Category Archives: Companies

Neuralstem Announces First Patient Treated in ALS Stem Cell Trial

ROCKVILLE, Md., Jan. 21 /PRNewswire-FirstCall/ — Neuralstem, Inc. (NYSE Amex: CUR) announced that the first ALS patient was treated with its spinal cord stem cells yesterday at the Emory ALS Center at Emory University, in Atlanta, GA.  A total of up to 18 patients is planned to be treated in this first U.S. clinical trial to evaluate human neural stem cells for the treatment of ALS (Amyotrophic Lateral Sclerosis, or Lou Gehrig’s disease).  ALS affects roughly 30,000 people in the U.S., with about 5,600 new diagnoses per year, according to the ALS Association.

“The treatment of the first patient with our spinal cord stem cells represents a significant milestone for the Company,” said Neuralstem President and CEO, Richard Garr.

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International Stem Cell Corporation and Absorption Systems Announce Potential Stem Cell Alternative to Live Animal Testing for Corneal Damage

OCEANSIDE, Calif. & EXTON, Pa.–(BUSINESS WIRE)–International Stem Cell Corporation (OTCBB:ISCO)), the first company to perfect a method of creating human “parthenogenetic” stem cells from unfertilized eggs, announces positive results of its collaboration with Absorption Systems to study ISCO’s stem-cell-derived human corneal tissue as an alternative to live animals for drug testing. Initial results using non-animal or “in vitro” tests indicate an excellent correlation between the rates at which drugs pass through ISCO’s lab-grown corneal tissue and rabbit corneal tissue. The results offer great promise for reducing the use of living animals for eye safety testing. ISCO’s human corneal tissue is created from parthenogenetic stem cells in the laboratories of Lifeline Cell Technology (Walkersville, MD), ISCO’s wholly-owned subsidiary.

See Intlstemcell.blogspot.com for complete article.

Stem cell trial for ALS treatment gets FDA OK

From ChicagoTribune.com

A University of Michigan neurologist is the principal investigator for the first human clinical trial of a stem cell treatment for amyotrophic lateral sclerosis.

Dr. Eva Feldman has worked with a team of neurologists to develop the protocol for injecting neural stem into patients’ spinal cords. The cells are patented by Neuralstem Inc., a Rockville, Md.-based biotech company.

The U.S. Food and Drug Administration has approved Neuralstem’s plan to test the safety of the treatment for the fatal, untreatable neurodegenerative disorder commonly called Lou Gehrig’s Disease.

The initial phase to determine the safety of the treatment is to take place at Emory University in Atlanta.

Next Big Market: Adult Stem Cell Drugs and Therapies

Written by M.E.Garza, Biomedreports.com

According to a new report in Fortune Magazine, marketable therapies emerging from work in the (less controversial) adult stem space could be the next multi-billion dollar market.

Research on adult stem cells has generated a great deal of excitement. Adult stem cells have already been used successfully with patients: to treat cartilage defects in children; restore vision to patients who were legally blind; relieve systemic lupus, multiple sclerosis, and rheumatoid arthritis; and to serve as an aid in numerous cancer treatments.

Scientists have found adult stem cells in many more tissues than they once thought possible. This finding has led researchers and clinicians to ask whether adult stem cells could be used for transplants. In fact, adult hematopoietic, or blood-forming, stem cells from bone marrow have been used in transplants for 40 years. Scientists now have evidence that stem cells exist in the brain and the heart. If the differentiation of adult stem cells can be controlled in the laboratory, these cells may become the basis of transplantation-based therapies. These Adult stem cells can be harvested from many areas of the body, including the bone marrow, fat and peripheral blood. Once the cells have been harvested, they are sent to the lab where they are purified and assessed for quality before being reintroduced back in the patient. Since the stem cells come from the patient there is no possibility for rejection and they are used in transplants to treat diseases, such as cancers like leukemia.

According to various studies, stem cells isolated from a patient (i.e. from the bone marrow or fat) have the ability to become different cell types (i.e. nerve cells, liver cells, heart cells and cartilage cells). Studies have also shown that these are capable of “homing in” on and repairing damaged tissue. Researchers feel they are far closer to commercializing drugs based on adult stem cells than any product based on embryonic stem cells. In fact, many clinics outside of North America already tout stem cell based treatments to treat chronic diseases for which there are inadequate standard therapies. These clinics currently accept patients with Diabetes Type 2, Autoimmune Diseases, Multiple Sclerosis, Degenerative Joint Disease, Autoimmune Diseases as well as Rheumatoid Arthritis and Osteoarthritis. Unfortunately, patients seeking those treatments in other countries most often run the risk of parting with their money and being disappointed with the results.

