- Mechanisms of action:
- Tumor Inhibition
- Protection of Normal Tissue by Inhibition of NF-kB & Activation of NrF2
- Strong CMC and Safety/Toxicology Position
- 72 month stability at Room Temperature
- No major toxicity
- most common AE in humans is a grade 1 injection site reaction
- minimal SAEs
- Intellectual property
- Strong IP with additional information available under terms of confidentiality
- Clinical Trials- data collection limited to long-term follow up
- High Grade Glioma -Phase 1/2
- Head and Neck Cancer – Phase 1/2
- Enrolling Clinical Trials – Phase 2
- Multiple Brain Metastasis (i.e. lung cancer, breast cancer)
- Anal Carcinoma
- Above clinical trials funded by NCI SBIRs and University of Nebraska
- Planned Clinical Trials – Phase 2
- Rectal Cancer, single-site study, IND open
- Head and Neck Cancer Randomized
- Pre-clinical data supports line extensions to prostate cancer and ovarian cancer
- The randomized Phase 2 clinical trial of 160 subjects in high-grade glioma is closed for enrollment. Enrollment was completed and patients are currently being followed for long term follow up.
- Orphan designation for treatment of gliomas and Fast Track Designation for HGG program has been granted by the FDA.
- 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.
Additional information available under terms of confidentiality.
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 email@example.com
BioMimetix attends BIO and JP Morgan meetings each year.