Cannabis, scorpions, and synthesizing better drugs

Cannabis and scorpions? What could these two things possibly have in common? In fact, both produce substances which have tremendous potential for healthcare applications.

PreveCeutical Medical Inc. (CSE: CAA, Forum) is a Canadian junior bio-tech company which will be the focus of an upcoming full-length Stockhouse feature article. Preveceutical is in the process of applying to the Canadian Securities Exchange for the listing of its common shares pending the successful reverse takeover of Carrara Exploration Corp. (CSE: CAA) and Carrara's symbol is provided for reference.

The Company’s business model centers on taking natural substances with exceptional potential in healthcare and then using these substances to synthesize pharmaceutical drugs.

Globally, the bio-tech sector already generates revenues of $133 billion (2015 numbers). This is despite the fact that many of these companies are still emerging and have not yet brought their product(s) to market. As these companies mature and gain market penetration, the overall value of the bio-tech space is clearly headed to multiples of its present level.

PreveCeutical is one of these bio-tech companies looking to bring its innovative, emerging technology to the marketplace. Unlike most of its bio-tech peers, PreveCeutical is not intending to simply commercialize natural substances into bio-pharmaceutical products. Instead, the Company’s mission is to manufacture pharmaceutical-grade, synthetic versions of these substances.

What are the advantages of synthesizing drugs instead of just refining the natural substances for human medicinal use? To answer this and other questions about PreveCeutical’s exciting and innovative bio-tech research, Stockhouse was fortunate enough to be able to pose some questions to two of the senior members of the Company’s scientific research team, Dr. Mak Jawadekar and Dr. Harry Parekh.

preveceutical.com

1. Dr. Jawadekar, you have roughly three decades of experience working for pharmaceutical giant, Pfizer. Could you briefly summarize the highlights of that experience as it relates to your new work with PreveCeutical?

After having received a Doctorate degree (Ph.D. in Pharmaceutics) from the University of Minnesota in 1982, I worked at Pfizer Global R & D HQ for over 28 years. I do believe that my experience enables me to research & develop molecules post ‘Discovery’ stage to IND stage as well as through various phases of Clinical development (Phases I through IV). While at Pfizer, I spearheaded Formulations R & D, Drug Delivery R & D and Clinical Trial Supply Chain Management as well as Research Pharmacy functions. For many years, I worked at the bench level with small molecules as well as with biologic (large) molecules including peptides for their formulations & drug delivery approaches. I worked on Pfizer’s Exubera, a novel product which allowed diabetic patients to have an option of inhalable, pulmonary delivery of Insulin (a Peptide). This experience allows me to quickly ascertain key, optimized paths for drug development in Pharmaceutical domain, without going through iterative /learning cycles. While at Pfizer, I also spearheaded ‘Strategic outsourcing of R & D activities’ with external CDMOs, CROs, CMOs, as well as educational institutions and created through co-development a portfolio of intellectual property, which allowed Pfizer Inc. to come up with patented portfolio of drug products, which became blockbusters for the company.

2. Dr. Parekh, your research background originates on the academic side of the pharmaceutical industry. Based at the University of Queensland (Australia) you have been doing research at the Pharmacy Australia Centre of Excellence (or “PACE”). What areas of your research are helping to advance research initiatives for PreveCeutical?

My team’s research spans the areas of drug discovery and delivery system engineering for small molecules as well as genes, and I’ve been developing these since 2005, so for over 12 years now. In relation to drug discovery applications I have developed a strategy to engineer complex peptides using a proprietary chemistry that delivers products in high yield and purity, so it’s highly efficient and also scalable. Given PreveCeutical’s interest in nature identical peptides it was a perfect alignment, applying my proprietary chemistry to generate nature identical peptides of highly defined structure and composition, eliminating variations that can be inadvertently introduced by nature; this is also expected to facilitate the regulatory path to market, where we plan to screen the synthesized nature identical peptides across a range of diseases, most notably cancer.

