Cellect Biotechnology Ltd. (NASDAQ: APOP) rocketed Tuesday afternoon, after the company disclosed that its ApoGraft for acute and chronic GvHD has been granted orphan drug status by the Food and Drug Administration.
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.
The FDA Orphan Drug Act provides incentives for companies to develop products for rare diseases affecting fewer than 200,000 people in the United States. Incentives may include tax credits related to clinical trial expenses, an exemption from the FDA user fee, FDA assistance in clinical trial design and potential market exclusivity for seven years following approval.
The Tel Aviv-based Cellect 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 transplants.
The stock’s price galloped $1.06, or 11.6%, midday Tuesday, to $10.19
