Summary
- Profile Type
- Technology offer
- POD Reference
- TOGR20240520010
- Term of Validity
- 20 May 2024 - 20 May 2025
- Company's Country
- Greece
- Type of partnership
- Research and development cooperation agreement
- Targeted Countries
- All countries
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General information
- Short Summary
- Individuals diagnosed with brain tumors of high malignancy generally have a prognosis of less than one year. However, the proposed novel drug has demonstrated remarkable success for the two first patients, who are alive and well 6.5 and 1.5 years respectively after treatment, with no evidence of recurrence and radiological evidence of the drug's efficacy.
- Full Description
-
Current drugs targeting brain tumors are administered intravenously. The physiological “blood-brain barrier"allows less than 2% of any drug to reach the brain and a much smaller percentage to reach the tumor. As a result, no therapeutic drugs’ concentrations are achieved at target cells.
Local administration of various drug regimens, through various drug delivery methods, for high grade gliomas has not extended patients’ survival till today.
The novel drug was developed solely for local administration - a combination of:
1) diaminobutyric acid (DAB), documented as effective for high grade glioma tumor destruction and patient-safe for intratumoral administration in two published studies, involving a total of 13 patients
https://acrobat.adobe.com/id/urn:aaid:sc:EU:c63fdc9e-0c93-433a-aa27-d0d4ac9439a5
and
https://acrobat.adobe.com/id/urn:aaid:sc:EU:07403f10-c8cd-4a42-8189-d83a2b39ad7a
and
2) Prazosin, documented as effective against TICs (tumor initiating cells) - responsible for high grade glioma tumors’ recurrences. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5130115/
The clinical result of the first two patients is optimal.
In both cases, after maximal safe tumor resection, two catheters were left at the tumor's excision bed, connected to drug infusion pumps and infused the novel drug - for 4 and 5 days respectively, at a flow rate regulated according to the patient's clinical status and intracranial pressure.
Our consortium’s scientific team welcomes any proposal for conducting an officially registered, CRO (clinical research organization) monitored, perspective clinical trial οf primary and recurrent high-grade glioma patients for evaluating the novel drug. - Advantages and Innovations
-
European Patent has already been granted and there is an ongoing PCT application.
First patient's case already published in a prestigious scientific journal.
Prazosin has been used as anti-hypertensive drug for decades and can be repurposed for a clinical trial with no regulatory delays.
Existing EU legislation demands a new drug file for the combination DAB + Prazosin, due to the fact that DAB has not been previously marketed as a drug.
High grade gliomas (rare and lethal disease with no existing therapy) allow for an "orphan drug designation", thus a pharmaceutical company benefits from significant marketing advantages globally: sales can start as soon as the novel treatment's patient safety parameters are established in an officially registered clinical trial - expected in a few months from the start of the clinical trial.
The partner wanted should be adept at navigating the regulatory frameworks, within the EU and US, as to establish an officially registered clinical trial of the above treatment, obtain “orphan drug designation” for the novel drug and market it while proving its clinical superiority over existing therapies for high grade gliomas. - Stage of Development
- Available for demonstration
- Sustainable Development Goals
- Goal 3: Good Health and Well-being
Partner Sought
- Expected Role of a Partner
- The chosen partner will be responsible for orchestrating and executing clinical trials in compliance with EMA and FDA regulations, aiming to establish “orphan drug designation” - and, eventually, clinical superiority over existing therapies - for the novel drug, as well as for marketing it.
- Type and Size of Partner
- Big companyR&D InstitutionSME 50 - 249University
- Type of partnership
- Research and development cooperation agreement
Call details
- Coordinator required
-
Yes
Dissemination
- Technology keywords
- 06001002 - Clinical Research, Trials06001012 - Medical Research
- Market keywords
- 05005014 - Oncology
- Sector Groups Involved
- HealthMaritime Industries and ServicesMobility - Transport - Automotive
- Targeted countries
- All countries
