PASADENA, Calif.--(BUSINESS WIRE)--ERC-USA, a clinical-stage biopharmaceutical company developing immunotherapies for the treatment of cancer, today announced that NYU Winthrop Hospital (NYU) has agreed to treat one of its recurrent, refractory glioblastoma multiforme (GBM) patients with ERC’s lead therapy, ERC1671, under federal and state Right-to-Try laws (RTT).
The expansion of ERC’s RTT program makes its unique immuno-oncology GBM treatment, ERC1671, available to a wider number of patients who have exhausted all other treatment options. NYU joins the University of California, Irvine Medical Center and John Theurer Cancer Center Hackensack, NJ in treating recurrent, refractory GBM patients with ERC1671 under RTT. GBM is the most common and aggressive form of brain cancer and patients with this recurrent, refractory disease have very few options.
ERC1671 has demonstrated a clinically meaningful survival benefit among treated patients with minimal toxicity in phase 2 clinical trials. In June, ERC announced that it had submitted its Marketing Authorization Application for ERC1671 to the European Medicines Agency for conditional approval.
ERC will shortly publish a summary of its RTT experience that will include the total number of patients and median survival data. The Company previously communicated that oncologists are reporting that certain terminal patients treated with ERC1671 under RTT are experiencing unprecedented regressions of their disease. Normally, regression of recurrent glioblastoma is not experienced. One patient has already demonstrated a remission that is now in its eighteenth month with no sign of recurrence. The durability of these responses is still not known, but to the families of these patients the responses are unexpected and welcome, and they are restoring some normalcy to the lives of these terminal patients and their families.
“We are extremely eager to expand our RTT program to NYU Winthrop Hospital and we are encouraged and excited by the responses we’ve observed so far in RTT patients to ERC1671. As awareness of ERC1671 grows in the neuro-oncology community, we have been experiencing a major increase in requests for treatment under RTT protocols,” commented Apostolos Stathopoulos, M.D., Ph.D., president and CEO of ERC Belgium, parent company to ERC-USA.
About ERC 1671
ERC1671 (Gliovac or Sitoiganap) is an advanced immunotherapy based on freshly extracted tumor cells and lysates that stimulates the patient’s immune system to recognize and reject cancer cells. The ERC1671 contains a combination of autologous tumor cells (cells from the patient receiving the treatment), and allogeneic tumor cells, generated from the glioma tumor tissues of three different donor cancer patients, and the lysates of all of these cells. Upon injection, this mixture stimulates the patient’s immune system to mount an immune response against the tumor cells, which may lead to their destruction.
Gliovac/ERC1671 is for patients suffering from a grade IV glioma (glioblastoma multiforme and gliosarcoma) when all other traditional treatments have failed. Further studies will target patients with newly diagnosed glioma with predictive marker indicating, unresponsiveness to Temozolomide chemotherapy (MGMT gene promoter unmethylation).
ERC1671 is currently in randomized, placebo-controlled Phase 2 clinical trials in the United States as part of combination treatment for glioblastoma multiforme and gliosarcoma and its Marketing Authorization Application has been submitted to the European Medicines Agency for conditional approval. The company’s therapeutic approach can be potentially applied to many other types of solid cancers.
ERC is based in Belgium with a cGMP manufacturing plant in the Netherlands and subsidiaries in the U.S.A., Canada, Australia and an international presence through country specific agreements. To learn more, please visit http://erc-immunotherapy.com.
ERC-USA is a subsidiary of Epitopoietic Research Corporation (ERC-Belgium SA), a clinical stage emerging Biopharmaceutical Company developing a safe, highly effective approach for the treatment of cancer, particularly cancers of the brain. ERC has built a network of leading neuro-oncologists in several countries in the world, among others in the US and Europe to propel its immunotherapies through clinical development and to market. ERC’s regimen of therapeutic vaccines has shown early promise in patients suffering from recurrent Glioblastoma multiforme (GBM), the deadliest of brain cancers.
About Right-to-Try Laws
The federal Right to Try Act, or the Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina Right to Try Act, was signed into law May 30, 2018. This law is a means for patients diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and are unable to participate in a clinical trial to access certain unapproved treatments. In addition to the federal law, several states have passed Right to Try Laws.