Seventeenth Patient Dosed in Neuralstem ALS Stem Cell Trial

ROCKVILLE, Md., July 25, 2012 /PRNewswire/ --Neuralstem, Inc. (NYSE MKT: CUR) announced that the seventeenth patient was treated in the ongoing Phase I trial of its spinal cord neural stem cells for the treatment of amyotrophic lateral sclerosis (ALS or Lou Gehrig's disease). This patient is also the second to return to the trial for additional injections. In this treatment, the patient received five injections in the cervical (upper back) region of the spinal cord, in addition to the ten he had previously received in the lumbar (lower back) region, for a total of 15 injections. The final previously treated patient of this cervical cohort is expected to return to the trial in August, provided the inclusion requirements continue to be met. This ground-breaking stem cell trial is taking place at Emory University Hospital in Atlanta, Georgia.

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"We are pleased that this phase of the trial, in which we have been permitted by the FDA to take the unprecedented step of dosing patients for the second time, is progressing as planned," said Karl Johe, PhD, Neuralstem's Chairman and Chief Scientific Officer. "These are the first patients in the world to receive our cells in both the lumbar and cervical regions of their spinal cords, where the stem cell therapy could support both walking and breathing."

About the Trial

The Phase I trial to assess the safety of Neuralstem's spinal cord neural stem cells and intraspinal transplantation method in ALS patients has been underway since January 2010. The trial is designed to enroll up to 18 patients. The first 12 patients were each transplanted in the lumbar (lower back) region of the spine, beginning with non-ambulatory and advancing to ambulatory cohorts.

The trial then advanced to transplantation in the cervical (upper back) region of the spine. The first cohort of three was treated in the cervical region only. The current cohort of three is receiving injections in both the cervical and lumbar regions of the spinal cord. In an amendment to the trial design, The Food and Drug Administration (FDA) approved the return of previously treated patients to this cohort. The second of these returning patients was just treated. The entire 18-patient trial concludes six months after the final surgery.

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 is in an FDA-approved Phase I safety clinical trial for amyotrophic lateral sclerosis (ALS), often referred to as Lou Gehrig's disease, and has been awarded orphan status designation by the FDA.

In addition to ALS, the company is also targeting major central nervous system conditions with its cell therapy platform, including spinal cord injury, ischemic spastic paraplegia and chronic stroke. The company has submitted an IND (Investigational New Drug) application to the FDA for a Phase I safety trial in chronic spinal cord injury.

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 CTE (chronic traumatic encephalopathy), Alzheimer's disease, anxiety, and memory disorders.

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Seventeenth Patient Dosed in Neuralstem ALS Stem Cell Trial

Stem Cell Treatment Alleviated Lorna Tolentino's Back Pain

By ROWENA JOY A. SANCHEZ

LT is noticeably more blooming these days (Publicity photo)

MANILA, Philippines As if by stroke of magic, Lorna Tolentinos back pain was eliminated after getting stem cell treatment at a hospital in Germany on July 3.

The whole process only took four days, which included a day for an interview about her health history. The second day was for the treatment itself, with Lorna receiving 10 injections. She rested on the third day and was discharged on the fourth.

In a recent interview with Bulletin Entertainment and some members of the media, Lorna enthused, Ang instant [na nawala] sa akin yung back pain talaga Kasi iba yung pakiramdam ng wala kang iniinda na sakit sa likod. Dati pag lumalakad ako, mabagal Pag lumalakad ako pinupukpok ko na tong paa ko dahil nagna-numb na yung dito (part of her legs) ko.

The back pain, she noted, was caused by scoliosis, a disorder that causes an abnormal curve of the spine, or backbone, according to medicinenet.com.

Although her aura is noticeably more bloomingwhich can perhaps be attributed to the treatmentthe Kapatid actress emphasized that it will take three months before the changes completely take effect.

Such immediate relief and the no side effects assurance apparently came with a huge price. The treatment is said to have cost P1 million. Lorna did not shell a single cent, though, with executive consultant Joey Santos shouldering the expenses.

Mabait sa akin si Lord, Lorna said.

According to Mayo Clinic, stem cell therapy, which is also known as regenerative medicine, "is the replacement of diseased, dysfunctional or injured cells with stem cells or their derivatives. It's somewhat similar to the organ transplant process but uses cells instead of organs."

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Stem Cell Treatment Alleviated Lorna Tolentino's Back Pain

Driver of breast cancer stem cell metastasis found

ScienceDaily (July 24, 2012) Researchers at the University of Michigan Comprehensive Cancer Center have found that a cancer gene linked to aggressive spread of the disease promotes breast cancer stem cells. The finding implies a new way to target the behavior of these lethal cells.

