Pluristem Therapeutics Inc. (PSTI) (PSTI.TA), a leading developer of placenta-based cell therapy products, announced today that it has entered into a strategic collaboration with Thermo Fisher Scientific to advance fundamental knowledge of cell therapy industrialization and to improve quality control of the end-to-end supply chain.
The collaboration combines Thermo Fisher’s experience in cell therapy development and bioproduction scaleup with Pluristem’s expertise in cell therapy manufacturing, clinical development and quality control. Together, the companies hope to transform cell therapy manufacturing into a large-scale, high capacity industry that will enable the production of millions of therapeutic doses of regenerative medicines.
Currently, over 850 companies worldwide are developing regenerative medicine and advanced therapies. There are more than 900 clinical trials underway, with several approved and marketed products worldwide. This sector holds the promise of addressing many unmet medical needs, but requires a change in the supply chain of equipment, consumables, reagents and storage systems to enable the treatment of millions of patients.
Bryan Poltilove, General Manager of Cell and Gene Therapy at Thermo Fisher, commented, “The cell therapy industry is expanding at an explosive pace, and Thermo Fisher provides total solutions for cell therapy research, development, and manufacturing. We look forward to advancing our relationship with Pluristem to further enable commercial manufacturing and benefit the broader global industry.”
“From early on, our strategy was to build an in-house manufacturing facility. Having achieved that, we are now in a unique position within the industry, and have a broad understanding of its needs. Thermo Fisher, known for its biopharmaceutical infrastructure, materials supply, logistics, and manufacturing expertise is a perfect partner for Pluristem. This initiative has the potential to advance the industry significantly, allowing regenerative medicine to realize its potential, treating millions of patients globally while reducing healthcare spending. We look forward to a long-term, mutually beneficial partnership,” stated Pluristem President and Co-CEO Yaky Yanay.
About Pluristem Therapeutics
Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX cells and is entering late-stage trials in several indications. PLX cell products release a range of therapeutic proteins in response to inflammation, ischemia, muscle trauma, hematological disorders, and radiation damage. The cells are grown using the Company’s proprietary three-dimensional expansion technology and can be administered to patients off-the-shelf, without tissue matching. Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.
Safe Harbor Statement
This press release contains express or implied forward-looking statements within the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. For example, Pluristem is using forward-looking statements when its discusses its collaboration with Thermo Fisher generally as well as its belief that such collaboration will advance fundamental knowledge of cell therapy industrialization and improve quality control of the end-to-end supply chain, that the companies hope to transform cell therapy manufacturing into a large-scale, high capacity industry that will enable the production of millions of therapeutic doses of regenerative medicines. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; Pluristem may encounter delays or obstacles in launching and/or successfully completing its clinical trials; Pluristem’s products may not be approved by regulatory agencies, Pluristem’s technology may not be validated as it progresses further and its methods may not be accepted by the scientific community; Pluristem may be unable to retain or attract key employees whose knowledge is essential to the development of its products; unforeseen scientific difficulties may develop with Pluristem’s process; Pluristem’s products may wind up being more expensive than it anticipates; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; Pluristem’s patents may not be sufficient; Pluristem’s products may harm recipients; changes in legislation may adversely impact Pluristem; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.