Formulation – MJ Shareholders https://mjshareholders.com The Ultimate Marijuana Business Directory Tue, 25 May 2021 14:38:12 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.5 Tryp Therapeutics Partners with Alcami for Proprietary Formulations https://mjshareholders.com/tryp-therapeutics-partners-with-alcami-for-proprietary-formulations/ Tue, 25 May 2021 14:38:12 +0000 https://www.cannabisfn.com/?p=2920564

Ryan Allway

May 25th, 2021

Psychedelics


San Diego, California–(Newsfile Corp. – May 25, 2021) – Tryp Therapeutics (CSE: TRYP) (OTCQB: TRYPF) (FSE: 8FW) (“Tryp”), a pharmaceutical company focused on developing compounds for diseases with unmet medical needs through accelerated regulatory pathways, announced today an agreement with Alcami Corporation (“Alcami”), a global pharmaceutical contract development and manufacturing organization (CDMO), to support the proprietary formulation of products for Tryp’s Psilocybin-for-Neuropsychiatric Disorders (PFNTM) program. Tryp’s collaboration with Alcami will initially focus on developing oral formulations for Tryp’s proprietary psilocybin Active Pharmaceutical Ingredient (“API”) being manufactured by Albany Molecular Research, Inc. (“AMRI”). “The support we have been engaged to provide is a testament to our broad capabilities, technical expertise, and ability to collaborate with customers to consistently deliver high quality results,” commented Pat Walsh, Chairman & Chief Executive Officer of Alcami. “We are proud to support Tryp and their transformational work in a variety of indications.”

Tryp expects to manufacture its initial batch of cGMP psilocybin API in September 2021. Alcami and Tryp will then develop the analytical methods and the final formulation of Tryp’s oral psilocybin product. “Our partnership with Alcami signals the further advancement of our proprietary manufacturing of synthetic psilocybin,” commented Jim Gilligan, Ph.D., President and Chief Science Officer of Tryp. “We have been impressed with Alcami’s expertise with developing both final formulations as well as the analytical methods that will ensure the consistently excellent quality of our products.”

About Tryp Therapeutics

Tryp Therapeutics is a pharmaceutical company focused on developing clinical-stage compounds for the treatment diseases with unmet medical needs through accelerated regulatory pathways. Tryp’s Psilocybin-For-Neuropsychiatric Disorders, or PFN™, program is focused on the development of synthetic psilocybin as a new class of drug for the treatment of certain neuropsychiatric-based disorders. Tryp’s lead PFN™ drug candidate is TRP-8802 for the treatment of fibromyalgia, a chronic pain syndrome estimated to affect more than 5 million people in the United States. The Company is also preparing to initiate a Phase 2a clinical study for eating disorders in partnership with Dr. Jennifer Miller at the University of Florida.

For inquiries, please contact us at:
E: [email protected]
W: www.tryptherapeutics.com

About Alcami

Alcami is a contract development and manufacturing organization headquartered in North Carolina with over 40 years of experience advancing products through every stage of the development lifecycle. Leveraging four US-based scientific campuses, Alcami serves biologics and pharmaceutical companies of all sizes providing customizable and innovative solutions for analytical development, clinical to commercial sterile and oral solid manufacturing, packaging, microbiology, and environmental monitoring services. Alcami’s private equity ownership includes Madison Dearborn Partners and Ampersand Capital Partners. For more information, please visit alcaminow.com.

Forward-Looking Information

Certain information in this news release, including statements relating to the anticipated closing date of the Placement, constitutes forward-looking information. In some cases, but not necessarily in all cases, forward-looking information can be identified by the use of forward-looking terminology such as “plans”, “targets”, “expects” or “does not expect”, “is expected”, “an opportunity exists”, “is positioned”, “estimates”, “intends”, “assumes”, “anticipates” or “does not anticipate” or “believes”, or variations of such words and phrases or state that certain actions, events or results “may”, “could”, “would”, “might”, “will” or “will be taken”, “occur” or “be achieved”. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances contain forward-looking information. Statements containing forward-looking information are not historical facts but instead represent management’s expectations, estimates and projections regarding future events.

Forward-looking information is necessarily based on a number of opinions, assumptions and estimates that, while considered reasonable by Tryp as of the date of this news release, are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking information, including but not limited to the factors described in greater detail in the “Risk Factors” section of Tryp’s final prospectus available at www.sedar.com. These factors are not intended to represent a complete list of the factors that could affect Tryp; however, these factors should be considered carefully. There can be no assurance that such estimates and assumptions will prove to be correct. The forward-looking statements contained in this news release are made as of the date of this news release, and Tryp expressly disclaims any obligation to update or alter statements containing any forward-looking information, or the factors or assumptions underlying them, whether as a result of new information, future events or otherwise, except as required by law.

