1. What kinds of cancers do the Company's products target?
1.1. We are likely to address a broad range of cancer targets; however, our best target profiles are:
1.1.1. Any cancer patient with solid tumors, in stage two to stage four, to shrink and de-bulk tumors and metastasis without major surgery – for those who:
1.1.1.1. Wish to pre-augment chemotherapy, to reduce the load and exposure to chemotherapy's side effects.
1.1.1.2. Wish to supplement other therapy's effectiveness, without any additional significant side-effects. 1.1.1.3 Have exhausted chemotherapy alternatives.
1.1.2. Any cancer patient with solid tumors, who refuses, or wishes to avoid chemotherapy, and who has a relatively healthy and intact immune system
1.1.3. Any cancer patient with solid tumors, in stage one, stage two, stage three, and stage four, for which surgery and/or chemotherapy is not an option, or not likely to be effective
2.2. White Blood Cell Activation: White blood cells are exposed to activators in the device that trigger a subset to actively hunt and kill cancer cells when returned to the body.
2.3. Vaccine Induction: Much like childhood vaccinations, Reveal removes particular immune system cells from the body and trains them to recognize the tumor cells, then returns them to the body, where a permanent response by the immune system to the tumor results. Unlike other vaccines, we explicitly remove inhibitors from the vaccine-inducing solution as a means of forcing a tumor response.
3.2. Previous experience with liver dialysis at Hemotherapies, showing toxin removal reversed liver disease and shrank tumors
3.3. Previous experience with cytokine storm dampening by Hemolife, with 100% survival in septic shock patients instead of 50%+ mortality.
3.4. Published results on plasmapheresis and success of NovaRx with an antibody to TGF-beta, showing conclusively that immune inhibitors are part of the problem.
3.5. Study in rats showing conclusively the local immune inhibition that surrounds tumors is a clinical fact.
4.2. On inhibitor removal, Lentz published in 2008 in the Journal of Therapeutic Apheresis
4.3. On toxin removal, Liver dialysis, a related technology, accidentally removed the same masking chemicals, and the liver tumors in patients shrank dramatically, often by 50% or more (Hemotherapies) 4.4 On vaccines, there is a 20-yr history of publication on dendritic cell therapies. These therapies alone have rarely achieved a 15% response rate. In addition, never once has the patient or vaccine-induction solution ever had inhibitors removed and macrophage activation used concurrently.
5.2. Cancer centers seek molecular targets for drugs. We are proposing a systems-based approach that treats the immune system as a black box requiring help. There is no "target" against which to form a "drug" and hence a drug-based product.
5.3. Drug companies, also, look for drugs, and these are not drugs
5.4. Drug companies have reviewed these solutions from the point of view of drug delivery. As an example, MAF analogues are under consideration by drug companies. However, as devices are outside the standard drug delivery business model, most pharmaceutical companies have not been able to come to grips with creating a subtractive or a catalytic combination, to enable therapy.
5.5. GcMaF is not patentable as a drug, but through a delivery mechanism, it is. This is an extremely unorthodox approach; even though, it is fully legal, and very clinically sound as an approach.
6.2. Training
6.3. Continuing medical education (CME)
6.4. Patent Portal to assist patients in managing their care and treatment
10.2. Microfluidic Aphaeretic
10.2.1. Toxin Removal filter
10.2.2. Leukopheresis with MAF with return of Leukocytes
10.2.3. MAF-generating filter
10.2.4. MAF-immobilized filter
10.2.5. Nagalase removal
10.3. Microfluidic (external, wearable)
10.3.1. MAF-generating
10.3.2. MAF-immobilized
10.3.3. Nagalase removal
10.4. Obesity Treatment using TGF-beta adjuvant removal
10.5. Viral (Hepatitis)
10.6. Many Autoimmune Diseases
10.7. Liver Disease
10.8. Myostatin adjuvant removal for cachectic patients
1.1.1. Any cancer patient with solid tumors, in stage two to stage four, to shrink and de-bulk tumors and metastasis without major surgery – for those who:
1.1.1.1. Wish to pre-augment chemotherapy, to reduce the load and exposure to chemotherapy's side effects.
1.1.1.2. Wish to supplement other therapy's effectiveness, without any additional significant side-effects. 1.1.1.3 Have exhausted chemotherapy alternatives.
1.1.2. Any cancer patient with solid tumors, who refuses, or wishes to avoid chemotherapy, and who has a relatively healthy and intact immune system
1.1.3. Any cancer patient with solid tumors, in stage one, stage two, stage three, and stage four, for which surgery and/or chemotherapy is not an option, or not likely to be effective
2. Describe Company product's and its biological and device actions. What is its History?
2.1. Subtraction Therapies: The immune inhibitors associated with cancer are at very low concentrations, Reveal removes them from the blood stream by specific molecular weight selection or targeted absorption.2.2. White Blood Cell Activation: White blood cells are exposed to activators in the device that trigger a subset to actively hunt and kill cancer cells when returned to the body.
