neurodegenerative processes in this disease. If successful in MPS I, this technique can be expanded to help treat other neurodegenerative disorders due to lysosomal storage.

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LA BioMed's Dr. Patricia Dickson researching treatments for neurodegenerative disorders

Stemedica Stem Cells Approved for Clinical Trials in Mexico for Chronic Heart Failure

SAN DIEGO, May 29, 2012 (GLOBE NEWSWIRE) -- via PRWEB - Stemedica Cell Technologies, Inc. announced today that its strategic partner in Mexico, Grupo Angeles Health Services, has received approval from Mexico's regulatory agency, COFEPRIS, for a Phase I/II single-blind randomized clinical trial for chronic heart failure. COFEPRIS is the Mexican equivalent of the United States FDA. The clinical trial, to be conducted at multiple hospital sites throughout Mexico, will utilize Stemedica's adult allogeneic ischemia tolerant mesenchymal stem cells (itMSC) delivered via intravenous infusion. The trial will involve three safety cohorts at different dosages, followed by a larger group being treated with the maximum safe dosage. The COFEPRIS approval is the second approval for the use of Stemedica's itMSCs. COFEPRIS approved Stemedica's itMSCs in 2010 for a clinical trial for ischemic stroke. These two trials are the only allogeneic stem cell studies approved by COFEPRIS.

Grupo Angeles is a Mexican company that is 100% integrated into the national healthcare development effort. The company is comprised of 24 state-of-the-art hospitals totaling more than 2,000 beds and 200 operating rooms. Eleven thousand Groupo Angeles physicians annually treat nearly five million patients a year. Of these, more than two million are seen as in-patients. In just over two decades, Groupo Angeles has radically transformed the practice of private medicine in Mexico and contributed decisively to reform in the country's health system. Grupo Angeles hospitals conduct an estimated 100 clinical trials annually, primarily with major global pharmaceutical and medical device companies.

"We are pleased that we will be working with the largest and most prestigious private medical institution in Mexico to study Stemedica's product for this indication. If successful, our stem cells may provide a treatment option for the millions of patients, both in Mexico and internationally, who suffer from this condition," said Maynard Howe, PhD, CEO of Stemedica Cell Technologies, Inc.

Roberto Simon, MD, CEO of Grupo Angeles Health Services, noted, "We are proud to be the first organization to bring regulatory-approved allogeneic stem cell treatment to the people of Mexico. We envision that this type of treatment may well become a standard for improving cardiac status for chronic heart failure patients and are pleased to be partnering with Stemedica, one of the leading companies in the field of regenerative medicine."

Nikolai Tankovich, MD, PhD, President and Chief Medical Officer of Stemedica commented, "For the more than five million North Americans who suffer from chronic heart failure, this is an important trial. Our ischemia tolerant mesenchymal stem cells hold the potential to improve ejection fraction--the amount of blood pumped with each heart beat--and therefore, dramatically improve quality of life."

For more information about Stemedica please contact Dave McGuigan at dmcguigan(at)stemedica(dot)com. For more information about Grupo Angeles and the chronic heart failure trial please contact Paulo Yberri at pyberri(at)angelesehealth(dot)com.

About Stemedica Cell Technologies, Inc. Stemedica Cell Technologies, Inc.(http://www.stemedica.com) is a specialty bio-pharmaceutical company committed to the manufacturing and development of best-in-class allogeneic adult stem cells and stem cell factors for use by approved research institutions and hospitals for pre-clinical and clinical (human) trials. The company is a government licensed manufacturer of clinical grade stem cells and is approved by the FDA for its clinical trials for ischemic stroke. Stemedica is currently developing regulatory pathways for a number of medical indications using adult allogeneic stem cells. The Company is headquartered in San Diego, California.

