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FDA grants orphan drug status to Cellect's Apograft for acute GVHD and chronic GVHD



The U.S. Food and Drug Administration (FDA) has granted orphan drug designation for Cellect Biotechnology Ltd.'s ApoGraft™ for the prevention of acute and chronic graft versus host disease(GvHD) in transplant patients. Cellect is a developer of stem cells selection technology.

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.

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.

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