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Cell Therapeutics Appoints New Chief Medical Officer

Posted: June 14, 2012 at 6:11 pm

June 14, 2012, SEATTLE /PRNewswire/ -- Cell Therapeutics, Inc. ("CTI") (NASDAQ and MTA: CTIC), a company focused on translating science into novel cancer therapies, today announced that former OncoMed Pharmaceuticals executive, Steven E. Benner, M.D., M.H.S., has joined CTI as Executive Vice President and Chief Medical Officer ("CMO"), reporting to James A. Bianco, M.D., Chief Executive Officer. Dr. Benner will take over all drug development activities at the company.Dr. Benner was previously senior vice president and chief medical officer at OncoMed, a venture-backed biotechnology company focused on the development of cancer stem cell targeting agents. Prior to OncoMed, he was CMO at Protein Design Labs ("PDL"), where he was accountable for all development activities including clinical development, clinical operations, biometry, regulatory affairs, and safety. He also served as Chair of the Portfolio and Clinical Development Management Committees of PDL. Before PDL he held several senior executive roles at Bristol-Myers Squibb in global development, life cycle management, and licensing and alliances.

"Dr. Benner brings to CTI his proven track record of success in advancing the development of innovative therapies for cancer patients," said Dr. Bianco. "His appointment is the first step in re-aligning our portfolio efforts, as we focus on advancing pacritinib into Phase III pivotal studies later this year."

With the new company initiative of the planned Pixuvri launch in Europe later this year, Jack W. Singer, M.D., will assume the newly-created role of Executive Vice President ("EVP") of Global Medical Affairs and Translational Medicine, responsible for cancer drug development strategy, global medical affairs, and life cycle management.

"Given Jack's impressive academic credentials, the respect he receives from an international network of key opinion leaders in the field, and his track record in oncology drug development, this was a natural promotion as we introduce Pixuvri in Europe," said Dr. Bianco.

"CTI has assembled an impressive late-stage portfolio of novel targeted therapies that address a spectrum of blood related cancers," said Dr. Benner. "With two drugs in Phase III and two more expected to enter Phase III trials within a year, this is an exciting and transformational time to join the team at CTI."

About Pixuvri (pixantrone)Pixuvri is a novel aza-anthracenedione with unique structural and physio-chemical properties. Unlike related compounds,Pixuvri forms stable DNA adducts and in preclinical models has superior anti-lymphoma activity compared to related compounds. Pixuvri was structurally designed so that it cannot bind iron and perpetuate oxygen radical production or form a long-lived hydroxyl metabolite -- both of which are the putative mechanisms for anthracycline induced acute and chronic cardiotoxicity. These novel pharmacologic properties allow Pixuvri to be administered to patients with near maximal lifetime exposure to anthracyclines without unacceptable rates of cardiotoxicity, and, because Pixuvri is not a vesicant, allow it to be safely delivered via a peripheral intravenous catheter.

In May 2012 Pixuvri received conditional marketing authorization in the EU as monotherapy for the treatment of adult patients with multiply relapsed or refractory aggressive NHL. The benefit of pixantrone treatment has not been established in patients when used as fifth line or greater chemotherapy in patients who are refractory to last therapy.The Summary of Product Characteristics ("SmPC") has the full prescribing information, including the safety and efficacy profile of Pixuvri in the approved indication. The SmPC is available at http://ec.europa.eu/health/documents/communityregister/html/h764.htm#ProcList.

Pixuvri is currently available in the EU through Named Patient Programs.

Pixuvri does not have marketing approval in the United States.

About Conditional Marketing AuthorizationSimilar to accelerated approval regulations inthe United States, conditional marketing authorizations are granted in the EU to medicinal products with a positive benefit/risk assessmentthat address unmet medical needs and whose availability would result in a significant public health benefit. A conditional marketing authorization is renewable annually. Under the provisions of the conditional marketing authorization for Pixuvri, CTI will be required to complete a post-marketing study aimed at confirming the clinical benefit previously observed.

