RANCHO CORDOVA, Calif., Oct. 19, 2015 (GLOBE NEWSWIRE) -- Cesca Therapeutics Inc. (NASDAQ:KOOL), an autologous cell-based regenerative medicine company, today announced that its Clinical GMP Cell Processing Laboratory “TotipotentRX Centre for Cellular Medicine” located at Fortis Memorial Research Institute (FMRI), New Delhi, N.C.R., India, performed a specialized T-cell preparation procedure designed for a unique haploidentical transplantation case. This potentially lifesaving procedure was provided for a child suffering from both Fanconi’s Anemia (non-malignant genetic disorder) and relapsed AML (malignant disorder). The patient is currently in stable condition.
Haploidentical transplantation is a treatment option gaining global acceptance as it increases the possibility of finding an acceptable donor match, known as an HLA match. With respect to HLA matching, parents are always a half-match for their children and siblings have at least a 75% chance of a match (full match and half match). Until recently closely related donor sources such as the patient’s parents came with a high risk of incompatibility and a high incidence of fatal Graft versus Host disease, where donor cells attack the recipient. New protocols that involve selection or removal of specific sub- types of T lymphocytes, as used in the TotipotentRX laboratory, are now providing more options with good results for patients in need of a life-saving bone marrow transplant. Furthermore, in the case of patient relapse, a closely related donor is more likely to be available for further cell therapy.
Dr. Venkatesh Ponemone, Ph.D., Executive Director GMP Laboratory and Clinical affairs, India stated, “We are very pleased by the achievement of this clinical milestone as it highlights our routine use of cell selection technology with Haploidentical transplantation and our capability to support the needs of cutting-edge healthcare. We are one of a very exclusive group of laboratories capable of this precision work and we look forward to expanding our approach for the betterment of a huge and underserved patient population in India. I’m personally very proud of Cesca’s vision and thankful for the opportunity to take part in giving many patients a second chance at life, particularly children.”
Mitchel Sivilotti, Senior Vice President and Chief Biologist at Cesca Therapeutics stated, “In India, there is an acute need for transplant donors as transplant registries are yet to reach the maturity of those in the U.S. and Europe. Historically, this has left patients with limited transplant options. Dr. Ponemone and his team have adopted advanced methodologies at a quality level unsurpassed in the region they serve. We are very fortunate to have this first-mover advantage and look forward to serving patients, technology partners and clinical trial sponsors through our unique infrastructure and world-class team at TotipotentRX.”
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
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