Back in the states, Robin Young, a medical industry analyst from RRY Publications, estimates that gross sales of adult cellular therapies will be well over $100 million this year. By 2018, he says stem cell therapy revenues could grow to $8.2 billion.

“Adult derived cells are the ones that have been studied for the past 10 to 15 years and are ready for prime time,” says Debra Grega, the executive director of the Center for Stem Cell and Regenerative Medicine at Case Western Reserve University. “Large pharmaceutical companies are now wanting to get into the adult stem cell therapeutic area. That indicates to me that there is enough safety and enough efficacy that they are willing to put money in.”

Pharmaceutical giant Pfizer (NYSE:PFE)  announced in November that it would invest up to $100 million in regenerative research, which would include both adult and embryonic stem cell research, over a three to five year period.

The overall stem cell market, however, is still quite small. The California-based outfit Geron (NASDAQ:GERN) dominates the embryonic stem cell market, and is perhaps 10 years away from commercializing a spinal cord treatment based on its research.

The frontrunner in the adult stem cell space, according to Forbes, is Osiris Therapeutics, Inc.(NASDAQ:OSIR)- currently trading at $14.20 per share. Genzyme Corp. (NASDAQ:GENZ) has signed a partnership alliance with Osiris Therapeutics to develop two  late-stage adult stem cell treatments — Prochymal and Chondrogen — thought to be useful to treat a variety of diseases by controlling inflammation, promoting growth of new tissue and preventing scars. The deal will pay Osiris $130 million upfront ($75 million initially and the difference to be paid on July 1, 2009).  Assuming the drugs reach the marketplace, Genzyme will pay up to $1.25 billion in development, regulatory and sales milestone payments.

Osiris is focused on developing and marketing products to treat medical conditions in the inflammatory, orthopedic, and cardiovascular areas. Their principal biologic drug candidate, Prochymal, is being evaluated in Phase III clinical trials for three indications, including acute and steroid refractory Graft versus Host Disease (GvHD), Crohn’s disease and for the repair of gastrointestinal injury resulting from radiation exposure, and is the only stem cell therapeutic granted both Orphan Drug and Fast Track status by the United States Food and Drug Administration (FDA). Prochymal is also being developed for the repair of heart tissue following a heart attack, for protection of pancreatic islet cells in patients with type I diabetes, and for the treatment of Chronic Obstructive Pulmonary Disease (COPD). The FDA could approve within a year which fights a painful illness called “graft-versus-host disease” which afflicts transplant recipients.  If they succeed, Osiris would be the first company to gain approval for a stem cell drug. Osiris will commercialize both drugs in the U.S. and Canada, and Genzyme will sell the drugs in all other countries.

Investors should be aware that there are only a limited number of stocks which are pure plays or semi-pure plays in the stem cell industry. Below are some of the companies working in the adult stem cell medicine space:

StemCells, Inc.(NASDAQ:STEM) – a company is engaged in the discovery and development of cell-based therapeutics to treat damage to, or degeneration of, major organ systems. Currently trading at $1.60 with a market cap of $164.09M.

Cytori Therapeutics Inc. (NASDAQ:CYTX) which develops, manufactures, and sells medical technologies to enable the practice of regenerative medicine. The Company’s commercial activities are focused on cosmetic and reconstructive surgery in Europe and Asia-Pacific, and stem and regenerative cell banking (cell preservation) in worldwide. Its product pipeline includes the development of new treatments for cardiovascular disease, spinal disc degeneration, gastrointestinal disorders, liver and renal disease and pelvic health conditions. They currently trade at $3.55 with a market cap of $121.02M.

Aastrom Biosciences, Inc.(NASDAQ:ASTM) engaged in the development of autologous cell products for the repair or regeneration of human tissue. The Company’s tissue repair cell (TRC) technology involves the use of a patient’s own cells to manufacture products to treat a range of chronic diseases and serious injuries affecting vascular, bone, cardiac and neural tissues. Aastrom’s TRC-based products contain increased numbers of stem and early progenitor cells, produced from a small amount of bone marrow collected from the patient. Late last month, the company made headlines after temporarily suspending enrollment and patient treatment in its U.S. Phase II IMPACT-DCM clinical trial following a report that a patient died at home after being released from the hospital following treatment in the trial. The stock trades at $0.36 pps with a market cap of $58.44M.

