Japanese Firm Luring Investors With Nobel-Winning Technology

Retina Institute Japan K.K., which is employing Nobel Prize-winning stem-cell technology to treat eye diseases, plans to sell a stake in itself to a group of Japanese companies next month ahead of a possible initial public offering in five years.

The company, based in Fukuoka City, Japan, will raise 1 billion yen ($10.2 million) from the sale to fund development of a treatment for age-related macular degeneration -- a leading cause of blindness in the elderly -- using technology developed by Riken, Japans state-controlled research institute, Chief Executive Officer Hardy Kagimoto said in an interview.

After raising about 32 billion yen so far from investors, Retina is developing technology from a discovery that won Shinya Yamanaka, a professor at Kyoto University, the Nobel Prize for medicine in October. Yamanaka discovered a way to turn ordinary skin cells into what are called induced pluripotent stem, or iPS, cells.

The development of retina treatment with iPS cells can lead to development of the cell-utilized therapies for a wide range of diseases, said Akitsu Hotta, an assistant professor at Kyoto University who studies stem cells. Retinas commercialization of the technology will be a big milestone.

Retina last month estimated the potential market for its treatments at $21 billion.

The sale of a 3 percent stake values Retina at 33 billion yen. Dainippon Sumitomo Pharma Co. (4506), which paid 1.5 billion yen for 5 percent of Retina, jumped as much as 8 percent in Tokyo trading the day after that deal was announced in March.

Shin Nippon Biomedical Laboratories Ltd. (2395), which said April 9 that it plans invest 300 million yen in Retina, jumped as much as 12 percent today. Tella Inc. (2191), which is buying 100 million yen of shares in the company, was up 7.4 percent. Both stocks have more than quadrupled over the past six months.

Investors are rushing to buy shares of companies that are involved in stem-cell therapy and treatment technologies, said Tsutomu Yamada, a Tokyo-based analyst at Kabu.com Securities Co.

Kagimoto, 36, declined to name the companies participating in the current round of fundraising and said he has no plans to sell shares to local or foreign private equity firms.

Retina is targeting an IPO in five years in Japan and the U.S. to finance commercialization of the treatment, said Kagimoto, whos also a medical doctor. The company will conduct a clinical trial in Japan for treatment for age-related macular degeneration, and similar testing in the U.S., he said.

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Japanese Firm Luring Investors With Nobel-Winning Technology

Sen. Carrell to receive stem cell transplant soon

OLYMPIA, Wash.

Republican state Sen. Mike Carrell, who has a blood condition and has been hospitalized since last month, will receive a stem cell transplant from his brother next week.

In an email sent to constituents this week, Carrell says he started initial treatment on Wednesday at the Seattle Cancer Care Alliance. He said that the 100-day process begins with low doses of chemotherapy to lower his body's defenses and help increase his chances that next Tuesday's procedure will be successful.

Earlier this year, Carrell was diagnosed with myelodysplastic syndrome, also known as pre-leukemia. The chronic disease affects blood-forming stem cells.

Carrell was hospitalized last month after contracting a complicating illness while serving in Olympia, and he has not been back to the Capitol since. Republican leaders have said he would only be called back to the Legislature if his presence is needed for a crucial vote. Lawmakers are nearing the end of the 105-day session, which is set to end on April 28.

Carrell said he'll first undergo a low dose of full-body radiation, and then within a few hours will be injected with his brother's stem cells.

"Doctors are hopeful that my brother's healthy stem cells will march in and take over for the weakened marrow cells in my body," he wrote.

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Sen. Carrell to receive stem cell transplant soon

Stem cell senescence drives aging, study suggests

Apr. 18, 2013 Declining levels of the protein BubR1 occur when both people and animals age, and contribute to cell senescence or deterioration, weight loss, muscle wasting and cataracts. Mayo Clinic researchers have shown that adult progenitor or stem cells -- important for repair and regeneration of skeletal muscle and maintenance of healthy fat tissue -- are subject to cellular senescence, and that clearance of these cells limits age-related deterioration of these tissues.

The findings appear today online in the journal Cell Reports.

BubR1 is an essential part of the mitotic checkpoint, the mechanism controlling proper cell division or mitosis. Without sufficient levels of BubR1, chromosomal imbalance will occur, leading to premature aging and cancer. Using mutant mice that expressed low levels of BubR1, the researchers found development of dysfunctional tissue with impaired cell regeneration. In analyzing the progenitor populations in skeletal muscle and fat, they found that a subset of progenitors was senescent and that the tumor suppressor p53 was acting to prevent this from happening through activation of p21.

"Earlier we discovered that senescent cells accumulate in tissues with aging and that removal of these cells delays age-related functional decline in these tissues," says Jan van Deursen, Ph.D., a Mayo Clinic molecular biologist and senior author of the study. "The key advance of the current study is that the progenitor cell populations are most sensitive for senescence, thereby interfering with the innate capacity of the tissue to counteract degeneration."

