WHAT TO EXPECT FROM Gliovac/ERC1671?

The prognosis of late stage glioma cancer is very poor. The observed percentage of patient survival is increased by Gliovac/ERC1671 when compared to untreated patients. Gliovac/ERC1671 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 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 may be an efficient treatment which could significantly increase patients survival.

Right To Try US program

GLIOVAC/ERC1671 Right-to-Try 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. 
Despite best efforts, it is not possible for all patients to participate in clinical trials.  For that reason, ERC has established a Right-to-Try program to make promising products available to patients facing serious or life-threatening conditions.  Patients interested in seeking Right-to-Try 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.  Requests for further information about how to apply for Right-to-Try or determine qualifications and capabilities required to administer ERC investigational product can be made to medicalaffairs@erc-immunotherapy.com
ERC typically will acknowledge receipt of a request for Right-To-Try, 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 Right-To-Try 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 at ERC Policy
 
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Gliovac/ERC1671 Treatment process

The cycle of the Gliovac/ERC1671 treatment

Step 1

Step 2

Step 3

Step 4

Our products

Gliovac/ERC1671

The ERC1671 (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.

What are the components of a Gliovac/ERC1671 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 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

A Phase 2 clinical trial of Gliovac/ERC1671 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

Gliovac before treatmentBefore
Gliovac after treatmentAfter 2 cycles