Skip to main content
Message Font: Serif | Sans-Serif
 
No. of Recommendations: 0

Aphria-staked Partner Has Slew of News on its Clinical Trials:Aprhia partner, Tetra Bio-Pharma, in which it holds 10 million shares, roughly a 9% stake, has had in the last three weeks a slew of cannabis clinical trials initiated and approved by Health Canada to begin, one a very important, ground-breaking late-stage Phase III clinical trial, and another also very important Phase IV clinical trial on the oil version of that blend. In October 2017 they announced a Phase IV clinical trial on their PPP005 cannabis oil here. Then on January 16th, 2018, Tetra announced here its Phase I clinical trial on its PPP005 cannabis oil which is from the same blend as its PPP001 dried cannabis product, both developed with Aphria, and on January 29th, they announced here they were approved to begin Phase II clinical trials on PPP005. So that's two studies ongoing they are doing on that Aphria-Tetra cannabis oil! If that wasn't enough, one week later they received regulatory approval to begin their late-stage Phase III clinical trial on their PPP001 cannabis products, which is being conducted by Sante Cannabis, Quebec's first and foremost medical marijuana research clinic. In their Jan 29 news release here, they stated, "This is a significant milestone in our mission to become a global bio-pharmaceutical leader in cannabinoids-based drug development. We currently have a strong pipeline of five cannabinoid-based products, all launched last year and using different delivery systems, in various stages towards Health Canada and FDA approval." And you read that right, that's Health Canada and the FDA; but if you know where else to look, you will find they are also smartly working with the EMA, the European equivalent of HC and FDA! That's a sharp marketing plan to have, for sure. 

The Slew of News Continues With a Blockbuster Landmark Phase III Clinical Trial: Then in still more major news, and intentionally, fortuitously coinciding with World Cancer Day 2018, in their February 4th news less than a week after their January 29th news, seen here, regarding their Phase III PPP001 clinical trial, they stated, "This is an especially significant and noteworthy milestone for the lead candidate in our product pipeline," said Bernard Fortier, Tetra's CEO, "as it positions Tetra to potentially be the first company with a Health Canada approved, cannabinoid-based drug on the market aimed at treating breakthrough pain in cancer patients. The advanced cancer pain market is a $2.4B market1; this is a significant and important opportunity for the Company as our drug PPP001 has the potential to help reduce the reliance on opioids for the management of severe pain." The company further stated it is considered by all to be a landmark study in the field, saying, "This trial is expected to be a landmark study, enrolling a total of 946 subjects, evaluating the therapeutic benefits of a cannabinoid prescription drug in improving quality of life and treating pain in terminal cancer patients." 

The Highest Quality Pharmaceutical-Grade Cannabis in Two Key Forms: Worldwide FirstsThey have the PPP001 dried cannabis from Aphria studied for cancer patients in Phase III clinical trials and PPP005 cannabis oil version , which is the same blend from Aphria, being studied in Phase II and Phase IV clinical trials for the overall $300 billion dollar chronic pain patients market in the USA alone. (If you add lost work production, the annual cost of chronic pain is estimated around $650 Billion annually in the USA.) So they have that patients market coverage by the same blend doing so in cannabis oil form while dried cannabis of the same blend enters its highly important Phase III for cancer patients. Again, both of those markets are covered by the same high-grade blend Tetra & Aphria developed together. These are also worldwide firsts, as no other Phase III study has every been conducted on medical cannabis. This weekend announcement on their Phase III clinical trial is the biggest announcement in that respect in the entire cannabis industry. The ramifications are truly enormous and the scope will be worldwide distribution of a product covered by insurance. For further information on that, refer to their related, recent news releases or contact the companies. 