Not only do the findings contribute to knowledge on cell senescence as it relates to aging and related diseases, but understanding the mechanisms may lead to future therapies, say the researchers.

Co-authors include Darren Baker, Ph.D., and Robbyn Weaver both of Mayo Clinic.

The research was supported by the Ellison Medical Foundation, the Noaber Foundation, the National Institutes of Health (CA96985 and AG41122), and the Mayo Clinic Robert and Arlene Kogod Center on Aging.

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VATICAN: A girl whose bones used to break every two months was awarded for her courage in successfully battling her disease during a stem cell research conference at the Vatican.

It feels amazing to win an award like this, said Elizabeth Lobato, who was given the Pontifical Hero Award April 11 at the Second International Adult Stem Cell Conference in Vatican City.

I heard I was the first to get this award from Rome and thats awesome, said the 14-year-old in an interview with CNA.

Elizabeth was diagnosed with osteogenesis imperfecta, commonly known as brittle bone disease, when she was just 10 months old. People affected by illness - which is caused by a genetic defect - often suffer from muscle weakness, hearing loss, loose joints, curved bones, scoliosis, brittle teeth and short stature.

But the teenager has grown over 13 inches since she began the adult stem cell treatment that involves her receiving bone marrow-derived stem cells from her father.

The teenager, still small for her age and currently in a wheelchair, is in Rome with her parents attending a conference promoting adult stem cell research.

The conference began April 11 at the Vaticans New Synod Hall under the co-sponsorship of the Pontifical Council for Culture and the New York City-based Stem for Life Foundation.

The first gathering was held back in Nov. 2011, but as the group of physicians, philanthropists and patients assembled in the Vatican hall today, the sense of excitement was palpable.

Since then it seems the entire world has awakened to a simple reality that adult stem cell therapies have the potential to usher in a new era of health and healing, said Doctor Robin Smith, chairman and president of the Stem for Life Foundation.

Adult stem cell therapies hold the promise to vanish countless diseases and dangerous medical conditions, to turn the tide of human suffering, to transform modern-day health care from one that focuses on managing symptoms to one that develops cures, she said.

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Neuralstem Obtains FDA Approval To Begin Phase II Stem Cell Trial In ALS

By RTT News, April 17, 2013, 08:11:00 AM EDT

(RTTNews.com) - Neuralstem Inc. ( CUR ) announced Wednesday that it has received approval from the Food and Drug Administration or FDA to commence a Phase II trial using NSI-566 spinal cord-derived human neural stem cells in the treatment of amyotrophic lateral sclerosis or ALS or Lou Gehrig's disease.

The company noted that the Phase II dose escalation and safety trial will expand to two centers, Emory University Hospital in Atlanta, Georgia, where Phase I was recently completed, and ALS Clinic at the University of Michigan Health System, in Ann Arbor, Michigan, subject to approval by the Institutional Review Board at each institution.

According to the company, The trial is designed to treat up to 15 patients, in five different dosing cohorts. All of the patients will be ambulatory and reside within close geographic proximity to the research center where they will participate. The first 12 patients will receive injections in the cervical region of the spinal cord only, where the stem cells could help preserve breathing function. The final three patients will receive both cervical and lumbar injections.

"The aim of this Phase II trial is to obtain the maximum tolerated dose using the same route of administration as in Phase I, which was through direct injections into the gray matter of the spinal cord," said Karl Johe, PhD, Neuralstem Chairman and Chief Scientific Officer.

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Neuralstem Obtains FDA Approval To Begin Phase II Stem Cell Trial In ALS

Neuralstem Receives FDA Approval To Commence Phase II Stem Cell Trial In Amytrophic Lateral Sclerosis

ROCKVILLE, Md., April 17, 2013 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR) announced that it has received approval from the Food and Drug Administration (FDA) to commence a Phase II trial using NSI-566 spinal cord-derived human neural stem cells in the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). This Phase II dose escalation and safety trial will expand to two centers, Emory University Hospital in Atlanta, Georgia, where Phase I was recently completed, and ALS Clinic at the University of Michigan Health System, in Ann Arbor, Michigan, subject to approval by the Institutional Review Board at each institution. The trial is designed to treat up to 15 patients, in five different dosing cohorts. All of the patients will be ambulatory and reside within close geographic proximity to the research center where they will participate. The first 12 patients will receive injections in the cervical region of the spinal cord only, where the stem cells could help preserve breathing function. The final three patients will receive both cervical and lumbar injections.

