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One Year Follow Up of Cytori Cell Therapy in Investigator Erectile … – GlobeNewswire (press release)

May 10, 2017 09:00 ET | Source: Cytori Therapeutics

SAN DIEGO, May 10, 2017 (GLOBE NEWSWIRE) -- Cytori Therapeutics, Inc.(NASDAQ:CYTX) announces one year follow up data of ADRCs (Cytori Cell Therapy) treatment in post prostatectomy erectile dysfunction. The related abstract and presentation will occur at the 2017 American Urological Association Annual Meeting, May 12-16 in Boston. The abstract is currently available in the Journal of Urology (online).

The investigator initiated, open label, Phase I, single arm pilot trial studied 21 men with post prostatectomy erectile dysfunction with insufficient clinical effect after maximal pharmacologic intervention. The abstract reports that following a single administration of Cytori Cell Therapy, eight of 14 (57%) of subjects with urinary continence at baseline recovered their erectile function and could implement sexual intercourse after 6 months with the effect sustained to 12 months after treatment. This was associated with a modest but statistically significant sustained improvement in the patients IIEF-5 score, a widely used measure of male sexual function. Efficacy was solely demonstrated in patients that were continent at inclusion of the trial. No serious adverse events and 8 minor events related to the liposuction were reported.

This data follows previously published six month follow-up from the same trial on a smaller subset of 17 men with erectile dysfunction following radical prostatectomy (publication available here).

In addition to this study in erectile dysfunction, Cytori Cell TherapyTM is currently being studied in the ADRESU trial in Japan for male urinary incontinence following prostatic surgery. This investigator initiated, phase III, multicenter, 45 patient trial of Cytoris ECCI-50 cellular therapeutic is based on promising pilot trial data published in the International Journal of Urology in 2014. Details of the pilot trial can be found on clinicaltrials.gov and the Japanese Ministry of Health Labour and Welfare website.

AboutCytori Therapeutics, Inc.

Cytori is a therapeutics company developing regenerative and oncologic therapies from its proprietary cell therapy and nanoparticle platforms for a variety of medical conditions. Data from preclinical studies and clinical trials suggest that Cytori Cell Therapy acts principally by improving blood flow, modulating the immune system, and facilitating wound repair. As a result, Cytori Cell Therapy may provide benefits across multiple disease states and can be made available to the physician and patient at the point-of-care through Cytoris proprietary technologies and products. Cytori Nanomedicine is developing encapsulated therapies for regenerative medicine and oncologic indications. For more information, visit http://www.cytori.com.

Cautionary Statement Regarding Forward-Looking Statements

This press release includes forward-looking statements regarding events, trends and business prospects, which may affect our future operating results and financial position. Such statements, including, without limitation, conduct of clinical trials and presentation of clinical data, are all subject to risks and uncertainties that could cause our actual results and financial position to differ materially. Some of these risks and uncertainties include, but are not limited to, inherent risk and uncertainty in conduct of investigator-initiated clinical trials, protection of intellectual property rights, regulatory uncertainties, risks in the collection and results of clinical data, final clinical outcomes, dependence on third party performance, performance and acceptance of our products in the marketplace, as well as other risks and uncertainties described under the heading "Risk Factors" in Cytori's Securities and Exchange Commission Filings on Form 10-K and Form 10-Q. We assume no responsibility to update or revise any forward-looking statements to reflect events, trends or circumstances after the date they are made.

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One Year Follow Up of Cytori Cell Therapy in Investigator Erectile ... - GlobeNewswire (press release)

Novel tissue-engineered islet transplant achieves insulin independence in type 1 diabetes – Science Daily

Science Daily

Novel tissue-engineered islet transplant achieves insulin independence in type 1 diabetes Science Daily Scientists from the Diabetes Research Institute (DRI) at the University of Miami Miller School of Medicine have produced the first clinical results demonstrating that pancreatic islet cells transplanted within a tissue-engineered platform can ...

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Novel tissue-engineered islet transplant achieves insulin independence in type 1 diabetes - Science Daily

Scientists Find The Cells At The Root Of Balding And Gray Hair – IFLScience

There is only one cure for gray hair... It is called the guillotine, PG Wodehouse once wrote. But lets not be so pessimistic, science might have found another way.

Scientists have identified the cells that allow our hair to grow, providingfurther insight into the mechanisms that cause hair to turn gray and bald. The researchers say this could be used to find treatments for balding and graying hair in the near future. The findings are published in the journal Genes & Development.