NEITHER THE CANADIAN SECURITIES EXCHANGE NOR ITS REGULATION SERVICES PROVIDER HAS REVIEWED OR ACCEPTED RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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Lexaria’s Newest DehydraTECH(TM) 2.0 Formulation Tested in Study HYPER-A21-2 Demonstrates Its Strongest CBD Absorption Results Ever https://mjshareholders.com/lexarias-newest-dehydratechtm-2-0-formulation-tested-in-study-hyper-a21-2-demonstrates-its-strongest-cbd-absorption-results-ever/ Thu, 20 May 2021 19:43:56 +0000 https://www.cannabisfn.com/?p=2920514

Ryan Allway

May 20th, 2021


  • New formulation delivers up to 2,708% more CBD into bloodstream*
  • Human clinical hypertension study HYPER-H21-1 also progressing

KELOWNA, BC / ACCESSWIRE / May 20, 2021 / Lexaria Bioscience Corp. (NASDAQ:LEXX) (NASDAQ:LEXXW) (CSE:LXX) (the “Company” or “Lexaria”), a global innovator in drug delivery platforms, is pleased to announce successful test results of two new “DehydraTECH™ 2.0″ cannabidiol (“CBD”) formulations in its second 2021 applied research and development study program, HYPER-A21-2.

“One of our latest DehydraTECH 2.0 formulations gave us the strongest absorption enhancement results we’ve ever recorded, at 2,708% more CBD into bloodstream during the study period than the representative industry standard MCT control formulation. It was also 174% more effective than the original DehydraTECH 2.0 formulation from 2019,” said Chris Bunka, CEO of Lexaria. “This is a 27-fold improvement in CBD delivery compared to the control formulation.”

Study HYPER-A21-2 included three additional new DehydraTECH 2.0 formulation variations designed to enhance CBD delivery performance and pharmacokinetic optimization. Two of the three new DehydraTECH 2.0 formulations delivered improved performance when compared to both Lexaria’s original DehdyraTECH 1.0 and 2019 DehydraTECH 2.0 concentration-matched formulations, as well as to a medium chain triglyceride (“MCT”) oil based control formulation representative of standard industry practices. The final formulation provided useful data but did not deliver enhanced performance compared to the original DehydraTECH 2.0. Summary data is shown below:

Formulation

AUClast (1) (hr∙kg∙ng /mL/mg)

% Improvement over MCT Formulation

(p value)

% Improvement over original DehydraTECH 1.0

(p value)

% Improvement over original DehydraTECH 2.0

(p value)

MCT Control (2)

13.17 ± 6.78

Original (2) DehydraTECH 1.0

64.6 ± 23.7

390%

(p=0.00002)

Original (3) DehydraTECH 2.0

134.7 ± 63.7

923%

(p=0.00009)

108%

(p=0.0036)

**NEW** DehydraTECH 2.0 Formulation 5 (4)

187 ± 95

1,322%

(p=0.0001)

190%

(p=0.001)

39%

(p=0.08)

**NEW** DehydraTECH 2.0 Formulation 6 (4)

370 ± 172

2,708%

(p=0.00005)

472%

(p=0.0001)

174%

(p=0.0008)

  1. AUC: Area Under the Curve, or total CBD delivery into the rodent bloodstream
  2. 60-minute study duration
  3. 60-minute study duration evaluated in 2019
  4. 120-minute study duration evaluated in 2021

Lexaria continues to build a robust body of evidence demonstrating that its patented DehydraTECH technology can significantly enhance the delivery of lipophilic active ingredients such as CBD across a range of uptake levels, with ultimate applications to wide ranging areas including consumer packaged goods as well as drugs with potential for disease treatment applications.

In each arm of the study, ten male Sprague-Dawley rats were dosed orally at a level of 25 mg/Kg CBD, and over the next 120 minutes multiple measurements were taken to assess delivery into the bloodstream and tissues comparing the DehydraTECH formulations to certain controls. There were a total of 120 animals for the new DehydraTECH 2.0 formulations evaluated in studies HYPER-A21-1 and HYPER-A21-2. Both studies HYPER-A21-1 and HYPER-A21-2 were conducted by an independent, premier animal testing laboratory located in the United States.

