Parkinson’s Disease Community Sponsor
ABOUT NORMAX
Our Purpose.
The purpose of Normax is to help save lives with mRNA vaccines, therapies, health technologies and finance, with our people, partners, investors, stakeholders, providers, customers and communities.
Our mRNA Vaccines.
Our mission is to drive down the cost of mRNA Vaccines to save more lives and to deliver sustainable returns for impact investors Normax will participate as a strategic partner in the global ecosystem for transformative research, development and manufacture of safe and effective mRNA vaccines for global public health and pandemic preparedness and prevention, with competitive financial performance. We plan to deliver safe and effective mRNA vaccines at large scale for about $4 dollars a dose.
About mRNA Vaccines.
mRNA vaccines have been proven safe and effective to save lives and help to end the pandemic. Probably you may have experienced the benefit of mRNA vaccines yourself. In principle, mRNA vaccine technology can be developed to prevent or treat almost any disease. All life is based on proteins which are programmed by DNA. When DNA is translated into mRNA, your body produces the proteins needed for your life and your health. Our first Normax mRNA vaccines in development for infectious disease are for COVID, Tuberculosis, HIV and Epstein-Barr virus (EBV).
Trust. Trust. Trust. Trust. Trust.
Most trusted People for Health Trust (supported by MedicalGPT)
- TRUST supported by MDs.
- TRUST supported by NURSEs.
- TRUST supported by SCIENTISTs.
- TRUST supported by PATIENTs.
- TRUST supported by MedicalGPT.
Normax aim is to use Biocomm and MedicalGPT to get the Patient (with “my shared interest”) BACK into the most trusted group by connecting trust between all 5 TRUSTED parties in the MD/Patient Relationship.
SPONSORED PRODUCT
Talineuren. Neuroprotective Therapy for Control of Parkinson’s Disease Enabled by Nanoparticle Delivery of GM1 Across Blood-brain barrier, observed in All Clinical Trial PD Patients, and with Regenerative Effects Observed in a Subset of PD Patients
Partners: InnoMedica Switzerland AG and Normax Biomed Limited
Principal Investigator: Dr. med. Michael Schüpbach, Parkinson’s Disease Specialist, Neurologist, Neurology Institut in Konolfingen – Switzerland
Project Manager: Dr. Camille Peitsch, R&D Director, InnoMedica.
Business Management: Dr. Stéfan Halbherr, CEO, InnoMedica, Dr. Jonas Zeller, CFO, InnoMedica, Peter A. Jensen, CEO & Chairman, Normax Biomed
Clinical Trials: Talineuren (TLN-1) Clinical Trials for Parkinson’s Disease
MEDICAL NEED
Talineuren safely delivers neuroprotective therapy for Parkinson’s Disease (PD) with Regenerative Properties for PD patients in early to late stage of disease. InnoMedica currently has Phase I and Phase IIa safety and efficacy data to present to the Biocomm Community.
TARGET PATHWAY CIRCUITRY
InnoMedica and Normax have partnered to co-invest in Phase IIb and Phase III Clinical Trials for Talineuren with monosialotetrahexosylganglioside (GM1) delivery across the blood brain barrier.
Design of Talineuren. Talineuren (TLN) is composed of a liposomal nanocarrier with a unique composition that crosses the blood brain barrier and the active pharmaceutical ingredient GM1 ganglioside with neuroprotective and neurorestorative properties. GM1 is inserted in the membrane of the liposome.
GM1, the “prototype” ganglioside. GM1 is a member of the ganglio-series of glycosphingolipids which has important physiological properties and impacts neuronal plasticity and repair mechanisms, and the release of neurotrophins in the brain.
TLN-1 – The paradigm shift in neurology. TLN-1 transports important biological building blocks into the brain – promoting nerve cell protection and regeneration. TLN-1 overcomes the blood-brain barrier, and (i) can be administered orally or intravenously, (ii) has hardly any side effects and is suitable for long-term treatments, (iii) corrects a lack of GM1 in the central nervous system and regenerates nerve cells, and (iv) is intended for use in Parkinson’s disease, amyotrophic lateral sclerosis (ALS), and many other nervous diseases.
CLINICAL PLAN
Experimental Stages: Completed in Switzerland under regulatory authority Swissmedic, the national authorization and supervisory authority for drugs and medical products: (1) Pre-clinical (murine). Result: Safe and Effective, (2) Phase I Clinical Data. Result: Safe and Effective. And (3) Phase IIa Clinical Data. Result: Safe and Effective (6 months).
Clinical Plan Proposed: (4) Phase IIb (50 PD Patients) in Switzerland. (5) Phase III (300 PD Patients). Route of dose administration: Intravenous, Once per Week.
Add-on therapy. Talineuren is used, as it was in the NEON study, in addition to standard symptom-relieving treatments already prescribed by physicians, with the goal of halting disease progression.
Study design. The LEAP study will be conducted in parallel at several study centers. In this double-blind study, neither the physicians nor the patients know whether Talineuren or a placebo will be administered. Clinical Supply. Talineuren is produced and ready, on-the-shelf, now, in sufficient quantities, to begin Phase IIb immediately following regulatory approval