The study exploredstem cells deep in the hair follicles known as hair progenitor cells, along with two proteins called KROX20 and stem cell factor (SCF). They found that KROX20 turned on" in skincells that became the hair shaft. These hair progenitor cells then produced SCF, which is essential for hair pigmentation. If cells with both KROX20 and SCF are present, they move up from the follicle, interact with pigment-producing melanocyte cells, and grow into pigmented hairs.

However, when the team deleted the KROX20-producing cells in mice, they didnt grow any hair and became bald. When they deleted the SCF gene in the hair progenitor cells in mice, their hair turned white.

This discovery was stumbled uponby chance, as KROX20 is typically associated with nerve development. The researchers found the cells while studying a disorder called neurofibromatosis type 1, a rare genetic disease that causes tumors to grow on nerves.

Although this project was started in an effort to understand how certain kinds of tumors form, we ended up learning why hair turns gray and discovering the identity of the cell that directly gives rise to hair," lead researcher Dr Lu Le, from the University of Texas Southwestern Medical Center, said in astatement."With this knowledge, we hope in the future to create a topical compound or to safely deliver the necessary gene to hair follicles to correct these cosmetic problems."

Dr Le added that the next step is to find out how both the KROX20 in cells and the SCF gene stop working properly as people age, as well as their role in male pattern baldness. In the meantime, its time to start embracing that gray streak or rocking the bald look.

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Scientists Find The Cells At The Root Of Balding And Gray Hair - IFLScience

Chinese CAR T firm ICT licenses Vericel’s cell therapy platform for Asia – BioWorld Online

By Shannon Ellis Staff Writer

SHANGHAI Innovative Cellular Therapeutics Co. Ltd. (ICT), of Shanghai, a leader among China's pack of emerging CAR T oncology companies, has struck a partnership deal with Vericel Corp., the first biotech to receive FDA approval for a tissue-engineered autologous cell scaffold.

The deal moves ICT beyond oncology and CAR T, to give the Chinese firm a portfolio of four cell therapies for the treatment of knee cartilage repair, burn victims and heart failure patients. The deal also means ICT has the Asia rights to three FDA-approved assets and one under clinical study.

"This is the first U.S. FDA cell therapy deal with a Chinese company," said Jimmy Wei, ICT CEO. "In China, we are increasing our standard of quality and we think cell therapy should be more globally standardized."

A clinical-stage. VC-backed company, ICT has two clinical programs running in China for its 19CAR series to treat late-stage leukemia and lymphoma as well as numerous self-discovered CAR T oncology candidates. (See BioWorld Today, May 25, 2016.)

Last year, ICT went hunting for late-stage or approved cell therapy products outside of China. With the help of a consulting firm, it came up with a list of 20 potential companies, but Vericel quickly rose to the top due to its number of FDA-approved therapies. Vericel had acquired its technology from Sanofi Genzyme, where its knee cartilage therapy had been tested on patients in China. (See BioWorld Today, March 11, 2016, and Dec. 15, 2016.)

The deal gives ICT the right to develop and distribute four candidates Carticel, MACI, ixmyelocel-T and Epicel in Greater China, South Korea, Singapore and other counties in Asia. The company also will be responsible for funding the development, manufacturing and commercialization in that territory.

"MACI, Epicel and Carticel are FDA-approved products and have successfully treated thousands of patients in United States," said Lei Xiao, ICT chairperson. "Ixmyelocel-T has been evaluated in a phase II study in the U.S., and the encouraging data suggest that it may be a treatment option for millions of heart failure patients."

Vericel will receive a $6 million up-front payment from ICT and is eligible to receive $8 million in development and commercial milestones. Vericel may also receive tiered royalties from ICT equal to a percentage of net sales of each licensed product in the low to middle double digits.

ICT will also purchase $5 million worth of stock in Vericel. Intended to be more than a licensing agreement, the equity arrangement will set the foundation for a long-term partnership, Wei said.

Vericel will issue to ICT a warrant, exercisable for the number of shares of Vericel's common stock equal to $5 million less any withholding tax payable divided by Vericel's closing price on May 9, 2017, with an exercise price of $0.01 per share.

