Sitoiganap

Unassigned

New Medicines

Gliovac · Recurrent or progressive glioma

Information

Gliovac
Advanced therapy medicinal product (ATMP) cell therapy
Epitopoietic Research Corporation
Epitopoietic Research Corporation

Development and Regulatory status

Pre-registration (Filed)
Pre-registration (Filed)
Phase II Clinical Trials
Yes
Yes
Jun 20 · ERC Belgium announces submission of MAA to EMA for conditional approval of Sitoiganap to treat recurrent glioblastoma [5].
Apr 20 · As a result of promising data, ERC plans to meet with the FDA Center for Biologics Evaluation and Research (CBER) to discuss the potential for Fast Track and Breakthrough Therapy designation of the Gliovac program. ERC is preparing a commercialisation request for its product and will submit it to the FDA in April 2020. The EMA CHMP has agreed to consider Gliovac for Conditional Marketing Authorisation and ERC has had two meetings with the CHMP, on 9th February 2018 and on 9th July 2018 to further its applications for such authorisation. ERC has been approved to apply for a Promising Innovative Medicine (PIM) designation in the UK and the ERC team submitted its application and was invited for a meeting with the MHRA on 29th July 2018. ERC will be submitting additional information to the UK authorities for PIM designation. If successful, this will allow ERC to market Gliovac in the UK, in the next 12 months. In this context, a commercialisation request has been submitted to the UK authorities at the end of Jan 20 [6].
Feb 19 · Has orphan drug status in EU and US [3].

Category

ERC 1671 comprises allogeneic and autologous haptenised and irradiated cells and cell lysates that are derived from patients with glioma
Annual incidence of malignant glioma is 3-5 per 100,000 [1].
Recurrent or progressive glioma
Intradermal

Further information

Yes
Suspended

Trial or other data

May 20 · Development of NICE TA suspended. The company has been unable to source all the necessary evidence to provide a submission so the company and NICE have agreed to put the appraisal on hold [7].
Apr 20 · ERC announces that Dana Farber Cancer Institute (DFCI) in Boston, a Harvard University hospital, has joined the ERC clinical trial as additional site. The Dana Farber IRB and SRB of Dana Farber have both endorsed the commencement of the trial. The first patients should be recruited by November 2019. DFCI is the largest brain cancer referral centre in the US. Once DFCI begins recruiting patients next month, ERC expects to be able to complete the clinical trial in 12 months [6].
Apr 20 · Under the US right-to-try law, ERC reports that the first patient in the US to be treated was a patient with grade IV recurrent GBM who requested treatment with ERC1671 (Gliovac) at UC Irvine in December 2018. Since this initial patient, ERC has provided ERC1671 to five patients with grade IV GBM. Patients have been treated in New York, New Jersey and California. All patients are still alive and have stable disease or have gone into remission. This is an astonishing result where 100% of patients have responded to our treatment [6].
Nov 19 · PII study (NCT01903330] is recruiting; timescales unchanged [4].
Nov 18 · PII study (NCT01903330] is still recruiting [2].
Mar 14 · PII trial to evaluate the efficacy and safety of ERC 1671 combined with granulocyte-macrophage colony-stimulating factor, cyclophosphamide and bevacizumab, compared with placebo and bevacizumab in patients with recurrent glioblastoma multiforme and gliosarcoma starts (NCT01903330). The trial will enrol approximately 84 patients in the US. Collection of primary outcome safety data will complete Mar 23 [2].

Evidence based evaluations