This article was originally distributed on PRWeb. For the original version including any supplementary images or video, visit http://www.prweb.com/releases/stemedica-clinical-trial/chronic-heart-failure/prweb9550806.htm

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Stemedica Stem Cells Approved for Clinical Trials in Mexico for Chronic Heart Failure

Osiris Receives Medicare Reimbursement Codes for Grafix®

COLUMBIA, Md.--(BUSINESS WIRE)--

Osiris Therapeutics, Inc. (OSIR), the leading stem cell company focused on developing and commercializing products to treat medical conditions in inflammatory, cardiovascular, orthopedic, and wound healing markets, announced today that it has received transitional pass-through status from the Center for Medicare & Medicaid Services (CMS), with C-Codes being designated for Grafix. Further, the product has been assigned pass-through status under Medicare's outpatient prospective payment system (OPPS), effective July 1, 2012. These codes will assist in facilitating reimbursement when Grafix products are used to treat Medicare patients with acute and chronic wounds in the hospital outpatient department and ambulatory surgical center settings.

We are very pleased with CMS, and their decision to assign pass-through codes for our Grafix line of Biosurgery products, said Frank Czworka, Executive Director, Wound Care of Osiris Therapeutics. This step will allow more Medicare patients and their providers to have greater access to these next-generation regenerative medicine products."

CMS also issued a preliminary positive decision for the assignment of permanent Healthcare Common Procedure Coding System (HCPCS) Q-codes for Grafix. If the decision is made permanent, it is anticipated that the Q-codes would be available starting in January 2013. The assignment of unique Q-codes will assist in facilitating reimbursement in the physician office setting, offering additional access for Medicare patients.

Non-healing wounds remain a serious unmet medical need and result in over 100,000 amputations each year in the United States alone. Current treatment options include growth factors and bioengineered dressings. However, when chronic wounds fail to respond to current standards of care, new advances are needed. Research shows that mesenchymal stem cells (MSCs) in normal skin play a critical role in the wound healing process. Grafix is the only commercially available product that provides viable, endogenous MSCs together with growth factors and an optimal tissue matrix, making it well suited to promote active dermal healing.

About Grafix

Grafix is a three-dimensional cellular matrix designed for application directly to acute and chronic wounds, including diabetic foot ulcers and burns. Flexible, conforming and immune neutral, this cellular repair matrix provides a rich source of viable, mesenchymal stem cells (MSCs) and growth factors directly to the site of the wound, while the matrix protects the area from inflammation, scarring, and infection. Grafix is manufactured using a unique proprietary process that preserves the matrix, cells and growth factors needed for successful healing.

About Osiris Therapeutics

Osiris Therapeutics, Inc. is the leading stem cell company, having developed the worlds first approved stem cell drug, Prochymal. The company is focused on developing and marketing products to treat medical conditions in inflammatory, cardiovascular, orthopedic and wound healing markets. Osiris currently markets Prochymal for pediatric refractory GvHD in Canada, Grafix for burns and chronic wounds, and Ovation for orthopedic applications. The companys pipeline of internally developed biologic drug candidates under evaluation includes Prochymal for inflammatory, autoimmune and cardiovascular indications, as well as Chondrogen for arthritis in the knee. Osiris is a fully integrated company with capabilities in research, development, manufacturing and distribution of stem cell products. Osiris has developed an extensive intellectual property portfolio to protect the company's technology, including 48 U.S. and 144 foreign patents.

Osiris, Prochymal, Grafix and Ovation are registered trademarks of Osiris Therapeutics, Inc. More information can be found on the company's website, http://www.Osiris.com. (OSIRG)

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Osiris Receives Medicare Reimbursement Codes for Grafix®

Skin Cells From Heart Failure Patients Made Into Healthy New Heart Muscle Cells

Editor's Choice Main Category: Cardiovascular / Cardiology Article Date: 25 May 2012 - 0:00 PDT

Current ratings for: 'Skin Cells From Heart Failure Patients Made Into Healthy New Heart Muscle Cells'

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This achievement is significant, as it opens up the prospect of treating heart failure patients with their own, human-induced pluripotent stem cells (hiPSCs) to fix their damaged hearts.

Furthermore, the cells would avoid being rejected as foreign as they would be derived from the patients themselves. The study is published in the European Heart Journal. However, the researchers state that it could take a minimum of 5 to 10 years before clinical trials could start due to the many obstacles that must be overcome before using hiPSCs in humans is possible.