The finding involves the cancer gene RhoC, which has previously been shown to promote metastasis of many types of cancer. RhoC levels increase as breast cancer progresses and high levels of RhoC are associated with worse patient survival.

Cancer stem cells are the small number of cells within a tumor that are believed to fuel the tumor's growth and spread. Researchers believe traditional chemotherapy and radiation treatments often become ineffective because they do not kill the cancer stem cells, and that the key to future treatments is to develop drugs that target and kill these cells.

This new study, which appears online in PLoS ONE, suggests a new way to get at the cancer stem cells.

"Targeting the specific molecular cogs driving the cancer stem cell machinery responsible for the cancer spreading has potential for future treatments. Eliminating cancer stem cells may ultimately be necessary to cure certain cancers, but in the meantime, we may be able to manage the cancer stem cell population and the invasive behaviors of these cells by disrupting the molecular machinery, using RhoC as a target," says senior study author Sofia D. Merajver, M.D., Ph.D., professor of internal medicine and epidemiology at the University of Michigan and scientific director of the breast oncology program at the U-M Comprehensive Cancer Center.

The researchers looked at breast cancer cell lines that were highly metastatic and cell lines from normal breast tissue. By inhibiting or overexpressing RhoC, they found that RhoC expression is necessary to cause metastasis in both cell lines, and that RhoC overexpression alone can cause metastasis. The researchers also tested this in mice and had similar results.

Merajver's lab, in conjunction with other U-M researchers, is studying a novel small molecule drug to inhibit RhoC, which has shown promising initial results in the laboratory. The researchers are continuing to develop this inhibitor, which will require several years of additional testing in the laboratory before potentially advancing to clinical trials.

Breast cancer statistics: 229,060 Americans will be diagnosed with breast cancer this year and 39,920 will die from the disease, according to the American Cancer Society

Additional authors: Devin T. Rosenthal, Jie Zhang, Liwei Bao, Lian Zhu, Zhifen Wu, Kathy Toy and Celina G. Kleer, all from U-M

Funding: Department of Defense Breast Cancer Research Program (BC083262); National Institutes of Health (T32-GM07315); Burroughs Wellcome Fund; Breast Cancer Research Foundation

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Driver of breast cancer stem cell metastasis found

Vitro Biopharma Strengthens and Expands Its Distribution Agreement With Neuromics

GOLDEN, Colo., July 24, 2012 (GLOBE NEWSWIRE) -- Vitro Diagnostics, Inc. (VODG), dba Vitro Biopharma, announced an expanded relationship with a key distributor of its stem cell-based products, privately-held Neuromics, Inc (www.neuromics.com). Vitro Biopharma officials recently met Neuromics principals at their corporate headquarters in Minneapolis, MN. Neuromics was formed in 2005 by Pete Shuster, a marketing and sales professional with extensive experience in the computer industry who is now focused on providing integral products to the life science industry. Neuromics competitive advantage is based on providing products that lower costs and raise the probability of successful outcomes and include bio-markers, growth factors, transfection reagents, apoptosis detection kits, primary cells and related media. They are designed to serve basic and drug discovery researchers focusing on finding root causes and therapies for neuro-degenerative, autoimmune, inflammatory response diseases and certain forms of cancer.

Vitro Biopharma and Neuromics recently entered a distribution agreement whereby Vitro provides its stem cell-based products to Neuromics' customers. Stem cell research continues to grow, based on positive results from several studies showing potential clinical benefit of stem cell-based cellular therapy. There is a growing demand for adult stem cells known as mesenchymal stem cells (MSCs). Vitro Biopharma manufactures and sells several fundamental tools needed to advance adult stem cell research and clinical studies, including human MSCs and derivatives, the MSC-Gro(TM) Brand of media optimized for growth and differentiation of MSCs as well as assay kits for determination of MSC quality, potency and response to toxic agents.

Based on the growing demand for MSC products provided by Vitro Biopharma for both research and clinical studies, Neuromics officials have committed increased resources to promote these products. Furthermore, both Vitro Biopharma and Neuromics are evaluating additional products that are perceived to enhance the competitive advantage of Vitro Biopharma's existing MSC product line through strategic combination. A strategic goal moving forward, is an additional partner to supply devices needed for FDA-compliant manufacture of clinical materials for use in pre-clinical and clinical studies. These devices are known as bio-reactors that allow for highly controlled and reproducible production of large numbers of stem cells needed to provide therapeutic benefit. Several characteristics of these bioreactors are essential in reaching the demanding goals needed to achieve regulatory compliant manufacturing to support stem cell therapy that maintains rigorous standards of safety and efficacy. We are presently evaluating suitable devices for this application that appear to be well-suited to the required needs, specifications and characteristics.

