GvHD is a transplant associated disease representing an outcome of two immune systems crashing into each other. In many transplantations from donors, and especially in Bone Marrow Transplantations (BMT), the transplanted immune mature cells (as opposed to stem cells) attack the host (patient receiving the transplant) and create severe morbidity and in many cases even death.
This disease happens as a result of current practices being unable to separate the GvHD causing cells from the much needed stem cells.Cellect's ApoGraft was designed to eliminate immune responses in any transplantation of foreign cells and tissues.
Cellect's AppoGraft technology can be utilized already today to help thousands of development and research centers globally engaged in adult stem cells based therapeutics by providing them with a simplified and cost efficient enriched stem cells for use as a raw material for a wide range of stem cells based therapeutics R&D. Before Cellect's ApoGraft, such procedures were extremely complex, inefficient and required substantial resources in both cost, time and infrastructure requirements. ApoGraft can now be used to significantly advance the use of stem cells across multiple therapeutics indications as well as research and biobanking purposes.
The FDA Orphan Drug Act provides incentives for companies to develop products for rare diseases affecting fewer than 200,000 people inthe United States. Incentives may include tax credits related to clinical trial expenses, an exemption from theFDAuser fee, FDAassistance in clinical trial design and potential market exclusivity for seven years following approval.
About Cellect Biotechnology Ltd.
Cellect Biotechnology (NASDAQ: "APOP", "APOPW") has developed a breakthrough technology for the selection of stem cells from any given tissue that aims to improve a variety of stem cell applications.
The Company's technology is expected to provide pharma companies, medical research centers and hospitals with the tools to rapidly isolate stem cells in quantity and quality that will allow stem cell related treatments and procedures. Cellect's technology is applicable to a wide variety of stem cell related treatments in regenerative medicine and that current clinical trials are aimed at the cancer treatment of 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 Company's pathway for commercialization of its technology. 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; 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 Annual Report on Form 20-F for the fiscal year ended December 31, 2016 filed with the U.S. Securities and Exchange Commission, or SEC, which is available on the SEC's website, http://www.sec.gov. and in the Company's period filings with the SEC and the Tel-Aviv Stock Exchange.
ContactCellect Biotechnology Ltd. Eyal Leibovitz, Chief Financial Officerwww.cellect.co +972-9-974-1444
View original content:http://www.prnewswire.com/news-releases/fda-grants-orphan-drug-status-to-cellects-apograft-for-acute-gvhd-and-chronic-gvhd-300513675.html
SOURCE Cellect Biotechnology Ltd.
Go here to see the original:
FDA Grants Orphan Drug Status to Cellect's ApoGraft for Acute GvHD and Chronic GvHD - PR Newswire (press release)
- 001 U.S. appeals court reinstates stem cell suit [Last Updated On: June 29th, 2010] [Originally Added On: June 29th, 2010]
- 002 The Business of Stem Cells (Part 1) - Bloomberg - Video [Last Updated On: October 13th, 2011] [Originally Added On: October 13th, 2011]
- 003 The Business of Stem Cells (Part 2) - Bloomberg - Video [Last Updated On: October 17th, 2011] [Originally Added On: October 17th, 2011]
- 004 Lifting the Ban: The Struggle for Stem Cells (I) - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 005 Inside Look: Stem-Cell Research Ban Lifted - Bloomberg - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 006 Virgin Launches Qatar Stem Cell Bank - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 007 Another Look - Stem Cell Debate - Bloomberg - Video [Last Updated On: October 18th, 2011] [Originally Added On: October 18th, 2011]
- 008 Obama Lifts Stem-Cell Research Ban - Bloomberg - Video [Last Updated On: October 19th, 2011] [Originally Added On: October 19th, 2011]
- 009 Adult Stem Cell - Video [Last Updated On: October 19th, 2011] [Originally Added On: October 19th, 2011]
- 010 More Perspective - Obama Uplifts Stem-Cell Research Ban - Bloomberg - Video [Last Updated On: October 19th, 2011] [Originally Added On: October 19th, 2011]
- 011 SCIENCE FRICTION - THE EMBRYO WAR - Video [Last Updated On: October 19th, 2011] [Originally Added On: October 19th, 2011]
- 012 Lifting the Ban: The Struggle for Stem Cells (II) - Video [Last Updated On: October 19th, 2011] [Originally Added On: October 19th, 2011]