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Advanced Cell Technology to Present at the 2012 Bio International Convention and the Clinical Outlooks for …

Posted: June 14, 2012 at 6:11 pm

MARLBOROUGH, Mass.--(BUSINESS WIRE)--

Advanced Cell Technology, Inc. (ACT; OTCBB: ACTC), a leader in the field of regenerative medicine, announced today that the company is presenting at two upcoming conferences: the 2012 Bio International Convention and Clinical Outlooks for Regenerative Medicine meeting, both in Boston, on Tuesday, June 19. The presentations will cover the companys three ongoing clinical trials using human embryonic stem cell-derived retinal pigment epithelial cells to treat macular degeneration, and other programs.

Gary Rabin, chairman and CEO, will present at the 2012 Bio International Convention on Tuesday, June 19 at 8:15 a.m. EDT, at the Boston Convention & Exhibition Center.

Matthew Vincent, Ph.D., director of business development, will present at the Clinical Outlooks for Regenerative Medicine meeting at 9:15 a.m. EDT on the same date, at the Starr Center, Schepens Eye Research Institute, at 185 Cambridge Street in Boston.

Both presentation slide decks will be available on the conference presentations section of the ACT website.

About Advanced Cell Technology, Inc.

Advanced Cell Technology, Inc., is a biotechnology company applying cellular technology in the field of regenerative medicine. For more information, visit http://www.advancedcell.com.

Forward-Looking Statements

Statements in this news release regarding future financial and operating results, future growth in research and development programs, potential applications of our technology, opportunities for the company and any other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements that are not statements of historical fact (including statements containing the words will, believes, plans, anticipates, expects, estimates, and similar expressions) should also be considered to be forward-looking statements. There are a number of important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements, including: limited operating history, need for future capital, risks inherent in the development and commercialization of potential products, protection of our intellectual property, and economic conditions generally. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in the companys periodic reports, including the report on Form 10-K for the year ended December 31, 2011. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. Forward-looking statements are based on the beliefs, opinions, and expectations of the companys management at the time they are made, and the company does not assume any obligation to update its forward-looking statements if those beliefs, opinions, expectations, or other circumstances should change. There can be no assurance that the Companys clinical trials will be successful.

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BrainStorm Receives 1.3 Million NIS Grant from Israel’s Office of the Chief Scientist

Posted: June 14, 2012 at 6:10 pm

NEW YORK & PETACH TIKVAH, Israel--(BUSINESS WIRE)--

BrainStorm Cell Therapeutics Inc. (BCLI), a developer of adult stem cell therapeutics targeting Central Nervous System (CNS) neurodegenerative diseases, announced today that Brainstorm Cell Therapeutics Ltd. received the first installment of the 2012 grant from Israels Office of the Chief Scientist (OCS) in the amount of approximately $350,000. The yearly grant for 2012 is $1,100,000 (~4.2 M NIS). The grant is awarded to BrainStorms Research and Development program towards the development of its leading and innovative NurOwn therapy for ALS using autologous adult stem cells.

We are thankful to the OCS for its continued support of our Research and Development program. The non-dilutive capital that we are receiving from the OCS will help move forward our NurOwn technology as a potential new treatment standard for patients with Amyotrophic Lateral Sclerosis (ALS) and Multiple Sclerosis (MS), said Dr. Adrian Harel BrainStorms newly promoted CEO.

BrainStorm is in Phase I/II human clinical trials in Israel with NurOwn, BrainStorms adult stem cell therapy in patients with ALS (often referred to as Lou Gehrig's Disease). The study is conducted at the Hadassah Medical Center and is headed by principal investigator Dimitrios Karussis, M.D., Ph.D., of the Hadassah Medical Center, together with a scientific team from BrainStorm headed by Prof. Eldad Melamed. The initial phase of the study is designed to assess the safety of NurOwn. As previously announced by Brainstorm (see our press release of March 29, 2012) the interim results for the first 12 patients are expected by July 2012.

The OCS grant will enable BrainStorm to continue its clinical program and accelerate its development of new CNS indications, said Chaim Lebovits, President of Brainstorm. I would also like to take this opportunity to congratulate Dr. Adrian Harel on the occasion of his promotion by the Board of Directors as CEO of Brainstorm. Dr. Harel is successfully leading the company, together with the entire wonderful team at Brainstorm, to the next exciting phase of developing our NurOwn product to treat ALS and other neurodegenerative diseases," said Lebovits.

