Stem cell therapies developer Gamida Cell Ltd. has raised $10 million in its fifth financing round from all its investors. The company will use the proceeds to support the global commercialization of its lead cell therapy product, StemEx, as an alternative therapeutic treatment for patients with blood cancers, such as leukemia and lymphoma, who can be cured by bone marrow transplantation but do not have a matched bone marrow donor.

Gamida Cell is developing StemEx with Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA), and it is seeking a strategic partner for the product’s global commercialization.

The company will also use the proceeds for the further development of other products, primarily a clinical trial of its NiCord treatment for sickle cell anemia and thalassemia.

Gamida Cell chairman Reuven Krupik said, The investors were unanimous in their decision to reinvest, understanding the importance of bringing StemEx to market as well as maintaining the companys leadership role in the stem cell industry. Gamida Cell is a game changer.”

Gamida Cell completed enrollment for a pivotal Phase III clinical trial of StemEx in February, and expects results in the fourth quarter. The company plans to launch the product in 2013, and it could be the first allogeneic stem cell product in the market.

The company’s current investors include Elbit Imaging Ltd. (Nasdaq: EMITF; TASE: EMIT), Clal Biotechnology Industries Ltd. (TASE: CBI), Israel Healthcare Venture, Teva, Amgen, Denali Ventures and Auriga Ventures.

Published by Globes [online], Israel business news – www.globes-online.com – on May 15, 2012

Copyright of Globes Publisher Itonut (1983) Ltd. 2012

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Stem cell co Gamida Cell raises $10m

Public release date: 15-May-2012 [ | E-mail | Share ]

Contact: Elisa Williams willieli@ohsu.edu 503-494-4530 Oregon Health & Science University

PORTLAND, Ore. Multiple myeloma patients are better equipped to halt progression of this blood cancer if treated with lenalidomide, or Revlimid, following a stem cell transplant, according to a study co-authored by a physician with the Oregon Health & Science University Knight Cancer Institute.

The study, published in the New England Journal of Medicine, found a 63 percent reduction in the risk of progressive myeloma or death for the stem cell transplant patients that were treated with lenalidomide maintenance therapy.

“These results add to the evidence that the combination of standard therapies such as stem cell transplantation with the emerging biologic therapies, like lenalidomide, have extended the lives of multiple myeloma patients,” said Richard Maziarz, M.D., of the OHSU Knight Cancer Institute who was one of the study’s co-authors. Maziarz serves as medical director of the Adult Stem Cell Transplantation Program & Center for Hematologic Malignancies at the OHSU Knight Cancer Institute. “We know that for at least three years following a transplant that maintenance therapy with this drug vastly improves the chances that the cancer won’t come back and worsen.”

These data were supported by similar Phase III studies reported from France and Italy in the same issue of the New England Jounal of Medicine demonstrating that maintenance therapy after stem cell transplantation was associated with improved disease control.

Multiple myeloma is a cancer that affects plasma cells, a type of white blood cell normally responsible for producing antibodies. In patients impacted by multiple myeloma, collections of abnormal plasma cells accumulate in the bone marrow, interfering with the production of normal blood cells. The study focused on patients who received an autologous hematopoietic cell transplant (AHCT). AHCT procedures use patients’ own blood stem cells.

While lenalidomide increased a patient’s ability to stave off progression of the disease, questions remain regarding future approaches recognizing that quality of life measurements were not incorporated within these studies, that long-term safety issues remain unclear as there was a small but discernable risk of second cancers observed in the treated patients. In addition to the need for that cost-benefit analysis, a comparison remains to be performed with other emerging myeloma maintenance therapies.

This Phase III study of lenalidomide was conducted at 47 medical centers and involved 568 patients. It was sponsored by the National Cancer Institute (NCI). Revlimid’s manufacturer, Celgene Corp., provided the NCI with lenalidomide for this research.

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Lenalidomide prolongs disease control for multiple myeloma patients after stem cell transplant

SEBASTIAN Toby, a 6-year-old golden retriever, loves to run and play catch. And Oreo, a 12-year-old border collie mix, also is a bundle of energy.

