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ZYUS Announces Database Lock for its Phase 1 First-in-Human Clinical Trial

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Phase 1 was conducted to assess the safety, tolerability, and pharmacokinetics of ZYUS’ lead drug product candidate in healthy adult participants

SASKATOON, Saskatchewan–(BUSINESS WIRE)–ZYUS Life Sciences Inc. (“ZYUS” or the “Company”), a Canadian-based life sciences company leading scientific research and global development of innovative cannabinoid-based pharmaceutical drug products, today announced the successful completion of database lock for its Phase 1 clinical trial to assess the safety, tolerability, and pharmacokinetics of Trichomylin® softgel capsules in healthy adult participants in Australia. The dataset has been transferred to the Company’s independent Clinical Research Organization for statistical analysis. Reaching a database lock also allows ZYUS to begin preparation for its Phase 2a clinical trial, expected to commence in 2023.

This achievement marks an important milestone in ZYUS’ mission, to develop cannabinoid-based pharmaceutical drug products with meticulous scientific rigor,” said ZYUS CEO Brent Zettl. “We continue to pursue our clinical studies in osteoarthritic pain as previously announced. We believe the results of this Phase 1 clinical trial will bring us another step closer to providing patients with a regulatory-approved cannabinoid-based prescription drug for the alleviation of chronic pain.”

About ZYUS Life Sciences Inc.: ZYUS is a Canadian-based life sciences company focused on the global development and commercialization of cannabinoid-based pharmaceutical drug product candidates and innovative exempt market therapeutics. Through clinical research, ZYUS is committed to furthering the understanding of cannabinoids with the clinical development of its pharmaceutical drug product candidates and intellectual property activities to protect its novel formulations. Additionally, ZYUS is dedicated to delivering high quality, cGMP / EU GMP-compliant cannabinoid products to patients through the exempt global medical market. The ZYUS vision is to elevate cannabinoid-based therapeutics as a standard of care and expand the potential of protein-based formulations in pursuit of a transformational impact on patients’ lives around the world. ZYUS: Advancing the Science of Well-Being. For additional information, visit www.zyus.com.

Forward-Looking Information:

This news release contains forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of ZYUS to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These forward-looking statements include, but are not limited to, expectations with respect to our business plans, product lines, research activities (including without limitation, the clinical progress of Trichomylin®, the availability of clinical trial results) and the prospects for regulatory approval, commercializing or selling any product or drug candidates.

Often, but not always, forward-looking statements can be identified by the use of words such as “expects,” “expected,” “expectation,” “anticipates,” “believes,” “intends,” “estimates,” “predicts,” “continues,” “potential,” “targeted,” “plans,” “possible” and similar expressions, or statements that events, conditions or results “will,” “may,” “could,” “would” or “should” occur or be achieved, or the negative of these terms or other comparable terminology. Forward-looking statements are based on certain assumptions including assumptions relating to the ability of ZYUS to continue to ensure product availability, consistency and quality through robust procurement, manufacturing and testing processes, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified , including risks related to: potential impacts due to the COVID-19; the reliability of the results of studies relating to human safety and possible adverse effects resulting from the administration of the Company’s product candidates; the Company’s ability to secure regulatory approval of its product candidates, and the success of future product advancements, including the success of future clinical trials. Consequently, actual results may differ materially from those expressed or implied by such forward-looking statements and readers should not place undue reliance on the forward-looking statements and information contained in this press release.

Readers are cautioned that the foregoing list of factors is not exhaustive. The forward-looking statements contained in this news release are made as of the date of this release and, accordingly, are subject to change after such date. ZYUS does not assume any obligation to update or revise any forward-looking statements or information, whether written or oral, that may be made from time to time by us or on our behalf, except as required by applicable law.

Contacts

ZYUS Media Inquiries

media@zyus.com
1-833-651-7723

ZYUS Investor Relations

Bruce M. Mann

investors@zyus.com
1-888-651-9987

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WeighPack Introduces High Precision Check Weigher for Tightest Tolerances

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LAS VEGAS–(BUSINESS WIRE)–#automation–WeighPack Systems’ WeightCheQ 0-250 features high precision electromagnetic force restoration (EMFR) weigh cell technology to achieve the highest tolerances possible while reading in three decimal points.


The WeightCheQ 0-250 is engineered with a weight range of 0 – 250 grams and will weigh product accurately and consistently to +/- 0.01 gram. This tight tolerance level makes it the perfect choice for check weighing pharmaceuticals, cosmetics, precious metals, cannabis pre-rolls and more.