The OCS has supported BrainStorm Cell Therapeutics Ltd. the Israeli Subsidiary since 2007, providing grants of a total of $1.75 million including this grant. The Company is required to pay royalties to the OCS, amounting to 3% - 5% of revenues derived from sales of the products funded with these grants, but only up to the amount equal to 100% of the grants received.

About the Office of the Chief Scientist

The Office of the Chief Scientist [OCS] in the Ministry of Industry, Trade and Labor is charged with execution of government policy for support of industrial R&D. The goal of the OCS is to assist in the development of technology in Israel as a means of fostering economic growth, encouraging technological innovation and entrepreneurship, leveraging Israel's scientific potential, enhancing the knowledge base of industry in Israel, stimulating high value-added R&D and encouraging R&D collaboration both nationally and internationally.

About BrainStorm Cell Therapeutics, Inc.

BrainStorm Cell Therapeutics Inc. is a biotech company developing adult stem cell therapeutic products, derived from autologous (self) bone marrow cells, for the treatment of neurodegenerative diseases. Brainstorm, through its wholly owned subsidiary, holds rights to develop and commercialize the technology through an exclusive, worldwide licensing agreement with Ramot at Tel Aviv University Ltd., the technology transfer company of Tel-Aviv University. The technology is currently in a Phase I/II clinical trials for ALS.

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ReNeuron Group plc – PISCES Trial Interim Data

Posted: June 14, 2012 at 6:10 pm

ReNeuron Group (Berlin: RQE.BE - news) plc

(the "Company")

Interim data from clinical trial of ReNeuron's stem cell therapy for stroke to be presented at leading scientific conference

Data show no safety concerns and evidence of sustained reductions in neurological impairment and spasticity

Guildford, UK, 14 June 2012: ReNeuron Group plc (the "Company") (LSE: RENE.L) is pleased to announce the presentation of interim data from the PISCES (Pilot Investigation of Stem Cells in Stroke) clinical trial of its ReN001 stem cell therapy for disabled stroke patients. In this open label, dose-ranging Phase I safety study, ReNeuron's ReN001 stem cell therapy is being administered in ascending doses to a total of 12 stroke patients who have been left disabled by an ischaemic stroke, the most common form of the condition.

The primary aim of the study is to test the safety and tolerability of the treatment in ascending doses of the ReN001 cells, in patients with moderate to severe functional neurological impairments resulting from their stroke. The secondary aim of the study is to evaluate efficacy measures for the design of future clinical trials with ReN001, including imaging measures as well as a number of tests of sensory, motor and cognitive functions.

To date, six patients have been treated in the PISCES stroke study, representing the first two of four dose cohorts. The interim data being presented are from the first five patients treated, at 2 x 12 month, 1 x six month and 2 x three month follow-up points.

No cell-related adverse events or adverse immune-related responses were reported in any of the patients treated to date. A number of the patients experienced minor procedure-related adverse events such as asymptomatic bleeds or superficial scalp infections at the implantation wound site.

Reductions in neurological impairment and spasticity were observed in all five patients compared with their stable pre-treatment baseline performance and these improvements were sustained in longer term follow-up.

Neurological deficits were measured using the National Institutes of Health Stroke Scale (NIHSS), a higher score representing a worse deficit. Patients are required to have a NIHSS score of at least 6 to participate in the study. The pre-treatment median score for the first five patients was 8 (range 6 to 10) and the three month post-treatment median score was 4 (range 3 to 9).

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Stem cells ‘help’ stroke patients

Posted: June 14, 2012 at 6:10 pm

14 June 2012 Last updated at 07:25 ET By Eleanor Bradford BBC Scotland Health Correspondent

The first patients to take part in a clinical trial of a stem cell treatment for stroke have seen reductions in their disability, according to doctors.

Six patients in the west of Scotland had human stem cells inserted close to the damaged part of their brain.

After receiving the treatment, they saw improvements in the limb weakness they suffered as a result of their stroke.

Howeve, doctors have cautioned against reading too much into the early results of the clinical trial.

It is the world's first trial of a neural stem cell therapy for stroke.

Stroke is the third largest cause of death and the single largest cause of adult disability in the developed world.

