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Journal Stem Cell Translational Medicine to Publish Article on FDA Communications and the Regulatory Pathway for Cell …

By Uncategorized

WASHINGTON, DC--(Marketwire - Oct 17, 2012) - The Alliance for Regenerative Medicine (ARM), the international organization representing the interests of the regenerative medicine community, announced the publication today of an article on FDA communications to help companies developing cell-based therapies by clarifying the development pathway. The article, entitled "Communications with the FDA on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?" will be published in the journal Stem Cells Translational Medicine. It is co-authored by representatives from ARM, Janssen R&D, GE Healthcare and Life Technologies, with the lead author from the California Institute for Regenerative Medicine (CIRM).

"There are a number of ways cell-based therapy companies can communicate with FDA that will help them navigate the road from the bench to a regulatory submission," said Michael Werner, Executive Director of ARM. "We hope that our combined experience as co-authors, and our attempt to create a single source of guidance on the regulatory process, will help companies bring new cell-based therapies through clinical trials and the regulatory review process more quickly so they can reach patients faster," added Mr. Werner.

Lead author Ellen Feigal, MD, Senior Vice President for Research and Development at the California Institute for Regenerative Medicine (CIRM) commented, "Cell-based therapies represent a fundamentally new way to treat or cure disease, but developing a new therapy is costly, time consuming and fraught with uncertainty. Our paper takes a practical approach to clarifying the path to market."

"Communications with the FDA on the Development Pathway for a Cell-Based Therapy: Why, What, When, and How?" provides detailed information on options for communicating with the FDA at different stages; the official communications tied to each stage of development; and the most common reasons regulatory applications are delayed. The article can be accessed at: http://stemcellstm.alphamedpress.org/content/early/recent

About CIRM: CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research opportunities. A list of grants and loans awarded to date may be seen here: http://www.cirm.ca.gov/for-researchers/researchfunding.

About ARM: The Alliance for Regenerative Medicine is a Washington, DC-based multi-stakeholder advocacy organization that promotes legislative, regulatory and reimbursement initiatives necessary to facilitate access to life-giving advances in regenerative medicine. ARM also works to increase public understanding of the field and its potential to transform human healthcare, providing business development and investor outreach services to support the growth of its member companies and research organizations. Prior to the formation of ARM in 2009, there was no advocacy organization operating in Washington, DC to specifically represent the interests of the companies, research institutions, investors and patient groups that comprise the entire regenerative medicine community. Today ARM has more than 120 members and is the leading global advocacy organization in this field. In March 2012, ARM launched a sister organization in Europe -- the Alliance for Advanced Therapies. For more information go to http://www.alliancerm.org.

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Journal Stem Cell Translational Medicine to Publish Article on FDA Communications and the Regulatory Pathway for Cell ...

NeoStem, Inc. Announces the Redemption of the Outstanding 7% Series E Preferred Stock

By Uncategorized

NEW YORK, Oct. 17, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), an emerging leader in the fast growing cell therapy market, today announced that it will redeem all outstanding shares of its Series E 7% Senior Convertible Preferred Stock ("Series E Preferred Stock").

On October 10, 2012, the Company gave notice to its Series E Preferred Stockholders that it is redeeming all of the outstanding shares of Series E Preferred Stock for an aggregate redemption price of $3.4 million, $2.5 million of which was funded by money placed into escrow when the Series E Preferred stock was issued in November 2010.

"We are pleased that we have been able to redeem this $10 million investment in full over a two year period. Equal to our focus on cell therapy product development and expanding our PCT contract development and manufacturing operations, we are committed to improving our balance sheet. Through the redemption of the Series E Preferred Stock, we will remove a significant overhang and simplify NeoStem's capital structure. The redemption of the Series E Preferred Stock is another example of a step taken by us to improve Common Stockholder value," said Dr. Robin Smith, Chairman and CEO of NeoStem. "We look forward to continued execution on our near term business strategy, including the forthcoming closing of the divestiture of our Erye China pharmaceutical subsidiary."

About NeoStem, Inc.

NeoStem, Inc. continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy market. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, Progenitor Cell Therapy, LLC ("PCT"), with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe this expertise and existing research capabilities and collaborations will enable us to achieve our mission of becoming a premier cell therapy company.

Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSELTM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert, giving us a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we believe we are well positioned to succeed.

For more information on NeoStem, please visit http://www.neostem.com.