Dr. Jim Musick, Vitro's President & CEO, said, "We are very pleased to expand our relationship with Neuromics, Inc and look forward to a long-term mutually beneficial business relationship. While we focus on product development, manufacturing and advancement of our product pipeline, our sales partnerships are important alliances in the expansion of revenue generation. Neuromics is an ideally suited sales partner due to their broad experience and success in distribution of critical life science products. We also see the importance of a complete manufacturing system to support stem cell-based cellular therapy. It is through the highly complex interactions of cells, cell culture media, extracellular matrices and other environmental conditions that together determine the characteristics of the stem cells intended for clinical use. We also anticipate additional expansion of our relationship with Neuromics as Vitro Biopharma's product pipeline advances through the commercialization process."

"Neuromics' strategic direction aligns tightly with Vitro's goal of 'Harnessing the Power of Cells(TM)'", said Shuster, "expanding capabilities enable us to serve an increasing segment of the Biotech and Pharma research community. This is especially true of the stem cell and regenerative medicine research community. Our relationship with Vitro Biopharma adds horsepower to these capabilities. Mesenchymal Stem Cells and Media are raw materials for high throughput and high content cell-based assays. Better materials help insure only the best targets, biologicals and compounds are passed on to downstream processes."

About Vitro Diagnostics, Inc.

Vitro Diagnostics, Inc. dba Vitro Biopharma (VODG);(http://www.vitrobiopharma.com), owns U.S. patents for production of FSH, immortalization of pituitary cells, and a cell line that produces beta islets for use in treatment of diabetes. Vitro also owns a pending international patent for generation of pluripotent stem cells. Vitro's mission is "Harnessing the Power of Cells(TM)" for the advancement of regenerative medicine to its full potential. Vitro operates within a modern biotechnology manufacturing, R&D and corporate facility in Golden, Colorado. Vitro manufactures and sells "Tools for Stem Cell and Drug Development(TM)", including human mesenchymal stem cells and derivatives, MSC-Gro(TM) optimized media for stem cell self-renewal and lineage-specific differentiation. Vitro recently formed a strategic alliance with HemoGenix(R), Inc. (http://www.hemogenix.com/) to jointly manufacture and distribute LUMENESC(TM) and LumiSTEM(TM) quantitative assays for determination of stem cell quality, potency and response to toxic agents.

About Neuromics, Inc.

Neuromics (http://www.neuromics.com), located in Minneapolis, MN, is a profitable and growing bio-regents company. The company was initially built by supplying bio-markers to Neuroscience Researchers. Today, Neuromics provides a range of solutions that include markers, growth factors, gene expression analysis tools, apoptosis detection kits, primary cells and related media. These solutions are increasingly being used in combinations by customers to help accelerate or improve the process of drug discovery.

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Vitro Biopharma Strengthens and Expands Its Distribution Agreement With Neuromics

Fort Myers doctor rejects settlement in stem cell case in which patient died

K.K.Yankopolus

Photo by Allie Garza

Dr. Zannos Grekos, a cardiologist whose practice is in Bonita Springs, speaks with a seminar attendant after one of his educational seminars about stem cell treatment, using one's own stem cells, for treating heart disease and other medical conditions, on Monday, March 14, 2011, at the Collier County Library. Allie Garza/Staff

FORT MYERS A Fort Myers physician has rejected a settlement agreement with state regulators over his role in a stem cell treatment with a patient who later died.

The deal that Dr. Konstantine Yankopolus turned down had him paying a fine of $25,000 and the state Department of Health's case expenses of $12,200. He would have been on probation for two years with another physician indirectly supervising him.

Yankopolus, who has a primary-care practice in Fort Myers, assisted Dr. Zannos Grekos in March with the controversial stem cell treatment on a 77-year-old Indiana man, according to state reports.

Now that Yankopolus has rejected the settlement terms, which would have needed approval of the state Board of Medicine, the state is reopening its complaint against him. An administrative hearing that had been canceled when the settlement was in the works will be scheduled again.

Yankopolus declined to comment about his decision to reject the deal and take his chances with what an administrative law judge may recommend for discipline. His license is now restricted he is prohibited from doing anything with stem cells.

The patient, Richard Poling, was seeking treatment for pulmonary hypertension and went into cardiac arrest in Grekos' Bonita Springs practice and died later at a hospital.

