Osiris Wins Canadian Approval for First Stem-Cell Therapy

By adminMay 18, 2012Stem Cell Treatment

By Meg Tirrell - 2012-05-18T13:44:15Z

Osiris Therapeutics Inc. (OSIR) surged the most in two years after the company said it won the worlds first approval for a stem-cell drug, gaining clearance in Canada to sell Prochymal for a disease that can attack patients who received bone-marrow transplants.

Osiris rose 8.8 percent to $5.72 at 9:40 a.m. New York time, after earlier reaching $6 for the biggest intraday increase since June 2010. The shares had fallen 28 percent in the 12 months before today.

Prochymal was approved for the treatment of acute graft versus host disease in children for whom steroids havent worked, the Columbia, Maryland-based company said yesterday in a statement. Steroids have a 30 percent to 50 percent success rate, and severe GvHD can be fatal in 80 percent of cases, according to the company.

The therapy uses mesenchymal stem cells derived from bone marrow that can take on different forms to combat the immune reaction that causes patients to literally peel out of their skin and shed their intestinal lining, Osiris Chief Executive Officer Randal Mills said in a telephone interview. The disease has no equal.

The company hasnt sought approval for this indication in the U.S., where regulators asked for more data before considering whether to allow sales of the drug, Mills said. Prochymal is used in eight countries, including the U.S., on an expanded-access program basis, which allows patients to receive experimental medicines without participating in clinical trials.

This is the first regulatory approval of a stem-cell drug -- where the active ingredient of the drug is a stem cell -- in the world, Mills said. Its a huge deal for us and a huge deal for the entire field of stem-cell therapy.

Osiris shares declined from an all-time high of $28.56 in 2007 as the biotechnology company faced clinical setbacks, including two studies in 2009 that failed to show statistical improvement of Prochymal versus placebo.

The Canadian approval was based on data showing a clinically meaningful response 28 days after starting therapy for 61 percent to 64 percent of patients treated, Osiris said in the statement.

Prochymal may draw $16.7 million in revenue next year with Canadian approval, estimated Edward Tenthoff, an analyst with Piper Jaffray & Co., before the companys announcement. He said that while Prochymal would be the first stem-cell drug to receive approval, other regenerative products used for wound- healing that employ stem cells are already on the market, such as Carticel from Sanofis Genzyme unit.

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Osiris Wins Canadian Approval for First Stem-Cell Therapy

First stem cell drug approved for systemic disease treatment

By adminMay 18, 2012Stem Cell Treatment

Osiris Therapeutics Inc said on Thursday that Canadian health regulators have approved its treatment for acute graft-versus host disease in children, making it the first stem cell drug to be approved for a systemic disease anywhere in the world.

Osiris shares rose 14 percent to $6.00 in extended trading after the news was announced.

Graft versus host disease (GvHD) is a potentially deadly complication from a bone marrow transplant, when newly implanted cells attack the patient's body. Symptoms range from abdominal pain and skin rash to hair loss, hepatitis, lung and digestive tract disorders, jaundice and vomiting.

The disease kills up to 80 percent of children affected, Osiris said. To date there have been no approved treatments for the disease. Canadian authorities approved the therapy, Prochymal, for use in children who have failed to respond to steroids.

Prochymal was approved with the condition that Osiris carry out further testing after it reaches the market. C. Randal Mills, the company's chief executive, said in an interview that could take three to four years.

Some investment analysts have been skeptical about Prochymal's future. In 2009, two late-stage clinical trials failed to show the drug was more effective overall than a placebo in treating the disease, though it showed promise in certain subgroups of patients.

Since then, the company has mined data from all its clinical trials to show that in patients with severe refractory acute GvHD -- those who have more or less failed all other therapies -- Prochymal demonstrated a clinically meaningful response at 28 days after therapy began in 61-64 percent of patients.

In addition, treatment with Prochymal resulted in a statistically significant improvement in survival when compared with a historical control population of pediatric patients with refractory GvHD.

The Canadian authorities approved the drug on the basis of that data, the company said.

FDA submission this year

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World's First Approved Stem Cell Drug; Osiris Receives Marketing Clearance from Health Canada for Prochymal

By adminMay 18, 2012Stem Cell Treatment

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

Osiris Therapeutics Inc. (NASDAQ:OSIR - News) announced today it has received market authorization from Health Canada to market its stem cell therapy Prochymal (remestemcel-L), for the treatment of acute graft-vs-host disease (GvHD) in children. The historic decision marks the worlds first regulatory approval of a manufactured stem cell product and the first therapy approved for GvHD a devastating complication of bone marrow transplantation that kills up to 80 percent of children affected, many within just weeks of diagnosis.

