SSNe: Frequently asked Questions

I would like to address persistent questions which have been asked of myself and Tamarisk in relation to our Serum Specific protein/peptide transport vehicle. I have included those asked of industry, press and the general public. Please understand that to be all inclusive here would be difficult at best. Therefore, I kindly ask those of you who have questions not addressed below to post your question to me here and I will answer to the best of my ability and to the extent that confidentiality is maintainable.

1. Has the technology been patented? Yes, our SSNe transport vehicle has been patented internationally with many years of protection yet remaining. Furthermore, improvements have been filed as well. I caution those of you searching my patents to make sure you have found the correct one as I have many in the field of drug delivery (a few dealing with intestinal disposition; 2 covering mucosa translocation).

2. Have any human trials been conducted? Yes, in 2009 we contracted Quest Diagnostics to perform a small single dose human trial with co-enzyme Q10 (see our homepage for a copy of Quest’ findings). Furthermore, approximately 110 human subjects across the United States have been chronically dosed with various nutritional supplements over the course of 3 years. In every case study, no matter the therapeutic agent involved, we have consistently witnessed a Cmax at approximately 1 hour post-administration and absolute bioavailabilities in excess of 90%.

3. Are trials underway or planned for Tamarisk’ oral insulin? Yes, human trials are in process and it is our desire to complete in the near future.

4. Will Tamarisk manufacture and market oral insulin and if not who will? Tamarisk is most certainly prepared to manufacture and market oral insulin should a deal not be struck with big pharma for use rights under license. We are currently in negotiations with multiple companies and do rather expect to either license or sell the rights to our platform technology to big pharma very soon.

5. When will oral insulin be available to the public? It is impossible to say at the moment as this depends upon our negotiations with pharma and the completion of phase clinicals. However, to the extent I’m able I will continue to update our progression publically.

6. What is the molecular source of the SSNe vehicle? Our SSNe transport vehicle is made up of a polymer backbone which has been modified through the covalent linkage of a hydrocarbon of >39 carbon atoms. Both components are 100% natural and non-toxic having GRAS status with the FDA. In addition, industrial quantities are widely available and inexpensive.

7. Why is this technology considered disruptive? We have been told by multiple executives, after their evaluation of our SSNe vehicle, that this technology is disruptive to the drug delivery sector. This statement is most likely rooted in the fact that the SSNe technology makes obsolete significant investments in current protein and peptide drug delivery research programs. Although this is the case, it has been my finding that many top pharma companies are more than excited about our innovation and have a true desire to see oral administration of proteins and peptides resolved and in clinical practice.

8. How did Tamarisk discover this while so many others have failed? The answer lies in a different way of thinking, observation and in the ability to imagine the impossible. Far to often textbook methodology takes one down a defined path which leaves little space for imagination. Furthermore, most scientists are mono-disciplined and stuck inside the narrow confines of current industry concepts, forever fearing to step out and enjoy the endless prospects found only within nature and limited only by ones own imagination. In fact Einstein once said “Imagination is more important than knowledge.” I am a student of multiple fields spanning from chemistry, molecular cell biology, biomimicry, genetics, immunology, pharmacology, virology, bacteriology, mathematics, biophysics and physics to list a few. I am able to pull bits and pieces of knowledge from multiple fields pooling it for the success of a research endeavor. Furthermore, I am forever the optimistic student of our surrounding macro and micro universe. To me nothing is impossible and we need only find an order of solution. Finally, all have focused their attention solely upon gastrointestinal transport of proteins and peptides and have failed to focus upon one critical aspect of success, protease activity at and within the epithelial membrane.

9. Have commercial feasibility studies been conducted on the SSNe manufacturing process? Yes, the manufacturing process was upscaled 3 years ago and a few thousand kilograms of product was run rapidly and cost effectively. In fact, since the encapsulation process itself is carried out at room temperature or below and since the nano encapsulate is generated from an aqueous collectant, little energy input is required and the process is 100% automated. With this process, encapsulation cost is all but completely eliminated and definitely falls within the scope of green chemistry.

