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COMPELLING DATA AND CLEAR MILESTONES
We have generated substantial pre-clinical data supporting the potential of our approach to protect peripheral nerves while maintaining chemotherapy exposure. Paired with extensive safety data and early human proof of concept case series, we are advancing rapidly toward key milestones.
MITOCHONDRIAL DYSFUNCTION IS CENTRAL TO CIPN FOR MANY CHEMO AGENTS
Neurotoxic chemotherapeutic agents target multiple aspects of the sensory peripheral nerve.
1.Ann Neurol. 2017 Jun 5;81(6):772–781.
2.Soejitno, A., Widyadharma, I.P.E. Chemotherapy-induced peripheral neuropathy biomarkers: current updates, challenges, and potentials. Egypt J Neurol Psychiatry Neurosurg 60, 92 (2024).
CFB-001 PRESERVES MITOCHONDRIAL STRUCTURE IN NEUROLOGIC TISSUE CELLS UNDER STRESS
TEM images show HQ (hydroquinone) caused substantial disruption of mitochondrial morphology
CFB-001 significantly protected mitochondria from HQ-induced oxidative stress
Study done by Jaffe G, et al. (Duke University)
CFB-001 DOESN’T AFFECT CISPLATIN IN MULTIPLE CANCER CELL LINES
Cancer cell lines tested:
A549 (Human lung cancer line)
HepG2 (Human liver cancer line)
HCT-15 (Human colorectal cancer line)
EMT-6 (Murine breast cancer line)
Cancer cells were seeded in 96-well plate (10,000 cells/well) and grown independently for 24 hours. Then the cells were treated with a serial concentration of cisplatin (triplicated wells) with or without the presence of 100 µM or 400 µM CFB-001. After 72 hours incubation, the living cells were determined by MTT.
CFB-001 at 100 µM and 400 µM did not affect the growth of A549, HepG2, HCT-15 and EMT-6 cancer cell lines.
CFB-001 at 100 µM and 400 µM did not affect the efficacy of cisplatin on A549, HepG2, HCT-15 and EMT-6 cancer cell lines.
CFB-001 DOESN’T AFFECT CANCER METASTASES IN MOUSE MODEL
Mouse model using the B16F10 melanoma cell line
Highly metastatic mouse model that is considered clinically relevant because it exhibits spontaneous metastasis, mimicking the progression of human melanoma.
B16F10 were cultured following the protocol of ATCC. 2 x 105 of cells in 0.1 mL PBS were injected into tail vein of the animals on day 1.
The mice were randomized with comparable body weights into vehicle group (n=8) and CFB-001 group (n=8) and the treatment was initiated on day 2 (1 day after cell injection). The treatments were given IP from day 2 to day 6.
The body weights and overall health status were monitored daily. The mice were euthanized on day 18. The lungs were collected and weighted. The lung metastatic nodules were analyzed.
Extensive B16F10 nodules were observed in the lungs. The lung tissues were collected and snap frozen. Body weights and lung index were summarized.
Doesn’t Affect Cancer Metastases in Mouse Model. There were no significant differences between vehicle group and CFB-001 group in body weight (p>0.05) or lung index (p>0.05).
ANIMAL MODELING OF CFB-001 IN CIPN WITH CISPLATIN
Mechanical pain sensitivity testing in mice with Cisplatin through two 4-day rounds of treatment
Tested using the von Frey test, which measured the withdrawal force of the mice after two rounds of Cisplatin IV dosing.
The test was conducted on all mice at baseline (day 1) and on study day 7, 15, and 21 with measurements taken 2 hours post-dosing on dosing days.
Animals treated with 1.0% of CFB-001 Topical Gel (Group 2, n=8) showed a higher withdrawal force response (less mechanical pain sensitivity) when compared to the placebo group (Group 1, n=8).
This increase reached statistical significance on study days 7 and 15: for example, on day 15: 0.15±0.02 g vs. 0.06±0.01 g for the placebo; p<0.01.
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