"I am very proud of the leadership role Canada has taken in advancing stem cell therapy and particularly gratified that this historic decision benefits children who would otherwise have little hope," said Andrew Daly, M.D., Clinical Associate Professor, Department of Medicine and Oncology at the University of Calgary, Canada and Principal Investigator in the phase 3 clinical program for Prochymal. "As a result of Health Canada's comprehensive review, physicians now have an off-the-shelf stem cell therapy in their arsenal to fight GvHD. Much like the introduction of antibiotics in the late 1920's, with stem cells we have now officially taken the first step into this new paradigm of medicine."

Prochymal was authorized under Health Canada's Notice of Compliance with conditions (NOC/c) pathway, which provides access to therapeutic products that address unmet medical conditions and which have demonstrated a favorable risk/benefit profile in clinical trials. Under the NOC/c pathway, the sponsor must agree to carry out confirmatory clinical testing.

Today is not only a great day for Osiris, but for everyone involved in the responsible development of stem cell therapies, said C. Randal Mills, Ph.D., President and Chief Executive Officer of Osiris. Most importantly, today is a great day for children and their families who bravely face this horrific disease. While today marks the first approval of a stem cell drug, now that the door has been opened, it will surely not be the last.

Health Canadas authorization was made following the recommendation of an independent expert advisory panel, commissioned to evaluate Prochymal's safety and efficacy. In Canada, Prochymal is now authorized for the management of acute GvHD in children who fail to respond to steroids. The approval was based on the results from clinical studies evaluating Prochymal in patients with severe refractory acute GvHD. Prochymal demonstrated a clinically meaningful response at 28 days post initiation of therapy in 61-64 percent of patients treated. Furthermore, treatment with Prochymal resulted in a statistically significant improvement in survival when compared to a historical control population of pediatric patients with refractory GvHD (p=0.028). The survival benefit was most pronounced in patients with the most severe forms of GvHD. As a condition of approval, the clinical benefit of Prochymal will be further evaluated in a case matched confirmatory trial and all patients receiving Prochymal will be encouraged to participate in a registry that will monitor the long-term effects of the therapy.

Refractory GvHD is not just deadly to the patients it afflicts, but is devastating for the family, friends, and caregivers who watch helplessly as the disease progresses, said Joanne Kurtzberg, MD, Head of the Pediatric Bone Marrow Transplant Program at Duke University and Lead Investigator for Prochymal. "I have personally seen Prochymal reverse the debilitating effects of severe GvHD in many of my patients and now, after nearly two decades of research, the data demonstrating consistently high response rates, a strong safety profile and improved survival clearly support the use of Prochymal in the management of refractory GvHD."

Prochymal is currently available in several countries, including the United States, under an Expanded Access Program (EAP). Prochymal will be commercially available in Canada later this year.

Today Osiris turns the promise of stem cell research into reality, delivering on decades of medical and scientific research, said Peter Friedli, Chairman and Co-founder of Osiris. It took 20 years of hard work and perseverance and I want to personally thank everyone involved for their dedication to this important mission.

In addition to the extensive intellectual property protection Osiris has around Prochymal, which includes 48 issued patents, Health Canada's decision will also provide Prochymal with regulatory exclusivity within the territory. Canada affords eight years of exclusivity to Innovative Drugs such as Prochymal, and an additional six-month extension is available since it addresses a pediatric population.

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World's First Approved Stem Cell Drug; Osiris Receives Marketing Clearance from Health Canada for Prochymal

Stem cell therappy to treat a chimp's torn ACL may prove beneficial for humans

By adminMay 17, 2012Stem Cell Doctors

Veterinarians hope a new medical procedure can treat a 25-year-old chimpanzee with a torn ACL, or anterior cruciate ligament, at the "Save the Chimps" in Florida.

The procedure involves injecting the chimp with her own stem cells.

"With chimps we don't want to do a lot of surgical work, put hardware in their knee, they tend to pull out that sort of thing," said Veterinarian Linda Gregard, M.D.

Dr. Darrell Nazareth with the Florida Veterinary League has been using stem cells to treat dogs with arthritis for the past two years, but this is his first chimp.

