IND Stages in Depth . . .
The Total Project will be divided into the following four stages of completion:
Stage 1 – This initial stage will consist of: Product Development, Research, Patent and Animal study
Stage 1 is the most extensive area of development, where the Company’s research team will create a new EDTA suppository formula to patent. This stage will include the testing of the new suppositories using advanced biochemical analyses where GLP contracted research labs will detect the levels of the active ingredient in the blood and urine of animals. The results of testing different formulas will direct the final stage. Provisional and non-provisional US Patent applications have already been submitted to the USPTO.
The Company will also review all of the research that WHP has conducted over the past eight years and write an extensive report to submit to the FDA. This involves verification of safety and efficacy (clinical benefit) as well as supporting claims of toxic heavy removal and the treatment of disease conditions. WHP’s studies, which are in the public domain, show support for prostate conditions, improvement of important blood markers such as cholesterol levels (HLD/LDL) as well as the reduction and excretion (elimination) of toxic heavy metals. The research studies that have been completed so far include: 1. Study in children with abnormally high levels of lead; 2. Living Longer Institute study – multiple heavy metals reduction; 3. Two studies at TLC on prostate conditions; 4. A preclinical study on bioavailability of chelation suppositories that is already published; and 5. A study at the International College of Iridology on quality of life and metal removal.
In addition, Dr. Rita Ellithorpe has had thousands of patients on Detoxamin® chelation suppositories. The Company will analyze and summarize her patient case records from the past eight years to utilize for future work and for the FDA submissions.
The Company has developed an animal model trial in concert with B. Braun Medical, Irvine, California. This study will be used, with approval of the FDA, as the Company’s second animal species tested to determine safety and dosing, absorption, digestion, metabolism, and excretion (ADME). This Company plans to have this animal trial pave the way for the Company’s IND number application and subsequent human clinical trials. The details of the animal trial can be found in the Company’s NIH grant proposal (PA-12-088, available upon request).
Stage - 2 Also as part of the initial stage, these will be addressed: IND Submission, Recruitment for Human Clinical Trials, Data Analysis, Analytical Method Development, Full US Patent
The main goal of initial clinical studies will be to show the Company’s new product’s bioequivalence to the widely accepted but costly and painful IV chelation therapy. The new product will contain the bioactive chelation drug used in the TACT study—calcium disodium EDTA. The clinical studies will examine the levels of EDTA in the blood and urine of human subjects using the new product. Levels of EDTA in the blood will be used to demonstrate absorption, maximum concentration, half-life and possibly other parameters. These parameters will be used to establish bioequivalence through a new route of delivery (suppository) compared to standard IV chelation therapy. EDTA levels in the urine will be used to determine total systemic absorption and excretion.
If the FDA accepts the new product as bioequivalent to IV chelation therapy, the Company plans to use the information gathered in the TACT study to greatly shorten and decrease the expense of the IND application through the 505(b)(2) process. The TACT study has been completed and results showed fewer deaths, fewer heart attacks, fewer strokes, fewer coronary revascularizations and fewer hospitalizations for angina in the patients who received the IV EDTA treatment.
Further research on the Company’s new suppository formula may entail a new clinical study on specific disease conditions such as cardiovascular and prostate disease improvements. In past research, the Company had good reason and evidence to believe that chelation suppositories will help normalize certain blood markers that are associated with heart disease. The Company plans to use this vital study with validated documentation to make treatment claims for cardiovascular disease.
Stage 3 - This stage will begin upon completion of the second stage of funding: Phase I/II Human Clinical Trials, International Patents, Data Analysis and Publication, Initiate 505(b)2 application
After initial experiments have shown that the new product is bioequivalent to IV chelation therapy, the Company plans to request formal “Type B” and “Type C” meeting with the FDA. In these crucial meetings, the company’s research staff and consultants plan to provide the FDA with safety data, efficacy data, a description of the new route of delivery of an already-approved FDA drug, and provide dosing and bioavailability information for the purpose of requesting the approval of an IND application. Our initial target claim is the reduction of lead blood levels.
The Company plans to have an FDA board of medical professionals attend the Company’s presentation, review its data, materials, patent, studies, etc. and provide the Company either a list of items they may require the Company to do or they may approve the application. The Company will need to anticipate future needs and combine drug development issues where practical, as the FDA normally only grants one “Type C” meeting for each potential application.
During this stage, the Company plans to also prepare a 505(b)(2) application for FDA approval of the new product as a new drug. The FDA normally requires an application fee of approximately $1.5 million. However, the Company believes it qualifies for a fee waiver as a small business submitting its first human drug application for review under FDCA Section 736(d)(1)(D).
IND approval should allow the Company or new owners of the patent to conduct the necessary expanded safety and efficacy studies needed for a NDA. It is estimated that Stages 1 to 3 will take up to one year to bring the Company to the point of an initial FDA review process for an IND.
Stage 4 – FDA Requirements for Approval of an IND
FDA could request further studies and could approve a submission immediately; most likely they will request further studies on either bioavailability or safety and efficacy studies in addition to the ones the Company will have submitted at the initial meeting. The guidance from the FDA meeting will be used to complete the tasks necessary for IND approval.
The Company estimates that all Stages may take approximately one to two years to complete the requirements necessary for a full IND approval by the FDA.
Once the Company has either the indication that it is close to IND approval or the actual approval itself, the Company plans to schedule meetings with pharmaceutical organizations to negotiate a joint venture with the Company or the sale and or licensing of the patents, along with a percentage of royalties tied to sales of the product over time.