We filed a 50-Page PRE-IND with the FDA, and on September 4, 2020 the FDA responded and wants us to run a toxicity test on a single species as a precursor to another test to determine dosing.
Clinical research shows Prostaglandin 1 (PGE-1), can be an effective treatment of ARDS (Acute Respiratory Distress Syndrome).
PGE-1 could treat COVID-19 lung problem that develops into deadly cytokine, and bradykinin storms and sepsis.
1 Lungs -- A cross section shows immune cells crowding an inflamed alveolus, or air sac, whose walls break down during the attack by the virus, diminishing oxygen uptake. Patients cough, fevers rise, and breathing becomes labored.
2 Heart and blood vessels -- The virus (teal) enters cells, likely including those lining blood vessels, by binding to the angiotensin-converting enzyme 2 (ACE2) receptors on the cell surface. Infections can also promote blood clots, heart attacks, and cardiac inflammation.
3 Brain -- Some COVID-19 patients have strokes, seizures, confusion, and brain inflammation. Doctors are trying to understand which are directly cause by the virus.
4 Eyes -- Conjunctivitis, inflammation of the membrane that lines the front of the eye and inner eyelid, is more common in the sickest patients.
5 Nose -- Some patients lose their sense of smell. Scientists speculate that the virus may move up the nose’s nerve endings and damage cells.
6 Liver -- Up to half of hospitalized patients have enzyme levels that signal a struggling liver. An immune system in overdrive and drugs given to fight the virus may be causing the damage.
7 Kidneys -- Kidney damage is common is severe cases and makes death more likely. The virus may attack the kidneys directly, or kidney failure may be part of the whole-body events like plummeting blood pressure.
8 Intestines -- Patient reports and biopsy data suggest the virus can infect the lower gastrointestinal tract, which is rich in ACE2 receptors. Some 20% or more of patients have diarrhea.
In serious cases, SARS-CoV-2 lands in the lungs and can-do deep damage there.
But the virus, or the body’s response to it, can injure many other organs.
Scientists are just beginning to probe the scope and nature of that harm.
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Prostaglandin 1 (PGE-1) is encapsulated in our patented liposome.
PGE-1 is an FDA generic drug known as Alprostadil.
Liprostin is made in the absence of a partition enhancing buffer.
Click Button for Information on Patent #9962393 B1.
Other Liposomes made with partition enhancing buffers have likely expired.
If PGE-1 is used with a Liposome to treat vascular diseases, they must get a license from us.
Generic Drug For
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Our liposomal PGE-1 has IN VITRO half-life of 1.5-hours.
Open Label Trials to determine IN VIVO (inside body) half-life
Raw PGE-1 has an ineffective half-life measured in a few minutes.
Needs a Liposome to slow down the release of drug.
We recently filed a provisional patent to specifically treat COVID-19 with Liprostin.
Critical Limb Ischemia
With Potential Treatments For
Prostaglandin E1 and survival in patients with the adult respiratory distress syndrome. A prospective trial.
A 7-day infusion of prostaglandin E1 (PGE-1), an immunomodulator, was evaluated in a prospective, randomized, placebo-controlled, double-blinded trial in surgical patients with the adult respiratory distress syndrome (ARDS). The drug seemed to improve pulmonary function--only two PGE-1 patients died with severe pulmonary failure compared with nine placebo patients (p = 0.01). Survival at 30 days after the end of the infusion--the predetermined end point of the study--was significantly better in the patients given PGE-1 (p = 0.03), with 15 of 21 PGE-1 patients (71%) alive at this time compared with seven of 20 placebo patients (35%). Improvement in overall survival in the PGE-1 patients did not reach statistical significance (p = 0.08). Overall survival in patients initially free of severe organ failure, however, was significantly better in the PGE-1 patients (p = 0.03). Of the six PGE-1 patients free of severe organ failure at time of entry, all survived to leave the hospital; of the 10 placebo patients initially free of severe organ failure, four survived. The drug had no serious side effects and did not potentiate susceptibility to infection. PGE-1 is a promising agent for the treatment of ARDS.
Alprostadil has a protective effect on ARDS induced by Oleic Acid in rats, possibly through inhibiting apoptosis, suppressing the activation of MAPKs and NF-κB signaling pathways, and decreasing ACE protein expression. Therefore, the use of Alprostadil in clinical ARDS treatment is promising.
When Alprostadil (generic Prostaglandin 1) is loaded into our patented, multilamellar liposomes and intravenously injected, the controlled drug system treats PAD by controlling
inflammation, increasing blood circulation, and reducing clotting.
Poor diet, excessive smoking, and lack of exercise lead to this debilitating disease.
First symptoms from artery blockage is known as Intermittent Claudication, which is pain in calf while walking.
This was antibiotic resistant wound that resisted all other treatments.
Patient would likely have suffered amputation