Movement for both dogs got easier about a month ago when they received a revolutionary stem cell treatment at the Highlands Animal Hospital.

Veterinarian Marcus Kramer performed the successful transplant procedures, which were developed by Kentucky-based MediVet-America.

Both dogs had been in significant pain with a restricted range of motion, as shown on X-rays.

“It’s made a big difference,” said Kramer. “The really amazing thing is that they both healed so quickly. Both dogs had problems with their hips and were suffering from osteoarthritis. Just 30-days later, they are able to walk and run again.”

Adult animal stem cell technology uses the pet’s own regenerative healing power to treat dogs, cats and horses suffering from arthritis, hip dysplasia and tendon, ligament and cartilage injuries. Under anesthesia, Kramer removed about 40 grams of fat from each dog and separated the stem cells from the fat. He then activated the stem cells under an LED light, and injected them back into the dogs.

Stem cell therapy allows an animal to get off pain and anti-inflammatory drugs, Kramer said. MediVet-America’s therapy is done entirely at the animal hospital in about three hours, and costs about $1,800 for dogs and $2,400 for horses. That compares to thousands of dollars that pet owners could expect to pay for medication over a pet’s lifetime.

Erica Kent, a spokesman for MediVet-America, said using the LED light is integral to the patented-process, because the light helps to awaken stem cells and makes them more active. The three-color light stimulates millions of dormant cells to initiate repair from the moment the cells are injected into the animal’s body, according to the MediVet-America website.

The company is also offering a program that allows pet owners to bank stem cells when animals are younger to use if their pet develops illnesses like arthritis in old age.

STEM CELL THERAPY

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Sebastian veterinarian performs stem cell treatment for pets

Friends of John Glaser, the former superintendent of the Napa Valley Unified School District, are seeking stem cell donors to help with his medical treatment.

Glaser is dealing with two cancers: Multiple myeloma and leukemia. He is in need of a second stem cell transplant, his supporters said.

Potential donors can request a cheek swab kit online, and mail the swab in to be registered in the worldwide pool of stem cell donors. To qualify for the registry, a person needs to be between the ages of 18 and 60 and in good health.

Those who match Glaser or another transplant patient would be asked to go to a nearby lab for a blood draw and have their blood cells further analyzed.

People who are chosen as donors would then return to the lab for a blood donation, where the stem cells would be extracted and their blood would be returned to them. The process takes three to four hours.

For more information on how to donate stem cells, visit marrow.org.

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Stem cell donors needed for former schools superintendent

When regenerative medicine firm Cytomedix (OTC:CMXI) acquired biotechnology company Aldagen, the stem cell-based stroke treatment in clinical trials was the centerpiece of the all stock deal.

Cytomedix is now making moves to develop other stem cell treatments from its Aldagen acquisition. Two more clinical trials will start later this year, CEO Martin Rosendale told analysts on a conference call to discuss first-quarter financial results. Rosendale wouldnt identify the indications that will be studied, and said only that they will be announced this summer: one for an arterial disease and the other a neurological condition.

Cytomedixs goal is to ultimately find large pharmaceutical partners to commercialize these treatments. These additional clinical studies dont represent those kinds of partnerships. Rosendale said there are two facilities that will conduct investigator-led clinical trials. But those trials will be funded by outside sources, not by Cytomedix.

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Two stem cell therapies from Cytomedix to start trials; stroke study expands

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QualityStocks News – International Stem Cell Scientists to Present Pre-Clinical Research Results at Gene and Cell …

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

CARLSBAD, Calif.–(BUSINESS WIRE)–

International Stem Cell Corporation (OTCBB: ISCO.OB – News) (www.internationalstemcell.com) today announced financial results for the three months ended March 31, 2012.