ThermoGenesis Corp.(NASDAQ:KOOL) designs, manufactures and markets automated and semi-automated devices and single-use processing disposables that enable hospitals and blood banks to manufacture a therapeutic dose of stem cells, wound healing proteins or growth factors from a single unit of cord blood or the patient’s own blood in less than one hour. They currently trade at just under $0.70 and have a market cap of $37.02M.

Opexa Therapeutics, Inc. (Nasdaq:OPXA) is a biopharmaceutical company developing autologous cellular therapies with the potential to treat major illnesses, including multiple sclerosis (MS) and diabetes. The Company has a global license from Baylor College of Medicine (or Baylor) to an individualized T-cell therapeutic vaccine, Tovaxin, which is in clinical development for the treatment of MS. MS is the result of a person’s own T-cells attacking the myelin sheath that coats the nerve cells of the central nervous system (CNS). Shares currently trade under $0.60 with a market cap of $7.29M.

At BioMedReports, we will continue to explore this potentially bountiful market within the healthcare sector in coming weeks, as it sounds like investors would greatly benefit from insight into the current marketplace.

“From a Wall Street perspective, adult stem cells are a much better investment,” said Stephen Dunn of Dawson James Securities.”

Reversal of Stem Cell Research Ban: 13 Stocks to Benefit

From SeekingAlpha.com

Earlier this week President Obama signed an executive order lifting the ban on federal funding for embryonic stem-cell research. In his speech made to the American people, he explained that scientific decisions must be “based on facts, not ideology.”

Back in 2001, President Bush moved to restrict federal funding for human embryonic stem cell research, making it the subject of his first prime-time televised speech from the White House. Now, Obama has flipped the tables with one swipe of the pen, a prospect that pleases many Democrats in the Congress. “Signing this executive order sends a clear signal around the world that our nation supports research based on science, not politics,” said Rep. Jim Langevin of Rhode Island, a strong backer of stem cell research.

While the Left argue that stem-cell research offers hope for millions of people suffering with debilitating conditions, right-to-life groups hotly oppose this move by the President because they equate it to murder.

This is clearly a very controversial topic. But for the time being, President Obama’s reversal this week of President Bush’s anti-embryonic stem cell policy has turned to the side of science and medicine. And while there is considerable uncertainty as to the ultimate benefits from embryonic stem-cells, companies involved in this research are going to clearly reap the benefits of this change in leadership and policy for at least the next four years.

There are only a limited number of stocks which are pure plays or semi-pure plays in the stem cell industry. However, with the reversal of this ban, this could become a very huge industry. The following list includes stocks that investors should keep on their radars.

Aastrom Biosciences (ASTM) – Aastrom Biosciences is involved in the development of cell products for the regeneration or repair of human tissues, based on its proprietary Tissue Repair Cell [TRC] technology.

Advanced Cell Technology (ACTC) – ACTC is involved in the development and marketing of human stem cell technology in the area of regenerative medicine and stem cell therapy.

Alexion Pharmaceuticals (ALXN) – Alexion Pharmaceuticals is involved in the development of biologic therapeutic products for the treatment of hematologic and cardiovascular disorders, autoimmune diseases, and cancer.

ARIAD Pharmaceuticals (ARIA) – Ariad is involved in the development of medicines for the treatment of cancer by regulating cell signaling with small molecules. Their cancer products are used to treat sarcomas, hormone refractory prostate cancer, and endometrial cancer.

BioTime, Inc. (BTIM) – BioTime develops blood plasma volume expanders and blood replacement solutions for hypothermic (low temperature) surgery, and organ preservation solutions and technology for use in surgery, emergency trauma treatment, and other applications.

Celera Group (CRA) – This NYSE company, founded in 1937, is involved in the discovery and validation of new diagnostic markers, using proprietary genomics and proteomics discovery platforms and diagnostic products based on those markers.

Cellgene (CELG) – Cellgene is involved in the discovery, production, and marketing of therapies designed to treat cancer and immune-inflammatory-related diseases. Their primary product includes THALOMID, for the treatment of erythema nodosum leprosum. Last year, the company received patent on placental stem cell recovery.

Cord Blood America Inc. (CBAI) – CBAI provides private cord blood stem cell preservation services to families in the United States. The company also engages in the collection, testing, processing, and preservation of peripheral blood and adipose tissue stem cells, which allows individuals to privately preserve their stem cells for potential future use in stem cell therapy.

