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Miltenyi Biotec and Cesca Therapeutics' Subsidiary TotipotentRX Announce Multi-Year Commercial Agreement for Bone Marrow Transplantation

RANCHO CORDOVA, Calif., Oct. 28, 2015 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today announced that its subsidiary, TotipotentRX, has signed a multi-year distribution agreement with Miltenyi Biotec GmbH (Germany) for clinical product sales throughout India. As part of the agreement, TotipotentRX's advanced haploidentical transplant program will incorporate Miltenyi Biotec's CliniMACS® Cell Separation System, used for selecting beneficial cells or depleting donor immune cells from grafts that may interfere with engraftment in preparation for bone marrow transplantation. TotipotentRX provides specialized clinical cell manufacturing technology, services and expertise to major hospital networks in the rapidly growing Indian transplant market, including its exclusive agreement with Fortis Healthcare. With this agreement Miltenyi reinforces Cesca's leadership position while strategically positioning itself for future growth in Asia.

Venkatesh Ponemone, Ph.D., Executive Director and Director of GMP Laboratory and Clinical Affairs at Cesca's subsidiary TotipotentRX, stated, "This landmark agreement is the beginning of what is anticipated to be a long and fruitful relationship with Miltenyi Biotec that will benefit Indian hematology and oncology patients. The combination of expertise, services and products that we now jointly provide is unmatched in the region. I believe this to be a crucial milestone in providing world-class care in our life-saving transplant programs and I look forward to leveraging Miltenyi Biotec's technology in the various collaborations we have underway."

Miltenyi Biotec is a global leader and pioneer in delivering comprehensive cell-based reagent/equipment systems to biomedical and clinical researchers. The CliniMACS Cell Separation System is based on proven magnetic cell separation methodology, the renowned MACS® Technology, enabling consistent generation of cellular products for a wide range of clinical applications. Many graft engineering haploidentical transplant protocols employ the use of Miltenyi Biotec products to deplete donor T and B lymphocytes prior to transplantation. Ex-vivo depletion of these cells can greatly reduce the risk of life-threatening Graft versus Host Disease (GVHD), a significant threat to the use of partially matched relatives as donors (haploidentical transplantation) frequently used in India. GVHD occurs when the donor's immune cells attack the recipient's tissue, causing serious damage to major tissues and organs throughout the body.

Kazi Deluwar Ahmed, MD, Managing Director of Miltenyi Biotec, Asia Pacific said, "It is our goal at Miltenyi Biotec to become the major solution provider for cell and gene therapies, both for clinical research and at commercial scale, and with the partnership with TotipotentRX (Cesca Therapeutics), our strengthened presence in India will enable us to reach out to more clinicians and patients with novel treatment options in Cell therapies."

Dr. Solomon Hamburg MD, PhD, clinical professor of medicine at the UCLA School of Medicine, CEO of the Tower Cancer Research Foundation at Cedars Sinai Medical Center and a member of Cesca's Medical Advisory Board, added, "This agreement will provide new protocols for transplantation using Miltenyi's cell separation technology in India and will enhance the significant capability already in the TotipotentRX facility. Overall this partnership will open up many more options for improving the quality of cell therapy in India."

About Cesca Therapeutics Inc.

Cesca Therapeutics Inc. (www.cescatherapeutics.com) is engaged in the research, development and commercialization of autologous cell-based therapeutics for use in regenerative medicine. The Company is a leader in the development and manufacture of automated blood and bone marrow processing systems that enable the separation, processing and preservation of cell and tissue therapy products. These include:

  • SurgWerks™; proprietary stem cell therapy point-of-care kits for the treatment of vascular and orthopedic indications that integrate the following indication specific elements:

-- Cell harvesting

-- Cell processing and selection

-- Cell diagnostics

-- Cell delivery

  • CellWerksTM; an integrated system which includes a protocol, disposables and equipment for intra-laboratory use in treatment of oncological and hematological disorders.
  • The AutoXpress® (AXP); a proprietary automated device, along with companion sterile blood processing disposables, for the harvesting of stem cells from cord blood.
  • The MarrowXpress (MXP); a device and disposable system based on the AutoXpress platform for the isolation and concentration of stem cells from bone marrow. Self-powered and microprocessor-controlled, the MXP contains flow control and optical sensors and concentrates white blood cells from bone marrow to a user-defined volume in 40 minutes while retaining over 90% of mononuclear cells (MNCs).
  • The BioArchive® System; an automated cryogenic device, used by cord blood stem cell banks in more than 30 countries, for cryopreservation and archiving of cord blood stem cell units for transplant.

Forward Looking Statement

The statements contained herein may include statements of future expectations and other forward looking statements that are based on management's current views and assumptions and involve known and unknown risks and uncertainties that could cause actual results, performance or events to differ materially from those expressed or implied in such statements, including our ability to initiate and prosecute the pivotal CLIRST III trial, our ability to obtain efficacy consistent with prior CLI studies, continued FDA approval, Medicare reimbursement approval, timing of the Company's future submission of IDE, PMA and/or Medicare reimbursement applications, or amendments to such applications, and outcomes from such submissions. Further, clinical trial outcomes are not predictable, and results may vary from the Company's expectations, including the start of any such clinical trials, patient follow up issues, and costs associated with such trials. Further description of other risks that could cause actual events to differ from the outcomes predicted by Cesca Therapeutics' forward-looking statements is set forth under the caption "Risk Factors" in Cesca Therapeutics annual report on Form 10-K and other reports it files with the Securities and Exchange Commission from time to time, and you should consider each of those factors when evaluating the forward-looking statements. Contact: Cesca Therapeutics Inc. http://www.cescatherapeutics.com. Cesca may, at its discretion, choose to publish on-going interim notifications, requests for further information as received from the FDA, Medicare or equivalent foreign agencies, but as a general policy only makes announcements regarding material or significant information, such as filing of applications, approvals, initiation of studies, and conclusions.

CONTACT: Cesca Therapeutics Inc. http://www.cescatherapeutics.com Investor Contact: Kirin Smith, PCG Advisory Group 646-863-6519, or ir@cescatherapeutics.com Media Contact: Sean Leous, PCG Advisory Group 646-863-8998 or sleous@pcgadvisory.com

Source:Cesca Therapeutics Inc.

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