The Right to Try Act, signed into law by President Donald Trump last spring, may be seeing its first fruits. A California brain cancer patient who did not qualify for participation in a clinical trial will get the chance to see if an experimental glioblastoma treatment will save his life.
The Right to Try Act, signed into law by President Donald Trump last spring, may be seeing its first fruits. A California brain cancer patient who did not qualify for participation in a clinical trial will get the chance to see if an experimental glioblastoma treatment will save his life.
ERC-USA, a subsidiary of Belgium-based Epitopoietic Research Corporation, has agreed to provide the patient access to ERC-1671 (Gliovac), which is currently in Phase II studies in the United States. Gliovac is already approved in Europe for patients suffering from a grade IV glioma (glioblastoma multiforme and gliosarcoma) when all other traditional treatments have failed. Treatment with ERC-1671 was initiated in late November 2018, the company said.
In a brief statement, ERC-USA said the patient appealed to the company under a 2017 California Right to Try Law, so it is unclear at this time if the federal law signed in May 2018 provided any additional weight to the company’s decision to allow the patient access to the medication. The law provides patients the right to seek access to experimental drugs that have yet to be approved if those drugs have been deemed safe through early studies. The decision to allow patients access is up to the developing companies.
The administration of Gliovac, paired with Genentech’s bevacizumab, to the patient will be overseen by ERC-USA and the University of California, Irvine (UCI). In the U.S., Gliovac is currently in a randomized, placebo-controlled mid-stage trial. Interim data has shown the medication could be a promising treatment for glioblastoma patients who have exhausted other therapies. Some of the data shared in August by ERC showed that median overall survival in patients treated with the combination of Gliovac and bevacizumab was 12.1 months, with one patient surviving for more than two years. OS in placebo patients was 7.6 months, the company reported in August 2018. When it came to progression-free survival (PFS), patients on the Gliovac arm saw median PFS of 7.3 months, while placebo patients saw median PFS of 5.4 months. Genentech’s bevacizumab, a monoclonal antibody targeting VEGF, is the only treatment approved by the U.S. Food and Drug Administration for recurrent glioblastoma patients
According to company data, Gliovac contains a combination of autologous tumor cells and allogeneic tumor cells. Those cells are generated from the glioma tumor tissues of three different donor cancer patients, and the lysates of all of these cells, the company said. When injected into the patients, the vaccine is designed to stimulate the immune system and potentially create an immune response against the tumor.
Apostolos Stathopoulos, president and chief executive officer of Epitopoietic Research Corporation, said the company appreciated the opportunity to “provide an option for a patient with such advanced disease” under the Right to Try Act. Stathopoulos added that the company believes this is an important step in “ensuring that all patients who may want to use this option would have access to medications that may prolong or improve their lives.”