3. Natural substances have been used for many years to alleviate various health disorders. When medical science seeks to produce synthetic versions of these substances, it is often accused of losing many of the healthcare benefits. Why is the research team at PreveCeutical confident that this will not be an issue with your own synthetics?

The fundamental advantage and goal of PreveCeutical’s approach is to retain the collective properties of nature identical molecules, so as to promote synergies that exist between them. Our strategy is to retain key beneficial properties, so replicating the synergies that nature brings, while taking ‘nature’ out of the equation. Using this approach we won’t be relying on nature, meaning we can effectively manufacture as much of the product as the market demands. Also, active ingredients from any natural sources also tend to have lots of variance in them depending upon the geographies and species. Regulatory authorities expect ‘consistency from batch to batch’ for obvious quality reasons. They also demand characterization of the molecule prior to its inclusion in the regulatory submissions. Beyond the quality & regulatory reasons, there is a limit up to which one can expect naturally sourced supply as the commercial demand grows globally. By synthesizing ‘nature identical’ compound(s), one can expect to scale-up the synthesis without any concerns of quality, thereby allowing us to synthesize final product which is qualified and meets the robust standards as defined by the global regulatory authorities.

4. The Company’s corporate presentation highlights the importance of peptides in your research. What is a “peptide”?

A peptide is a chain of amino acids, with the sequence of amino acids in a given peptide responsible for their specific biological activity. With around 20 or so natural amino acids, there are endless permutations & combinations possible. Nature, however, gives us very important clues upon which sequences to focus upon. That is the reason why PreveCeutical will be focusing upon “nature identical” peptides. One of the most well-known examples of peptide drugs is insulin. The global peptide medicine market was estimated to be worth ≈US$17.5 billion in 2015, with an annual growth rate of over 10% p.a. expected over the next 5-7 years alone reaching revenues of almost US$50 billion by 2025!

5. One branch of PreveCeutical’s work involves developing efficacious drugs from the venom of blue scorpions. What healthcare benefits are you seeking to derive from this seemingly dangerous substance?

We aim to screen the peptides isolated from Caribbean Blue Scorpion venom across some of the most aggressive diseases where there exists unmet clinical need, such as cancer. There are numerous research papers in the public domain which show anecdotal safety & efficacy of venoms, taken through the proven routes of administration on cancerous cells/tumors. Our initial focus will be on targeting a very aggressive form of brain cancer, given that literature evidence exists of other species of scorpion venom having positive effects. From there, we plan to expand the program to screen our library of nature identical peptides in a high throughput screening (HTS) manner across a range of other cancers.

6. The second branch of the Company’s research focuses on the use of cannabinoids. What are the principal focal points of this branch of PreveCeutical’s research?

This program of research brings together Dr. Parekh’s expertise in chemical fingerprinting and delivery system engineering. Initially, through meticulous analysis of different cannabinoid extracts, we’ll build an inventory of ‘chemical fingerprints’ – these will serve as a quality control filter for subsequent batches of cannabinoid extracts. Next, we will infuse a given mixture of cannabinoids into a proprietary formulation intended for delivery via a nasal spray. The aim here is to promote direct delivery of cannabinoids to the brain/systemic circulation with extended release properties being our goal, so we can maintain cannabinoid levels to treat a range of acute and chronic conditions where cannabinoids have shown great promise. Our proprietary nasal formulations will also be designed to be universally-patient friendly, meaning formulations that can be used in children and adults alike.

7. PreveCeutical has a third, exciting line of bio-tech research which is totally separate from its work on blue scorpion peptides and cannabinoids. Can you briefly introduce this other branch of the Company’s research initiatives?

This involves a broader, longer term program of Research and Development with the aim of developing a ‘curative’ gene therapy approach for diabetes and obesity. Dr. Parekh and his multidisciplinary team of experts across Australia have been working towards this goal for over 4 years. Having collectively generated convincing results in models of disease this program paves the way for preclinical evaluation of proprietary delivery platforms and gene-therapeutics toward a single gene target implicated in both diabetes and obesity.


FULL DISCLOSURE: Preveceutical Medical Inc. is a paid client of Stockhouse Publishing.