Three Months ended March 31, 2012

Consolidated net revenues for the three months ended March 31, 2012 were $1.08 million compared to $1.52 million in the corresponding period a year ago. The year-over-year decrease in revenues is due to fewer sales generated from the Lifeline Skin Care (LSC) direct sales channel, partially offset by higher Lifeline Cell Technology (LCT) sales generated from larger distributors. LSC and LCT accounted for 51% and 49% of total revenue in the three months ended March 31, 2012 compared to 75% and 25%, respectively, in the comparable period a year ago.

For the three months ended March 31, 2012, development expenses were $3.80 million, representing a decrease of approximately 5% compared to the corresponding period in 2011. The decrease primarily reflects lower general and administrative expenses resulting from decreased stock-based compensation expense and lower laboratory-related expenses. The decrease was partially offset by higher cost of sales ratio resulting from increased sales concentration of lower margin products, and higher marketing and selling expense related to LSC. The Company continued to invest in its sales and marketing infrastructure, including significant enhancements to the e-commerce platforms, increased advertising and strengthening the sales and customer service organization.

Cash and cash equivalents at March 31, 2012 were $6.01 million compared to $1.34 million at December 31, 2011, reflecting an increase of $4.67 million resulting from two financing transactions including the issuance of shares of Series G preferred stock for $5.00 million and issuance of shares of common stock for a total of $2.08 million in the first quarter of 2012.

Q1 2012 Business Highlights:

The Company continued to focus its research and development efforts on the creation of additional parthenogenetic stem cell lines for therapeutic use and on the advancement of the disease area research programs, particularly pre-clinical in vivo safety and efficacy studies in Parkinsons disease and new methods for high-throughput cell culture and stem cell differentiation.

ISCOs wholly-owned subsidiary Lifeline Skin Care drove sales by expanding acquisition of both retail and trade customers, increasing the average order value and enhancing customer loyalty and retention. New retail customers were attracted by an increased social media presence and national exposure on TV shows such as ABCs The Talk and the use of risk-free introductory offers and free sample promotions. In addition, LSC continued to increase the number of strategic marketing partnerships. Although LSC revenue for the quarter was lower than the same period in 2011, the sales were generated from more diversified sources with much greater growth potential and reduced reliance on individual third parties.

Lifeline Cell Technology, ISCOs wholly-owned subsidiary specialized in cells and media research products, grew revenue across all three sales channels including domestic, international and OEM, showing a 39% increase over the same quarter of 2011.

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International Stem Cell Corp Announces First Quarter 2012 Financial Results and Business Highlights

NEWTON, Mass., May 14, 2012 /PRNewswire/ –Parcell Laboratories, a leading adult stem cell company based in Newton, MA, was awarded the prestigious 2012 Innovation Award by the Smaller Business Association of New England (SBANE). Parcell joins the select list of winning companies from the last 26 years whose innovations have delivered proven value to customers.

SBANE uses its highly competitive Innovation Awards program to showcase technology driven enterprises that are potentially “game changers” in their markets. Parcell’s ELA stem cell technology is a platform technology that has unlimited applications for tissue regeneration and is positioned to change the face of regenerative medicine. “We are honored to have been recognized by SBANE for our accomplishments and to be included among the roster of extremely successful companies that have been previous winners of the award,” said Pamela Layton, the CEO of Parcell Laboratories. “The award is a testament to the dedication and tenacity of our terrific team.” Past award winners include some of the most recognizable names in New England business, including Staples, Genzyme, Ben & Jerry’s and Nantucket Nectars.

Parcell Laboratories holds the license and intellectual property to the ELA stem cell, which is considered to be the earliest lineage adult stem cell in the adult body. The cell is able to differentiate into all tissues and has the added benefit of being immune privileged, allowing it to be implanted without the risk of rejection. Parcell’s ELA cells are being used by surgeons nationwide to enhance bone regeneration in the aging spine. The product is marketed under the name of PureGen Osteoprogenitor Cell Allograft by Alphatec Spine of Carlsbad, CA. Parcell is also in the development phase of therapeutics using the ELA stem cell for disc and cartilage repair.

Press Contact Susan Kinslow Kinslow@parcelllabs.com +617-928-9803

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Parcell Laboratories Honored as 2012 SBANE Innovation Award Winner

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