"We're not using embryonic stem cells, we're not taking embryos and taking their stem cells from there. We're just using the patient's own tissue," said Dr. Nazareth.

The technology harnesses the bodies own ability to heal itself and doctors hope it could find wider use in humans.

After injecting two billion stem cells into Angie's knee, doctors will find out in the next two to three weeks if the stem cell therapy treatment was successful.

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Stem cell therappy to treat a chimp's torn ACL may prove beneficial for humans

Stem cell therapy to treat a chimp's torn ACL may prove beneficial for humans

By adminMay 17, 2012Stem Cell Doctors

Veterinarians hope a new medical procedure can treat a 25-year-old chimpanzee with a torn ACL, or anterior cruciate ligament, at the "Save the Chimps" in Florida.

The procedure involves injecting the chimp with her own stem cells.

"With chimps we don't want to do a lot of surgical work, put hardware in their knee, they tend to pull out that sort of thing," said Veterinarian Linda Gregard, M.D.

Dr. Darrell Nazareth with the Florida Veterinary League has been using stem cells to treat dogs with arthritis for the past two years, but this is his first chimp.

"We're not using embryonic stem cells, we're not taking embryos and taking their stem cells from there. We're just using the patient's own tissue," said Dr. Nazareth.

The technology harnesses the bodies own ability to heal itself and doctors hope it could find wider use in humans.

After injecting two billion stem cells into Angie's knee, doctors will find out in the next two to three weeks if the stem cell therapy treatment was successful.

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Stem cell therapy to treat a chimp's torn ACL may prove beneficial for humans

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

By adminMay 17, 2012Stem Cell Medical Center

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

By adminMay 17, 2012Stem Cell Medical Center

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

By adminMay 17, 2012Stem Cell Medical Center

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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9 Small Businesses Awarded Scholarships to Attend International BIO Convention

By adminMay 17, 2012Stem Cell Clinic

MADISON, Wis.--(BUSINESS WIRE)--

Nine Wisconsin biotechnology companies have been awarded scholarships to support attending the Biotechnology Industry Organizations (BIO) International Convention in Boston, MA. June 18-21, 2012. All recipients plan to participate in BIOs one-on-one partnering with potential customers from around the world, or to present to potential investors.

The grant fund was assembled by BioForward, and includes funds provided by Wisconsin Economic Development Corporation and Marshfield Clinic Applied Sciences. Scholarship recipients are small biotechnology businesses that demonstrate a strategic approach to the Business Forum, and have a financial need.

The scholarship recipients are:

Centrose preclinical stage company developing a novel antibody-drug conjugation technology that targets a wide variety of diseased cells.

DNASTAR company focused primarily on developing and commercializing software for scientists working with DNA sequence analysis.

InvivoSciences - contract research organization providing engineered tissue-based phenotypic compound screening services for pharmaceutical, cosmetic, biotech, food, and chemical companies.

NeoClone company designing and manufacturing monoclonal antibodies, for their ability to seek out and bind to a specific target such as a virus, toxin, bacterium or tumor cell.

Primorigen company developing innovative high-throughput protein and cell-based assay systems and novel stem cell biology research products.

Quintessence Biosciences private, clinical stage biopharmaceutical company developing novel anti-cancer compounds based on patented EVade Ribonuclease technology.

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9 Small Businesses Awarded Scholarships to Attend International BIO Convention

Amgen's BiTE® Antibody Blinatumomab (AMG 103) Achieved High Rate of Complete Response in Adult Patients With Relapsed …

By adminMay 17, 2012Stem Cell Clinic

THOUSAND OAKS, Calif., May 16, 2012 /PRNewswire/ --Amgen (AMGN) today announced updated results from a Phase 2 study that showed treatment with blinatumomab (AMG 103) helped achieve a high-rate of complete response (CR) in 72 percent of adult patients with relapsed or refractory B-precursor acute lymphoblastic leukemia (ALL) treated in the study. Blinatumomab is the first of a new class of agents called bi-specific T cell engagers (BiTE) antibodies, designed to harness the body's cell-destroying T cells to kill cancer cells. Blinatumomab targets cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas, such as ALL. Full results of the study will be presented during an oral abstract session at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) on June 4 (Abstract Number 6500, 8:00 a.m. - 8:15 a.m. CDT, E354a).

In this Phase 2 single-arm dose-ranging trial, 26 of the 36 patients treated with blinatumomab across all of the tested doses and schedules achieved a CR with partial hematologic recovery (CRh*). All but two patients achieved a molecular response, meaning there was no evidence of leukemic cells by polymerase chain reaction. No treatment related deaths or serious adverse events (AEs) were reported in the study.

