Alexavi, a biotech services company, and Double Bond Pharmaceutical are working in cooperation to make Temozolomide gel (under the brand name Temodex^®) available for eligible brain tumour patients prior to global registration. Alexavi is managing the Temozolomide gel Named Patient Early Access Program on behalf of Double Bond Pharmaceutical. Temozolomide gel is available by prescription only; physicians may contact Alexavi for more information and to place an order by filling out the form below.

Temozolomide gel is a locally acting form of the chemotherapy drug temozolomide and has been successfully tested in clinical trials. It is administered directly at the site of the tumour following surgical removal, in the form of a hydrogel, thus ensuring that the therapeutic effect occurs precisely where it is needed. Temozolomide is a prodrug which destroys the tumour’s DNA and triggers the death of tumour cells, and, in gel form, its efficacy is not dependent on the methylation status of the MGMT gene. Temodex^® is currently registered in the Eurasian Economic Union, used as a first line treatment of gliomas in Belarus since 2014 and is intended to be used in combination with the current Standard of Care (surgery + chemoradiation) for the treatment of glioblastoma and other malignant astrocytic, oligodendroglial and oligoastrocytic brain tumours. Temodex^® (Temozolomide gel) obtained Orphan Drug Designation from the European Medicines Agency in 2016.

Glioblastoma, the most common and aggressive malignant form of all primary brain tumours, affects glial cells and accounts for 52% of all brain tissue tumour cases and 20% of all tumours inside the skull. About 50% of the patients diagnosed with glioblastoma die within one year, and 90% within three years. Temozolomide gel has shown a prolonged overall survival of 9 months in patients with glioblastoma and other malignant astrocytic, oligodendroglial and oligoastrocytic brain tumours, irrespective of MGMT status.

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Summary of Product Characteristics for Temodex® (Temozolomide gel)

Clinical study: I. Karlsson, D. Veevnik, et al. Local delivery of temozolomide via a biologically inert carrier (Temodex) prolongs survival in glioma patients, irrespectively of the methylation status of MGMT. Neoplasma 2019; 66(2): 288–293

REPORT on the conduction of a prospective, open, parallel (historical control) clinical trial of the medicinal product Temodex, powder for gel preparation for local intraoperative chemotherapy manufactured by RUE Belmedpreparaty in patients with malignant brain tumours, Phase I-II

D. Veevnik, A. Fedulov, et al. Local chemotherapy in treatment of brain tumors. Part 1. Characteristics of neurosurgical intervention and the course of the postoperative period in patients with brain tumors secondary to local chemotherapy. Oncology Original Studies 2015; 4(7): 22-34.

D. Veevnik, A. Fedulov, et al. Local chemotherapy in treatment of brain tumors. Part 2. Efficiency of treatment of patients with neuroepithelial brain tumors secondary to intraoperative local chemotherapy. Oncology Original Studies 2015; 4(7): 35-50.

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Question	Response
What is Temozolomide gel used for?	Temozolomide gel is intended to be used in combination with the current Standard of Care (surgery + chemoradiation) for the treatment of glioblastoma and other malignant astrocytic, oligodendroglial and oligoastrocytic brain tumours, irrespective of of MGMT status.
How is Temozolomide gel used?	Temozolomide gel is administered directly at the site of the tumour following surgical removal, in the form of a hydrogel, thus ensuring that the therapeutic effect occurs precisely where it is needed.
What class of drug is Temozolomide gel?	Temozolomide gel is a locally acting form of the chemotherapy drug temozolomide. Temozolomide is in a class of medications called alkylating agents. They work by slowing or stopping the growth of cancer cells in the body.
What is the active ingredient in Temozolomide gel?	The active pharmaceutical ingredient in Temozolomide gel is an imidazotetrazine derivative of the alkylating agent dacarbazine. It is a prodrug which destroys the tumour’s DNA and triggers the death of tumour cells, and, in gel form, its efficacy is not dependent on the methylation status of the MGMT gene..
Who is eligible for the Early Access program?	Patients with glioblastoma or other malignant astrocytic, oligodendroglial or andoligoastrocytic brain tumours. Patients must be at least three years old. Treatment is administered during surgery.
How do I order Temozolomide gel?	The Early Access program should only be initiated and requested by the treating physician on behalf of a specific patient. The treatment is limited to the requested patient only and the physician who initiated the treatment request bears the liability for the treatment. To order, contact the Temozolomide Gel Early Access Program Administrator by completing this form or emailing Temodex@AlexaviHealthcare.com Information required will include: • Shipping address and whose attention • Prescription(s) or drug fulfilment request • Payment or Purchase Order (PO) process for your facility and who the contact is for payment • Scheduled date of patient surgery if it has been scheduled The Temozolomide Gel Program Administrator will walk you through any additional details, questions and requirements.
What is the price of Temozolomide gel?	For a price quote, please contact our Program team at Temodex@AlexaviHealthcare.com
Is there an additional price for the transport of Temozolomide gel?	Transport fees will be added to the quoted (per dose) invoice.