OTTAWA, Dec. 20, 2018 (GLOBE NEWSWIRE) -- Tetra Bio-PharmaInc. (“Tetra” or “TBP”) today announced that its Phase 1 clinical trial in healthy volunteers using vaporized PPP001 has been successfully concluded. This trial was aimed at determining the pharmacokinetics (PK) and safety of a 4-day titration followed by a single dose of vaporized PPP001 in 12 healthy volunteers. Preliminary review of the human clinical data indicates that the treatment was well tolerated. Based on these positive results, Tetra Bio-Pharma expects to move into Phase 2 clinical trials in fibromyalgia patients.
Tetra Bio-Pharma also completed a first series of analyses of the cannabis vapor generated by the Mighty Medic vaporizer manufactured by Storz & Bickel, thus providing a deeper understanding of the process of administering cannabinoids to patients. This gives health regulators like Health Canada, a detailed view of the efficiency of the delivery system.
“We are thrilled with the results of this trial which was completed both on time and on budget,” stated Dr. Guy Chamberland, CEO and CSO of Tetra Bio-Pharma. “We look forward to investigating this vaped version of PPP001 in patients who suffer from the debilitating pain of fibromyalgia. The Mighty Medic technology provides an alternative delivery method for PPP001, along with a new therapeutic indication for fibromyalgia which will give us access to a much larger patient population. According to the National Fibromyalgia Association there are more than 10 million people who suffer from this disease in the U.S. alone.”
About Tetra Bio-Pharma Tetra Bio-Pharma (TSX-V: TBP) (OTCQB: TBPMF) is a biopharmaceutical leader in cannabinoid-based drug discovery and development with a Health Canada approved, and FDA reviewed, clinical program aimed at bringing novel prescription drugs and treatments to patients and their healthcare providers. The Company has several subsidiaries engaged in the development of an advanced and growing pipeline of Bio Pharmaceuticals, Natural Health and Veterinary Products containing cannabis and other medicinal plant-based elements. With patients at the core of what we do, Tetra Bio-Pharma is focused on providing rigorous scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators, physicians and insurance companies.
For more information visit: www.tetrabiopharma.com
My pesonal research on Dec. 11th lead me to Purdue as well as mentioned in the post below. However, one of the point which catched my attention is the fact that Purdue is ONE OF THE MOST IMPORTANT private company appointed by the TRUMP COMMISSION ON OPIOID CRISIS. This is a MAJOR door opening for Tetra in the "NEW POST OPIOID ERA" if everything goes well for their # DIN. I imagine Purdue CAN'T sell Tetra product considering potential interest conflict, Rhodes can! Times will tell. For now this is a strategic move that FEW OTHER TETRA COMPETITORS HAVEN'T SEEN IN THE REARVIEW MIRROR !!!
These are some points mentioned on their factsheet. -Investing in research to develop non-opioid pain medications.
-Delivering the US Surgeon General’s TurnTheTideRx materials, which review considerations when prescribing opioids for chronic pain, to healthcare professionals.
-Sharing the Centers for Disease Control and Prevention (CDC) Guideline for Prescribing Opioids for Chronic Pain with thousands of prescribers and pharmacists.
-Supporting the National Sheriffs’ Association (NSA) with a grant to provide front-line officers with the rescue drug naloxone.
-Working with the National Institutes of Health (NIH) as part of President Trump’s Opioid Commission on a public-private partnership focused on the development of non-addictive pain medications, innovative addition deterrent formulas and treatments for overdose.
Tetra is known to have established a partnership with the American company Rhodes Technologies, a subsidiary of Purdue Pharmaceuticals. Be aware that this ad is HUGE.
Who is Purdue Pharma? It is an unlisted family business. She defines herself as a pioneer in the development of drugs to reduce pain, one of the main causes of human suffering. Purdue Pharma designs painkillers such as codeine, oxycodone, fentanyl, and hydrocodone. On their site, OxyContin is presented as an analgesic reserved for cases of severe pain, especially of cancerous origin. It has generated $ 35 billion in sales since 1995 solely through its star painkiller, OxyContin. Tie yourself the PPP001 arrives.