(Logo: http://photos.prnewswire.com/prnh/20061221/DCTH007LOGO )

"The aim of this Phase II trial is to obtain the maximum tolerated dose using the same route of administration as in Phase I, which was through direct injections into the gray matter of the spinal cord," said Karl Johe, PhD, Neuralstem Chairman and Chief Scientific Officer. "As a result of the excellent safety and tolerability demonstrated in Phase I, we will be able to proceed more aggressively in Phase II. In Phase I, we started with just five injection sites per patient, and advanced to a maximum of 15 injections of 100,000 cells each. In Phase II, we will advance up to a maximum of 40 injections, and 400,000 cells per injection based on safety.

"Finally, we will be adding another center, the University of Michigan, where the trial will be under the direction of study principal investigator, Dr. Eva Feldman, and site investigator, Dr. Parag Patil," Dr. Johe concluded. "We are also delighted to continue the trial where it originated, at Emory, under the direction of site principal investigator, Dr. Jonathan Glass. We want to thank the patients and their families who have so bravely taken part in the trial so far and continue to support our efforts."

"We are delighted to bring this trial to Michigan, where the research for this clinical trial originated," said Eva Feldman, MD, PhD, Director of the A. Alfred Taubman Medical Research Institute and Director of Research of the ALS Clinic at the University of Michigan Health System. "In Phase I, we demonstrated that the therapy appeared to interrupt progression of the disease in one subgroup of patients over a long period of time. We are eager to advance this trial to the next phase, using considerably more cells to assess the impact and safety." Dr. Feldman is an unpaid consultant to Neuralstem.

"Emory is proud to have conducted the pioneering Phase I trial where we successfully completed 18 transplants in 15 patients, and saw that the cells and the surgical technique were well-tolerated, and that the cells survived, long-term," said Jonathan Glass, MD, Director of the Emory ALS Center. "These are critical elements required for any cell therapy to help this patient population. We are looking forward to progressing the dosage to the maximum safe tolerated dose, where we could also hope to see meaningful effects for the patients."

About Neuralstem

Neuralstem's patented technology enables the ability to produce neural stem cells of the human brain and spinal cord in commercial quantities, and the ability to control the differentiation of these cells constitutively into mature, physiologically relevant human neurons and glia. Neuralstem completed an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, in February 2013, and has received FDA approval to begin Phase II. Neuralstem has been awarded orphan status designation by the FDA for its ALS cell therapy.

In addition to ALS, the company is also targeting major central nervous system conditions with its NSI-566 cell therapy platform, including spinal cord injury, ischemic stroke and glioblastoma (brain cancer). The company received approval to commence a Phase I safety trial in chronic spinal cord injury in January 2013.

Neuralstem also has the ability to generate stable human neural stem cell lines suitable for the systematic screening of large chemical libraries. Through this proprietary screening technology, Neuralstem has discovered and patented compounds that may stimulate the brain's capacity to generate new neurons, possibly reversing the pathologies of some central nervous system conditions. The company is in a Phase Ib safety trial evaluating NSI-189, its first neurogenic small molecule compound, for the treatment of major depressive disorder (MDD).Additional indications could include traumatic brain injury (TBI), Alzheimer's disease, and post-traumatic stress disorder (PTSD).

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Stem Cell Facelift – Do the Results Match the Hype?

A recent New York Times article examines the legitimacy of doctors' claims that stem cell facelifts effectively reduce the visual signs of aging. Dr. Simon Ourian of Epione Beverly Hills is skeptical of the anecdotal evidence reported to date.

Los Angeles, California (PRWEB) April 17, 2013

As reported by the Times, the stem cell facelift harvests fat from the thigh, stomach or other area with excess fat, then separates out stem cells to boost the effectiveness of injections around the eyes, the hollows of the cheeks or another part of the face that is lacking volume. For stem cell facelift opponents, the main issue is not necessarily stem cell use. Rather, they simply claim that all success is anecdotal and cannot be attributed directly to the stem cells.

I definitely fall into the skeptics camp, says Dr. Ourian, Medical Director of Epione Beverly Hills. Until there is verifiable, scientific data I dont plan on introducing this procedure to my practice and patients.

The article goes on to say that some are skeptical, believing that many doctors who promise great results simply remove fat, spin it a bit in a centrifuge and inject it into the face. This line of thinking considers the treatment a form of decades-old fat grafting, and that the stem cells that happen to be included in the extracted fat are merely going along for the ride.

I dont believe the physicians currently offering the treatment have any intent to deceive their patients, says Dr. Ourian. According to the article, they have gotten good results and are willing to move forward on that basis.

Dr. Ourian has been a pioneer in laser technology and non-invasive aesthetic procedures including Restylane, Juvderm, Radiesse and Sculptra. These treatments are used for the correction or reversal of a variety of conditions such as acne, acne scars, skin discoloration, wrinkles, stretch marks, varicose veins, cellulite, and others. More information about the stem cell facelift can be found on Epiones website.

