- Breakthrough Therapy Designation enables enhanced collaboration with the U.S. Food and Drug Administration, supporting an accelerated and efficient clinical development pathway for PP-007
- Breakthrough Therapy Designation granted in addition to PP-007’s Fast Track Designation, demonstrating FDA’s recognition of potential clinical benefit over existing treatments
- PP-007 shows potential to address a significant unmet need in patients with large vessel occlusion in acute ischemic stroke, a population with significant disability and mortality
- Stroke is a leading cause of serious long-term disability worldwide
SOUTH PLAINFIELD, N.J.--(BUSINESS WIRE)--Prolong Pharmaceuticals, LLC, a clinical-stage biopharmaceutical company, announced today that its investigational therapy, PP-007 (PEGylated carboxyhemoglobin, bovine), has received Breakthrough Therapy Designation (BTD) from the U.S. Food and Drug Administration (FDA) for the treatment of Acute Ischemic Stroke (AIS) with Anterior Large Vessel Occlusion (A-LVO).
Breakthrough Therapy Designation is intended to expedite the development and review of investigational therapies for serious or life-threatening conditions where preliminary clinical evidence indicates the potential to demonstrate substantial improvement over existing therapies on clinically meaningful endpoints.
Dr. Kirsten Gruis, MD, Chief Medical Officer of Prolong Pharmaceuticals said, “This designation from the FDA supports the significant potential of PP-007, a novel therapeutic that improves oxygen delivery and cerebral blood flow, to be a first-in-class therapy to improve outcomes in AIS patients with anterior circulation large vessel occlusions.”
John Pakulski, Senior Vice President of Regulatory Affairs at Prolong Pharmaceuticals noted, “This Breakthrough Therapy Designation builds on PP-007's existing Fast Track Designation, further strengthening Prolong's collaborative pathway with the FDA to bring a much-needed treatment to AIS-LVO patients as efficiently as possible.”
PP-007 is an investigational therapy designed to improve oxygen delivery in ischemic tissue. The therapy is currently being evaluated under an active Investigational New Drug (IND) application.
Under the Breakthrough Therapy program, FDA provides intensive guidance on an efficient drug development program, including timely and intensive advice, organizational commitment involving senior managers at the FDA, more efficient and collaborative cross-disciplinary reviews, and potential for rolling and priority reviews. The goal of the program is to facilitate shorter development and approval timelines for medicines treating serious conditions with preliminary clinical evidence demonstrating substantial improvement over available therapies.
About PP-007
PP-007 (PEGylated carboxyhemoglobin bovine, also known as SANGUINATE®) is a novel clinical stage biopharmaceutical product. In addition to numerous published non-clinical studies of ischemia/hypoxia and anemia, over 300 individuals in 12 clinical trials have received single or multiple dose treatments with PP-007 including subarachnoid hemorrhage, severe life-threatening anemia, and other diseases or conditions with an underlying ischemia/hypoxia component, such as beta thalassemia and sickle cell disease. PP-007 is an investigational drug product and not approved for use in any country or indication.
About Acute Ischemic Stroke (AIS)
Acute ischemic stroke (AIS) results from an obstruction of blood flow to the brain, leading to rapid neurological decline. Among these patients, anterior large vessel occlusion (LVO) represents a particularly severe subtype, associated with high rates of disability and death despite current standard-of-care interventions.
About Prolong Pharmaceuticals, LLC
Prolong Pharmaceuticals is an advanced clinical stage pharmaceutical company that is vertically integrated with a proprietary state-of-the-art manufacturing facility headquartered in South Plainfield, New Jersey. Prolong Pharmaceuticals is developing PP-007 as a treatment for acute ischemic stroke to lessen the debilitating comorbidities associated with reduced quality of life, increased medical cost, and significant mortality. For more information visit: www.prolongpharma.com.
Contacts
Media Contact:
Ronald Jubin, Ph.D.
Vice President, Early Development
Prolong Pharmaceuticals
(908) 315-5762
rjubin@prolongpharma.com