Forward-Looking Statements for NeoStem, Inc.

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's or its partners' successful development of AMR-001 and other cell therapeutics, the size of the market for such products, its competitive position in such markets, the Company's ability to successfully penetrate such markets and the market for its contract development and manufacturing ("CDMO") business, and the efficacy of protection from its patent portfolio, as well as the future of the cell therapeutics industry in general, including the rate at which such industry may grow. Forward looking statements also include statements with respect to satisfying all conditions to closing the disposition of Erye, including receipt of all necessary regulatory approvals in the PRC. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors, including but not limited to matters described under the "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2012 and in the Company's other periodic filings with the Securities and Exchange Commission, all of which are available on its website. The Company does not undertake to update its forward-looking statements. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.

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NeoStem, Inc. Announces the Redemption of the Outstanding 7% Series E Preferred Stock

FDA issues warning letter to local stem cell company

By Stem Cell Treatment

The Food and Drug Administration has informed the Sugar Land company involved in Gov. Rick Perry's adult stem-cell procedure that it is illegally marketing an unlicensed drug.

In a warning letter, the FDA gave Celltex Therapeutics Corp. 15 business days to submit a plan to address the agency's concerns, including correcting previously cited manufacturing problems. The letter said that failure to respond promptly could result in seizure or injunction by the FDA.

"Based on (our) information, your product violates the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act," says the letter, sent on Sept. 24 and publicly posted Tuesday.

The letter comes about six months after the FDA made a 10-day inspection of the facilities where Celltex banks and grows stem cells taken from prospective patients. The agency subsequently filed a report, obtained by the Chronicle in June, detailing dozens of manufacturing deficiencies, from incorrectly labeled products to failed sterility tests.

The new warning letter reiterates those problems and asks for more information about them.

David Eller, Celltex's CEO, was unavailable Tuesday, but a public relations official said the company on Wednesday would make available a redacted copy of its letter to the FDA.

In a previous news release, Eller said Celltex "respectfully but firmly" disagreed with the FDA's position that its process causes the cells to be considered biological drugs and thus subject to the federal agency's regulations. Biological drugs involve living human cells, as opposed to chemically synthesized drugs.

"We are considering all options as we work with the agency toward a resolution," Eller said in the release.

Adult stem cells multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have recently shown promise for tissue repair in other diseases, though most scientists in the field consider them not ready for mainstream use.

Treatment, at a price

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FDA issues warning letter to local stem cell company

FDA issues warning to local stem cell company

By Stem Cell Treatment

The Food and Drug Administration has informed the Sugar Land company involved in Gov. Rick Perry's adult stem-cell procedure that it is illegally marketing an unlicensed drug.

In a warning letter, the FDA gave Celltex Therapeutics Corp. 15 business days to submit a plan to address the agency's concerns, including correcting previously cited manufacturing problems. The letter said that failure to respond promptly could result in seizure or injunction by the FDA.

"Based on (our) information, your product violates the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act," says the letter, sent on Sept. 24 and publicly posted Tuesday.

The letter comes about six months after the FDA made a 10-day inspection of the facilities where Celltex banks and grows stem cells taken from prospective patients. The agency subsequently filed a report, obtained by the Chronicle in June, detailing dozens of manufacturing deficiencies, from incorrectly labeled products to failed sterility tests.

The new warning letter reiterates those problems and asks for more information about them.

David Eller, Celltex's CEO, was unavailable Tuesday, but a public relations official said the company on Wednesday would make available a redacted copy of its letter to the FDA.

In a previous news release, Eller said Celltex "respectfully but firmly" disagreed with the FDA's position that its process causes the cells to be considered biological drugs and thus subject to the federal agency's regulations. Biological drugs involve living human cells, as opposed to chemically synthesized drugs.

"We are considering all options as we work with the agency toward a resolution," Eller said in the release.

Adult stem cells multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have recently shown promise for tissue repair in other diseases, though most scientists in the field consider them not ready for mainstream use.

Treatment, at a price

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FDA issues warning to local stem cell company

FDA issues warning to Sugar Land stem cell company

By Stem Cell Treatment

The Food and Drug Administration has informed the Sugar Land company involved in Gov. Rick Perry's adult stem-cell procedure that it is illegally marketing an unlicensed drug.