Although there has been advances in stem cell biology and tissue engineering, one of the major problems scientists have faced has been lack of good sources of human heart muscle cells and rejection by the immune system. Furthermore, until now, scientific have been unable to demonstrate that heart cells created from hiPSCs could integrate with existing cardiovascular tissue.

"What is new and exciting about our research is that we have shown that it's possible to take skin cells from an elderly patient with advanced heart failure and end up with his own beating cells in a laboratory dish that are health and young - the equivalent to the stage of his heart cells when he was just born," said Professor Lior Gepstein, Professor of Medicine (Cardiology) and Physiology at the Sohnis Research Laboratory for Cardiac Electrophysiology and Regenerative Medicine, Technion-Israel Institute of Technology and Rambam Medical Center in Haifa, Israel, who led the study.

In the study, Professor Gepstein, Ms Limor Zwi-Dantsis, and their colleagues retrieved skin cells from two male heart failure patients, aged 51 and 61 years, and reprogrammed the cells by delivering 3 transcription factors (Sox2, Oct4, and Klf4) in addition to a small molecule called valproic acid, to the cell nucleus. The team did not include a transcription factor called c-Myc as it is a known cancer-causing gene.

Professor Gepstein said:

In addition, the team used an alternative strategy involving a virus transferred reprogramming data to the cell nucleus. However, the team removed the virus after the information had been transferred in order to avoid insertional oncogenesis.

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Skin Cells From Heart Failure Patients Made Into Healthy New Heart Muscle Cells

UCI stem cell researcher to receive $4.8 million in state funding

CIRM grant will advance work on multiple sclerosis treatment

Irvine, Calif., May 24, 2012

A UC Irvine immunologist will receive $4.8 million to create a new line of neural stem cells that can be used to treat multiple sclerosis.

The California Institute for Regenerative Medicine awarded the grant Thursday, May 24, to Thomas Lane of the Sue & Bill Gross Stem Cell Research Center at UCI to support early-stage translational research.

CIRMs governing board gave 21 such grants worth $69 million to 11 institutions statewide. The funded projects are considered critical to the institutes mission of translating basic stem cell discoveries into clinical cures. They are expected to either result in candidate drugs or cell therapies or make significant strides toward such treatments, which can then be developed for submission to the Food & Drug Administration for clinical trial.

Lanes grant brings total CIRM funding for UCI to $76.65 million.

I am delighted that CIRM has chosen to support our efforts to advance a novel stem cell-based therapy for multiple sclerosis, said Peter Donovan, director of the Sue & Bill Gross Stem Cell Research Center.

MS is a disease of the central nervous system caused by inflammation and loss of myelin, a fatty tissue that insulates and protects nerve cells. Current treatments are often unable to stop the progression of neurologic disability most likely due to irreversible nerve destruction resulting from myelin deficiencies. The limited ability of the body to repair damaged nerve tissue highlights a critically important and unmet need for MS patients.

In addressing this issue, Lane who also directs UCIs Multiple Sclerosis Research Center will target a stem cell treatment that will not only halt ongoing myelin loss but also encourage the growth of new myelin that can mend damaged nerves.

Our preliminary data are very promising and suggest that this goal is possible, said Lane, a Chancellors Fellow and professor of molecular biology & biochemistry. Research efforts will concentrate on refining techniques for production and rigorous quality control of transplantable cells generated from high-quality human pluripotent stem cell lines, leading to the development of the most therapeutically beneficial cell type for eventual use in patients with MS.

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UCI stem cell researcher to receive $4.8 million in state funding

Boston scientists grow lung tissue from cystic fibrosis patients’ skin cells

By Carolyn Y. Johnson, Globe Staff

Two teams of Boston scientists have developed new ways to turn stem cells into different types of lung tissue, surmounting a major hurdle for scientists trying to harness the power of stem cell biology to study and develop treatments for major lung diseases.

One team then used skin cells from cystic fibrosis patients to create embryonic-like stem cells, then working in lab dishes used those cells to grow tissue that lines the airways and contains a defect responsible for the rare, fatal disease. The technique -- essentially a recipe for growing such lung tissue -- could provide a powerful platform to screen drugs and study the biology of the disease.