Grekos was under a state order not to do anything with stem cells because of his similar treatment of an earlier patient, a 66-year-old breast cancer survivor. She died from her injuries after she fell in her home hours after the procedure.

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Fort Myers doctor rejects settlement in stem cell case in which patient died

Stem Cell Therapy: Cure For Autism?

By ANGELO G. GARCIA

MANILA, Philippines Parents of children with autism, or other developmental condition for that matter, go to great lengths to find a cure for their children. Even though these may not exist yet for most conditions, parents exhaust all possible means to look for ways to improve the lives of their children.

For some parents, the cost of these cures is of no question.

For instance, Janise Tang Piap immediately took charge of the situation upon learning that her son, Ethan, has autism. Janise turned to a battalion of doctors and therapists and even attended several conferences to understand her son's condition and how to improve it.

I took charge. I researched, I attended conferences. I was like a mad scientist, she recalls. Of course, the more important thing for a parent is to accept the fact that your child does have disability before you take charge.

MAD SCIENTIST

Janise did not stop at therapies though and proceeded to do further research until she came upon stem cell therapy that are being done in South America and China. She went as far as saving the umbilical cord blood cells of her second baby who was born in 2009, thinking that someday, this could be useful in the cure for autism.

Last year, she found out about Villa Medica, a clinic in Edenkoben, Germany that specializes in stem cell treatment for various conditions such as Parkinson's disease, diabetes Mellitus and autism.

Without missing a beat, Janise decided that stem cell therapy could help Ethan and they went on with the procedure.

Today, a year after the procedures, Janise is more than happy at the results, at improvements she never dreamt of happening to her son who is now nine years old.

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Stem Cell Therapy: Cure For Autism?

Stem cell treatment for the heart ready for Phase II clinical trials (Weekend Rounds)

A review of life science current events reported by MedCity News this week.

Stem cell treatment for ischemia, heart failure raises enough for clinical trials. The regenerative medicine company Juventas Therapeutics, which had already said it added Takeda Pharmaceuticals to its roster of investors, said this weekend it has raised enough money to take its treatments for heart failure and a severe form of peripheral artery disease through its latest round of clinical trials.

CEO: $270M acquisition of US Endoscopy is STERIS most significant dealin many years. While STERIS has not historically had a presence in the procedural area of gastrointestinal endoscopy focusing instead on reprocessing products like soaks and scrubs Rosebrough said the integration of US Endoscopys portfolio of bleed management, retrieval and other GI-related devices is directly aligned with the companys strategy to target growing markets around its core products.

Ohio business leader Baiju Shah to depart BioEnterprise for biotech investment fund. Shah, the founder and longtime CEO of BioEnterprise, will join BioMotiv, the for-profit side of the $250 million Harrington Project for Discovery & Development housed at University Hospitals Case Medical Center, as CEO.

Pain device maker Neuros Medicals $3.5M round led by Boston Scientific, Glengary. The companys device, called the Electrical Nerve Block, comprises a pacemaker-sized generator and a lead that wraps around a peripheral nerve, and delivers stimulation to block pain. The four-year-old company will use the money to add staff and continue testing of the Electrical Nerve Block, it said in a statement.

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Stem cell treatment for the heart ready for Phase II clinical trials (Weekend Rounds)

The Yin and Yang of Stem Cell Quiescence and Proliferation

Newswise KANSAS CITY, MO Not all adult stem cells are created equal. Some are busy regenerating worn out or damaged tissues, while their quieter brethren serve as a strategic back-up crew that only steps in when demand shoots up. Now, researchers at the Stowers Institute for Medical Research have identified an important molecular cue that keeps quiescent mouse hematopoietic (or blood-forming) stem cells from proliferating when their services are not needed.

Publishing in the July 20, 2012 issue of Cell, the team led by Stowers Investigator Linheng Li, Ph.D., report that Flamingo and Frizzled 8, a tag team best known for its role in establishing cell polarity, are crucial for maintaining a quiescent reserve pool of hematopoietic stem cells in mouse bone marrow. Their finding adds new insight into the mechanism that controls the delicate balance between long-term maintenance of stem cells and the requirements of ongoing tissue maintenance and regeneration.

Hematopoietic stem cells daily produce billions of blood cells via a strict hierarchy of lineage-specific progenitors, says Li. Identifying the molecular signals that allow hematopoietic stem cell populations to sustain this level of output over a lifetime is fundamental to understanding the development of different cell types, the nature of tumor formation, and the aging process. My hope is that these insights will help scientists make meaningful progress towards new therapies for diseases of the blood.