2.3. Vaccine Induction: Much like childhood vaccinations, Reveal removes particular immune system cells from the body and trains them to recognize the tumor cells, then returns them to the body, where a permanent response by the immune system to the tumor results. Unlike other vaccines, we explicitly remove inhibitors from the vaccine-inducing solution as a means of forcing a tumor response.
3. What evidence does the Company have to support its clinical claims?
3.1. Previous experience with dogs at Therapheresis, showing elimination of metastasi in 6 treatments or less.3.2. Previous experience with liver dialysis at Hemotherapies, showing toxin removal reversed liver disease and shrank tumors
3.3. Previous experience with cytokine storm dampening by Hemolife, with 100% survival in septic shock patients instead of 50%+ mortality.
3.4. Published results on plasmapheresis and success of NovaRx with an antibody to TGF-beta, showing conclusively that immune inhibitors are part of the problem.
3.5. Study in rats showing conclusively the local immune inhibition that surrounds tumors is a clinical fact.
4. Who has published and how recent?
4.1. On MAF, Yamamoto has published results of small human clinical trials in breast, prostate and colorectal cancer in 2008, all patients free of disease at 4 or more years.4.2. On inhibitor removal, Lentz published in 2008 in the Journal of Therapeutic Apheresis
4.3. On toxin removal, Liver dialysis, a related technology, accidentally removed the same masking chemicals, and the liver tumors in patients shrank dramatically, often by 50% or more (Hemotherapies) 4.4 On vaccines, there is a 20-yr history of publication on dendritic cell therapies. These therapies alone have rarely achieved a 15% response rate. In addition, never once has the patient or vaccine-induction solution ever had inhibitors removed and macrophage activation used concurrently.
5. Why have leading cancer research centers missed the Company's findings?
5.1. "Missed" is too strong. Rather, ignored the literature, because there is strong research bias against devices that originated with the success of antibiotics. Everyone keeps looking for a "silver bullet" and thus ignore a direct functional alternative - gently augmenting the existing immune system.5.2. Cancer centers seek molecular targets for drugs. We are proposing a systems-based approach that treats the immune system as a black box requiring help. There is no "target" against which to form a "drug" and hence a drug-based product.
5.3. Drug companies, also, look for drugs, and these are not drugs
5.4. Drug companies have reviewed these solutions from the point of view of drug delivery. As an example, MAF analogues are under consideration by drug companies. However, as devices are outside the standard drug delivery business model, most pharmaceutical companies have not been able to come to grips with creating a subtractive or a catalytic combination, to enable therapy.
5.5. GcMaF is not patentable as a drug, but through a delivery mechanism, it is. This is an extremely unorthodox approach; even though, it is fully legal, and very clinically sound as an approach.
6. What are the Company's services?
6.1. Comprehensive Cancer Treatment kits6.2. Training
6.3. Continuing medical education (CME)
6.4. Patent Portal to assist patients in managing their care and treatment
7. Where are the treatments performed and by whom? Who will be channel partners, distributors, and strategic alliances?
7.1. Treatments are provided by regular nurses and regular doctors after a modicum of training. Specialists exist for apheretic treatment, but this is not a necessary condition. The know-how is available at most mid-to-large medical practices.8. What is the Company's path to market?
8.1. We expect to learn on dogs and use such knowledge, via a CE mark process in Asia and an IDE process with the FDA, to be in humans as early as 18 months but no later than 36 months. This is 3x to 5x faster than a drug process path to market.9. Why treat dogs when people can benefit too?
9.1. Any errors, or adjustments, made in dogs have a smaller impact and less consequence than in people; while at the same time, a vast array of repeatable and predictable process knowledge may be gleaned from the treatment of dogs that can also be directly applied to the human treatment path. Moreover, this pathway allows the fastest route into treatment in humans! While also giving dog owners access to a new treatment, in a situation with few other options but euthanasia.10. What are the Company's products and R&D Pipeline?
10.1. Cancer – Reveal will design a set of Microfluidic blood/plasma filters and protocols that when used alone or in combination will result in considerable remissions from cancer for a majority of patients with solid tumors. Initial targets will be breast, colon and lung cancer. The first filters, designed with off-the-shelf technology, will be used with extracorporeal aphaeresis machines. Later, a technology called "microfluidics" will be used to miniaturize the process so that patients will strap on a wearable device, the approximate size of two cigarette packs, that will allow 7x12 or 7x24 treatment for upto 3 months. Microfluidic versions of Reveal's products10.2. Microfluidic Aphaeretic
10.2.1. Toxin Removal filter
10.2.2. Leukopheresis with MAF with return of Leukocytes
10.2.3. MAF-generating filter
10.2.4. MAF-immobilized filter
10.2.5. Nagalase removal
10.3. Microfluidic (external, wearable)
10.3.1. MAF-generating
10.3.2. MAF-immobilized
10.3.3. Nagalase removal
10.4. Obesity Treatment using TGF-beta adjuvant removal
10.5. Viral (Hepatitis)
10.6. Many Autoimmune Diseases
10.7. Liver Disease
10.8. Myostatin adjuvant removal for cachectic patients