In a warning letter, the FDA gave Celltex Therapeutics Corp. 15 business days to submit a plan to address the agency's concerns, including correcting previously cited manufacturing problems. The letter said that failure to respond promptly could result in seizure or injunction by the FDA.

"Based on (our) information, your product violates the Federal Food, Drug, and Cosmetic Act and the Public Health Service Act," says the letter, sent on Sept. 24 and publicly posted Tuesday.

The letter comes about six months after the FDA made a 10-day inspection of the facilities where Celltex banks and grows stem cells taken from prospective patients. The agency subsequently filed a report, obtained by the Chronicle in June, detailing dozens of manufacturing deficiencies, from incorrectly labeled products to failed sterility tests.

The new warning letter reiterates those problems and asks for more information about them.

David Eller, Celltex's CEO, was unavailable Tuesday, but a public relations official said the company on Wednesday would make available a redacted copy of its letter to the FDA.

In a previous news release, Eller said Celltex "respectfully but firmly" disagreed with the FDA's position that its process causes the cells to be considered biological drugs and thus subject to the federal agency's regulations. Biological drugs involve living human cells, as opposed to chemically synthesized drugs.

"We are considering all options as we work with the agency toward a resolution," Eller said in the release.

Adult stem cells multiply to replenish dying cells. Long used to treat leukemia and other cancers, they have recently shown promise for tissue repair in other diseases, though most scientists in the field consider them not ready for mainstream use.

Treatment, at a price

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FDA issues warning to Sugar Land stem cell company

Stem cell doctor in court: Day 2

By Stem Cell Treatment

COLLIER COUNTY -

A Southwest Florida doctor spent another day in court fighting for his right to practice medicine.

Bonita Springs cardiologist Zannos Grekos' license is currently suspended because two of his patients died after undergoing a controversial stem cell procedure.

Wednesday was day two of what's scheduled to be a four day trial. The courtroom was again filled with patients supporting Grekos and his stem cell treatment.

This hearing focuses only on the first patient that died after getting that treatment. Her family was also in attendance and wants Grekos' medical license revoked.

Dr. Richard Roland spoke about a call he got from Grekos in 2010. He had just performed a stem cell procedure on his patient Domenica Fitgzerald and something went wrong.

Roland was Fitzgerald's ICU doctor.

"I was quite shocked. My first comment was, 'You did what?' His response was, 'Yes. We've been having good luck with these procedures,'" Dr. Roland said. "I had concerns that this was criminal."

Fitzgerald's family says the breast cancer survivor was looking for a cure for nerve damage caused by chemotherapy.

They say Grekos gave her false hope.

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Stem cell doctor in court: Day 2

Patient's husband testifies in stem cell doctor's hearing

By Stem Cell Treatment

COLLIER COUNTY, Fla - A controversial stem cell doctor is fighting for his medical license in Collier County court.

Two of Dr. Zannos Grekos' patient who underwent experimental stem cell procedures died and as part of his defense, his attorney's say, family members of those patients could have done more to save their lives.

This week long hearing focuses on a 69 year old patient of Dr. Grekos who died in 2010. For the first time Tuesday that woman's husband talked about her experimental procedure, but he also describes her untimely death hours after receiving a stem cell treatment.

In March of 2010, Dr. Zannos Grekos preformed a cerebral angiogram and experimental stem cell procedure on a 69 year old woman, but as soon as she got home, her husband Jack says things go scary as his wife's condition took a turn for the worst.

"I thought she had a stroke, but I didn't know, I'm not a doctor," says Jack while testifying Tuesday. "But, there was nothing there, she was just blank."

Jack told the courtroom his wife went to Dr. Grekos' practice Regenocyte in Bonita Springs to cure a walking disability that occurred from breast cancer treatments. They were told by Dr. Grekos, worst case, it wouldn't work, but Tuesday he described the moments leading up to his wife's death.

"They told me she would be fine by the morning. I just kept an eye on her. Then, after she vomited and it was real bad. Then I called 911."

In cross examination Dr. Grekos' attorney, Richard Ozelie, referred to a deposition that describes how Jack's wife hit her head on the floor. According to a state report the patient suffered a severe brain stem injury. But, today in court Jack said his wife didn't fall, but slid out of a reclining chair.

Ozelie asks Jack, "Is it your testimony that your wife did not fall?"

"That's right, she did not fall, she couldn't even get up," says Jack.