Dendreon Corporation (DNDN) – This company is involved in the discovery, development, and marketing of active immunotherapies, monoclonal antibodies, and small molecule product candidates to treat cancer. They manufacture the DACSÒSC stem cell enrichment device.

Geron (GERN) – This Menlo Park, California company develops cell-based therapies derived from human embryonic stem cell platforms for treatment of various diseases.

Integra Lifesciences Holdings (IART) – Integra develops, manufactures, and sells medical devices, implants, biomaterials, and instruments to the neurosurgery, surgery, and soft tissue repair markets.

Invitrogen Corporation (IVGN) – Invitrogen sells products and services which support academic and government research institutions, pharmaceutical companies and biotechnology companies, including tools for gene acquisition, gene cloning, gene expression,

StemCells Inc. (STEM) – This Palo Alto company is involved in the discovery and development of adult stem cell therapeutics for treating damage to the central nervous system, liver, and pancreas.

Video – International Stem Cell Corporation CEO Ken Aldrich

International Stem Cell Corporation is a California company that has developed breakthrough human stem cell lines that promise to eliminate the rejection of transplanted cells by the patients immune system.

International Stem Cell Corporation Chairman and CEO Ken Aldrich

Geron gets FDA OK for embryonic stem-cell based therapy

From BizJournals.com

The U.S. Food and Drug Administration has granted clearance of an investigational new drug application that lets Geron Corp. move forward with the world’s first study of a human embryonic stem cell based therapy in man, the company said late Thursday.

Menlo Park-based Geron (NASDAQ:GERN) said it plans to initiate a Phase I multi-center trial that is designed to establish the safety of the drug GRNOPC1 in patients with “complete” American Spinal Injury Association grade A subacute thoracic spinal cord injuries.

“The FDA’s clearance of our GRNOPC1 IND is one of Geron’s most significant accomplishments to date,” said Dr. Thomas B. Okarma, Geron’s president and CEO. “This marks the beginning of what is potentially a new chapter in medical therapeutics — one that reaches beyond pills to a new level of healing: the restoration of organ and tissue function achieved by the injection of healthy replacement cells.”

The ultimate goal for the use of GRNOPC1 is restore spinal cord function by injecting hESC-derived oligodendrocyte progenitor cells directly into the patient’s injured spinal cord.”

Geron funded the original research at the University of Wisconsin-Madison that led to the first isolation of hESCs. The production of oligodendrocytes from hESCs is covered by patent rights licensed to Geron from the University of California.

TAP Launches Unique Automated Stem Cell Picker at Stem Cells World Congress To Help Researchers Rapidly Select Stem Cells of Consistent Quality

SOURCE: The Automation Partnership

CAMBRIDGE, England, Jan 20, 2009 (BUSINESS WIRE) — The Automation Partnership (TAP), a world leading supplier of innovative automation for life science today announced CellCelector(TM), the world’s first commercial automated stem cell picker is on show at the Stem Cells World Congress in Palm Springs, USA.

CellCelector consists of an inverted Olympus microscope, robotic arm and liquid handling station all fully integrated to powerful image acquisition and analysis software. This walk away system allows researchers to set parameters for cell or colony types they want (including size, proximity to other colonies or roundness). The picking tool on the robotic arm gently picks and dispenses cells into a microplate well in just 30 seconds. CellCelector benefits researchers by reducing the time and effort required for this challenging task and assuring the cells chosen are of consistent quality.

CellCelector can fit into any standard laminar flow hood, thus ensuring cells remain contamination free. The system can also be fitted with an autoclave compatible metal tool for scraping adherent cells or a disposable glass capillary for picking single cells, both of which are designed with features for maintaining cell integrity and viability.

CellCelector, developed by German cell biology automation specialists, Aviso is being successfully used in prestigious universities and institutes across Europe with murine and human stem cells. The system, now available in the USA and Canada, exclusively from TAP will also be shown on Booth 437, LabAutomation 2009, Palm Springs, USA.

David Newble, TAP’s CEO Designate, states: “TAP has been renowned for supplying automated cell culture technology for 20 years. We are excited to be partnering with Aviso to continue expanding TAP’s expertise into stem cell applications. The Aviso CellCelector complements our automated cell culture products, such as CompacT SelecT and like them, CellCelector will ensure researchers can increase throughput and improve the quality of their stem cells.”

The Automation Partnership
Matthew Walker, Head of Communications
Tel: +44 (0) 1763 227200
Fax: +44 (0) 1763-227201
matthew.walker@automationpartnership.com