The current working model, which grew out of earlier work by Li and others, postulates that hematopoietic stem cells (HSC), which are part of the reserve pool sit quietly and only divide a few times a year. They jump into action only when needed to replace active HSCs damaged by daily wear and tear or to increase their numbers in response to injury or disease. But how quiescent and active hematopoietic stem cell subpopulations are maintained and regulated in vivo is largely unknown.

What is known is that both populations of cells reside in adjacent specialized microenvironments, which provide many of the molecular cues that guide stem cell activity. Frequently cycling HSCs constitute around 90 percent of all hematopoietic stem cells and are found in the central marrow, where they seek the company of endothelial and perivascular cells. The main home base of quiescent hematopoietic stem cells is trabecular bone, the spongy part typically found at the end of long bones. Here, these cells engage in a constant molecular dialog with preosteoblasts, the precursors of bone-forming osteoblasts, which are characterized by the expression of N-cadherin.

Trying to decode the nature of the conversation graduate student and first author Ryohichi Sugimura focused on Flamingo (Fmi), a surface-based adhesion molecule, and Frizzled 8 (Fz8), a membrane-based receptor. Both molecules are part of the non-canonical arm of the so-called Wnt signaling pathway, a large network of secreted signaling molecules and their receptors. The canonical arm of the Wnt-signaling pathway exerts its influence through beta-catenin and helps regulate stem cell self-renewal in the intestine and hair follicles.

After in vitro experiments had revealed that Fmi and Fz8 accumulate at the interface between co-cultured quiescent hematopoietic stem cells and preosteoblasts, Sugimura and his colleagues were able to show that Fmi also regulates Fz8 distribution in vivo. This observation provided the first hint that these cooperation partners may carry at least part of the conversation that instructs hematopoietic stem cells to sit still. It also confirmed the previous finding by Lis team that a portion of HSCs resides in the N-cadherin+ osteoblastic niche.

When Sugimura examined the expression patterns of individual members of the Wnt signaling network within quiescent HSCs microenvironment he found that levels of canonical Wnt ligands where low. Levels of non-canonical Wnt ligands and inhibitors of the canonical arm of the Wnt signaling network, on the other hand, were high.

These observations indicated that the osteoblast niche provides a microenvironment in which non-canonical Wnt signaling prevails over canonical Wnt-signaling under normal conditions, says Sugimura. It also suggested that Fmi and Fz8 may play a direct role in maintaining the pool of quiescent hematopoietic stem cells.

Mice that had been genetically engineered to lack either Fmi or Fz8 provided the crucial clue: Not only had the number of quiescent hematopoietic stem cells plummeted in these mice, their hematopoietic stem cell function was reduced by more than 70 percent as well.

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The Yin and Yang of Stem Cell Quiescence and Proliferation

Stem cell procurement plan gets ministry OK

A health ministry panel will allow cord blood banks to provide raw material to create induced pluripotent stem cells for regenerative medicine, a move that would boost the establishment of an "iPS Stock" system proposed by Kyoto University professor Shinya Yamanaka.

Only cord blood not used in leukemia treatment would be provided to the iPS Stock for use in creating iPS cells, said the members of the panel under the Ministry of Health, Labor and Welfare.

The details of conditions for the provision will be discussed by eight banks storing cord blood and Kyoto University, the members said.

In a related move, Yamanaka said Tuesday he aims to team up with the Japanese Red Cross Society in the hope that by allowing scientists to tap into the society's data on human leukocyte antigen types, which can be compared with blood types for cells, the iPS Stock would be able to promptly procure the types of cells unlikely to be rejected by transplant recipients.

Establishing the iPS Stock would help physicians to shorten the time and reduce the costs associated with procuring cells for transplant treatment. But as patients would be receiving other people's cells, it is necessary to work on steps to reduce rejection.

Because only 1 in 1,000 has HLA types unlikely to cause rejection, collecting several dozen of the rare types would enable physicians to cover around 80 percent of the Japanese population.

A likely challenge, however, is to create a new system to secure donors' consent regarding the use of the banks, originally intended for the treatment of diseases such as leukemia, for the iPS Stock.

An advantage of using the banks is that blood and bone marrow stored by the banks run by the Red Cross and other organizations have had their HLA types checked prior to registration, making it easier for medical personnel to find the desired blood with rare properties.

This compares with soliciting volunteers to provide blood, which entails checking around 200,000 samples for the desired types, at enormous cost.

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Stem cell procurement plan gets ministry OK