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Patient's husband testifies in stem cell doctor's hearing

Stem-cell fraud hits febrile field

By Stem Cell Treatment

Hisashi Moriguchi was besieged by reporters after giving a press conference retracting his claims.

J. Sato/Getty

Rarely has such a spectacular scientific claim been debunked so rapidly. For a few brief hours last week, Hisashi Moriguchi, a project researcher at the University of Tokyo, was riding high, lauded by his nations press for pioneering work on induced pluripotent stem (iPS) cells. His feat was said to be the first successful use in humans of a technology that days earlier had won his countryman, Kyoto Universitys Shinya Yamanaka, a share of the Nobel Prize in Physiology or Medicine1.

Yet a swift investigation by Nature and several stem-cell researchers found that Moriguchis claim to have cured six heart-failure patients with cells derived from iPS cells was untrue; that he had lied about his university affiliations; and that he had plagiarized key parts of his research papers2. At a hastily convened press conference on 13 October, Moriguchi recanted. I admit that I lied, he told reporters, adding that his career as a researcher is probably over.

The sad episode could be written off as one researchers runaway fantasy. But it highlights the febrile nature of the iPS-cell field, particularly in Japan. Many researchers fear that the therapeutic promise of these cellswhich could open the way to creating replacement tissues to treat diseasewill spur a premature rush to clinical applications before their safety and efficacy can be proven.

The story kicked off when Moriguchis claims were splashed over the front page of Yomiuri Shimbunthe highest-circulation newspaper in the worldon 11October. He described how he had reprogrammed patients liver cells into an embryonic state, with the potential to develop into many different cell types. After converting these iPS cells into heart-muscle cells, he supposedly injected them into six patients in the United States to successfully repair their damaged heart tissue.

But inconsistencies in the account quickly became apparent. Alerted by Nature, Harvard Medical School and the Massachusetts General Hospital, both in Boston, denied that the procedures had taken place there, or that Moriguchi was affiliated with them, as he had claimed. In an interview with Nature, Moriguchi could not provide details of the ethics review board that had approved the procedures; the source of the clinical-grade cells; or the names of collaborators. He claimed to have carried out an incredible range of activities almost single-handedly and described unconventional and unlikely methods for producing the cells. Yet he trained as a nurse, lacks a medical degree, and his most recent research was in medical economics. Nature also discovered that the publications that Moriguchi had used to support his claims3, 4 contained technical images copied from other sources, as well as plagiarized passages from other articles5, 6. We are all doing similar things, so it makes sense that wed use similar words, Moriguchi told Nature.

On 13 October, the day after Nature ran its expos2, Moriguchi held a press conference in New York, where he had been attending a meeting of the New York Stem Cell Foundation. He admitted that most of his claims were untrue, but maintained that he had injected iPS-cell-derived heart cells into one patient, and that he could produce notes to prove it. The University of Tokyo and the Tokyo Dental and Medical University, where Moriguchi claimed to have carried out collaborative studies, have subsequently launched investigations into the affair. Nature Publishing Group, which has published papers by Moriguchi in its journal Scientific Reports, says that it is aware of the issues surrounding these publications and is investigating.

Researchers trying to understand why Moriguchi would engage in such reckless fabrication have noted a climate that allows such claims to gain prominence with little challenge. Since Yamanakas discovery of iPS cells in 2006, some Japanese media and government officials have taken a highly competitive tone about the technology. In its original article about Moriguchis claims, Yomiuri Shimbun noted that a burdensome regulatory system was holding back Japans clinical research relative to the United States, and, in a 2009 correspondence published in Nature7, Moriguchi argued that Japan is in danger of being overtaken in the field of human iPS-cell research.

Scientists, journalists and regulators here need to be especially careful not to let their pride in Yamanakas achievement affect their critical faculties, or overwhelm them in national fervour, says Douglas Sipp, who researches stem-cell ethics and regulation at the RIKEN Center for Developmental Biology in Kobe, Japan.

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Stem-cell fraud hits febrile field

Harvard Ophthalmologist Dr. Ula Jurkunas Introduces Stem Cell Transplant for Eyes

By Stem Cell Treatment

Grants Pass, OR (PRWEB) October 16, 2012

Harvard Ophthalmologist and Corneal Stem Cell Researcher Ula Jurkunas, MD, has announced an important new stem cell transplant procedure for the eyes.

