Ambulero Receives Positive Pre-IND Response from FDA for AMB-301 Treatment of Rare Vascular Disease
27 Sep 2022
Gene TherapyOrphan DrugFirst in ClassCell Therapy
Sept. 27, 2022 16:15 UTC
MIAMI--(BUSINESS WIRE)-- Ambulero, Inc., a Miami, Florida-based spinout from the University of Miami Miller School of Medicine (“Ambulero” or “Company”) developing new gene and cell therapies for severe vascular disease, announces it received a positive response from a Type B Pre-IND meeting with the FDA to develop AMB-301 as a treatment for a rare vascular condition called Buerger’s Disease.
AMB-301 is a first-in-class gene therapy vector encoding E-selectin. Over a decade of basic research by Drs. Omaida C. Velazquez and Zhao-Jun Liu suggests providing E-selectin to damaged tissues can promote angiogenesis and improve limb and muscle cell function. Buerger’s disease is a debilitating vascular disease that can lead to severe limb damage and amputation, often in young patients. There are no effective treatments and existing therapies are largely ineffective. AMB-301 is a promising gene therapy candidate for enhancing blood vessel formation, restoring tissue integrity and potentially eliminating need for amputation in some patients.
Robert L. Buchanan, CEO of Ambulero, commented, “This is our second positive interaction with the FDA in less than a year. Last October, we received an important Orphan Drug Designation for AMB-301. Today, we received FDA concurrence and guidance on our proposed manufacturing, nonclinical pharmacology and toxicology studies, as well as our Phase 1/2a clinical trial design.”
About Ambulero
Ambulero is a privately-held biotechnology company advancing a new gene and cell therapy platform to treat serious vascular diseases. The Company is sourcing new investors to support development of its novel gene and cell therapy pipeline. See .
Forward Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as “potential,” “promising ”, ‘anticipate”, among others. These forward-looking statements are based on Ambulero's current expectations and actual results could differ materially as there are significant risks in the development of new gene and cell therapy products. Ambulero does not undertake an obligation to update or revise any forward-looking statement. All Ambulero's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
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