STILL AWAITING COMMERCIAL CLARITY

Currently, the commercial pathway for cell therapies in China is still uncertain. Biotechs like ICT are able to conduct small-scale clinical trials under the oversight of the National Health and Family Planning Commission (NHFPC) China's health ministry and are able to collect clinical trial data in a much quicker fashion than the CFDA-regulated process for new drugs. But getting authorization to charge for cell therapies is not permitted, although some companies find ways to charge hospitals in a process that is difficult to scale.

But that grey area makes it a buyer's market for forward-thinking Chinese biotechs on the hunt for China rights to global assets, at least for the time being.

"We should see more clarity with the regulatory pathway this year," Wei said. "After that, we can quickly launch the products. But once the pathway is more clear, the price of [in-licensing] those products will be much more expensive. . . . After the pathway is set, you will never get the price we got."

He said there are currently three regulatory models for China to consider: the U.S. system, in which the FDA approves cell therapies similarly to the way it approves drugs; a system like Japan's, where cell therapies are regulated by the MoH as a technology; or a hybrid of the two systems, a way that could work well in China if it could balance cost-effectiveness with tight manufacturing quality control.

MANUFACTURING PLATFORM

Manufacturing is a serious bottleneck for scaling autologous cell therapies, which require extracting a patient's cells to be processed before being reinserted into the patient's body. ICT has chosen to focus on building a logistics and manufacturing platform shared across cell therapies rather than stick strictly to a specific therapeutic area, such as oncology.

"We think the future for cell therapy companies is to build a core in manufacturing. There needs to be a cost advantage based on doing more than one product in order to achieve an economy of scale," said Wei. "There is a lot of similarity across therapies. The manufacturing process and systems that we will put in place [from Vericel] will be very helpful even for our CAR T product."

ICT hopes to take advantage of Vericel's quality control system that follow U.S. FDA standards in anticipation that China's guidelines could closely resemble those of U.S.

The company also is looking to bring its portfolio of CAR T candidates to U.S. and Europe and is currently in talks with potential partners.

MEETING AN UNMET NEED IN CHINA

In the end, Wei said he is optimistic that the benefits of Vericel's therapies particularly for burn victims and heart patients who currently have few options in China will win over the regulator concerns. Lacking detailed market data, it is predicted that the Chinese patient population for those two groups is four to five times as large as in the U.S.

FDA-approved Epicel therapy treats severe burn patients with more than 30 percent of their total body surface area burned using cultured epidermal autografts, or CEA. Vericel recently presented data demonstrating an 84 percent survival rate from the Epicel clinical experience databases in more than 950 patients with a mean total body surface area of 67 percent, which continues to support a probable survival benefit of Epicel in severe burn patients.

Ixmyelocel-T is an investigational autologous expanded multicellular therapy manufactured from the patient's own bone marrow using Vericel's highly automated, fully closed cell-processing system.

That process selectively expands the population of mesenchymal stromal cells and alternatively activated macrophages, which are responsible for production of anti-inflammatory and pro-angiogenic factors known to be important for repair of damaged tissue. It has been designated as an orphan drug by the U.S. FDA for use in the treatment of dilated cardiomyopathy (DCM).

The ixCELL-DCM trial was a multicenter, randomized, double-blind, placebo-controlled phase IIb study designed to assess the efficacy, safety and tolerability of ixmyelocel-T compared to placebo when administered via transendocardial catheter-based injections to participants with end-stage heart failure due to ischemic DCM, who have no reasonable revascularization options (either surgical or percutaneous interventional) likely to provide clinical benefit. All participants were on maximized pharmacological heart failure treatment and had an automatic implantable cardiac defibrillator or cardiac resynchronization therapy. The primary endpoint is the number of all-cause deaths, cardiovascular hospital admissions, and unplanned outpatient and emergency department visits to treat acute decompensated heart failure over the 12 months following administration of ixmyelocel-T compared to placebo.

MACI (autologous cultured chondrocytes on porcine collagen membrane) is an autologous cellular scaffold product that is indicated for the repair of symptomatic single or multiple full-thickness cartilage defects of the knee with or without bone involvement in adults. The MACI implant consists of autologous cultured chondrocytes seeded onto a resorbable type I/III collagen membrane. Autologous cultured chondrocytes are human-derived cells which are obtained from the patient's own cartilage for the manufacture of MACI.

An autologous chondrocyte implant, Carticel is used to treat cartilage defects in the knee in patients who have had an inadequate response to a prior arthroscopic or other surgical repair procedure.

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Chinese CAR T firm ICT licenses Vericel's cell therapy platform for Asia - BioWorld Online