Lexaria also confirms that its HYPER-H21-1 human clinical hypertension study is currently underway and dosing is nearly complete, utilizing a formulation most closely resembling the original 2019 DehydraTECH 2.0. Along with a more than a 3-fold increase in dose quantity, these formulation improvements are expected to be more effective than the original DehydraTECH 1.0 formulation used in Lexaria’s foundational 2018 human clinical study that nonetheless evidenced significant blood pressure reduction, as published and available at PubMed. Lexaria thus expects improved pharmacokinetic performance in its current human clinical study to translate into further improved pharmacodynamic performance. Lexaria will provide details on the outcomes of study HYPER-H21-1 when they become available.

* Compared with control formula utilizing medium chain triglycerides (coconut oil) representative of standard industry practices

About Lexaria Bioscience Corp.
Lexaria Bioscience Corp.’s proprietary drug delivery technology, DehydraTECH™, improves the way active pharmaceutical ingredients (APIs) enter the bloodstream by promoting healthier oral ingestion methods and increasing the effectiveness of fat-soluble active molecules, thereby lowering overall dosing. The Company’s technology can be applied to many different ingestible product formats, including foods, beverages, oral suspensions, tablets, and capsules. DehydraTECH has repeatedly demonstrated since 2016 with cannabinoids and nicotine the ability to increase bio-absorption by up to 5-10x, reduce time of onset from 1 – 2 hours to minutes, and mask unwanted tastes; and is planned to be further evaluated for orally administered bioactive molecules, including anti-virals, cannabinoids, vitamins, non-steroidal anti-inflammatory drugs (NSAIDs), and nicotine. Lexaria has licensed DehydraTECH to multiple companies including a world-leading tobacco producer for the development of smokeless, oral-based nicotine products and for use in industries that produce cannabinoid beverages, edibles, and oral products. Lexaria operates a licensed in-house research laboratory and holds a robust intellectual property portfolio with 19 patents granted and approximately 60 patents pending worldwide. For more information, please visit www.lexariabioscience.com.

CAUTION REGARDING FORWARD-LOOKING STATEMENTS
This press release includes forward-looking statements. Statements as such term is defined under applicable securities laws. These statements may be identified by words such as “anticipate,” “if,” “believe,” “plan,” “estimate,” “expect,” “intend,” “may,” “could,” “should,” “will,” and other similar expressions. Such forward-looking statements in this press release include, but are not limited to, statements by the company relating the Company’s ability to carry out research initiatives, receive regulatory approvals or grants or experience positive effects or results from any research or study. Such forward-looking statements are estimates reflecting the Company’s best judgment based upon current information and involve a number of risks and uncertainties, and there can be no assurance that the Company will actually achieve the plans, intentions, or expectations disclosed in these forward-looking statements. As such, you should not place undue reliance on these forward-looking statements. Factors which could cause actual results to differ materially from those estimated by the Company include, but are not limited to, government regulation and regulatory approvals, managing and maintaining growth, the effect of adverse publicity, litigation, competition, scientific discovery, the patent application and approval process, potential adverse effects arising from the testing or use of products utilizing the DehydraTECH technology, the Company’s ability to maintain existing collaborations and realize the benefits thereof, delays or cancellations of planned R&D that could occur related to pandemics or for other reasons, and other factors which may be identified from time to time in the Company’s public announcements and periodic filings with the US Securities and Exchange Commission on EDGAR. There is no assurance that any of Lexaria’s postulated uses, benefits, or advantages for the patented and patent-pending technology will in fact be realized in any manner or in any part. No statement herein has been evaluated by the Food and Drug Administration (FDA). Lexaria-associated products are not intended to diagnose, treat, cure or prevent any disease. Any forward-looking statements contained in this release speak only as of the date hereof, and the Company expressly disclaims any obligation to update any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise, except as otherwise required by law.

The CSE has not reviewed and does not accept responsibility for the adequacy or accuracy of this release.

INVESTOR CONTACT:

Phone: 866-221-3341

This article was published by CFN Enterprises Inc. (OTCQB: CNFN), owner and operator of CFN Media, the industry’s leading agency and digital financial media network dedicated to the burgeoning CBD and legal cannabis industries. Call +1 (833) 420-CNFN for more information.

About Ryan Allway

Mr. Allway has over a decade of experience in the financial markets as both a private investor and financial journalist. He has been actively involved in the cannabis industry since its inception, covering public and private companies.


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