As you are aware, we are pending an acquisition of the Salzman Group and their proprietary and novel drug R-107 which acts as a nitric oxide (NO) donor. NO normally exists in a gaseous state and is approved as such by the FDA for administration to patients via inhalation therapy requiring twice daily applications of same using an expensive special type of delivery device, and complex administration by trained respiratory therapists. In contrast, R-107 is a liquid that is readily administered by a single intramuscular injection and provides a steady-measured dosage over a 48 period.
In November we will be conducting a Chlorine Inhalation Lung Injury (CILI) phase 1 safety trial in Australia with 32 healthy volunteers to prove the safety of R-107 and, expect it to be complete by the end of the fourth quarter. With this action we will have also just conducted the phase one for the COVID treatment as well since both applications use the same drug (R-107). At that point, we will seek funding from the Biomedical Advanced Research and Development Authority (BARDA) for the COVID application and our primary focus will then return to COVID and between CILI phases remain there until completed.
The reason for this article is to discuss some possible non COVID and CILI related applications of our recent and pending acquisition of the Salzman Group.
To date, BARDA, as well as the Department of Homeland Security (DHS) have been quite supportive of our CILI program - and for good reason. In a mass casualty event involving an accidental or deliberate chlorine spill, the sheer numbers of injured victims requiring immediate help would overwhelm both primary and secondary aid facilities where ventilators (already in short supply) which can provide emergency nitric oxide (NO) are located. Our injectable applications of NO (R-107) which could be prepositioned with all emergency services as well as hospitals would save many lives.
This scenario - as well as our unique solution was recognized in October of 2017 when the US Department of Health and Human Services awarded us with a $16 million grant to develop R-107 to treat the life-threatening effects of chlorine inhalation – a potential terrorism threat.
While we are quite excited about the BARDA opportunity presented to us this website has recently been bombarded with many inquiries about other potential directions that our proprietary drug R-107 could possibly take in the future - as well as health issues that it and R-100 could address - hence this article.
As stated, while our primary focus is on COVID and CILI as applied to victims and those in extreme distress during a mass casualty event, I wish to assure my fellow investors and those concerned that Kalytera is aware of, and, has already taken steps to investigate the other possible military, scientific, recreational and health care market applications of this novel drug.
Kalytera is in the process of investigating some of the wide array of possible applications R-107 may be capable of addressing, and, this author is sure they will eventually be examining each in detail to assess their relevance to our future market placement. These may include but, are in no way limited to the possible emergency applications listed below.
Chemical Warfare
The vast possibilities and market opportunities the CILI application brings to the US and global military market in the defense against the use of Chemical Warfare choking agents (CW).
While many treaties banning the research, development and use of CW have been signed and almost universally ratified, the world remains a dangerous place, rogue nations still may elect to utilize CW thus, the US and our allies must be prepared to defend against those who would use these horrifying weapons. Ergo, Kalytera will continue to move forward researching the capabilities of R-107 against not only chlorine inhalation but all choking agents used in CW. This application and market is potentially massive as every nation on earth would seek to protect their military assets from this vile threat.
Performance Enhancement
For personnel such as Special Forces, rescue personal and others about to operate for a short period of time requiring maximum oxygen retention and muscular performance R-107 could provide 48 hours of timed and evenly administered nitric oxide while on target. As well as being able to be expediently administered in the field it also has properties which can prevent or diminish muscle soreness enabling soldiers already on operations to recover more quickly.
Extreme Altitude Performance Enhancement
Mountain climbers, high altitude rescue, high altitude pilots/astronauts’ populations who reside in high altitude environments could find beneficial properties to aid in their mission goals.
The inhalation of nitric oxide improves arterial oxygenation in high-altitude pulmonary edema, and this beneficial effect may be related to its favorable action on the distribution of blood flow in the lungs. A defect in nitric oxide synthesis may contribute to high-altitude pulmonary edema.
Treatment - Prevention of Decompression Sickness
Saturation divers, submariners, deep sea rescue may find R-107 a useful tool.
Injury Treatment – Health & Wellness
NO has anti-bacterial properties that can kill invading microorganisms and thus has the potential to aid in the treatment and recovery of injuries. Under emergency or battlefield conditions where casualties face a wide range of life-threatening injuries and are often far - both time and space from secondary help R-107 could provide a lifesaving treatment thus, due to the lack of immediate aid are at risk from infections caused by multi-drug resistant bacteria.
Nitric oxide is a powerful, broad spectrum anti-bacterial agent that is naturally produced by the human immune system thus, if given as soon as possible after injury greatly enhances the healing process. NO’s ability to attack multiple cellular targets limits the chance for bacteria to develop resistance to it.
As well, NO is being studied for it’s ability to regulate inflammation, revitalize tissue, prevent clotting and lower blood pressure.
The above items are not the stuff of science fiction rather, the use of NO for those and various other applications are presently being investigated by laboratories and pharmaceutical companies the world over. However, their progress is hindered by the challenges associated with chemically storing – and applying NO to the human body in emergency situations – often in remote and extreme conditions.
Examples of their delivery vehicles varies from expensive unwieldy ventilators, orally ingested pills, skin creams & ointments to disposable canisters of NO gas.
Conversely, our novel drug R-107 and it’s intra muscular injection applications eliminates most of the problems associated with the other forms of administration with the added benefits of not only by passing the body’s filtration system to achieve a guaranteed dosage of the drug but a steady consistent flow of the payload over a 48 hour period.
As you are aware the main properties of R-107 that stand out are that it is injected so that it by passes the kidney and other body filtering processes thus what is entered into the body is what is applied to the problem thus the application is immediate so no need to have a time delay while the drug is being processed and no need for special equipment or personnel to administer.
During the upcoming period we will also be investigating non-emergency uses of R-107 in conjunction with other companies as well as the USDOD.
The soon to be released interview with Andrew Salzman will verify the information contained in this article. Consider this a preparatory resource.
The soon to be released interview with Andrew Salzman will verify much of the items discussed in this article.