WHAT TO EXPECT FROM Gliovac/ERC1671/SITOIGANAP?

The prognosis of late stage glioma cancer is very poor. The observed percentage of patient survival is increased by Gliovac/ERC1671/SITOIGANAP when compared to untreated patients. Gliovac/ERC1671/SITOIGANAP is currently in clinical development and although the treatment may offer a benefit to patients in overall survival and/or quality of life, we cannot offer, at this moment in time, any guarantees as to its ultimate efficacy or clinical benefit.
 
The overall survival rate for patients that have been treated with Gliovac/ERC1671/SITOIGANAP on a compassionate use basis, reached 39, 36, 34 and 22 weeks, which is largely above the statistical theoretical survival of 9 weeks. This will be confirmed scientifically after the completion of our clinical trial, presently taking place in the US.
Preliminary data suggests that Gliovac/ERC1671/SITOIGANAP may be an efficient treatment which could significantly increase patients survival.

GLIOBLASTOMA TREATMENT - GLIOVAC/ERC1671/SITOIGANAP EARLY ACCESS PROGRAM

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., patients interested in seeking Right-to-Try (RTT) access to an ERC investigational product should talk to their physician.  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 Chris Beardmore at compassionateuse@anovaevidence.com

Patients interested in seeking early access to ERC products may also be approved under the U.S. Food and Drug Administration’s Expanded Access program.  Cases may be approved to proceed under Expanded access when ERC products are used in combination with other investigational products, when the case is serious but not life-threatening or at the request of the patient’s treating physician.  For more information, please contact ERC at expanded-access@erc-immunotherapy.com

In Australia, patients interested in seeking early access to an ERC investigational product under Category A of the TGA Special Access Scheme (SAS) should talk to their physician.  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 early access 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. 

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Gliovac/ERC1671/SITOIGANAP Treatment process

The cycle of the Gliovac/ERC1671/SITOIGANAP treatment

Step 1

Step 2

Step 3

Step 4

Step 1

Tissue collection

Gliovac/ERC1671/SITOIGANAP is manufactured from the patients tumour. That means that the patient has to provide us with a sample of their own tumour tissue. A “specific kit” containing conservation media is sent to the surgeon before the operation. The tissue is collected by the surgery, with a maximum amount of the tumour tissue being provided. (1-2 cms) At the same time Blood is also collected for analysis to ensure that the tissue is safe. ,(i.e; For HIV, Hepatitis B and C, Syphilis, and HTLV)

Step 2

Transport to ERC-The Netherlands

The transportation is arranged by ERC due to specific transport conditions which comply with all regulations.

Step 3

Production of Gliovac/ERC1671/SITOIGANAP​ in The Netherlands

The manufacturing period takes around 3 weeks after the tissue has been received at the manufacturing site. The delay in manufacturing is mainly due to quality testing and safety assessments and the need to ensure that production takes place in a sterile environment.

Step 4

Treatment, administration of Gliovac/ERC1671/SITOIGANAP

After approval of the quality of the personalized vaccine product it can be shipped to the patient’s treating physician for injection.

Our products

Gliovac/ERC1671/SITOIGANAP

The ERC1671/SITOIGANAP (Gliovac™) vaccine is an advanced immunotherapy based on freshly extracted tumour cells and lysates that stimulates the patient’s immune system to recognise and reject cancer cells.
 
The vaccine contains a combination of autologous tumour cells, and allogeneic tumour cells, generated from the glioma tumour tissues of three different donor cancer patients, and the lysates of all of these cells. Upon injection, this mixture should stimulate the patient’s immune system to mount an immune response against the tumour cells, which could lead to their destruction.
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What are the components of a Gliovac/ERC1671/SITOIGANAP Cycle and when are they administered?

1 CYCLE = 5 DOSES OF 2 COMPONENTS (5 intradermal injections during a 15 day period- therefore covering one month of treatment). The treatment is preceded by a priming of 3 days of cyclophosphamide (regulator of the immune cells), which is given orally. Gliovac/ERC1671/SITOIGANAP is co-administered with GM-CSF (an activator of immune cells).
A cycle of treatment lasts for 2 1/2 weeks followed by a 2 week rest period before the next cycle begins. I.e (Mon, Thu, Mon, Thu, Mon)

After 6 cycles (6 months) of treatment follows a Rest period of 2 months.  

Thereafter, if necessary, the following administration schedule is implemented
 
  • Booster cycles 7 & 8 – from week 34
  • Rest period of 4 months
  • Booster cycle 9 & 10 – from week 58
  • Rest period of 6 months
  • Booster cycle 11 & 12 – from week 90

The maximum amount of cycles that can be administered is 12 during a 2 year period.

For more information, please contact ERC.
 
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Clinical Trials with Gliovac/ERC1671/SITOIGANAP

A Phase 2 clinical trial of Gliovac/ERC1671/SITOIGANAP entitled “ ERC1671/GM-CSF/Cyclophosphamide for the Treatment of Glioblastoma Multiforme”  is now recruiting at University of California, Irvine.
For more information please contact:
 
The Chao Family Comprehensive Cancer Center 
University of California, Irvine Medical Center   
Phone: 01-877-827-8839    
Email:   UCstudy@uci.edu  
 
Details of the clinical trial can be found at:   https://clinicaltrials.gov/ct2/show/NCT01903330?term=Bota&rank=1

Patient treated with Gliovac/ERC1671/SITOIGANAP

Gliovac before treatmentBefore
Gliovac after treatmentAfter 2 cycles