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MONTREAL, Nov. 18, 2021 /CNW/ – AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, announced today that an agreement has been reached with the pan-Canadian Pharmaceutical Alliance (pCPA) for VENCLEXTA® (venetoclax) in combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukemia (CLL). The regimen combines six 28-day cycles of obinutuzumab with 12 cycles of VENCLEXTA.1
Effective November 10, on Québec’s Listes des médicaments, VENCLEXTA is listed in combination with obinutuzumab, for the treatment of adult patients with previously untreated chronic lymphocytic leukemia. For full criteria, consult the list of medications in effect.2
“Being able to prescribe a therapy, such as venetoclax in combination with obinutuzumab, that has a finite treatment duration and manageable side effects is a welcomed option for my patients. After completing the prescribed treatment regimen, I can tell them that they can stop their medication because this effective combination helps to delay disease progression,” explains Dr. Sarit Assouline, Physician, Division of Hematology, Sir Mortimer B. Davis-Jewish General Hospital, Senior Investigator, Lady Davis Institute for Medical Research, Associate Professor, Department of Oncology, McGill University.
In October 2020, the Institut national d’excellence en santé et en services sociaux (INESSS) recommended that the Minister include VENCLEXTA, in combination with obinutuzumab, on the Listes des médicaments for the treatment of CLL. INESSS concluded that “the results of the intermediate analysis show that the venetoclax/obinutuzumab combination as first-line therapy in patients with CLL prolongs progression-free survival in a statistically and clinically meaningful way compared to the chlorambucil/obinutuzumab combination.”3
“Lymphoma Canada is pleased that this combination is available on the Listes des médicaments in Québec for the treatment of chronic lymphocytic leukemia. Due to the nature of the disease and its high relapse rate, it is important to offer patients effective treatment options so that they can face their cancer journey with the comfort of knowing that there are always alternatives,” says Antonella Rizza, Chief Executive Officer, Lymphoma Canada.
VENCLEXTA, in combination with obinutuzumab, is the third indication for VENCLEXTA for the treatment of CLL, a first-in-class B-cell lymphoma-2 (BCL-2) inhibitor. BCL-2 is a protein that prevents cancer cells from undergoing apoptosis, the process that leads to the natural death or self-destruction of cancer cells. VENCLEXTA is also approved in combination with rituximab for the treatment of adult patients with CLL who have received at least one prior therapy, and as a monotherapy for the treatment of patients with CLL with 17p deletion who have received at least one prior therapy, or patients with CLL without 17p deletion who have received at least one prior therapy and for whom there are no other available treatment options.1
“We are very proud of this tremendous milestone bringing VENCLEXTA plus obinutuzumab to people living with CLL in Quebec. This combination is a much-needed treatment option and reinforces our commitment to people living with blood cancer,” says Tracey Ramsay, Vice President and General Manager, AbbVie Canada.
CLL, which is typically a slow-progressing cancer of the bone marrow and blood[4], is one of the most common types of leukemia in adults. In Canada, CLL accounts for approximately 1,745 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year.5
VENCLEXTA is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
About AbbVie in Oncology
At AbbVie, we strive to discover and develop medicines that deliver transformational improvements in cancer treatment by uniquely combining our deep knowledge in core areas of biology with cutting-edge technologies, and by working together with our partners – scientists, clinical experts, industry peers, advocates, and patients. We remain focused on delivering these transformative advances in treatment across some of the most debilitating and widespread cancers. We are also committed to exploring solutions to help patients obtain access to our cancer medicines. AbbVie’s oncology portfolio consists of marketed medicines and a robust pipeline containing multiple new molecules being evaluated worldwide in more than 300 clinical trials and more than 20 different tumor types.
About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.ca. Follow @abbviecanada on Twitter or find us on LinkedIn.
