CELZ - Creative Medical stock rises on seeking FDA orphan drug status for Brittle diabetes therapy

2023-03-23 09:24:09 ET

Creative Medical Technology ( NASDAQ: CELZ ) said it filed an application to U.S. Food and Drug Administration (FDA) seeking orphan drug designation (ODD) for its ImmCelz (CELZ-100) platform to treat Brittle Type 1 Diabetes.

The company noted that the the ImmCelz immunotherapy product uses its cell-free system which has previously been validated to supercharge the patient's own cells to treat certain immune disorders.

Currently, there is no FDA approved treatment for Brittle Type 1 Diabetes. Human islet cell transplantation has been tried and is currently under FDA review. However, it requires immunosuppression which has potential concerns, the company added.

CELZ said that ImmCelz therapy, when given with islet cells (PHPI), is a promising approach to overcome transplant rejection in patients with brittle diabetes.

"As such, there is an impetus to move away from the use of immunosuppressive therapy and instead shift toward developing immune therapies such as ImmCelz to fight against transplant rejection and autoimmunity," said Courtney Bartlett – Director of Clinical Operations.

The use of the ImmCelz platform with human Islet cell transplantation has been given its own designation as CELZ-101, according to the company.

The FDA grants orphan drug status to therapies which are aimed at treating or preventing rare diseases that affect fewer than 200K people in the U.S. The designation provides certain incentives, including seven years of market exclusivity, if approved.

Brittle diabetes is a difficult to manage diabetes and is characterized by severe swings in blood sugar.

CELZ +7.67% to $0.56 premarket March 23

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