This high-performance weigher will automatically reject product that is outside of the user’s set tolerance level and deposit it into a convenient accumulation drawer for reuse. An easy-to-read visual operation interface notifies the user when product is within the targeted weight by illuminating a green light and then changing to a red light when the target weight is out of tolerance.

The 0-250 includes a large color touchscreen, does not require compressed air and easily integrates into existing packaging lines for an immediate improvement in any quality assurance process.

This compact, modular check weigher also features heavy-duty stainless steel frame construction, food-grade belts, upstream and downstream data links, 20-recipe storage and does not require changeover parts to move between product lines.

See video of this system in action at www.weighpack.com/primary-packaging-video-library/.

For product inquiries, visit www.weighpack.com/weighpack-sales-inquiries/.

Paxiom is the national sales, system integration and service provider for the state-of-the-art packaging machine technology manufactured by WeighPack, ValTara and EndFlex. From weighing, filling, bagging and wrapping to cartoning, tray forming, case packing and palletizing, Paxiom has delivered over 7,000 packaging solutions to over 30 countries. Customers can see these solutions in person by visiting an Xperience Center in Las Vegas, Miami, Milwaukee, Montreal, Toronto or Schio, Italy.

Contacts

David Morgan, Director of Marketing, dmorgan@weighpack.com, 702-450-0808 x625

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IGC Commences Phase 2 Clinical Trials Evaluating Drug Candidate IGC-AD1 for the Treatment of Agitation in Dementia From Alzheimer’s Disease

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Company To Host Conference Call on Friday, December 2 at 11 a.m. ET

POTOMAC, Md.–(BUSINESS WIRE)–#IGC–India Globalization Capital, Inc. (NYSE American: IGC) (“IGC” or the “Company”), announced that it has begun “A Phase 2, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Trial of the Safety and Efficacy of IGC-AD1 on Agitation in Participants with Dementia due to Alzheimer’s Disease”.

The Company has commenced the Phase 2 study at two U.S. sites with plans to add between three to five additional sites in the United States, Canada, and possibly South America to increase population diversity, promoting both the inclusion of underrepresented populations and helping the Company to better understand the impact of IGC-AD1 on the population of the Americas. The trial will enroll 146 patients with one half, the treated group, receiving IGC-AD1, and the other half, the control group, receiving a placebo. The goal of the trial is to evaluate and establish the efficacy of IGC-AD1 in helping patients with Alzheimer’s dementia reduce neuropsychiatric symptoms (“NPS”) such as agitation, which affects 76% of individuals with Alzheimer’s (Mussele et al., 2015). Currently, there is no Food and Drug Administration (“FDA”) approved drug for treating agitation in dementia related to Alzheimer’s (Jones et al., 2021).

“We believe that IGC-AD1 has the potential to revolutionize the treatment of Alzheimer’s Disease as the first and only low-dose natural THC-based formulation candidate currently undergoing FDA trials,” commented Ram Mukunda, CEO of IGC. “Approximately 8 million people are affected by Alzheimer’s in North America and over 55 million worldwide. We believe the diverse population we have selected for this study will allow us to accurately look at both the impact of variations of the gene CYP2C9 that metabolizes THC, as well as APOE e4 a gene that increases the risk of developing Alzheimer’s. This data will help us to further understand the metabolism of IGC-AD1 for a diverse population, which is important in treating a disease that has a global impact like Alzheimer’s. Through these and further trials, we look forward to establishing IGC-AD1’s efficacy in treating the symptoms related to Alzheimer’s Disease.”

IGC-AD1 relies on low-doses of THC, a psychoactive cannabinoid, and another compound as active agents in trials for Alzheimer’s. The formulation has recently completed Phase 1 of clinical trials required by the FDA and demonstrated in Alzheimer’s cell lines the potential to be effective in suppressing or ameliorating a key protein that is responsible for Aβ plaques; a key hallmark of the disease.

For further information, please visit https://clinicaltrials.gov/ct2/results?cond=&term=IGC-AD1&cntry=&state=&city=&dist=

Conference Call Details

Management will host a conference call and webcast with an accompanying slide presentation on Friday, December 2, 2022, at 11:00 a.m. ET.

Interested investors may participate via the webcast using the following link: https://www.webcaster4.com/Webcast/Page/2938/47255

To participate via conference call, please use the following dial-in numbers and use access code 638516 when prompted by the operator.

  • (888) 506-0062 (Domestic)
  • (973) 528-0011 (International)

A replay of the call will also be available at the above link.

