MSF Development plan
Past MSF Testing
Two safety trials
A small pilot safety trial was carried out in 1995/1996 in 10 normal persons. The results of this study are in full accord with the excellent safety profile of MSF also seen in rats, dogs, and monkeys. Because of severe budget constraints, that first trial in humans was carried out in Mexico and was not FDA-compliant.
The next safety trial was carried out in Germany under the direction of the Swiss company, Senexta Therapeutics SA. This Phase 1 safety trial in 22 normal persons was FDA-compliant. Published results from this second safety trial further confirmed the excellent safety profile previously seen in the earlier pilot safety trial.
One efficacy trial
A small pilot efficacy trial was carried out in 1995/1996 in 15 Alzheimer’s patients. This initial test of the effectiveness of MSF in Alzheimers patients showed that MSF was well tolerated, and that it provided unprecedented improvement in memory and quality of life for Alzheimer’s patients.
Five-stage MSF development plan
1. First stage
$1 million budget
Our first stage entails developing components and capabilities needed for later stages.
A. To move forward as quickly as possible on this development program, we purchased access to proprietary information relating to past testing of MSF.
B. We believe the past formulation, packaging, and dosing schedule of MSF can likely be improved with respect to bioavailability, shelf life, and specificity of action of MSF therapeutics. To this end, we are starting new formulation, packaging, stability, and dosing studies in March of 2013. For this we have rented lab space from Dr. Summerton’s biotechnology company, GENE TOOLS, LLC (www.gene-tools.com), and are purchasing supplies, equipment, and a pre-fab clean room. We have also lined up the technical services and personnel needed for these studies and for subsequent operations required in later stages of this program.
C. A serious limitation of many drugs, particularly the FDA-approved drugs currently used for revival of memory in Alzheimer’s patients, is the use of only one or a very few dose levels to treat patients ranging in size from quite small (under 100 pounds) to quite large (over 300 pounds). This can lead to excessive side effects in the smaller patients and inadequate memory revival in the larger patients.
Further, very preliminary results suggest that patients with greater memory loss may require a larger dose of drug to achieve memory revival.
We believe that to achieve maximum benefit for patients one should determine the optimal dose of MSF for each patient, that being the dose which achieves the best level of memory recovery without undue side effects. This will require a simple, reliable, and quantitative test of the patient’s memory which can be periodically administered at relatively low cost, both during clinical trials and thereafter during commercial distribution. Just such a test is now under development by consultants at the Univ. of Oregon.
D. Before we can begin the second stage of this development program we need to raise an estimated $3 million to fund that second stage (see below). We hope to raise these funds by a new internet phenomenon referred to as crowd funding. This entails a large number of individuals of mostly modest means directly contributing to a specific worthy goal – such as completing development of MSF and getting it to patients.
Considerable time and effort is being committed to getting this fund raising effort organized and functional – including particularly an animation video which explains in non-technical terms just why MSF is superior to the FDA-approved drugs currently used for reviving memory in Alzheimer’s patients.
2. Second stage
1 year duration
$3 million budget
crowd funded ?
Both 6-month and 9-month pre-clinical animal studies on two different MSF formulations are needed to support a planned exploratory clinical study and a subsequent adequate, well-controlled safety/efficacy clinical trial.
3. Third stage
1 year duration (includes 6 months for startup)
$ 16 million budget
funded by organizations and government entities ?
For the third stage of our program we plan a
24-week double-blind exploratory adaptive dose-escalation study to rigorously compare MSF with donepezil (Aricept), the best current drug for reviving memory in Alzheimer’s patients. This exploratory study will also test out our adaptive procedure for determining and providing the optimal dose of drug for each patient (our version of personalized medicine).
4. Fourth stage
1 year duration (includes 5 months wind down)
$ 8 million budget funded by organizations and
government entities ?
Adequate, Well-Controlled Safety/Efficacy Trial
In the fourth stage of our development program we plan a more conventional double-blind 32 week clinical trial designed to provide a longer-term, adequate, and well-controlled comparison of the safety and efficacy of MSF and its comparator drug, donepezil (Aricept).
5. Fifth stage
1 year duration (starting shortly after start of
$ 3 million budget
funded by conventional bank loan ?
Begin construction of a pilot-scale production facility that will be used as soon as MSF is given marketing approval by the FDA. While additional funds will be required to complete this production facility, and have it approved by the FDA, and subsequently expand it as our market expands, initial funds will be needed for planning and for initial construction to begin while we wait for marketing approval from the FDA. Once such marketing approval is given, then raising additional funds (probably through a conventional bank loan) to complete and later expand the facility is not expected to be a problem.