6th Cannabinoid-Derived Drug Development Summit in Boston
Table of Contents
Professor Memo visited the 6th Cannabinoid-Derived Drug Development Summit in Boston USA in September, 11-13 of this year. The conference was of particular interest according to Professor Memo because ‘it was focused on defining strategies to accelerate CB therapeutics to clinical recognition.’
Evaluation of in vivo effects of non-psychotropic phytocannabinoids mixtures
- Relevance of preclinical data (bothin vitro and in vivo) in providing valuableinformation to clinical study design. Clarifying the mechanism of action is crucial to foresee both the therapeutic applications and limits.
- Conceptualize the presence of different molecules in CB extracts, each of themendowed with a unique pharmacological profile. In the near future, advances in medicinal chemistry will make an increasing number of CB-based molecules available. The pharmacological properties of most of them are absolutely unknown. Availability of pure compounds (derived from plant extraction or chemical synthesis) will obviously help to obtain recognition from Regulatory Agencies (FDA and EMA). Furthermore, parallel PK studies are revealing new metabolizing pathways that suggest the presence of pharmacologically active CB metabolites.
- Need for optimization of CB-based formulation in terms of quality, stability and reproducibility. The extreme variability in CB body absorption, distribution, deposition and clearance after a single dose administration hinders the definition of ‘active dose’ or ‘active regime’ thus making it more difficult to get the formal FDA/EMA approval.
- Overcoming the barriers of traditional clinical trials with unconventional, short-lasting, pilot, open studies (such as evidence-based retrospections). It is now clear that the design of clinical trials to demonstrate the therapeutic efficacy of a CB-based preparation must follow novel rules. Most of the studies are retrospective. The prospective studies are mainly intra-subjects, lasting a few months, on a voluntary basis and open. The results from these ‘real life trials’ are scientifically weak but highly suggestive for a specific health use.
- Possibility to combine individual CBs with other known drugs (i.e. Statins) or natural recipes (entourage effect). CBD is definitely the most studied CB with more than 200 ongoing clinical trials linked to pain management and muscle and neurological diseases. CBD is going to be defined by the international regulatory agencies as the first CB-based “drug” endowed with clinically well recognized therapeutic properties. Different is the case of natural recipes. It is generally recognized that natural combination of different CBs and Terpenes, for example, may generate new active pharmacological preparations that require a specificad hoc approach….’
- With information exchanged during various meetings at this summit and after having listened to a number of the speakers, professor Memo was unambiguous about the fact that: ‘in my view, the preclinical data are sufficient to be considered a scientifically solid base for the translation to humans.’
Further substantiation and publishing of the findings in peer-reviewed journal(s) would be useful to further solidify the scientific base professor Memo found.
A scientific document to this effect is being worked on and: ‘the paper demonstrating the effects of extracts containing different amounts of individual CBs in the generation of specific pharmacological profiles was presented at the National Congress of the Italian Society for Neuroscience, in Turin, this year’.
About professor Maurizio Memo
With a distinguished background in Biology and Pharmacology, professor Maurizio Memo at the University of Brescia, Italy has, over the past few years, performed several pre-clinical in-vivo trials using the recipes of four of our proprietary formulations.
Click here for more on Prof. Maurizio Memo
Suffice to say, (in-vivo) tests conducted on our proprietary and patent pending formulations yielded very promising results.
Given the amount of empirical testing and research over the preceding 30-40 years already carried out by Dr. Ir. Ron J. Glas himself, it confirms once again how these formulations and the string of further formulations still locked away in the RonJGlas-Repository, have tremendous potential that needs to be further developed, tested and validated one step at a time.
As the owners/guardians of the Dr. Ron J. Glas-Repository, our focus is on bringing the best functional recipes to consumers worldwide.
In support of this, we understand and underwrite the scientific importance of research and validation and for this we are always open to promising, new, scientific and commercial partnerships.
Ron J. Glas: ‘Decoding Cannabis, Restoring Your health’ and in the end that’s all it should really be about.