Growing lung tissue in the laboratory has long been a goal of stem cell scientists, but has been more technically difficult than growing other types of tissues, such as brain cells or heart cells. Such lung tissue is valuable because it could be used to screen potential drugs and more closely probe the problems that underlie diseases such as asthma, emphysema, and rare genetic diseases. Such techniques may also one day help researchers grow replacement tissues and devise ways to restore or repair injured lung tissue.

A team led by Massachusetts General Hospital researchers created lung tissue from a patient with the genetic mutation that most commonly underlies cystic fibrosis and researchers hope the technique will also be a powerful tool to study other diseases that affect the airway tissue, such as asthma and lung cancer. The other team, led by Boston University School of Medicine scientists, was able to derive cells that form the delicate air sacs of the lung from mouse embryonic stem cells. The team is hoping to refine the recipe for making the cells so that they can be used to derive lung tissue from a bank of 100 stem cell lines of patients with lung disease. Both papers were published Thursday in the journal Cell Stem Cell.

Vertex Pharmaceuticals, a Cambridge biotechnology company, earlier this year received approval for Kalydeco -- the first drug to directly target the underlying cause of cystic fibrosis. That compound was discovered by screening massive numbers of potential drugs against cells engineered to carry the same defect that underlies cystic fibrosis.

We had to use engineered cells, and certainly using more native human cells ... would be potentially beneficial, said Dr. Frederick Van Goor, head of biology for Vertexs cystic fibrosis research program. We had to rely on donor tissue obtained from patients with cystic fibrosis, and its a bit more challenging, because the number of donor lungs you can get and the number of cells you can derive from there are more limited.

Van Goor said it was too soon to say whether the company would use the new technology in screening, but noted that the tests the company had used to determine whether a drug was likely to work against the disease had, in some cases, given scientists false leads. Some molecules that worked on the engineered cells did not work in the complicated biology of the lung.

Its a significant event for the lung field, said Dr. Thiennu Vu, associate professor of medicine at the University of California San Francisco, who was not involved in the research. She added that much work remains before such cells could be used to repair or replace damaged tissue, and even before such cells would necessarily be useful for drug screening. It will be important, she said, to refine the recipe to ensure that the technique yields pure populations of the specific types of functional lung cells.

In the competitive world of science, where credit for being the first to do something is crucially important, the two research teams accomplishments are an unusual example of competitors turning into collaborators -- forging a relationship that both teams felt helped speed up progress.

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Boston scientists grow lung tissue from cystic fibrosis patients’ skin cells

Cytomedix Announces Expansion of Phase 2 Study to Treat Post-Acute Ischemic Stroke at Up to 15 U.S. Clinical Sites

GAITHERSBURG, MD--(Marketwire -05/16/12)- Cytomedix, Inc. (OTC.BB: CMXI) (the "Company"), a regenerative therapies company commercializing and developing innovative platelet and adult stem cell technologies for wound and tissue repair, announced that the independent Data Safety Monitoring Board (DSMB) reviewing the safety data from the ongoing RECOVER-Stroke trial has recommended that the Phase 2 trial of ALD-401, a unique and differentiated stem cell population derived from patients' own bone marrow, can continue as designed. This determination follows a review of the clinical safety data on the first 10 patients that were treated post-acutely for ischemic stroke.

The double-blind, placebo-controlled trial of 100 patients is designed to assess the safety and efficacy of ALD-401 to improve clinical outcomes in patients with unilateral, cerebral ischemic stroke with an NIH stroke scale score of between 7 and 22 when administered between 13 and 19 days post the ischemic event. The primary endpoint of the study is safety and the secondary efficacy endpoint is neural function based on the modified Rankin Scale assessed at three months following treatment.

Currently being conducted at three clinical sites, the trial will now expand up to a total of approximately 15 U.S. clinical sites with this clearance by the DSMB. The study has gained Investigation Review Board ("IRB") approval from a number of leading healthcare institutions under the guidance of key opinion leaders in the field of ischemic stroke. Additional DSMB reviews are scheduled at 30 and 60 patients per the clinical protocol.

