- Lexaria Bioscience is a global innovator in drug delivery platforms whose lead technology, DehydraTECH, has been shown to increase the bioavailability of APIs
- The company recently announced that Catherine Turkel, PharmD, Ph.D., has joined its board of directors
- Dr. Turkel, who brings over 20 years’ experience, has previously formulated Food and Drug Administration (“FDA”) registration and commercial strategic plans, as well as led global development programs for pharmaceutical and biologic treatments
- Dr. Turkel will lend her drug registration experience and regulatory expertise to Lexaria at a time when the company is journeying toward regulatory approval for DehydraTECH-CBD, its drug candidate for the treatment of hypertension
- Lexaria recently had a pre-IND meeting with the FDA, where it received positive feedback
Companies should bring on board members with strategic growth experience who have “been there, done that,” a June 2022 article in Forbes advises (https://ibn.fm/59n6H). Strategic growth, the article observes, “is one of the most important areas of governance for boards. The more experience on a board, the more efficient you are at developing tried and tested growth strategies… Members with experience down certain paths can guide a company to anticipate and avoid known obstacles, helping to accomplish goals faster.”
As Lexaria Bioscience (NASDAQ: LEXX), a global innovator in drug delivery platforms, charts the long path toward regulatory approval for DehydraTECH(TM)-processed cannabidiol (“CBD”), a prospective treatment for hypertension, the importance of bringing on board members with prior drug registration experience as well as regulatory expertise is not lost on the company. Lexaria recently announced that Catherine Turkel, PharmD, Ph.D., has joined its board of directors (https://ibn.fm/bZbJP).
With more than 20 years’ experience, Dr. Turkel has worked as an executive in start-up and mid-size pharma/biotech companies. She founded and was the CEO of Nezee Therapeutics, served as the President and R&D head at Novus Therapeutics – which has been renamed Eledon Pharmaceuticals Inc. (NASDAQ: ELDN) – and currently serves as an independent Board Director at private company Object Pharma and non-profit Prostate Cancer Research. She is also a Dean Advisor at Chapman University School of Pharmacy.
Dr. Turkel has formulated Food and Drug Administration (“FDA”) registration and commercial strategic plans and spearheaded global development programs for pharmaceutical and biologic treatments from Phase 1 through Phase 4 across such therapeutic areas as otology, urology, aesthetics, ophthalmology, rare diseases, psychiatry, cardiovascular, neurosciences, and pain. At a previous stint working with Allergan – now a part of AbbVie (NYSE: ABBV) – Dr. Turkel designed and led the pharmaceutical company’s BOTOX(R) Chronic Migraine registration program, leading to revenue of over a billion dollars.
“Lexaria is delighted to welcome Dr. Turkel as we continue to position the company for advancement following our recent successful pre-IND (pre-investigational new drug) meeting with the FDA,” commented Lexaria Chair and CEO Chris Bunka. “Catherine’s practical development and regulatory expertise will be of increasing value to Lexaria, and we look forward to working with her.”
The onboarding of Dr. Turkel comes on the heels of a Pre-IND meeting regarding Lexaria’s DehydraTECH-CBD for the treatment of hypertension. Reporting that the meeting had yielded positive feedback from the FDA, the company’s August 10 announcement noted that the FDA had seconded its proposal to pursue an abbreviated regulatory pathway that would enable a faster route to commercial approval (https://ibn.fm/s6vqg). In addition, the FDA favorably received the company’s proposed Phase 1b clinical trial protocol that will involve ~100 patients with hypertension with the intention of opening the IND application to allow Lexaria to work toward full registration of its potential treatment.
“As a result of the favorable FDA response, Lexaria expects to remain on track to file its full IND application with the FDA by late 2022/ early 2023, as previously announced. This is up to 6-9 months sooner than if the FDA had required modifications in Lexaria’s current IND-enabling work plan, such as performance of additional non-clinical study work,” the August 10 news release reads.
Lexaria has shown, through human testing, that DehydraTECH-processed CBD delivers promising results with no serious adverse effects. In 2018, the company administered the substance to 12 participants in a human clinical study (“HCS”) that evidenced 317% more CBD delivered to the blood at 30 minutes than controls. Moreover, three HCSs conducted in 2021, HYPER-H21-1, HYPER-H21-2, and HYPER-H21-3, evidenced rapid and sustained drop in blood pressure, a 23% average drop in overnight blood pressure and reduced arterial stiffness, and attenuated pulmonary artery systolic pressure, respectively (https://ibn.fm/12iYb).
For more information, visit the company’s website at www.LexariaBioscience.com.
NOTE TO INVESTORS: The latest news and updates relating to LEXX are available in the company’s newsroom at https://ibn.fm/LEXX
About QualityStocks
QualityStocks is committed to connecting subscribers with companies that have huge potential to succeed in the short and long-term future. It is part of our mission statement to help the investment community discover emerging companies that offer excellent growth potential. We offer several ways for investors to learn more about investing in these companies as well as find and evaluate them.
QualityStocks (QS)
Scottsdale, Arizona
www.QualityStocks.com
480.374.1336 Office
Editor@QualityStocks.com
Please see full terms of use and disclaimers on the QualityStocks website applicable to all content provided by QS, wherever published or re-republished: http://www.qualitystocks.net/disclaimer.php
No comments:
Post a Comment