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1 |
Venclexta Product Monograph. AbbVie Corporation, Canada. https://www.abbvie.ca/content/dam/abbvie-dotcom/ca/en/documents/products/VENCLEXTA_PM_EN.pdf. Accessed November 9, 2021 |
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2 |
Régie de l’assurance maladie du Québec’s Listes des médicaments. https://www.ramq.gouv.qc.ca/fr/a-propos/liste-medicaments-fournis-etablissement. Accessed November 9, 2021 |
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3 |
Institut national d’excellence en santé et en services sociaux. https://www.inesss.qc.ca/fileadmin/doc/INESSS/Inscription_medicaments/Avis_au_ministre/Novembre_2020/Venclexta_2020_10.pdf. Accessed November 9, 2021 |
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4 |
Lymphoma Canada. Chronic lymphocytic leukemia.www.lymphoma.ca/lymphoma/lymphoma-101/types-lymphoma/cll. Accessed November 9, 2021. |
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5 |
Canadian Cancer Statistics. Chronic lymphocytic leukemia statistics.www.cancer.ca/en/cancer-information/cancer-type/leukemia-chronic-lymphocytic-cll/statistics/?region=on. Accessed November 9, 2021. |
SOURCE AbbVie Canada
For further information: Muriel Haraoui, AbbVie Canada, 514-717-3764, muriel.haraoui@abbvie.com
– Significant Reduction in Dermatitis Severity Demonstrated
NAPLES, Fla., Nov. 18, 2021 /CNW/ – Enveric Biosciences (NASDAQ: ENVB) (“Enveric” or the “Company”), a patient-centric biotechnology company developing next-generation mental health and cancer support care therapies by leveraging psychedelic-derived molecules for the mind and synthetic cannabinoids for the body, today announced that EV102, the Company’s cannabidiol (CBD) based product in development for topical prescription treatment of radiodermatitis, has demonstrated significant and meaningful reduction in dermatitis severity, skin redness, and duration in a preclinical rodent model.
“Cancer patients around the world suffer the harsh side effects of various anti-cancer treatments,” said Dr. Joseph Tucker, CEO of Enveric Biosciences. “Radiodermatitis, the most common side effect of radiation therapy, is a physical skin irritation with symptoms ranging from red rash to open wounds. EV102 was topically applied during a daily treatment regimen and resulted in a nearly 50% reduction in redness scoring severity. Similar results were obtained for overall dermatitis severity, which includes desquamation (skin peeling) and ulceration as part of a composite score. Extending these promising results was an observed reduction in overall duration of dermatitis symptoms.” The significance of these preclinical findings will be evaluated in a planned human evaluation in 2022.
“At Enveric, we are focused on improving quality of life for cancer patients. The encouraging results of EV102 positions us to take the next steps in bringing safer and more effective prescription treatment options to market. We expect results from the preclinical study to support our efforts to move EV102 to a Phase I clinical study, targeted to begin in the second half of 2022,” concluded Dr. Tucker.
Radiodermatitis (also called radiation dermatitis) is a condition caused by the high-energy X-rays delivered during radiation therapy. It affects nearly 95% of patients who receive radiation for cancer treatment, with approximately 85% of patients having moderate-to-severe skin reactions. Radiodermatitis usually begins to occur within 1-4 weeks of treatment and persists for the duration of radiation therapy. The severity of the skin reactions ranges from mild erythema (red rash) to dry desquamation (itchy, peeling skin) to the more severe moist desquamation (open wound) and severe ulceration. Radiodermatitis can be similar to the discomfort of a mild-to-severe sunburn: painful, difficult to move or wear clothing, itching, and peeling skin. In the most severe cases, ulceration can occur, disrupting the treatment.
About Enveric Biosciences
Enveric Biosciences (NASDAQ: ENVB) is an innovative biotechnology company developing a next-generation mental health and oncology treatment clinical discovery platform, leveraging psychedelic-derived molecules for the mind and synthetic cannabinoids for the body. Enveric’s robust pipeline supports drug development from the clinic to commercialization for millions of patients in need around the world suffering from conditions that include cancer-related distress, PTSD and more. For more information, please visit www.enveric.com.
Forward-Looking Statements
This press release contains forward-looking statements and forward-looking information within the meaning of applicable securities laws. These statements relate to future events or future performance. All statements other than statements of historical fact may be forward-looking statements or information. Generally, forward-looking statements and information may be identified by the use of forward-looking terminology such as “plans”, ” expects” or “does not expect”, “proposed”, “is expected”, “budgets”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. Forward-looking statements consist of statements that are not purely historical, including any statements regarding beliefs, plans, expectations, or intentions regarding the future. Such forward-looking statements are based on the beliefs of management as well as assumptions made by and information currently available to management. Actual results could differ materially from those contemplated by the forward-looking statements as a result of certain factors, including, but not limited to, the ability to achieve the value creation contemplated by technical developments; the impact of the novel coronavirus (COVID-19) on Enveric’s ongoing and planned clinical trials; the geographic, social and economic impact of COVID-19 on Enveric’s ability to conduct its business and raise capital in the future when needed; delays in planned clinical trials; the ability to establish that potential products are efficacious or safe in preclinical or clinical trials; the ability to establish or maintain collaborations on the development of therapeutic candidates; the ability to obtain appropriate or necessary governmental approvals to market potential products; the ability to obtain future funding for developmental products and working capital and to obtain such funding on commercially reasonable terms; Enveric’s ability to manufacture product candidates on a commercial scale or in collaborations with third parties; changes in the size and nature of competitors; the ability to retain key executives and scientists; and the ability to secure and enforce legal rights related to Enveric’s products, including patent protection. A discussion of these and other factors, including risks and uncertainties with respect to Enveric, is set forth in Enveric’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Enveric disclaims any intention or obligation to revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.
