Asterias receives approval from the FDA to initiate Phase 1 / 2a clinical trial of AST-OPC1 -
Asterias Biotherapeutics Inc. (OTCBB: ASTY) has received approval of the US Food and Drug administration (FDA) to initiate a Phase 1 / 2a clinical trial of its product, AST-OPC1, in patients with a complete lesion of the cervical spinal cord. The trial was approved following the success of the Phase 1 clinical study of the product, and is designed to evaluate the safety and activity of AST-growing OPC1 doses in patients complete lesions of the cervical spinal cord the first targeted indication for AST-OPC1 and the first of future clinical trials of product registration.
"we thank the scientists, clinical researchers and FDA to work with us to develop AST-OPC1," said Pedro Lichtinger, President and CEO of Asterias. "We are excited to work with our new partner, CIRM, in the execution of this clinical trial. The FDA approval provides Asterias with an imminent access to the $ 14.3 million grant from CIRM previously announced, which provides non-dilutive funding to support both clinical trial and other product development activities for AST-OPC1. "
AST-OPC1 is a population of human embryonic stem cell-derived cells (hESCs) that contains oligodendrocyte progenitor cells (OPCs). OPCs and oligodendrocytes perform support functions to nerve cells in the nervous system central. the basis for this newly cleared clinical phase 1 / 2a comes from the results of the clinical trial phase 1 AST-OPC1, which reached its primary endpoints of safety and feasibility when administered five patients with neurologically complete lesion of the spinal cord, vertebral rib. These five patients received a low dose of two million AST-OPC1 cells and were followed to date for 2 to 3 years. No serious adverse events been observed associated with delivery of the cells, the cells themselves, or short-term immunosuppression regimen used. There was no evidence of the expansion of the masses, expanding cysts, infections, leaks cerebrospinal fluid, increased inflammation, neural tissue damage or immune responses targeting AST-OPC1 in these patients. In four of the five subjects, MRI series conducted throughout the 2 to 3 years follow-up period indicate that reducing cavitation of the spinal cord may occur and that AST-OPC1 may have had positive effects in the reduction of the spine deterioration of the marrow tissue.
The new clinical study phase 1 / 2a is an open label, single-arm testing three escalating doses of AST-OPC1 13 patients with subacute, C5-C7, a complete neurological injury marrow cervical spinal. These individuals have essentially lost feeling and movement below their site of injury with severe paralysis of upper and lower limbs. AST-OPC1 will be administered 14 to 30 days after injury. Patients will be followed by neurological tests to assess the safety and potency. Selection of clinical trial sites is ongoing and the Company expects to begin patient enrollment in the first quarter of 2015.
The new clinical trial differs from the original clinical study that doses ranging up to 10 times higher will be tested. In addition, the trial will focus on patients with neurologically complete injuries of the cervical spinal cord. Because of the anatomy of the spinal cord and the existence of results more sensitive measures to assess the movement of the arms and hands, it is presently believed that the detection efficiency is much more likely to occur in patients suffering from cervical lesions. It is this population that Asterias anticipates will be the target for the first clinical trials for registration of AST-OPC1. The results of the clinical phase 1 / 2a should provide support for a Phase 2b extension study to be conducted to demonstrate further the safety and efficacy of the product.
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