In 1995, the laboratory launched OxyContin, a powerful drug based on pure oxycodone, a cousin of heroin. It is not the first painkiller, but the use was previously reserved for the treatment of severe pain associated with diseases such as cancer. OxyContin has become a drug with huge commercial success.
In 2007, Purdue paid one of the heaviest fines ever levied against a pharmaceutical company for labeling and misleading its OxyContin product, with three leaders found to be criminally culpable. Although the company has changed the labeling by warning against the abuse of its products, Purdue continues to market, sell opioids and be involved in the trials around the opioid crisis. Its product oxycodone is considered the main culprit of this crisis.
For years, Purdue, who has been sued dozens of times, has defended himself arguing that their product was not in question but rather the use. It is necessary to crush the drug to turn it into a hard drug that can be sniffed or injected. But the packaging of OxyContin could serve as a user's guide: there was a warning that reducing the powdered medicine made it "potentially" toxic.
The responsibility of these large groups in the opioid crisis, which causes 145 deaths by overdose each day in the United States according to the authorities, is regularly pointed out. The complaint concerns a dozen laboratories, but one of them occupies a special place in the eyes of specialists in this epidemic: Purdue Pharma.
What does Tetra do with this company, moreover, is in the same niche as Purdue, "severe pain"? Tetra has made major advances both for its PPP001 drug and to strategically position itself on D-Day all over the world. If he succeeds in having his star drug approved by Health Canada and the FDA, we will see the birth of a new company in this world of big pharma.
By partnering with Purdue, through her subsidiary Rhodes, Purdue seeks to repair the damage, improve her image, she is still responsible for several deaths a day. Tetra would be a good solution because we know that cannabis can never cause death even if it is abused. A Purdue / Tetra partnership would make society look good for sure, not all companies want to be viewed negatively. They also do not want to lose money because if PPP001 ever replaces opioids, many companies will be losing revenue, which is why the alternative for Purdue is Tetra.
Purdue, through its subsidiary Rhodes, has partnered with Tetra Bio-Pharma for PPP 002/003/004. The press release does not indicate PPP001. But could Purdue keep it for itself? If everything works well for Tetra and its PPP001 and we have a real association with Purdue, we will have there, a major breakthrough in the United States, then around the world. I may dream, but this vision that I have, seems really plausible. The beauty and the beast, united, that's not what the story tells !!!
I'm not worried about SP anymore until the DIN is approved and issued. I think this is what all the big investors are waiting for at this point. Plus it seems like big companies are more focused on recreational MJ like Constellation and Altria. If the SP dives after a DIN, then I don't know what would need to be done by this Company.
Let's not forget that TBP is still a relatively small company with no revenue YET (will soon), and maybe we lose sight of that because of the significant progress we're making (ie: Meetings with Congress, Hemp drink deal, etc.). Like I said in the past, if anyone isn't holding until at least 2021, then you're wasting your time and might as well get out now and put it in Canopy or something.
I like the fact that other companies are doing trials because it tells the story of the future in Pharma and if you are first to market or have the most offerings then all that follow will be graded against your pipeline,that being said I think we are in that pole position. The OTC line aswell as the drink and NHP line will see revenue on many fronts and show Tetra to be a diversified company and if it remains whole will be worth many billions in the future and then theres the possibility of selling off a division or two to expand the real gravy train which will be the division holding the PPP001 thru PPP005 line. A GW type market cap is closer then you think and although we have 5 times the amount of shares as GW we will have 10 times the revenue ,then theres Tilray ,look at the action that took it to $300.00 a share ,that type of feeding frenzy could very well touch our Tetra in 2020-2021.That $300.00 was US dollars. Lets get thru Dec and enjoy all that 2019 offers.