Doctors

Rationale to use Gliovac/ERC1671/SITOIGANAP

Patients suffering from glioblastoma multiforme (GBM) have an extremely poor prognosis. GBM is the most malignant glioma with the median overall survival being 14 months from diagnosis when treated with standard radio and chemotherapy care in EU [endif]--(Stupp et al. 2005; Stupp et al. 2010). When relapsing, according the size of the tumour, KPS, and tumour localisation, statistics suggest that death is imminent between 1 to 4.5 months (95% IC) [endif]--(Park et al. 2010). In the USA, bevacizumab is administered as a second line of treatment (Chamberlain 2011), but it is currently not approved by the EU authorities with its efficiency still being discussed.

The therapeutic vaccine Gliovac/ERC1671/SITOIGANAP has shown efficacy and immune responses in the tumour-bearing host, manifested by tumour reduction as visible on MRI scans.

GLIOBLASTOMA TREATMENT - GLIOVAC/ERC1671/SITOIGANAP EARLY ACCESS PROGRAM

Patients facing serious illnesses and who have exhausted all available treatment options often want to know if and how they can receive early access to investigational products that haven’t yet been approved by government regulatory agencies. ERC is committed to making its products available to patients, when appropriate, throughout the development process.

ERC believes participating in clinical trials is the best way for patients to access medicines prior to approval. In pursuit of ERC’s objective to develop highly effective and safe therapeutic approaches, the successful completion of a clinical trial program of investigational products is the most effective way of ensuring timely review and decision-making by government regulatory agencies. This will ultimately result in access to new, safe and effective approved therapies for patients. For these reasons, ERC prioritizes access to its investigational products through active and accruing clinical trials and encourages interested patients to enroll.

Early Access to GLIOVAC/ERC1671/SITOIGANAP

Despite best efforts, it is not possible for all patients to participate in clinical trials. For that reason, ERC has established an early access program in a number of regions.

In the U.S., Right-to-Try (RTT) can be used to make promising products available to patients facing serious or life-threatening conditions. An eligible physician may request access to one of ERC’s investigational products by completing the ERC Right to Try Request Form. For more information please contact Benjamin Freilich MD benfmd@erc-usa.com

In Australia, Category A of the TGA Special Access Scheme (SAS) can be used to make promising products available to patients facing serious or life-threatening conditions. An eligible physician may request access to one of ERC’s investigational products by completing the ERC Special Access Scheme Request Form.
Requests for further information about how to apply for RTT or SAS or determine qualifications and capabilities required to administer ERC investigational product can be made to medicalaffairs@erc-immunotherapy.com

ERC is also willing to consider early access requests outside of these regions.

ERC typically will acknowledge receipt of a request, with required medical documentation, within three business days. ERC professionals will carefully consider requests taking into account access to open and accruing clinical trials, the serious/life-threatening nature of the disease, biological rational or clinical data supporting potential benefit medical appropriateness, and applicable laws and regulatory requirements. All physicians who receive ERC investigational product through RTT or SAS are required to comply with all applicable laws and regulations, and contractual conditions, including those related to safety reporting.

ERC’s Right to Try Policy can be found here.
ERC’s Special Access Scheme Policy can be found here.

The scientific staff

ERC has established broad scientific expertise and the means to develop its product. The production of the vaccine requires the collaboration with a Tissue Bank , Tumour Tissue bank-The Netherlands (TTB-NL) approved for traceability of the donated tumour tissue sample and according to EU legislation. Facilities to produce Gliovac/ERC1671 under GMP facilities in a clean room environment have been developed in the Netherlands at “ERC-The Netherlands”.

The clinical trials sponsored by ERC are carried out according to International Conference on Harmonisation (ICH) and the WHO Good Clinical Practice (GCP) standards. Compliance with Good Clinical Practice provides assurance that the rights, safety and well-being of trial subjects are protected, and that the results of the clinical trials are credible and accurate. Clinical trials are performed in compliance with the protocol given approval/favourable opinion by the ethical committee and the appropriate regulatory authority(ies).

For more info visit the scientific staff page.

Action mechanism of Gliovac/ERC1671/SITOIGANAP

Gliovac/ERC1671/SITOIGANAP is defined as a “Transplant Cancer Immune Recognition Therapy”. The principle behind cancer transplantation as a therapy is to work with the host’s immune system to generate an immunologic response against the allogeneic (from another tumour donor) tumour transplanted cells. The Gliovac/ERC1671/SITOIGANAP consists of the transplantation of non-proliferative allogeneic (in combination with autologous) cancer cells and lysates, that are recognised by the immune system as “non-self” elements and induce an allo-immune rejection of the cancer cells.

The product is composed of three different allogeneic cancer cell and lysates preparations (called an allogenic vaccine) from three different donors (donor A, B and C), and autologous cells and lysates, preparated from the patient (patient D). When allogeneic specific cancer cells are inoculated into the patient, the immune system will recognise the component as non-self and induce an allo-immune rejection. The immune cells will be activated against allogeneic components including the specific tumour associated antigens (TAA), which are less or not prevalent on normal non-cancer cells.

