Why the Polymedix Acquisition is worth it:
We already have two drugs that are in the clinical process: The costs of developing just these two drugs to this stage was $150 Million. Costs included are drug discovery, intellectual property protection, patents, all the research and analyzing of the properties of the drugs are covered, the in vitro toxicity and efficacy studies completed, the stability and purity tests, the PoC, the two IND applications, Phase I of both drugs and now since Brilacidin has passed Phase I with the IND application they can go directly to a Phase II for Oral Mucositis. That is a LOT of Research and Developmental costs that went into Brilacidin and Delparantag.
They have all the research that went into all of the other compounds.
Delparantag passed Phase II with Efficacy but it displayed Hypertension...which scared off Polymedix from finding a way to deal with this. ***CELLCEUTIX has a compound called KM-732 that deals with Emergency Hypertension!! In pre-clinical studies has shown to significantly Decrease BOTH Systolic and Diastolic blood pressure and displayed no toxicity! Plus blood pressure was reduced within a FEW minutes after administration.
Wake up People. These guys made this acquisition for several reasons. I bet ya that they find a way to deal with the Hypertension, but they have to take things one step at a time. You can sense the excitement from listening to Leo.
Delparantag will be a Major block buster if they can reformulate this by possible using KM-732.
Now they are planning on filing IND for Brilacidin for Oral Mucositis.
The IND should be accepted as I know PYMX was working on this; not sure how much they accomplished. They can use some info in which they filed the IND for skin infections.
Here are the basic steps of IND:
1.Introductory Statement and General Investigational Plan:
Information requested here is intended to place the drug development plan into perspective and help the FDA anticipate sponsor needs.
2. Investigator’s Brochure:
Researchers investigating the safety, tolerability, efficacy, and dose response of the investigational drug are informed as to the drug’s physical and biological properties and any results from previous investigations in this document.
3. Protocol:
Protocols establish how each proposed clinical trial will be conducted.
There are four primary clinical trial phases.
Phase I investigations generally evaluate drug safety and tolerability in healthy human volunteers.
Phase II investigations further evaluate safety and tolerability as well as dose response and efficacy in a small sampling of humans suffering from the target disease or infliction.
Phase III investigations replicate and expand upon Phase II investigations in a much larger sampling.
Phase IV investigations are typically post market approval investigations that continue to study the therapeutic to determine long-term implications of its use.
4. Chemistry, Manufacturing, and Controls:
These requirements are designed to assure the proper identification, quality, purity, and strength of the investigational drug.
5. Pharmacology:
This section describes the drug’s physical and biologic effects in animals and its mechanism of action.
6. Toxicology:
This section describes the toxic effects of the drug in animals and in vitro.
7. Previous Human Experience:
8. Additional Information: IND:
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