- Mechanisms of action:
- Tumor Inhibition
- Protection of Normal Tissue by Inhibition of NF-kB & Activation of NrF2
- Strong CMC and Safety/Toxicology Position
- 60 month stability at Room Temperature
- No major toxicity
- most common AE in humans is a grade 1 injection site reaction
- minimal SAEs
- Intellectual property
- Method of Use Patents submitted worldwide 2019
- Method of Synthesis Patent submitted worldwide 2019
- Clinical trials, Phase 2, ongoing in:
- High Grade Glioma
- Multiple Brain Metastasis (i.e. lung cancer, breast cancer)
- Anal Carcinoma
- Above clinical trials funded by NCI SBIRs and University of Nebraska
A randomized Phase II clinical trial of 160 subjects in high-grade glioma is underway. Enrollment is over 85% complete and is projected to finish in mid-2021.
Orphan and Fast Track Designation for the treatment of glioma patients.
Pre-clinical data supports line extensions to prostate cancer and ovarian cancer.
BioMimetix is seeking an investment to fund expansion of clinical trials.
- Atopic Dermatitis
BioMimetix has completed a Phase 1 clinical trial in pruritus, atopic dermatitis and psoriasis which provided:
- Establishment of a therapeutic dose with a clean safety profile.
- Reduction/clearing of inflammatory skin lesions.
- Rapid reduction in pruritus.
- No significant systemic absorption.
Re-formulation is in process to optimize dermal penetration, cosmesis and stability. Re-formulated topical ointment is undergoing stability testing and bridging safety/toxicology studies, and GMP manufacturing.
Phase 2 clinical trials to begin Q3 2021 for atopic dermatitis and pruritus.
A development and commercialization partner is being sought to expedite Phase 2 clinical trials and lead market entry activities.
More information is available under confidentiality terms
For investment inquiries, please contact James Crapo, MD at firstname.lastname@example.org
BioMimetix attends BIO and JP Morgan meetings each year.