Indeed, tumour cells express specific surface antigens. These antigens are not produced by healthy cells but are specific to tumour cells and are common between patients with the same tumour type.

By using non-proliferative cancer cell transplantation, it is not just one cancer-related antigen, but a whole set of tumour antigens associated to the glioblastoma, that is inoculated.

By using three different donors, the set of TAA is even broader. Injection of the autologous vaccine preparation will amplify the response of immune cells targeting the TAA present in the patient that is treated.

Upon activation, effector lymphocytes of the immune system are able to identify non-self tumour antigens and destroy the cancer cells that carry these antigens. The immune cells will proliferate and ensure the surveillance within the body, the cancer cells detection, their destruction and eventually patient recovery and immune resistance against the tumor.

Gliovac/ERC1671/SITOIGANAP is an advanced immunotherapy based on transplantation of tumour cells and lysates in order to stimulate immunity to reject cancer cells [endif]--(Stathopoulos et al. 2008; Stathopoulos A 2012b, 2012a, Bota et al., 2015; Schijns et al., 2015). Gliovac/ERC1671/SITOIGANAP is a cancer treatment composed of a combination treatment consisting of autologous glioma tumor cells, and allogeneic glioma tumour cells, generated from three different glioma donor cancer patients, and the lysates of all of these cells. Upon intradermal administration of glioma cancer treatment Gliovac/ERC1671/SITOIGANAP, the mixture of the autologous and allogeneic vaccine (cells and lysates) stimulates the immune system to mount an immune response against glioma tumour-associated antigens, which leads to the destruction of glioma tumour cells.

Visible results after 4 weeks of vaccination

The patient shows continuous regression of clinical symptoms, robust immune response, leading to a beneficial inflammation around the tumor bed and no viable tumor. The patient survived for another 7 months (a total of 15 months after relapse)

Before

After 3 cycles

DONATION OF TUMOUR TISSUE

If you are willing to help other GBM patients during the clinical development phases, you may provide tumour as raw material for the production of Gliovac/ERC1671/SITOIGANAP. Gliovac/ERC1671/SITOIGANAP is manufactured using patients’ glioma tumour tissue. ERC has set up a tissue bank to collect tissue in compliance with European Regulatory Affairs. The tissue bank provides you all the required documents, kits for shipment of tissue and ERC will manage all the shipment.

If you are interested, please contact us and we will provide you with a transport kit and instructions for the patient and the treating physician according to EU regulation for tissue donation to the TTB-NL.

Gliovac/ERC1671/SITOIGANAP : AN ANTI-CANCER IMMUNOTHERAPY – PRODUCT AND PROGRESS

The Gliovac/ERC1671/SITOIGANAP approach is a cell-based therapy recognised by Health Authorities as an ATMP (Advance Therapeutic Medicinal product) by the Committee for Advanced Therapies at the EMA (Record reference: EMA/CAT/324279/2012). Gliovac/ERC1671/SITOIGANAP has been granted an Orphan drug designation by the Committee for Orphan Medicinal Products at the EMA in November 2013 (Record reference: EU 3/13/1211) and by FDA (12/01/2011).

ERC has reported success in the development of a therapeutic immune responses in glioblastoma tumour patients, manifested by tumour reduction. Primary results on patients at the advance stage of their illness show that the Gliovac/ERC1671/SITOIGANAP therapy can be protective in early and advanced malignant glioma and is able to break anti-tumour immune tolerance. The approach has been also successfully tested and described in a feasibility first-in-man study. [Bota et al., 2015, Schijns et al., 2015].

The safety, and preliminary efficacy results of the “first-in-man” studies were so encouraging that US Health authorities (Food and Drug Administration - FDA) allowed directly a phase II study (NCT01903330).
This double blinded, randomised, two-arm phase II study is performed at the University of California Irvine, currently updating to add the two clinical centres, including of Dana Faber Cancer centre (Boston) and the University of Southern California. This study compares the standard treatment for recurrent glioma in the USA with the product ERC1671 (Gliovac/ERC1671/SITOIGANAP) in 86 patients, and is currently recruiting patients.

The scientific approach of ERC is supported by confirming letters of eminent Professors from Pittsburg University, John Hopkins Cancer Center and Harvard who are well experienced in the field of glioma tumour therapies.

Recently, the ERC has been granted of a “Seal of Excellence” certificate by the European Commission in a highly competitive evaluation process.

Eventually Gliovac/ERC1671 may not only complement, but even replace existing treatments post surgery and become (part of) the standard treatment. Also, our initial indication is glioma, but it is very likely that the patented concept of the Gliovac/ERC1671 approach can be further utilised for the treatment of other solid tumours, which are surgically treated.

ERC

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