About IGC

India Globalization Capital Inc. develops advanced cannabinoid-based formulations for treating diseases, including but not limited to Alzheimer’s disease, Parkinson’s disease, chronic pain, and pet seizures. The Company’s leading drug candidate, IGC-AD1, has demonstrated, in Alzheimer’s cell lines, the potential to be effective in suppressing or ameliorating a key protein responsible for Aβ plaques and has recently entered Phase 2 clinical trials for agitation in dementia from Alzheimer’s. The Company also has lines of various CBD-based consumer products such as Holief, which includes gummies and pain relief creams for women experiencing premenstrual syndrome (“PMS”) and dysmenorrhea (“period cramps”), and Sunday Seltzer, which includes a CBD-infused energy beverage – all currently available for purchase. The Company operates facilities in the US under GMP certification (Good Manufacturing Practices). The Company also operates an Infrastructure business based in India. The Company is headquartered in Maryland, U.S.A.

Forward-looking Statements

This press release contains forward-looking statements. These forward-looking statements are based largely on IGC’s expectations and are subject to several risks and uncertainties, certain of which are beyond IGC’s control. Actual results could differ materially from these forward-looking statements as a result of, among other factors, the Company’s failure or inability to commercialize one or more of the Company’s products or technologies, including the products or formulations described in this release, or failure to obtain regulatory approval for the products or formulations, where required; general economic conditions that are less favourable than expected, including as a result of the ongoing COVID-19 pandemic; the FDA’s general position regarding cannabis- and hemp-based products; and other factors, many of which are discussed in IGC’s U.S. Securities and Exchange Commission (“SEC”) filings. IGC incorporates by reference the human trial disclosures and Risk Factors identified in its Annual Report on Form 10-K filed with the SEC on June 23, 2022, as if fully incorporated and restated herein. In light of these risks and uncertainties, there can be no assurance that the forward-looking information contained in this release will occur.

Contacts

IMS Investor Relations

Walter Frank

igc@imsinvestorrelations.com
(203) 972-9200

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Marshall Farrer, President, Europe, Expands Leadership Role and Adds Chief Strategic Growth Officer Responsibilities

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LOUISVILLE, Ky.–(BUSINESS WIRE)–Brown-Forman Corporation (NYSE:BFA,BFB) announced today that Marshall Farrer, President, Europe, will expand his leadership responsibilities and be named Executive Vice President, Chief Strategic Growth Officer, effective January 1, 2023.


In addition to stewarding Brown-Forman’s European business, Farrer, in his new role as Chief Strategic Growth Officer, will work closely with Lawson Whiting, President and CEO, and the entire Brown-Forman Executive Leadership Team, on developing key partnerships and new growth opportunities to achieve the company’s short-term objectives and long-term ambitions.

“Marshall’s understanding of our consumers, the spirits industry, and the global market trends will help unlock new pathways to growth for Brown-Forman,” said Whiting. “His expertise at advancing strategic initiatives, opportunities, and relationships, coupled with 24 years of global spirits knowledge, make Marshall the ideal person to not only lead our European business, but also take on this important corporate development work.”

Farrer has served on the Executive Leadership Team since 2020. In his role as President, Europe, he leads Brown-Forman’s operations in the owned distribution markets of the United Kingdom, Germany, France, Poland, Spain, Czechia, Belgium, and Luxembourg as well as the remaining developed markets in Europe utilizing partners for distribution. He is also a member of the Brown-Forman Board of Directors, joining in 2016, and a fifth-generation Brown family shareholder.

Farrer is based in Amsterdam, Netherlands. He serves as an executive sponsor for SEED, Brown-Forman’s first employee resource group established outside of the United States, which endeavors to challenge stereotypes as well as inspire, empower, and educate employees about the unique experiences of different racial groups and ethnicities.

About Brown-Forman:

For more than 150 years, Brown-Forman Corporation has enriched the experience of life by responsibly building fine quality beverage alcohol brands, including Jack Daniel’s Tennessee Whiskey, Jack Daniel’s Tennessee RTDs, Jack Daniel’s Tennessee Honey, Jack Daniel’s Tennessee Fire, Jack Daniel’s Tennessee Apple, Gentleman Jack, Jack Daniel’s Single Barrel, Woodford Reserve, Old Forester, Coopers’ Craft, The GlenDronach, Benriach, Glenglassaugh, Slane, Herradura, el Jimador, New Mix, Korbel, Sonoma-Cutrer, Finlandia, Chambord, Fords Gin, and Gin Mare. Brown-Forman’s brands are supported by approximately 5,200 employees globally and sold in more than 170 countries worldwide. For more information about the company, please visit brown-forman.com. Follow us on LinkedIn, Instagram, and Twitter.

