Endogenous Stem Cells Activators, Inc. (ESAI)'s Drug KRONOS IV (four) Helps Brain’s Own Stem Cells Fight Alzheimer’s

LAS VEGAS, NV--(Marketwire - May 29, 2009) - Endogenous Stem Cells Activators, Inc. (ESAI) had developed KRONOS IV (four) whose active ingredient is a generic drug presently on the market and approved by the FDA in the treatment of a certain medical condition. Our evidence shows that KRONOS IV qualifies as an off-label drug.

Alzheimer’s is a disease that destroys gradually the hippocampus, the area of the brain where memory functions are stored. One of the mysteries of Alzheimer’s is that in the same hippocampal area there are large amounts of stem cells that can potentially stop the disease and repair the hippocampus, except that they are dormant or inactive. ESAI has strong evidence that KRONOS IV can activate these cells and coax them through a process of neurogenesis into differentiating / transforming into active neurons, cells that can potentially repair or rebuild the damaged hippocampus.

If our concept is valid, then after administering of KRONOS IV improvements in the cognitive functions including memory should follow. Indeed physicians in the US and France treating AD patients for many years, have reported earlier that there were impressive improvements regarding memory, attention and orientation, in controlling incontinences, and as important in the improvement of the Quality of Life (QoL) of the patient and of the patient’s family.

In order to have KRONOS IV reach the AD patient, on a fast track basis, the ESAI should fulfill two requirements.

1. To document that KRONOS IV is an off-label drug. 2. To show reasonable evidence that KRONOS IV is safe and effective in the treatment of AD Patients. 1. Off-label status - In this respect the FDA is very clear “FDA does recognize however (that) once a drug or medical device had been approved or cleared by FDA, generally healthcare professionals may lawfully use or prescribe that product for uses or treatment regimens that are not included in the product labeling.” FDA’s “Guidance for industry, January 2009" 2. To show reasonable evidence that our drug is safe and effective in AD. In this respect ESAI had developed a clinical program by which three Nevada physicians in the field of neurology, geriatrics, and psychiatry, after receiving KRONOS IV safety data including acute and subacute toxicity, pharmacology and bioavailability, they would commence a clinical testing program as follows: The protocol to be followed would be to a certain extent, identical with the protocol that is being used under FDA regulations, including conditions of admittance and rejection and primary and secondary endpoints. The number of patients to receive the drug would be ten for each group and the duration of the study would be six months. KRONOS IV would be administered in i.m. injectable form, three times a week, in series of twelve per month for a total of seventy-two injections over a six month period. The KRONOS IV used in these trials would be manufactured by a Nevada compounding pharmaceutical company. 

The three Nevada physicians would keep their colleagues informed about the results obtained, and if a consensus would be reached that the drug is safe and achieving improvements in AD, than the Nevada physicians would start writing prescriptions for Nevada patients as well as for Nevada visitors.

We expect this to happen by February or March 2010.

The KRONOS IV drugs for commercial sale would be manufactured by the same compounding pharmacist company who manufactured the initial drug and the patients would obtain it by medical prescription in Nevada pharmacies.

Financing: ESAI proposes to raise initially one million dollars through a 504 Reg D in Nevada, or through other financial instruments, money that would be needed to secure more space for the company, attract key people, file patents and other ways to protect our intellectual property, and to produce a Private Offering Memorandum, intended to state in detail about our plans for the next five years.

In a capsule form we would need funding to either build a facility to produce KRONOS IV or alternatively to reach an agreement with the compounding pharmaceutical company that produced the first batch of KRONOS IV by which they would expand their capacity of producing KRONOS IV many times over.

Our five year estimates show that we would need about seven million two hundred thousand vials to treat 100,000 patients with AD, on a ratio of seventy-two vials needed by the patient over a for six month treatment. At the first reading it looks like we will be needing an enormous amount of vials, and yet on the second look one should realize that 100,000 patients treated represent less than 2% of the total 5.3MM AD patients registered in the US. We estimate that the retail price (at the pharmacy level and after all the mark-ups had been taken into consideration) will be $100 per vial.

Nevada To Become A Leader In The Treatment Of Alzheimer’s Disease.

As noticed, Nevada would be the place where all actions re: KRONOS IV (four) would take place.

However that wouldn’t be the first time, when Nevada would take a bold step in bringing in an innovative treatment geared to improve the lives of the over the age of 60 Nevadans. And that is “The Story of Gerovital H3 (GH3).” That happened in 1977 when Rom-Amer Pharmaceuticals, a company formed by Dr. Sapse and an investment banker friend, approached the Nevada Legislators asking for help in introducing in Nevada, Gerovital H3 (GH3), a drug identified by Dr. Sapse as an anti-depression drug with a reversible selective monoamine oxidaze inhibitory activity (MAOI), but best known to 100+ countries from all over the world as the anti-aging drug from Romania. Rom-Amer Pharmaceuticals went initially to the FDA asking for approval of GH3 as an anti-depression drug based on its MAOI activity but in spite of successful double blind studies and others carried out at UCLA - USC - Duke, NY University, Palm Spring Institute, among others, the FDA was reluctant to grant Rom-Amer the approval for GH3 because “GH3 is known the world over as an anti-aging drug and people would buy it as an anti-aging and not as anti-depression drug.” At that time “anti-aging” was a dirty word.

Anyway people from all over would go to Bucharest, Romania for the GH3 treatment, among them prominent Nevada businessmen, politicians, entertainment, celebrities, hotel owners and others.

The Nevada legislators considered favorably the Rom-Amer request and attached the approval of the GH3 to Bill AB121 pending and related to another matter. The Bill passed successfully through all the legislative commissions and signed into law Friday, May 20th, 1977 by Mike O’Callaghan, the Governor of Nevada. Next day the shares of the Rom-Amer Pharmaceuticals skyrocketed and a few months later when the first batch of GH3 reached the pharmacies, planes were full with people from all over, flying to Las Vegas to buy GH3 and the Las Vegas hotels were booked to capacity.

Today Gerovital H3 (GH3) is available all over the United States and large segments of the population over 60 are using it.

The story of Gerovital H3, of Dr. Sapse, and Rom-Amer Pharmaceuticals, are described in Herbert Bailey’s best seller (in its tenth edition) “GH3, will it keep you young longer?” published by Bantam Books in 1980, including how Dr. Sapse and an investment banker friend formed Rom-Amer Pharmaceuticals with $1,000 (one thousand dollars, $500 each) raised $10MM from Nevada investors and took it public (OTC). After the GH3 approval in Nevada, Rom-Amer was sold to a pharmaceutical company from Germany at an undisclosed eight figures.

We are optimistic that the story of KRONOS IV would be as successful or more so, and that the state of Nevada would be the first to come out with a treatment of Alzheimer’s, soon enough to still be able to save lives and suffering of the existing AD patients.

Patents to Dr. Sapse, related to the matters above:

1) Method of treating geriatric depression US Patent # 4,041,174 - August 28, 1977 2) Protected Complex of Procaine for the Treatment of Symptoms from Narcotic Addiction, Tinnitus and Alzheimer’s Disease. US Patent # 4,956,391 September, 1990 3) Protected Complex of Procaine for the Treatment of Symptoms from Narcotic Addiction, Tinnitus and Alzheimer’s Disease. US Patent # 5,064,858 September, 1991 4) Patent Pending: Method of Activating Endogenous Stem Cells, 2009