- 013 The Business of Stem Cells (Part 3) - Bloomberg - Video [Last Updated On: October 20th, 2011] [Originally Added On: October 20th, 2011]
- 014 Virginia 18th State to Legislate Cord Blood Education - Video [Last Updated On: December 16th, 2011] [Originally Added On: December 16th, 2011]
- 015 Republican Presidential Candidate Video Question - Video [Last Updated On: December 16th, 2011] [Originally Added On: December 16th, 2011]
- 016 News Update: Judge Rules Against Obama's Stem Cell Policy - Video [Last Updated On: December 16th, 2011] [Originally Added On: December 16th, 2011]
- 017 Stem Cell Based Lab Grown Meat coming soon - Video [Last Updated On: December 16th, 2011] [Originally Added On: December 16th, 2011]
- 018 5 Things you should know about stem cell research - Video [Last Updated On: December 16th, 2011] [Originally Added On: December 16th, 2011]
- 019 San Diego Biotechs Impacted By Stem Cell Ruling - Video [Last Updated On: December 17th, 2011] [Originally Added On: December 17th, 2011]
- 020 The Real American News Show (4-08-09) - Video [Last Updated On: December 17th, 2011] [Originally Added On: December 17th, 2011]
- 021 Eugenics - Human Sperm Created in British Lab - Video [Last Updated On: December 17th, 2011] [Originally Added On: December 17th, 2011]
- 022 Neuroethics at the World Science Festival - Video [Last Updated On: December 20th, 2011] [Originally Added On: December 20th, 2011]
- 023 Stem Cell Research, Ethics and Religion - Video [Last Updated On: December 20th, 2011] [Originally Added On: December 20th, 2011]
- 024 Call for Obama Assassination Free Speech, Not a Crime - Video [Last Updated On: January 3rd, 2012] [Originally Added On: January 3rd, 2012]
- 025 Stem Cells Explained - Jeunesse Luminesce on www.WiseMLM.com - Video [Last Updated On: January 31st, 2012] [Originally Added On: January 31st, 2012]
- 026 Inventing life: patent law and synthetic biology [Last Updated On: February 28th, 2012] [Originally Added On: February 28th, 2012]
- 027 After-Birth Abortion Claim Points Instead to Pre-Birth Humanity [Last Updated On: March 3rd, 2012] [Originally Added On: March 3rd, 2012]
- 028 The UFC's Supposed Testosterone Epidemic: Critics Living in the Past [Last Updated On: June 14th, 2012] [Originally Added On: June 14th, 2012]
- 029 Celltex Responds to Media Reporting on FDA Visit [Last Updated On: June 28th, 2012] [Originally Added On: June 28th, 2012]
- 030 Dish-Grown Sperm and Eggs Produce Mouse Pups [Last Updated On: October 6th, 2012] [Originally Added On: October 6th, 2012]
- 031 Stem cells: this election's neglected child [Last Updated On: October 17th, 2012] [Originally Added On: October 17th, 2012]
- 032 Ministers may split cost of new washing machine for Yamanaka: Tanaka [Last Updated On: October 17th, 2012] [Originally Added On: October 17th, 2012]
- 033 Stem cell - Wikipedia, the free encyclopedia [Last Updated On: May 19th, 2015] [Originally Added On: May 19th, 2015]
- 034 Stem Cell Research and the Law | Hinnovic [Last Updated On: May 19th, 2015] [Originally Added On: May 19th, 2015]
- 035 Stem Cells and the law - Europe's stem cell hub | EuroStemCell [Last Updated On: May 19th, 2015] [Originally Added On: May 19th, 2015]
- 036 Is Stem Cell Research Ethical ? Ethical issues stem cell ... [Last Updated On: May 19th, 2015] [Originally Added On: May 19th, 2015]
- 037 Stem Cell Research, Morality, and Law [Last Updated On: May 21st, 2015] [Originally Added On: May 21st, 2015]
- 038 Jewish Law - Articles - Stem Cell Research in Jewish Law [Last Updated On: May 25th, 2015] [Originally Added On: May 25th, 2015]
- 039 Stem cell laws - Wikipedia, the free encyclopedia [Last Updated On: June 1st, 2015] [Originally Added On: June 1st, 2015]
- 040 Stem Cells and Cloning | New Jersey Right to Life ... [Last Updated On: June 1st, 2015] [Originally Added On: June 1st, 2015]
- 041 Stem cell laws and policy in the United States - Wikipedia ... [Last Updated On: June 4th, 2015] [Originally Added On: June 4th, 2015]
- 042 Background and Legal Issues Related to Stem Cell Research [Last Updated On: June 4th, 2015] [Originally Added On: June 4th, 2015]
- 043 stemcellbioethics - home [Last Updated On: June 8th, 2015] [Originally Added On: June 8th, 2015]
- 044 Stem cell patents: legal aspects | Europe's stem cell hub ... [Last Updated On: June 8th, 2015] [Originally Added On: June 8th, 2015]
- 045 History of Stem Cell Research - Popular Issues [Last Updated On: June 15th, 2015] [Originally Added On: June 15th, 2015]
- 046 "Ethical Issues in Human Stem Cell Research: Executive ... [Last Updated On: June 15th, 2015] [Originally Added On: June 15th, 2015]
