On March 15, 2012, the U. S. Food and Drug Administration (FDA) notified HepaHope that the clinical hold of HepaHope's Hepapherisis™ therapy to treat human subjects in a proposed Phase I/IIa clinical trial was removed. HepaHope, Inc. may proceed with the clinical study without restrictions. HepaHope will announce more detailed information regarding the clinical study, including the locations of the clinical sites and patient enrollment information as the initiation of the clinical study progresses.
The City of Hope Medical Research Center has signed an agreement to provide HepaHope with a variety of malignant human tumor tissue samples in a joint project to evaluate the potential of HepaHope's Chemosensitivity Testing device for use in personalized medicine.
HepaHope received an acknowledgement letter from the USDA APHIS advising that the company had passed its inspection and is in compliance with the Animal Welfare Act, regulations and standards.
As a result of receiving no USDA inspection observations, HepaHope was notified that a USDA dealer's license to sell its Veterinary application of the HepaPheresis™ treatment was approved.
HepaHope submitted an application to the USDA, APHIS in support of a dealer's license to market the veterinary application of the HepaPheresis™ System.
HepaHope will conduct veterinary hospital field tests on animals experiencing acute liver failure, using the HepaPheresis™ System based on USDA's, APHIS (Animal Plant Health Inspection Service) approval letter to perform these studies.
HepaHope is looking to establish a Veterinary application of it's Bioartificial liver program to treat acute liver failures in companion animals.
In an FDA teleconference, the FDA stated that no more in vivo efficacy studies in animals are needed to remove the clinical hold, only a well designed in vitro pharmacodynamic study that shows BioReactor function (ammonia clearance, for example) in the HepaPheresis™ System is needed.
HepaHope signs agreement with HepaHope Korea to manufacture and distribute the Chemosensitivity Testing System and BioTester™
HepaHope presents research data at San Francisco AASLD conference
HepaHope signs an agreement with Quintiles for its clinical trial program