Matinas Has Many Imminent Potentially Game Changing Catalysts.
The Phase I Study of Encochleated Amikacin.
The Phase I study should meet the safety endpoint. The ongoing Phase I study of encochleated amikacin uses healthy subjects, and the only endpoint is safety. In that the Phase I studies of encochleated amphotericin B showed no toxicity, and only minor adverse events at the highest dosages, it would be a huge surprise if encochleated amikacin did not show similar safety in this ongoing Phase I trial.
I suspect that when the amikacin Phase I results are announced sometime this month, the share price will pop.
The Phase II Studies of Encochleated Amphotericin B.
However, the truly game changing clinical studies are the two ongoing trials for encochleated amphotericin B in which the endpoints are safety AND EFFICACY. If these results show that encochleated amphotericin B is as effective as non-encochleated amphotericin B, and has no toxicities, then we will truly have a disruptive technology, and a buy out will definitely be a possibility.
Topline results from the two Phase II studies are expected to be announced in 1H 2017.
The Phase III Pivotal Trial For the Prophylactic Use of Encochleated Amphotericin B.
From there, Matinas intends to ask the FDA for a pivotal Phase III registration trial for the prophylactic use of encochleated amphotericin B. If that trial were to be approved, that means the FDA will have found that this drug, which is so toxic it can only be administered in a hospital as a last resort, and for very short periods of time, is safe enough to be taken orally, at home, for a many months.
This would truly be game changing and disruptive especially if encochleation is shown to make many other highly toxic drugs safe and effective.
Conclusion
With so many catalysts on the near horizon, these are truly exciting times for Matinas. If Matinas' enclochleation technology can make effective but toxic drugs safe to administer, it is difficult to imagine this company not being the object of a big-pharma bidding war. If Matinas chooses to go it alone, the licensing fees from pharmaceutical companies seeking to use its patented encocleation technologies for a number of their effective but toxic drugs, together with Matinas' sale of its own encochleated drugs, should make Matinas a big player in the pharmaceutical industry.
LM