10. How much “know-how” is involved in the encapsulation of different therapeutic agents? Although our SSNe technology is broad spectrum in nature one must conduct therapeutic encapsulations from a molecular classification stand point. For example, a therapeutic peptide requiring an acidic environment for shelf stability must be treated differently than one requiring a neutral or alkaline environment.

Serum-Specific Drug Transport Vehicle, Oral Route

Oral Drug Delivery has just made a giant leap forward.  How did we do it?  Through “Spike” element conjugation and nano-encapsulation of therapeutically active agents.

Serum-Specific Drug Transport: Molecular Basis of

Tamarisk Technologies has revolutionized drug delivery with its development and clinical successes of the first serum-specific drug deliver vehicle. The Serum-Specific Nano-Encapsulate particles (SSNe) exhibit 100% resistance to both gastric and intestinal fluids. Upon oral administration SSNe particles pass freely, uninhibited, into the intestinal pool where they act like fat, look like fat, and breach the enterocyte membrane much more efficiently than micelle constituents.

The SSNe particle consists of a natural polymeric back-bone equipped with covalently linked C40 chains, referred to as the “Spike”. Upon drug encapsulation the polymeric back-bone forms multiple double-double helix aggregates which sandwich a therapeutic agent, whether macro- or micro in molecular structure, within helical cores which further cross-link to adjacent helixes to form spherical partices of 25-40nm in size with expossed “Spikes” protuding externally from the vehicle surface, similar to that of transmembrane protein protrusion from cellular membranes. It is these spikes which protect the particle and its therapeutic payload from gastrointestinal dissolution.

SSNe particles enter intestinal epithelial cells through simple diffusion across the plasma membrane. Although primary enterocyte entry follows simple diffusion, there is also evidence suggesting micelle interaction and cholesterol dependent NPC1L1 transport as a seconday mode of of SSNe entry.

Upon entry into the cytoplasmic space of enterocytes, intact SSNe particles associate with cellular constituients and are in turn transported together with fatty acids and monoglyceride through the endoplasmic reticulum and golgi apparatus where they associate with cholesterol, lipoprotein and other lipids for packaging within chylomicrons. SSNe containing chylomicrons are then extruded from the golgi apparatus into exocytotic vesicles, which are in turn transported to the basolateral aspect of the enterocyte. The vesicles fuse with the plasma membrane, undergoing exocytosis, dumping the SSNe loaded chylomicrons into the extracellular space. Virtually all steps in this pathway can be visualized using electron microscopy.

Next, rather than being absorbed directly into capillary blood, SSNe containing chylomicrons are transported into the lymphatic vessel that penetrates into each villus. SSNe chylomicron rich lymph then drains into the lymphatic circulation which rapidly flows into the blood. Blood-borne chylomicrons are rapidly dissociated freeing the SSNe particles which are likewise disassembled by serum components releasing the therapeutic payload directly into the bloodstream. SSNe particles have consistently and reproducible presented bioavailabilities of 85-97% of administered therapeutic agent, no matter the size or solubility of the molecule.

SSNe particles have been successful in the nano-encapsulation, oral administration and serum disposition of multipe therapeutic agents. Most recently Tamarisk successfully administered and clinically validated the therapeutic significance and broad spectrum of SSNe drug disposition through the nano-encapsulation of 5 therapuetic proteins: Insulin, Peptide YY3-36, EPO, Tumor Necrosis Factor and Herceptin. All of which presented, in triplicate, with >90% bioavailability of intact therapeutically active peptide within rodents. Human trials of SSNe Oral Insulin, Peptide YY, and Pegylated Interferon are currently underway.

At Tamarisk we prefer to act rather than talk. Therefore, I continually challenge the industry to send me drugs of low or non-existent oral bioavailability and we will encapsulate them in our SSNe transport vehicle, at Our expense, and return them for evaluation.

The Holy Grail of Drug Delivery has Arrived………..questions, comments? I look forward to hearing from you.

Dr DeBrouse