Important Information on Forward-Looking Statements:

This press release contains statements, estimates, and projections that are “forward-looking statements” as defined under U.S. federal securities laws, including statements regarding executive responsibilities and strategic actions. Words such as “aim,” “anticipate,” “aspire,” “believe,” “can,” “continue,” “could,” “envision,” “estimate,” “expect,” “expectation,” “intend,” “may,” “might,” “plan,” “potential,” “project,” “pursue,” “see,” “seek,” “should,” “will,” “would,” and similar words indicate forward-looking statements, which speak only as of the date we make them. Except as required by law, we do not intend to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise. By their nature, forward-looking statements involve risks, uncertainties, and other factors (many beyond our control) that could cause our actual results to differ materially from our historical experience or from our current expectations or projections.

These risks and uncertainties include, but are not limited to:

  • Our substantial dependence upon the continued growth of the Jack Daniel’s family of brands
  • Substantial competition from new entrants, consolidations by competitors and retailers, and other competitive activities, such as pricing actions (including price reductions, promotions, discounting, couponing, or free goods), marketing, category expansion, product introductions, or entry or expansion in our geographic markets or distribution networks
  • Route-to-consumer changes that affect the timing of our sales, temporarily disrupt the marketing or sale of our products, or result in higher fixed costs
  • Disruption of our distribution network or inventory fluctuations in our products by distributors, wholesalers, or retailers
  • Changes in consumer preferences, consumption, or purchase patterns – particularly away from larger producers in favor of small distilleries or local producers, or away from brown spirits, our premium products, or spirits generally, and our ability to anticipate or react to them; further legalization of marijuana; shifts in consumer purchase practices; bar, restaurant, travel, or other on-premise declines; shifts in demographic or health and wellness trends; or unfavorable consumer reaction to new products, line extensions, package changes, product reformulations, or other product innovation
  • Production facility, aging warehouse, or supply chain disruption
  • Imprecision in supply/demand forecasting
  • Higher costs, lower quality, or unavailability of energy, water, raw materials, product ingredients, or labor
  • Impact of health epidemics and pandemics, including the COVID-19 pandemic, and the risk of the resulting negative economic impacts and related governmental actions
  • Unfavorable global or regional economic conditions, particularly related to the COVID-19 pandemic, and related economic slowdowns or recessions, low consumer confidence, high unemployment, weak credit or capital markets, budget deficits, burdensome government debt, austerity measures, higher interest rates, higher taxes, political instability, higher inflation, deflation, lower returns on pension assets, or lower discount rates for pension obligations
  • Product recalls or other product liability claims, product tampering, contamination, or quality issues
  • Negative publicity related to our company, products, brands, marketing, executive leadership, employees, Board of Directors, family stockholders, operations, business performance, or prospects
  • Failure to attract or retain key executive or employee talent
  • Risks associated with acquisitions, dispositions, business partnerships, or investments – such as acquisition integration, termination difficulties or costs, or impairment in recorded value
  • Risks associated with being a U.S.-based company with a global business, including commercial, political, and financial risks; local labor policies and conditions; protectionist trade policies, or economic or trade sanctions, including additional retaliatory tariffs on American whiskeys and the effectiveness of our actions to mitigate the negative impact on our margins, sales, and distributors; compliance with local trade practices and other regulations; terrorism; and health pandemics
  • Failure to comply with anti-corruption laws, trade sanctions and restrictions, or similar laws or regulations
  • Fluctuations in foreign currency exchange rates, particularly a stronger U.S. dollar
  • Changes in laws, regulatory measures, or governmental policies – especially those that affect the production, importation, marketing, labeling, pricing, distribution, sale, or consumption of our beverage alcohol products
  • Tax rate changes (including excise, corporate, sales or value-added taxes, property taxes, payroll taxes, import and export duties, and tariffs) or changes in related reserves, changes in tax rules or accounting standards, and the unpredictability and suddenness with which they can occur
  • Decline in the social acceptability of beverage alcohol in significant markets
  • Significant additional labeling or warning requirements or limitations on availability of our beverage alcohol products
  • Counterfeiting and inadequate protection of our intellectual property rights
  • Significant legal disputes and proceedings, or government investigations
  • Cyber breach or failure or corruption of our key information technology systems or those of our suppliers, customers, or direct and indirect business partners, or failure to comply with personal data protection laws
  • Our status as a family “controlled company” under New York Stock Exchange rules, and our dual-class share structure

For further information on these and other risks, please refer to our public filings, including the “Risk Factors” section of our annual report on Form 10-K and quarterly reports on Form 10-Q filed with the Securities and Exchange Commission.

Contacts

Elizabeth Conway

Director

External Communications

502-774-7737

elizabeth_conway@b-f.com

Sue Perram

Vice President

Investor Relations

502-774-6862

sue_perram@b-f.com

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