At the time of the analysis, median survival was 9.0 (8.2, 15.8) months with a median follow-up period of 10.7 months. In the group of patients who received the selected dose, median survival was 8.5 months. The median duration of response in the 26 patients who responded to treatment was 8.9 months.

"For these patients with limited treatment options, the remission rate observed in the trial is a vast improvement over the current standard of care," said Professor Max Topp, Department of Internal Medicine II, University of Wuerzburg and chair of the study. "These results also represent significant progress in our research of immunotherapies; a new approach to fighting cancer that we believe could make a real difference for patients."

For patients who received the selected dose and schedule, the most common adverse events were grade one or two and included pyrexia (70 percent), headache (39 percent), tremor (30 percent) and fatigue (30 percent). These were most frequently seen at the onset of treatment in cycle one. Reversible central nervous system events led to treatment interruptions in six patients with two patients permanently discontinuing treatment. Cytokine release syndrome led to treatment interruption in two patients.

In addition to the results from this study, data from studies of 12 Amgen investigational molecules and marketed products will be presented at the ASCO Annual Meeting. These include results from studies of the immunotherapy talimogene laherparepvec, pipeline molecules such asrilotumumab (AMG 102) and AMG 386, and marketed products. A complete listing of Amgen abstracts of interest can be found at http://www.amgen.com/media/amgen_asco_2012.html. Abstracts are available online at http://www.asco.org.

Phase 2 Study DesignThis Phase 2 dose-ranging study evaluated the efficacy, safety and tolerability of blinatumomab in adult patients with B-precursor ALL who had relapsed following treatment with standard front-line chemotherapy or allogeneic stem cell transplant. Patients received blinatumomab for 28 days followed by two weeks off therapy over a six week treatment cycle, for up to five treatment cycles. Patients received a continuous intravenous infusion of blinatumomab at an initial dose of five or 15 micrograms per meter squared per day, ranging up to 30 micrograms for the remainder of the treatment. The primary endpoint of the study was the rate of CR/CRh*. Secondary endpoints included molecular response rate, duration of response and overall survival. As of April 13, 2012, all 36 patients were evaluable for efficacy and safety.

About BlinatumomabBlinatumomab (AMG 103) is a bispecific T cell engager (BiTE) antibody designed to direct the body's cell-destroying T cells against target cells expressing CD19, a protein found on the surface of B-cell derived leukemias and lymphomas. The modified antibodies are designed to engage two different targets simultaneously, thereby juxtaposing T cells to cancer cells. Blinatumomab is the first of the BiTE antibodies and Amgen has received orphan drug designation from the U.S. Food and Drug Administration for the treatment of ALL, chronic lymphocytic leukemia (CLL), hairy cell leukemia, prolymphocytic leukemia and indolent B cell lymphoma and from the European Medicines Agency for the treatment of indolent B cell lymphoma, ALL, CLL and mantle cell leukemia (MCL).

About ALLAcute lymphoblastic leukemia (ALL) is an aggressive cancer of the blood and bone marrow the spongy tissue inside bones where blood cells are made. The disease progresses rapidly and affects immature blood cells, rather than mature ones.(1) Worldwide, ALL accounts for more than 12 percent of leukemia. Of the 42,000 people diagnosed worldwide, 31,000 will die from the disease.(2)Patients with ALL have abnormal white blood cells (lymphocytes) that crowd out healthy white blood cells, red blood cells and platelets, leading to infection, anemia (fatigue), easy bleeding and serious side effects.(3,4)

AboutAmgenAmgen discovers, develops, manufactures and delivers innovative human therapeutics. A biotechnology pioneer since 1980, Amgen was one of the first companies to realize the new science's promise by bringing safe, effective medicines from lab to manufacturing plant to patient. Amgen therapeutics have changed the practice of medicine, helping millions of people around the world in the fight against cancer, kidney disease, rheumatoid arthritis, bone disease and other serious illnesses. With a deep and broad pipeline of potential new medicines, Amgen remains committed to advancing science to dramatically improve people's lives. To learn more about our pioneering science and vital medicines, visit http://www.amgen.com/. Follow us on http://twitter.com/amgen.

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Amgen's BiTE® Antibody Blinatumomab (AMG 103) Achieved High Rate of Complete Response in Adult Patients With Relapsed ...