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SOURCE Enveric Biosciences
Toronto, Ontario- November 18, 2021 – PharmaDrug Inc. (CSE: PHRX) (OTCQB: LMLLF) (“PharmaDrug” or the “Company“), a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs, is pleased to announce positive research results for their preclinical cancer study which evaluated the effectiveness of cepharanthine-2HCl alone, or when used in combination with standard of care (SoC) chemotherapy on four undisclosed cancers. The Company is now focused on advancing to IND-enabling studies to support future FDA clinical studies in 2022.
Further to the Company’s research update on its large in vitro cancer screen studies, the Company had previously identified a short list of 23 cancers that were highly responsive to cepharanthine-2HCl. Four instances of drug synergy (cepharanthine+chemotherapy) were revealed in the latest drug combination study. Cancer cell types and standard of care (SoC) treatments remain confidential for the purpose of filing subsequent intellectual property, but here the company provides results for the four most promising types of cancer tested. The inhibitory concentration of cepharanthine (CEPN) as well as experimental positive control required to kill fifty percent of the cells (IC50) is displayed below. Lower IC50 values represent greater potency of a drug for a particular cancer. Cepharanthine displays favorable IC50 values against multiple cancer types and its safety profile in humans is supported by multiple decades of human use in Japan for alternate indications. As noted in the table below, esophageal cancer was approximately 5-times more responsive to cepharanthine than the experimental positive control; a clinically approved chemotherapeutic agent.
Combination index (CI_IC50) of less than 1.00 demonstrates drug combination synergy. Combination index values were generated from co-application of CEPN and a relevant clinical SoC agent for each cancer type. The experimental positive control used for in vitro studies is an approved chemotherapeutic agent.
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The Company has shipped its drug product, PD-001 to the clinical research organization (CRO) in support of the upcoming IND-enabling animal studies. These studies are designed to evaluate PD-001 efficacy, alone and in combination with SoC in two animal cancer models. The Company’s prime cancer focus continues to be esophageal cancer for several reasons previously stated including the orphan drug designation awarded by the FDA earlier this year. The Company has also selected a second cancer type to pursue for these studies based on multiple considerations including cepharanthine potency, ability of cepharanthine to provide synergistic benefits with SoC drugs, relative market size/need and the suitability of available animal models to provide high translation value to the program. In vitro cancer cell models, while quite useful for screening cancer types responsive to a given drug, are not ideally suited to assess a particular drug’s benefit in overcoming adaptive chemoresistance. The currently designed animal models aim to more thoroughly tackle the serious clinical issue of chemoresistance. PharmaDrug will disclose additional positive findings for the preceding 2 in vitro cancer studies once its patent council has had an opportunity to review all of the recently generated data and file a provisional patent by the end of this year. The Company also expects to publish the results in a prominent scientific journal in the near future.
Daniel Cohen, CEO of PharmaDrug commented, “We are extremely excited about the most recent research results and the potential of cepharanthine to treat various cancers alone, and in combination with SoC drugs. Moving our research from in vitro (cell culture-based models) into accepted animal models of cancer is a critical step along our path to the clinic. Careful study design has allowed us to reveal non-obvious situations where cepharanthine provides synergistic benefit to existing treatment. These findings will be leveraged to pursue new intellectual property protection and to hopefully provide new treatment options for patients suffering from difficult to treat cancers. Our move toward IND-enabling animal efficacy studies to support future human clinical studies in oncology will be commencing as planned in November.”