Grace Russell Epione Medical Corporation (888) 951-3377 Email Information

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Stem Cell Facelift – Do the Results Match the Hype?

Stem Cell Therapeutics Licenses Exclusive Rights to Clinical Cancer Stem Cell Program

TORONTO, ONTARIO--(Marketwired - Apr 17, 2013) - Stem Cell Therapeutics Corp. (TSX VENTURE:SSS), a biopharmaceutical company developing cancer stem cell-related technologies, today announced the execution of a definitive license agreement with University Health Network ("UHN"), Toronto, Canada. The agreement, developed in collaboration with MaRS Innovation, provides Stem Cell Therapeutics ("SCT") with exclusive worldwide rights to an innovative clinical cancer stem cell program.

As announced on November 6, 2012, the technology licensed by SCT is based on Dr. Aaron Schimmer's discovery that an FDA-approved antibiotic, tigecycline, selectively targets leukemia cells and leukemic stem cells by inhibiting mitochondrial protein synthesis and thus shutting down the cells energy supply. A Phase I multicenter dose- escalation clinical trial in patients with relapsed or refractory acute myeloid leukemia (AML) is nearing completion and data are expected this summer. Dr. Schimmer will join Dr. John Dick as a scientific advisor to SCT. Furthermore, a clinical advisory board, chaired by Dr. Schimmer, will be assembled in the near term to guide and assist in the future development of the program.

"Using tigecycline to eradicate cancer stem cells, which are resistant to conventional chemotherapy and believed to be responsible for disease relapse, is an innovative and potentially curative approach to the treatment of AML," commented Dr. Bob Uger, SCT's Chief Scientific Officer. "This program will provide the foundation for further research into mitochondrion-targeting therapies, an area that is of substantial interest to the scientific community."

The newly acquired tigecycline program complements SCT's other cancer stem cell program, SIRPaFc. The latter is an antibody-like Fc fusion protein that targets the CD47 protein with high affinity, facilitating the elimination of cancer cells and cancer stem cells by the patient's own immune system. This program is at a preclinical stage and IND-enabling studies are expected to start pending the conclusion of an ongoing pharmacokinetic and safety study.

"We use two distinctly different approaches to target cancer stem cell in these programs. Tigecycline is a repurposed small molecule aimed at an intracellular metabolic target, while SIRPaFc is a novel biologic targeting an extracellular immunoregulatory pathway," remarked SCT's Chief Executive Officer, Dr. Niclas Stiernholm. "In our quest to become a Canadian cancer stem cell powerhouse with a diverse arsenal of product candidates, we are now assessing other opportunities and expect to add new collaborations and projects in due course."

"The conclusion of our recent financing, followed by the acquisition of Trillium and the licensing of the tigecycline technology completes my task of refocusing and reinvigorating the company," added David Allan. "The appointment of Dr. Stiernholm as CEO of SCT now permits me to become non-executive chairman, a role in which I look forward to supporting the new management team, particularly assisting with the company's activities and visibility in the capital markets."

The initial consideration of $1.6 million for the UHN License is to be satisfied by the issuance of 5,028,571 SCT common shares and 1,600,000 SCT common share purchase warrants to UHN and MaRS Innovation, each warrant allowing its holder to acquire one additional common share at an exercise price of $0.40 until March 15, 2018. Additional consideration under the UHN License includes an annual license maintenance fee and development milestones. The securities issued by the Corporation will be subject to a statutory four-month hold period from the date of their issuance.

About Cancer Stem Cells:

The cancer stem cell (CSC) concept postulates that the growth of tumors is driven by a rare population of dedicated cells that have stem cell-like properties, including self- renewal. While the bulk of a tumor consists of rapidly proliferating cells and differentiated cells, neither of which is capable of self-renewal, a small population of CSCs provides for long-term maintenance of the cancer. Although the CSC concept was first postulated in the 1960s, it wasn't until 1994 that proof of their existence was demonstrated, when Dr. John Dick and colleagues in Toronto isolated CSCs (known as leukemic stem cells, or LSCs) from bulk acute myeloid leukemia cells. More recently, CSCs have been identified in many other human malignancies, including solid tumors such as bladder, brain, breast, colon, ovarian and prostate cancers. There is accumulating evidence that CSCs are resistant to conventional chemotherapies and radiation. Thus, CSCs are thought to be responsible for a phenomenon well known to oncologists: most patients will experience an initial response to conventional chemotherapies but will ultimately relapse. To cure cancer CSCs need to be destroyed, but the current armament of therapies is poorly equipped to do so.

About Acute Myeloid Leukemia (AML):

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Stem Cell Therapeutics Licenses Exclusive Rights to Clinical Cancer Stem Cell Program