Balancing Product Clinical Trials to Cover Areas of Greatest Patient Need:Since clinical trials need to be targeted very specifically, they used the two forms of their proprietary Tetra-Aphria blend to cover two top major diseases and conditons of patients, that is, terminally-ill cancer patients and chronic-pain sufferers. You have to like how they did that. And both forms are equally popular ways to ingest the medicine; so they have coverage with the same blend through its two most popular forms. Then they have the non-presription MMJ market covered with the same blend available in a non-prescription format known as Rx Princeps. In breaking news from their new roadmap just out, they are bringing out the Rx Princeps oil version in Q2 2018 (March-May), too. From their roadmap: "Q2 2018 Launch of Rx Oil capsules under ACMPR through Aphria." (They now have the Aprhia logo on the pipeline roadmap beside PPP001 and PPP005, which was before kept close to the vest, private. I think they are happy with how Rx Princeps dried cannabis is going and are making the decision to rollout the oil version. That's the only logical explanation of that. 

Other Key Delivery Methods, Products and Patient Needs: Tetra has four other targeted clinical trials with two other partners, dealing with dronabinol in a form that eliminates most of the side effects that patients report occurring. Dronabinol is a synthetic form of THC, once listed as a Schedule I drug, then a Schedule II drug, and then to Schedule III in 1999, after which in 2003 WHO reccomended moving it to Schedule IV, as it has been seen more and more as a safe, non-addictive, medically-beneficial drug for patients with chemo-induced nausea & vomiting and for chronic pain, and dronabinol shows no indications of patients script-hunting or doctor shopping as you find for addictive drugs like the prescribed opioids currently available. On the other hand, because a lot of patients don't like the current forms of Dronabinol for the side effects, Tetra's Dronabinol XL PPP002 and PPP003 are extended release forms that should eliminate or drastically lower the side effects that turn patients off to the other drug forms. It's a case of getting too much THC at one time, so by titrating the dosage in an extended release manner, with the extended release version by Tetra, the patient still gets the right daily dosage without overloading it at the front end, thereby eliminating the cause of the side effects. Though their four other pipeline products are not in the news this past week and month, it would be wise to consider them at this time, for context's sake. The other two are a treatment for ocular pain & in?ammation and a topical cream for treatment of neuropathic pain. And of course you have their line of natural health products, which we can discuss at another time. 

Conclusion:
Needless to say, there is a lot of good going on and they are moving into the revenue stage now with their Rx Princeps on sale through Aphria and through their Rx Princeps cannabis oil soon to launch in March to May timeframe preparing for legalization in Canada expected to happen July 2018. Each of those two are supported by clinical trial data, of the highest quality cannabis, developed with great care and attention to patient needs. This is all very good how they have laid this out with coverage over areas of great need. The company also has performed on its goals repeatedly and it would be wise to expect their sales program to perform well as they continue to, with their partners, do what they need to do to get the jobs done. I think Tetra has proven to Aphria and many investors that they can easily stand comparison to Cara Therapeutics or Insys Therapeutics, among others, and that they said they'd be first and they accomplished that multiple times now this last twelve months. Insys has no products in Clinical Testing, for example. And Cara is only studying synthetic compounds. Tetra is steeped in the natural forms of cannabis. People want natural. One's health is of top concern. I find this in line with the difference between synthetic opioids and natural cannabis use. The former is so destructive to the health, and the latter is so healing to the health. So the choice is all the easier. You can find Aphria on Canadian and US stock markets, and their partner Tetra Bio-Pharma is also a public company. Or you can invest in Tetra indirectly by purchasing Aphria shares.

Print the post  

Announcements

What was Your Dumbest Investment?
Share it with us -- and learn from others' stories of flubs.
When Life Gives You Lemons
We all have had hardships and made poor decisions. The important thing is how we respond and grow. Read the story of a Fool who started from nothing, and looks to gain everything.
Contact Us
Contact Customer Service and other Fool departments here.
Work for Fools?
Winner of the Washingtonian great places to work, and Glassdoor #1 Company to Work For 2015! Have access to all of TMF's online and email products for FREE, and be paid for your contributions to TMF! Click the link and start your Fool career.