HOUSTON, July 5, 2017 /PRNewswire/ -- ViraCyte, LLC, a clinical stage biopharmaceutical company developing cellular immunotherapies for severe infections, today announced that it has been awarded $3.75M from National Institutes of Health (NIH) and the Food and Drug Administration (FDA) to advance its T cell immunotherapies.
ViraCyte announced that the NIH National Heart, Lung and Blood Institute (NHLBI) has awarded the Company a $3 million Phase IIB Small Market Award under the NIH Small Business Innovation Research (SBIR) program. The Program supports the development of innovative technologies addressing rare diseases and/or young pediatric populations to advance the commercialization of promising new products. ViraCyte will perform advanced clinical development of a T cell immunotherapy for BK virus in stem cell transplant recipients. BK virus causes severe disease including hemorrhagic cystitis and nephritis, and can lead to renal failure, hemorrhage, and death in transplant recipients.
ViraCyte also announced that it has been awarded a $750,000 Orphan Products Clinical Trials Grant by the FDA Office of Orphan Product Development (OOPD). The OOPD funds the clinical development of products for use in rare diseases for which there are limited or no current therapeutic options. ViraCyte will initiate a Phase I clinical trial to evaluate the safety and preliminary effectiveness of Viralym-A, a T cell immunotherapy product for treatment of Adenovirus in stem cell transplant recipients. Adenovirus causes severe pneumonia and bowel disease that is frequently fatal in these patients.
There are currently no FDA-approved treatment options for BK virus or Adenovirus. "We are very pleased the NIH NHLBI and FDA OOPD have recognized ViraCyte's commitment to addressing critical unmet medical needs with these two highly competitive awards," stated Dr. Ann Leen, Co-Founder and Chief Scientific Officer at ViraCyte. "This is an important milestone towards advancing our T cell immunotherapy products into pivotal trials."
About ViraCyte, LLC
ViraCyte's current products restore natural immunity against life threatening viruses in patients with severely weakened immune systems, such as adults and children who have recently undergone a hematopoietic stem cell transplant (HSCT). ViraCyte's lead T cell products are in Phase 1 and Phase 2 clinical trials, with effectiveness rates of greater than 90% in patients who have failed conventional therapy. More information can be found at www.viracyte.com
ViraCyte is a resident company at JLABS @ TMC, Houston, Texas.
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SOURCE ViraCyte, LLC