Speaking on the Sharon Kleyne Hour Power of Water radio show, Dr. Jurkunas, predicted that the procedure will offer a significant benefit to patients with certain corneal diseases, and corneal injuries such as chemical and thermal burns (The cornea is the eyes clear portion).

Stem cell research has been in the news because the 2012 Nobel Prize for Medicine was awarded for stem cell research.

Dr. Jurkunas explained to host Sharon Kleyne that the human eye produces its own adult (non-embryonic) stem cells. These are found between the limbus (where the clear cornea meets the white of the eye) and the conjunctiva (the red meaty tissue in the eyes inner corner). Their function is to replenish corneal cells to keep the cornea clear and healthy.

Production of corneal stem cells, according to Dr. Jurkunas, can become impaired due to a disease entity such as an infection, severe allergy, severe dry eye, immunological disorder or chronic inflammation; or due to injury such as a chemical or thermal burn. These traumas can cause the cornea to become cloudy and ulcerated. Prior to the present corneal stem cell research, there had been no reliable, non-invasive treatment for these conditions.

Corneal stem cell transplantation, Dr. Jurkunas explains, has the advantage of utilizing the patients own tissue as donor cells. Stem cells may be taken either from healthy tissue elsewhere in the diseased eye, from the patients other eye, or from the patients inner cheek (which has many similarities to eye tissue and also produces adult stem cells). Donor stem cells are then isolated and grown in culture. The final step is to transfer them to the affected cornea using a stem cell bandage.

The procedure, says Dr. Jurkunas, has resulted in dramatic corneal clearing and sight restoration. Although research is ongoing and the procedure remains experimental, corneal stem cell therapy is available in clinical trials. Widespread applications of the procedure, including routine testing for corneal stem cell deficiency, are anticipated. Stem cell therapy, according to Dr. Jurkunas, could eventually be used for macular degeneration, glaucoma and other eye diseases.

Dr. Jurkunas stressed the importance of water and hydration in maintaining a healthy tear film and cornea. The tear film covering the cornea is 99% water and is essential to the light refraction that enables vision. Dry eye and related eye infections, according to Dr. Jurkunas, can damage both the cornea and adjacent stem cell producing tissues that enable the cornea to repair itself. Water in the tear film stimulates the healthy production of stem cells. Water is also critical to keeping stem cells viable during transplantation.

Mrs. Kleyne and Dr. Jurkunas agree that non-invasive therapies using the bodys own tissues, such as corneal stem cell transplantation, could eventually prove indispensable in combating the worldwide health effects of global drying and dehydration.

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Harvard Ophthalmologist Dr. Ula Jurkunas Introduces Stem Cell Transplant for Eyes

Hearing starts for doctor accused of using stem cell procedure

By Stem Cell Treatment

An administrative hearing got underway Tuesday between state health care regulators and Dr. Zannos Grekos, a Bonita Springs cardiologist, regarding his controversial stem cell practice and whether he committed medical malpractice.

More than a dozen observers are present in the Collier County courtroom, many of them supporters of Grekos who have said previously that he changed his life when he injected them with their own stem cells to treat damaged heart muscle, lung tissue or for spinal injuries.

The state Department of Health in 2011 issued an emergency restriction on Grekos medical license, ordering him not to do anything with patients and their own stem cells.

The order came after an investigation found he had had performed stem cell procedure in 2010 on a 69-year-old woman, using her own blood, in hopes it would provide relief against nerve damage in her legs that occurred from earlier breast cancer treatment. After the treatment with Grekos, she suffered brain damage and later was taken off life support.

Three family members of the patient, Domenica Fitzgerald, are present and her husband, John Fitzgerald, will be a witness for the state. The start of the hearing is bittersweet for him and his family.

We need closure, he said.

Grekos is fighting the state's complaint and is seeking to have his license reinstated. Before the start of the hearing and during breaks, Grekos greeted his supporters and hugged several of them.

The hearing is before administrative law judge J. Lawrence Johnson, and is scheduled to last four days. The judge has ordered witnesses not to be present in the courtroom except during their testimony.

In opening statements, the prosecutor for the state health department, Robert Milne, said that the treatment Grekos performed had no scientific backing in research, and a neurosurgeon with the University of South Florida will testify about that.

In addition, Milne said that chemotherapy destroys stem cells and so Grekos' extraction of bone marrow aspirate in the patient, to use her stem cells, had no therapeutic value.

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Hearing starts for doctor accused of using stem cell procedure

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