Commenting on the clearance to continue the Phase 2 trial, Martin P. Rosendale, Chief Executive Officer, stated, "We are very encouraged by the decision of the DSMB to recommend the continuation of the RECOVER-Stroke trial and look forward to expanding this important trial to additional leading stroke clinical sites across the U.S. The only currently approved treatment options (tissue plasminogen activator (tPA) and mechanical retrievers) must be used within a very short time frame from the onset of the stroke. Consequently, less than 5% of stroke patients receive any approved treatments. ALD-401 is being delivered to patients suffering from the often devastating effects of ischemic stroke approximately two weeks following the stroke.

"Strokes remain one of the leading causes of long-term disability. With the majority of strokes occurring in patients 65 years and older, it is also a major financial burden for our healthcare system. Preclinical research with ALD-401 has shown improvements in motor function, in mitigation of the decrease in brain volume, the reversal of decline in stroke-induced cell viability, and improved blood flow in the brain. We are hopeful that ALD-401 will continue to demonstrate these regenerative activities in this trial and look forward to advancing its clinical development," added Mr. Rosendale.

"We are grateful to our early investigators, which include the University of Texas Health Science Center at Houston, Duke University Medical Center, and the Los Angeles Brain and Spine Institute, for their support and guidance through the early enrollment of this trial. We also look forward to working with a number of premier academic and private health leaders as we expand the study. Importantly, we want to recognize the care and thoughtful guidance received from our independent DSMB," commented James Hinson, M.D., Cytomedix' Chief Medical Officer. "We just concluded an Investigator's Meeting and were especially pleased and encouraged to see the underlying enthusiasm for this potential treatment option among leading clinicians in stroke treatment and research."

About Stroke

According to the American Stroke Association, stroke is a disease that affects the arteries leading to and within the brain. It is the fourth leading cause of death and a leading cause of disability in the United States. A stroke occurs when a blood vessel that carries oxygen and nutrients to the brain is either blocked by a clot or bursts. When that happens, part of the brain cannot get the blood and oxygen it needs, so it starts to die. Strokes are typically classified into two major categories: ischemic and hemorrhagic. Approximately 800,000 patients in the United States suffer a stroke each year and approximately 87% of these strokes are ischemic.

About ALD-401

ALD-401 is the population of ALDHbr stem cells produced using Cytomedix' proprietary technology to sort a specified quantity of bone marrow collected from the patient receiving the therapy. These adult stem cells express high levels of the enzyme ALDH, and preclinical research suggests that they may promote the repair of ischemic tissue damage. This is tissue damage caused by inadequate blood flow resulting from the obstruction of blood vessels supplying blood to the tissue. Investigators have completed preclinical research showed improvements in motor function, improvements in the slowing of decrease in brain volume, the reversal of decline in stroke-induced cell viability, and improved blood flow, or perfusion, in the brain.

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Cytomedix Announces Expansion of Phase 2 Study to Treat Post-Acute Ischemic Stroke at Up to 15 U.S. Clinical Sites

Stem cell debate could flare in Neb. regents race

A long-standing dispute over embryonic stem cell research is likely to resurface during the general election race for candidates of the University of Nebraska Board of Regents.

Regent hopefuls in at least one district differ on the use of research, which has divided the board in past years and caught the attention of an influential Nebraska anti-abortion group.

The primary vote will eliminate candidates from three of four seats that are up for re-election. The nonpartisan, unpaid board has eight members plus one nonvoting student regent for each of the four University of Nebraska campuses. The top two vote-getters in the primary advance to the November general election, where they will compete for a six-year term in office.

The Board of Regents voted 4-4 in 2008 on a proposition to limit the stem cell research at the university to types allowed under President George W. Bush. The board needed a majority of its eight members to approve the measure, and many backers thought they had the necessary votes.

Outgoing state Sen. Lavon Heidemann, a Republican primary winner vying for a seat on the board, said he expected embryonic stem cell research to surface as an issue in the general election. Heidemann's general election opponent, Mike Jones, has said he supports embryonic stem cell research.

Both candidates are seeking to replace Regent Jim McClurg of Lincoln, who did not seek re-election after his vote to allow expanded stem cell research.