The trial is being conducted at the Institute of Neurological Sciences at the Southern General Hospital in Glasgow, and is being led by Glasgow University neurologist Professor Keith Muir.

He said: "So far we've seen no evidence of any harmful effects. We're dealing with a group of people a long time after a stroke with significant disability and we don't really expect these patients to show any change over time.

"So it's interesting to see that in all the patients so far they have improved slightly over the course of their involvement in the study."

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Stem cell stroke trial promising

Posted: June 14, 2012 at 6:10 pm

14 June 2012 Last updated at 10:45 ET By Pallab Ghosh Science correspondent, BBC News

Doctors in Scotland have said five stroke patients involved in an experimental stem cell treatment have shown signs of slight improvement.

They have stressed that it is too soon to tell whether the improvement is due to the therapy.

The medical team has talked about the first results of the treatment at a conference in Japan.

The procedure is controversial as brain cells from a foetus were originally used to create the stem cells.

A team, from Glasgow's Southern General Hospital, has been injecting the stem cells into the brains of stroke patients.

The trial began in November 2010. The participants are all men over the age of 60 who have been severely disabled by a stroke and have shown no sign of improvement for at least a year.

We hope to tease out over the next 18 months whether the improvement is due to the treatment

The doctors hope that the treatment will repair their damaged brain tissue and restore some of their movement and ability to speak.

The trail is at an early stage, and doctors are primarily looking to see that the treatment is safe. But they have found that five of the six patients treated so far have shown some slight signs of improvement.

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Vein grown with patient's stem cells is transplanted

Posted: June 14, 2012 at 12:19 pm

Nation & World briefing

LONDON -- For the first time doctors have successfully transplanted a vein grown with a patient's own stem cells in another example of producing human body parts in the lab.

In this case, the patient was a 10-year-old girl in Sweden who was suffering from a severe vein blockage to her liver. In March, the girl's doctors decided to make her a new blood vessel to bypass the blocked vein instead of using one of her own or considering a liver transplant.

They took a 31/2-inch section of vein from a deceased donor, which was stripped of all its cells, leaving just a hollow tube. Using stem cells from the girl's bone marrow, scientists grew millions of cells to cover the vein, a two-week process. The new blood vessel was then transplanted into the patient.

Because the procedure used her own cells, the girl did not have to take any drugs to stop her immune system from attacking the new vein, as is usually the case in transplants involving donor tissue.

Suchitra Sumitran-Holgersson of the University of Gothenburg, one of the study's authors, and her colleagues published the results of their work online Thursday, June 14, in the British medical journal Lancet. The work was paid for by the Swedish government.

Bishops continue to fight mandate

ATLANTA -- The nation's Roman Catholic bishops on Wednesday promised steadfast opposition to President Barack Obama's mandate that birth control be covered by health insurance, saying it is one

Bishops insisted repeatedly that they had no partisan agenda. They said they were forced into action by state and federal policies that they said would require them to violate their beliefs in order to maintain the vast public-service network the church has built over a century or longer.

"It is not about parties, candidates or elections as others have suggested," said Baltimore Archbishop William Lori, chairman of the bishops' religious-liberty committee. "The government chose to pick a fight with us."

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Girl's stem cells used to make her a new vein

Posted: June 14, 2012 at 12:19 pm

1:00 AM Since the new vein was transplanted, the 10-year-old with blockage to her liver is much improved.

The Associated Press

LONDON - For the first time doctors have successfully transplanted a vein grown with a patient's own stem cells, another example of scientists producing human body parts in the lab.

In this case, the patient was a 10-year-old girl in Sweden who was suffering from a severe vein blockage to her liver. Last March, the girl's doctors decided to make her a new blood vessel to bypass the blocked vein instead of using one of her own or considering a liver transplant.

They took a 3-inch section of vein from a deceased donor, which was stripped of all its cells, leaving just a hollow tube. Using stem cells from the girl's bone marrow, scientists grew millions of cells to cover the vein, a process that took about two weeks. The new blood vessel was then transplanted into the patient.

Because the procedure used her own cells, the girl did not have to take any drugs to stop her immune system from attacking the new vein, as is usually the case in transplants involving donor tissue.

