Management expects additional positive upcoming results from its trial in healthy volunteers
TEL AVIV, Israel, Feb. 08, 2017 (GLOBE NEWSWIRE) -- Cellect Biotechnology Ltd. (Nasdaq: APOP ) (TASE: APOP ), a developer of stem cells selection technology, today announces that it has treated the first blood cancer patient in the recently initiated Phase I/II trial of its stem cell technology ApoGraft™.
The trial is intended to assess the Cellect ApoGraft™ process which is designed to prevent Graft-versus-Host Disease (GvHD), a common complication associated with stem cell transplant in which the transplanted immune cells attack the recipient's body cells and organs. GvHD is a life-threatening condition occurring in up to 50% of stem cell transplants. In this trial, the company will be testing stem cells transplanted from a matched donor related to the patient.
Referring to the trial on healthy volunteers, the company plans to release definitive and complete results of this trial before the end of Q1 this year.
Cellect CEO, Shai Yarkoni commented, “Enrolling our first cancer patient to be treated using our groundbreaking method is a critical milestone for millions of patients worldwide. ApoGraft™ has been proven to be effective in assisting successful stem cells transplants and preventing GvHD during our animal studies. I am excited with prospects of Cellect becoming a key contributor to the fast-growing market for stem cells based products enabling 21 st century regenerative medicine.”
The study is being conducted at the Department of Hematology and Bone Marrow Transplantation, Rambam Medical Center, Haifa, Israel. The primary objective of the trial is to assess the safety and tolerability of ApoGraft™ administered to patients with hematological malignancies undergoing allogeneic stem cell transplantation from a matched related donor.
About GvHD Despite improved prophylactic regimens, acute GvHD disease still occurs in 25% to 50% of recipients of allogeneic stem cells transplantation. The incidence of GvHD in recipients of allogeneic stem cells transplantation is increasing due to the increased number of allogeneic transplantations survivors, older recipient age, use of alternative donor grafts, and use of peripheral blood stem cells. GvHD accounts for 15% of deaths after allogeneic stem cells transplantation and is considered the leading cause of non-relapse mortality after allogeneic stem cells transplantation.
About ApoGraft01 study Study ApoGraft01 (Clinicaltrials.gov identifier: NCT02828878 ), is an open label, Staggered Four-Cohort, Phase I/II, safety and proof-of-concept study of ApoGraft process in the prevention of acute Graft-versus-Host Disease (GvHD). The study which will enroll 12 patients, aims to evaluate the safety, tolerability and efficacy of the ApoGraft process in patients suffering from hematological malignancies undergoing allogeneic stem cells transplantation from a matched related donor.
About Cellect Biotechnology Ltd. Cellect Biotechnology is traded on both the NASDAQ and Tel Aviv Stock Exchange (NASDAQ: APOP ) (NASDAQ: APOPW ) (TASE: APOP ). The Company has developed a breakthrough technology for the selection of stem cells from any given tissue for any clinical indication; a technology that aims to enable a variety of stem cells applications.
The Company’s technology is expected to provide pharma companies, medical research and hospitals with the tools to rapidly produce stem cells in quantity and quality that will enable commercialization of all stems cell based treatments and procedures. Cellect’s technology is applicable to a wide variety of stem cells related treatments in regenerative medicine while this specific clinical trials is aimed at the cancer treatment by bone marrow transplantations.
Forward Looking Statements This press release contains forward-looking statements about the Company’s expectations, beliefs and intentions. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. For example, forward-looking statements are used in this press release when we discuss the upcoming results from the 12 months' trial in healthy volunteers and timing of announcement thereof, our becoming a key contributor to stem cell based products and the potential of our technology and its proposed uses. These forward-looking statements and their implications are based on the current expectations of the management of the Company 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. In addition, historical results or conclusions from scientific research and clinical studies do not guarantee that future results would suggest similar conclusions or that historical results referred to herein would be interpreted similarly in light of additional research or otherwise. 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; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; 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; our patents may not be sufficient; our products may harm recipients; changes in legislation; and inability to timely develop and introduce new technologies, products and applications, which could cause the actual results or performance of the Company to differ materially from those contemplated in such forward-looking statements. Any forward-looking statement in this press release speaks only as of the date of this press release. The Company undertakes no obligation to publicly update or review any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by any applicable securities laws. More detailed information about the risks and uncertainties affecting the Company is contained under the heading “Risk Factors” in Cellect Biotechnology Ltd.'s final prospectus dated July 29, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, www.sec.gov and in the Company’s periodic filings with the SEC and the Tel-Aviv Stock Exchange.
Contact Cellect Biotechnology Ltd. Eyal Leibovitz, Chief Financial Officer www.cellectbio.com + 972-9-974-1444 LifeSci Advisors Bob Yedid, Managing Director 646-597-6989 bob@lifesciadvisors.com
