We are fully funded until the end of P2 not P1. Successful completion of P1 means we move directly into P2.
BISANTRENE HAS ALREADY REACHED APPROVAL AS A SINGLE AGENT. No one in their right mind is going to develop RC220 as a monotherapy because that means displacing an established market. Also, the world-first mechanisms of Bisantrene indicate that it is perfect for combination with drugs that already work but have issues with either cardiotoxicity or resistance. Following this line of thinking through means a pharma company doesn't have to worry as much about competing for market share, as it harmonizes with existing therapies making them better. You seriously need to read the preclinical programs that have been completed so far. Bisantrene is highly synergistic with a very wide range of drug classes from tyrosine kinase inhibitors, immunotherapy, anthracyclines, proteasome inhibitors, mTOR inhibitors, BCL-2 inhibitors, hypomethylating agents, alkylating agents, etc. Additionally, Bisantrene has demonstrated cardioprotection against anthracyclines in vitro and in vivo, HER2 monoclonal antibodies and proteasome inhibitors in vitro, and etoposide, carboplatin, and multiple antimetabolites in humans. Many of the drugs or drug classes are rated severely cardiotoxic by the FDA, but none are considered more the benchmark, understood, or used as frequently in patients as Doxorubicin.
The children included in the clinical trial below were extremely sick and 90% of them had received high doses of Ara-C (as well as many other therapies) and had failed treatment. When combining Bisantrene with Ara-C, 46% of children previously resistant or relapsing from Ara-C treatment responded and there were 0 cases of cardiotoxicity. Bisantrene has maintained this effect in all combination trials.
The FDA has been very clear that they want safer more efficacious treatments --> decreasing the cardiotoxicity of Doxorubicin while making it work better fits that description perfectly. While that would be great thing for patients, it also happens to be an inconceivably large opportunity.
RAC Price at posting:
$1.68 Sentiment: Buy Disclosure: Held
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