"This is the future for tissue engineering, where we can make tailor-made organs for patients," said Suchitra Sumitran-Holgersson of the University of Gothenburg, one of the study's authors.

She and colleagues published the results of their work online Thursday in the medical journal Lancet. The work was paid for by the Swedish government.

The science is still preliminary, and one year after the vein was transplanted, it needed to be replaced with another lab-grown vein when doctors noticed the blood flow had dropped. Experts from University College London raised questions in an accompanying commentary about how cost-effective the procedure might be, citing "acute pressures" on health systems that might make these treatments impractical for many patients.

Similar methods have already been used to make new windpipes and urethras for patients. Doctors in Poland have also made blood vessels grown from donated skin cells for dialysis patients.

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Vein grown from stem cells saves 10-year-old girl

Posted: June 14, 2012 at 12:19 pm

Doctors in Sweden have replaced a vital blocked blood vessel in a 10-year-old girl using the first vein grown in a lab from a patient's own stem cells.

The successful transplant operation, reported online in The Lancet medical journal on Thursday, marks a further advance in the search for ways to make new body parts.

It could open the door to stem cell-based grafts for heart bypass and dialysis patients who lack suitable blood vessels for replacement surgery, and the Swedish team said it is now working with an undisclosed company to commercialize the process.

"I'm very optimistic that in the near future we will be able to get both arteries and veins transplanted on a large scale," said Suchitra Sumitran-Holgersson, professor of transplantation biology at the University of Gothenburg, and a member of the team that performed the operation in March 2011.

The advantage of using tissue grown from a patient's own cells is that there is no risk of organ rejection and hence no need for lifelong immunosuppressive drugs.

Four years ago, a 30-year-old woman received the world's first transplant of a tailor-made windpipe, grown in a similar way by seeding a stripped-down donor organ with her own stem cells. Other such trachea operations have followed since.

The latest case involved a young girl with an obstructed hepatic portal vein, which drains blood from the intestines and spleen to the liver. Its blockage can be fatal.

The team from the University of Gothenburg took a 9 cm (3.5 inch) section of groin vein from a deceased donor and removed all the living cells, leaving just a protein scaffold tube. Stem cells extracted from the girl's bone marrow were then injected onto the tube and two weeks later the graft was implanted.

The new blood vessel immediately restored normal blood flow, the doctors said, although after a year it narrowed and a second stem cell-based graft was needed.

Martin Birchall and George Hamilton of University College London said in a commentary in The Lancet that the Swedish doctors had spared the young girl the trauma of having veins harvested from deep in her neck or leg and avoided the need for a liver transplant.

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Fat Stem Cells Grow Bone Faster And Better

Posted: June 14, 2012 at 12:19 pm

Featured Article Academic Journal Main Category: Bones / Orthopedics Also Included In: Stem Cell Research Article Date: 14 Jun 2012 - 4:00 PDT

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They write about their work in the 11 June online first issue of a paper published in the new peer-reviewed journal Stem Cells Translational Medicine, which aims to span stem cell research and clinical trials.

The two co-senior authors of the study are Chia Soo, vice chair for research at University of California - Lost Angeles (UCLA) Plastic and Reconstructive Surgery, and Bruno Pault, professor of Orthopedic Surgery at UCLA. Both are members of the Eli and Edythe Broad Center of Regenerative Medicine and Stem Cell Research at UCLA.

Soo told the press that fat tissue is considered a good source of mesenchymal stem cells, the sort that can be coaxed to form various tissue types such as bone, cartilage and muscle, because there is plenty of it and it is easy to get hold of with procedures like liposuction.

One conventional method of growing these stem cells from fat tissue relies on culturing the fat cells for weeks to isolate the stem cells that form bone. These processes can increase the risk of infection and lead to genetic instability.

Another traditional method, called stromal vascular fraction (SVF), uses fresh, non-cultured cells, but it is not easy to extract SVF cells from fat tissue because there are many kinds of them, not all capabale of forming bone.

For this study, the researchers isolated and purified human perivascular stem cells (hPSC) from fat tissue, and using lab animals, showed these cells are a better option for making bone than SVF cells.

They also showed that a growth factor called NELL-1, speeded up bone formation.

Soo told the press:

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