"It's not the only issue but is important," Heidemann said, pointing to his endorsement by the group Nebraska Right to Life. "I think that's going to pop up throughout the campaign."

The primary winners of another district _ Norfolk attorney David Copple and Columbus veterinarian Jim Pillen _ have both voiced opposition to stem cell research. One of the two will replace Regent Chuck Hassebrook, who has voted to allow the expanded research.

About $88 million in federal funding went to embryonic stem cell research in 2008, according to the National Institutes of Health, but the University of Nebraska saw none of that funding at the time because of tight federal guidelines. When the guidelines were lifted, university scholars applied for millions of dollars in research grants.

The race for the University of Nebraska Board of Regents attracted a number of well-known politicians and business executives for Tuesday's primary who have promised to keep college affordable and use the university as an engine for economic growth.

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Stem cell debate could flare in Neb. regents race

Cellerant Announces Publication Demonstrating Significant Survival Benefits and Preclinical Proof of Concept With …

SAN CARLOS, Calif.--(BUSINESS WIRE)--

Cellerant Therapeutics, Inc., a biotechnology company developing novel hematopoietic stem cell-based cellular and antibody therapies for blood disorders and cancer, announced the publication of a radiation countermeasure study demonstrating that cryopreserved, allogeneic mouse myeloid progenitor cells significantly improved survival in mice irradiated with lethal doses of radiation. The study, published on May 4, 2012 in the scientific journal, Radiation Research, represents the first report of an effective radiation countermeasure for Acute Radiation Syndrome (ARS) across a broad range of lethal radiation doses when administered as late as seven (7) days after irradiation. These results show that myeloid progenitor cells are one of the most promising radiation countermeasures among all therapeutics currently under development with respect to efficacy, timing and practicality of administration.

The work was carried out in collaboration with scientists at the Armed Forces Radiobiology Research Institute (AFRRI) and is entitled Myeloid Progenitors: A Radiation Countermeasure that is Effective when Initiated Days after Irradiation which appears online ahead of print on the website http://www.rrjournal.org/doi/abs/10.1667/RR2894.1?journalCode=rare.

The publication describes the use of Cellerants cryopreserved, allogeneic myeloid progenitor cells developed in mice to elucidate its potential as a radiomitigator against lethal doses of ionizing radiation in various strains of mice. Pooled allogeneic myeloid progenitor cells were transfused into unmatched recipients irradiated with lethal doses of ionizing radiation known to cause ARS in hematopoietic tissues. Survival benefit was dose dependent and significant even when administration of the product was delayed up to seven (7) days post-irradiation. The ability to delay the administration of a radiomitigator by 24 to 48 hours is critical to allow for the time it takes disaster teams to respond to radiation victims in an emergency situation.

"These study results exceed our expectations of the potential survival benefits of myeloid progenitor cells, said Ram Mandalam, President and CEO of Cellerant. "We are excited about the data as it represents demonstration of proof of concept for our CLT-008 human myeloid progenitor therapy as a radiation medical countermeasure. We continue to work closely with AFFRI in performing further studies and with the government in advancing our product closer to approval for therapeutic use.

Cellerant is developing CLT-008, human myeloid progenitor cells, for the treatment of ARS under a United States Government contract awarded on September 1, 2010 and valued up to $170 million over five years with the Biomedical Advanced Research and Development Authority (BARDA) in the Office of the Assistant Secretary for Preparedness and Response of the Department of Health and Human Services.

In ARS applications, CLT-008 is intended to provide hematopoietic cellular support after exposure to ionizing radiation from a nuclear weapon or from a nuclear accident. Cellerant has conducted various preclinical studies to evaluate whether a single administration of myeloid progenitor cells has the potential to provide effective treatment for ARS in an emergency situation when administered up to seven days post-exposure to radiation. CLT-008 is being developed under the U.S. Food and Drug Administrations Animal Rule for ARS. This approval pathway is available when human efficacy studies are neither ethical nor feasible and requires demonstration of efficacy in representative and well-characterized animal models along with safety and pharmacokinetic testing in human clinical trials. There is currently no FDA-approved medical countermeasure to treat ARS. If licensed by the FDA, the federal government could purchase CLT-008 for the Strategic National Stockpile under Project Bioshield. Project Bioshield is designed to accelerate the research, development, purchase and availability of effective medical countermeasures for the Strategic National Stockpile.