- 047 Global Stem Cells Group to Participate in the 15th ... [Last Updated On: June 19th, 2015] [Originally Added On: June 19th, 2015]
- 048 Stem Cell Research - Newsbatch [Last Updated On: June 19th, 2015] [Originally Added On: June 19th, 2015]
- 049 NIH Fact Sheet on Human Pluripotent Stem Cell Research ... [Last Updated On: June 28th, 2015] [Originally Added On: June 28th, 2015]
- 050 Gordie Howe's Stem Cell Treatment Raises Issues [Last Updated On: June 28th, 2015] [Originally Added On: June 28th, 2015]
- 051 The FDAs Misguided Regulation of Stem-Cell Procedures ... [Last Updated On: July 3rd, 2015] [Originally Added On: July 3rd, 2015]
- 052 CGS : Egg Extraction For Stem Cell Research: Issues for ... [Last Updated On: July 3rd, 2015] [Originally Added On: July 3rd, 2015]
- 053 Practical Problems with Embryonic Stem Cells [Last Updated On: August 5th, 2015] [Originally Added On: August 5th, 2015]
- 054 Judaism and Stem Cell Research - Torah.org [Last Updated On: September 15th, 2015] [Originally Added On: September 15th, 2015]
- 055 Cloning/Embryonic Stem Cells - Genome.gov [Last Updated On: September 16th, 2015] [Originally Added On: September 16th, 2015]
- 056 What are embryonic stem cells? [Stem Cell Information] [Last Updated On: September 18th, 2015] [Originally Added On: September 18th, 2015]
- 057 Scientific Experts Agree Embryonic Stem Cells Are ... [Last Updated On: September 20th, 2015] [Originally Added On: September 20th, 2015]
- 058 Stem Cell Research Legal Issues and Political Impact [Last Updated On: September 23rd, 2015] [Originally Added On: September 23rd, 2015]
- 059 Ethics of Stem Cell Research (Stanford Encyclopedia of ... [Last Updated On: October 24th, 2015] [Originally Added On: October 24th, 2015]
- 060 Embryonic stem cell research: an ethical dilemma | Europe ... [Last Updated On: August 4th, 2016] [Originally Added On: August 4th, 2016]
- 061 Stem Cell Network [Last Updated On: August 4th, 2016] [Originally Added On: August 4th, 2016]
- 062 stemcellbioethics - Legal and Political History of Stem ... [Last Updated On: August 4th, 2016] [Originally Added On: August 4th, 2016]
- 063 Societal and Legal Issues of Stem Cell Research - Yola [Last Updated On: August 4th, 2016] [Originally Added On: August 4th, 2016]
- 064 What are Stem Cells? - Health News - Medical News Today [Last Updated On: September 25th, 2016] [Originally Added On: September 25th, 2016]
- 065 Stem Cells & Spinal Cord Injuries - sci-info-pages.com [Last Updated On: November 27th, 2016] [Originally Added On: November 27th, 2016]
- 066 Stem cell controversy - Wikipedia [Last Updated On: November 27th, 2016] [Originally Added On: November 27th, 2016]
- 067 Charity Watchlist - Get Involved | American Life League [Last Updated On: January 28th, 2017] [Originally Added On: January 28th, 2017]
- 068 Stem cell laws - Wikipedia [Last Updated On: January 29th, 2017] [Originally Added On: January 29th, 2017]
- 069 Stem cell agency faces leadership challenge - Capitol Weekly [Last Updated On: July 3rd, 2017] [Originally Added On: July 3rd, 2017]
- 070 Pros And Cons Of Stem Cell Research - Popular Issues [Last Updated On: July 3rd, 2017] [Originally Added On: July 3rd, 2017]
- 071 Stem Cell Therapy: You can be sexually active again - Vanguard ... - Vanguard [Last Updated On: July 9th, 2017] [Originally Added On: July 9th, 2017]
- 072 Bedford inmate's family criticizes jail staff - Altoona Mirror [Last Updated On: July 9th, 2017] [Originally Added On: July 9th, 2017]
- 073 More Americans Than Ever Say Polygamy Is Morally Acceptable - HuffPost [Last Updated On: August 1st, 2017] [Originally Added On: August 1st, 2017]
- 074 Charlie Gard Dies, Leaving a Legacy of Thorny Ethics Questions - New York Times [Last Updated On: August 1st, 2017] [Originally Added On: August 1st, 2017]
- 075 India needs biannual amendment to Stem Cell Rules, Section 8 of Rules controversial: Dr Totey - pharmabiz.com [Last Updated On: August 1st, 2017] [Originally Added On: August 1st, 2017]
- 076 Patents in Brazil - Lexology (registration) [Last Updated On: August 2nd, 2017] [Originally Added On: August 2nd, 2017]
- 077 Opinion: Human genome editingwe should all have a say - Phys.Org [Last Updated On: August 2nd, 2017] [Originally Added On: August 2nd, 2017]
- 078 Britain can lead the world in gene editing - The Times [Last Updated On: August 12th, 2017] [Originally Added On: August 12th, 2017]
- 079 Dolphins QB Ryan Tannehill will reportedly have surgery, miss entire season - FOXSports.com [Last Updated On: August 12th, 2017] [Originally Added On: August 12th, 2017]
- 080 Stem cell research: the debate continues to rage - CosmicNovo.com (Science and Technology) [Last Updated On: August 12th, 2017] [Originally Added On: August 12th, 2017]