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U.S. FDA Grants Fast Track Designation to Pluristem’s PLX-PAD for the Treatment of CLI

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  • Pluristem’s Ongoing Phase III CLI trial has been selected for accelerated approval pathways in both the U.S. and Europe

  • Fast Track Designation allows for expedited review of drugs to treat serious conditions with unmet medical need

HAIFA, Israel, Sept. 18, 2017 (GLOBE NEWSWIRE) — Pluristem Therapeutics, Inc. (NASDAQ:PSTI) (TASE:PSTI), a leading developer of placenta-based cell therapy products, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to the company’s ongoing Phase III study of PLX-PAD cells for the treatment of Critical Limb Ischemia (CLI) in patients ineligible for revascularization. The FDA’s Fast Track Designation is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and unmet medical needs. With Fast Track Designation, there is an increased possibility for a priority review by the FDA of PLX-PAD cells for the treatment of CLI.

Zami Aberman, Pluristem Therapeutics - FDA Fast Track Designation“We are extremely pleased with the FDA’s decision to grant Fast Track Designation to PLX-PAD in the treatment of CLI. Up to 40% of patients with CLI are ineligible for revascularization and are at high risk of amputation and death within the first year of diagnosis. This disease takes a heavy toll on patients and their families, while the cost of treating CLI in the U.S. alone is estimated at over $25 billion per year. We are working tirelessly to provide a cell therapy that will address this severe unmet medical need,” said Zami Aberman, Chairman and Co-CEO of Pluristem.

“Regulators in some of the largest healthcare markets in the world are now in alignment regarding the need for accelerated approval pathways for our cell therapy product in the treatment of CLI. Programs like the Fast Track Designation offer real hope for patients battling this disease and we look forward to accelerating the path to market for PLX-PAD,” stated Pluristem President and Co-CEO, Yaky Yanay. [Read more…]

RoosterBio Launches New cGMP Stem Cell Product Portfolio

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RoosterBio Launches New cGMP Stem Cell Product Portfolio, Maintaining Unwavering Commitment to Driving the Explosive Regenerative Medicine Industry

Next Generation Products are Harbinger of Paradigm Shift in the Adult Stem Cell Industry

RoosterBioFrederick, MD, USA. September 14, 2017 – RoosterBio Inc, today, proudly announces the launch of its CliniControl™ (CC) product portfolio, clinically-relevant starting and ancillary materials that generate unprecedented efficiencies in adult stem cell manufacturing, accelerating clinical translation of human Mesenchymal Stem/Stromal Cell (hMSC)-based therapies.  The CliniControl product portfolio will radically simplify major steps in product development and clinical translation, improving the likelihood of commercial success for RoosterBio customers.

The first in the CliniControl line of products, RoosterNourish™-MSC-CC bioprocess medium sets the new standard of industry-leading performance.  RoosterNourish-MSC-CC is a first-in-class, standardized, xeno-free (XF) bioprocess medium engineered to support not only 2D (plastic adherent), but also 3D suspension culture of hMSCs in allogeneic and autologous therapeutic manufacturing.  Formulated specifically for clinical research process and product developers, RoosterNourish-MSC-CC yields superior media productivity, leading to drastically reduced cost of goods as compared to other hMSC culture media.   The highly productive RoosterNourish medium is designed for batch 2D and fed-batch 3D cultures and seamlessly translates between culture platforms enabling scalable hMSC culture,  delivering robust, reproducible and standardized results at a commercially-viable cost of goods.  [Read more…]

LifeCell Becomes India’s Biggest Cord Blood Stem Cell Registry for Unrelated Use

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Achieves landmark milestone within four months of launch of revolutionary banking model

CHENNAI, August 7, 2017 – In spite of being a highly populated country, India has lacked availability of donor cord blood samples and registered bone marrow donors. The number of cord blood units preserved with public banks in India is collectively around 5,000. The probability of finding a matching unit from this small inventory is low, leaving over 70% of Indian patients requiring donor stem cells in the lurch. According to an ICMR study only when the inventory increases to >250,000 would almost every patient find a match. [Read more…]

Donor Egg Bank to Provide Free Cord Blood Processing through FamilyCord

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World’s Largest Frozen Egg Bank offers a Lifetime of Security

Rockville, MD, Aug. 1, 2017— Donor Egg Bank, a California Cryobank company, continues to set the standard for the frozen donor egg industry by offering a truly once in lifetime opportunity to their intended parents – free processing for their future babies’ cord blood stem cells through sister company FamilyCord – a $1,500 savings.

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AgeX Therapeutics Obtains $10 Million in Capital and Commences Operations

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AgeX TherapeuticsAugust 02, 2017, ALAMEDA, Calif.–AgeX Therapeutics, Inc. (AgeX), a subsidiary of BioTime, Inc. (NYSE MKT: BTX), today reported that it has successfully raised $10 million in equity financing to fund its operations. Following the financing, BioTime continues to own about 87% of AgeX’s outstanding shares. The financing is expected to fund preclinical development at AgeX as well as building the company’s operational infrastructure. The financing may also lead to a registration and distribution of a to-be-determined percentag of the AgeX shares to BioTime shareholders, after which AgeX would trade as a public company. [Read more…]

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