Cell Therapy Archives | Page 56 of 61

Cellerant Therapeutics Awarded 20th RMAT in U.S.

July 7, 2018 By Cade Hildreth, Founder & President Leave a Comment

On July 2nd, 2018, Cellerant Therapeutics was awarded a Regenerative Medicine Advanced Therapy (RMAT) designation for romyelocel-L (human myeloid progenitor cells) by the U.S. FDA. The treatment is used for the “prevention of serious bacterial and fungal infections in patients with de novo acute myeloid leukemia (AML) undergoing induction chemotherapy.”

Cellerant RMAT Designation

Romyelocel- is a universal, off-the-shelf cell therapy, because it does not require HLA matching between patient and donor. Neutropenia is a major side effect of myelosuppressive chemotherapies, including induction therapy. This can endanger patients by placing them at risk for life-threatening infections.

According to Ram Mandalam, President and CEO of Cellerant, “Receiving RMAT designation for romyelocel-L is an important milestone and recognition by the FDA of the potential of romyelocel-L to serve this unmet medical need.” [Read more…]

Things To Know About An Autologous Stem Cell Transplant

July 3, 2018 By Cade Hildreth, Founder & President Leave a Comment

“Autologous stem cell transplant” can be a mouthful to say. Many people don’t know what it means – let alone what a reliable option it is for defeating blood and bone-borne cancers. It has also demonstrated improvements in progression-free survival (PFS). Many of those who undergo the procedure can drive their cancer into remission or permanently defeat it. [Read more…]

RMAT Designations Accelerate: 3 New RMATs in Two Weeks

June 25, 2018 By Cade Hildreth, Founder & President Leave a Comment

In the past two week, the U.S. FDA has awarded three new RMAT designations, bringing the total number of awards to 19.

The new RMAT designations were awarded to:

Nightstar Therapeutics: Gene therapy (NSR-REP1) for choroideremia treatment – June 14, 2018
Caladrius Biosciences: CD34+ cell therapy (CLBS14) for refractory angina – June 19, 2018
Voyager Therapeutics: Gene therapy (VY-AADC ) for Parkinson’s disease – June 22, 2018

[Read more…]

RegMed Innovative Spikes on Heels of CAR-T, Gene Therapy, & Digital Pill Approvals

May 23, 2018 By Cade Hildreth, Founder & President Leave a Comment

The regenerative medicine industry is a high-value, fast-growth market. With two CAR-T approvals, as well as the first gene therapy and digital pill approvals in the United States, we have had a lot of FDA “firsts.” The market gathered momentum when the Swiss pharmaceutical giant Novartis made history as the first company to win FDA approval for a CAR-T cell therapy in the U.S. in August 2017 (Kymriah). In October 2017, Kite Pharma became the second company to get FDA approval of a CAR-T cell therapy (Yescarta), further “snowballing” the effect. [Read more…]

Abeona Becomes First Company to Secure Two RMATs

April 27, 2018 By Cade Hildreth, Founder & President Leave a Comment

Abeona Therapeutics announced the U.S. FDA granted a Regenerative Medicine Advanced Therapy (RMAT) designation to ABO-102, the company’s AAV-mediated gene therapy for the treatment of Sanfilippo syndrome Type A (MPS IIIA), a rare autosomal-recessive lysosomal storage disease.

It was the 16th RMAT designation awarded by the FDA and a landmark achievement in that it makes Abeona the first company to achieve two RMAT designations.

Headquartered in Dallas, TX, Abeona (NASDAQ: ABEO) is a clinical-stage biopharmaceutical company focused on developing novel cell and gene therapies for life-threatening rare genetic diseases. Abeona’s first RMAT designation was for its EB-101 gene therapy for Epidermolysis Bullosa in January 2018. [Read more…]