About CLT-008

CLT-008 is a unique, off-the-shelf, cryopreserved, cell-based therapy that contains human Myeloid Progenitor Cells derived from adult hematopoietic stem cells that have the ability to mature into functional granulocytes, platelets and red blood cells in vivo. In preclinical models, CLT-008 has been shown to be highly effective in providing protection from lethal radiation, preventing infection, facilitating stem cell engraftment and improving overall survival with a high degree of efficacy. Cellerant is developing CLT-008 as an effective treatment for chemotherapy-induced neutropenia, protection following exposure to acute radiation, and facilitating engraftment of cord blood transplantation.

CLT-008 is currently in a Phase 1 study in patients undergoing cord blood transplants for the treatment of hematological malignancies. CLT-008 is intended to rapidly produce neutrophils and platelets in vivo and facilitate long-term engraftment in patients undergoing bone marrow or cord blood transplantation. A second Phase I/II study is evaluating CLT-008 in acute leukemia patients with chemotherapy-induced neutropenia. CLT-008 may shorten the time to neutrophil recovery and decrease the risks of febrile neutropenia and infection.

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Cellerant Announces Publication Demonstrating Significant Survival Benefits and Preclinical Proof of Concept With ...

Local News In Cancer Care

MANILA, Philippines As the Cancer Center of the Makati Medical Center celebrates its first year, the hospital unveils to the public two of its latest offerings: the Cellular Therapeutics Laboratory and its new cutting-edge radiation treatment TomoTherapy.

In two seperate occasions, the hospital invited select media representatives to witness its unveiling. Present on the first occasion was neurosurgeon Dr. Eric Flores, head of the new and impressive state-of-the art facility. "This is the future of medicine. It's time the hospital enters the molecular age,"

In the medical field, stem cell therapy is used to treat a host of diseases, from Parkinson's Disease and Multiple Sclerosis to Type 1 Diabetes and a slew of orthopedic ailmetns. It has aided doctors in successful plastic and reconstructive surgeries, and can even give a patient immunity from cancer.

In MakatiMed, stem cells are used to repopulate the blood and bone marrow with normal blood elements after ablative chemotherapy in the treatment of such conditions as leukemia, multiple myeloma Hodgkin's and Non-Hodgkin's Lymphoma. Stem Cell Rescue can also make Type 1 Diabetes a thing of the past: after ablataive chemotherapy ot the abnormal cellular immune system, stem cells produce a normal immune system, thereby allowing normal cells in the pancreas to grow.

Dr. Flores also expounds on the reasons why the hospital's new laboratory is the best in the country.

"Compared to other facilities in the Philippines, our laboratory is unmatched in terms of providing the best cellular product of quality. In comparison with other laboratories, the lab is at least three notches better in providing a sterile environment. Most cancer patients have weakened immune systems, hence, we put premium importance in the quality and sterility of the product."

He continues, "Separation of the cellular products is carried out within our Biosafety level 5 facilities automated magnetic-based cell separation. Our technology is approved by the US-FDA in clinical trials to perform cell purification without compromising cell physiology. Thus, the laboratory is totally unmatched in terms of the cell purity and cell viability of the product."

Dr. Flores also stressed on the 10-point DNA matching capability. "In a condition wherein the stem cells will be sourced out from a donor, our laboratory will perform the strictest standards in identifying a possible cross-match for the recipient. We have the technology to push this cellular transplantation process that will significantly minimize complications. Full disclosure of the patient's cell status, characteristics and quality will be provided."

New radiation therapy system

Meanwhile, another recent addition to the hospital's superb cancer care is TomoTherapy treatment, a new radiation therapy system which employs intensity modulated radiation therapy (IMRT). It is valued as the most superior radiation treatment technique for delivering the desired dose to the tumor while limiting healthy tissue exposure.

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Local News In Cancer Care