Rational Use of Cepharanthine to Treat Cancer
PharmaDrug’s cancer program is based on cepharanthine’s known anti-cancer activities. Cepharanthine has been shown in multiple preclinical efficacy models to inhibit cancer cell proliferation, induce cancer cell apoptosis (death) and restore cancer cell sensitivity to multiple unrelated classes of chemotherapy. Multidrug resistance in particular, continues to represent a considerable clinical challenge. As such, preclinical cancer studies aimed at elucidating the mechanisms that underly chemoresistance; including the critical role drug efflux pumps play in this phenomenon by reducing the intracellular concentration of chemotherapeutic drugs, are of particular interest to PharmaDrug. Cepharanthine has been shown in preclinical studies to potently reverse chemoresistance by downregulating expression of ABCB1, the transcript of which codes for multidrug resistance protein 1, (MDR1, aka P- glycoprotein). Importantly, several prior in vitro and in vivo studies have shown that cepharanthine-mediated reductions in ABCB1 expression restores cancer cell sensitivity to a range of chemotherapeutics including taxanes, vinca alkaloids and platinum-based drugs1-4. Collectively the studies currently being undertaken by the Company aim to identify and provide focus to novel opportunities in oncology by revealing optimal drug combinations and situations where PD-001 can prevent, lessen, or reverse chemoresistance, and/or provide additive or synergistic benefit to existing treatments. PharmaDrug’s planned animal efficacy studies, designed around the outcome of the current in vitro study, are most ideally suited to experimentally examine the role of cepharanthine in restoring chemosensitivity.
About PD-001 (Enteric-coated Cepharanthine)
Cepharanthine is a natural product and an approved drug used for more than 70 years in Japan to successfully treat a variety of acute and chronic diseases. In clinical research, Cepharanthine has been shown to exhibit multiple pharmacological properties including anti-oxidative, anti-inflammatory, immuno-regulatory, anti-cancer, anti-viral and anti-parasitic effects5,6. However, historically cepharanthine’s low oral bioavailability has represented a major obstacle to realizing its full clinical potential.
The Company is focused on advancing the clinical development of an improved oral formulation of cepharanthine (PD-001) to treat rare cancers and infectious diseases. Compared to generic cepharanthine, PD-001 has been shown in rodent and non-rodent models to possess markedly superior bioavailability (more easily absorbed). These findings support the development of an orally administered formulation, and in so doing, removes the undesirable requirement for frequent intravenous dosing.
About PharmaDrug Inc.
PharmaDrug is a specialty pharmaceutical company focused on the research, development and commercialization of controlled-substances and natural medicines such as psychedelics, cannabis and naturally-derived approved drugs. PharmaDrug owns 100% of Pharmadrug Production GmbH (“Pharmadrug Production”), a German medical cannabis distributor, with a Schedule I European Union narcotics license and German EuGMP certification allowing for the importation and distribution of medical cannabis to pharmacies in Germany and throughout the European Union. PharmaDrug recently acquired Sairiyo Therapeutics (“Sairiyo”), a biotech company that specializes in researching and reformulating established natural medicines with a goal of bringing them through clinical trials and the associated regulatory approval process in the US and Europe. Sairiyo is currently developing its patented reformulation of cepharanthine, a drug that has shown substantial third party validated potential for the treatment of COVID-19 and rare cancers. Sairiyo is also conducting R&D in the psychedelics space for the treatment of non-neuropsychiatric conditions. The Company also owns 100% of Super Smart, a company building a vertically integrated retail business with the goal to elevate the use of functional mushrooms, and psilocybin mushrooms where federally legal, as natural based medicines.
For further information, please contact:
Daniel Cohen, Chairman and CEO
dcohen@pharmadrug.co
(647) 202-1824
Caution Regarding Forward-Looking Information:
THE CANADIAN SECURITIES EXCHANGE HAS NOT REVIEWED NOR DOES IT ACCEPT RESPONSIBILITY FOR THE ADEQUACY OR ACCURACY OF THIS RELEASE.
This press release contains “forward-looking information” within the meaning of applicable securities legislation. All statements, other than statements of historical fact, included herein are forward-looking information. Generally, forward-looking information may be identified by the use of forward-looking terminology such as “plans”, “expects” or “does not expect”, “proposed”, “is expected”, “budgets”, “scheduled”, “estimates”, “forecasts”, “intends”, “anticipates” or “does not anticipate”, or “believes”, or variations of such words and phrases, or by the use of words or phrases which state that certain actions, events or results may, could, would, or might occur or be achieved. In particular, this press release contains forward-looking information in relation to: the development and commercialization of cepharanthine, the results of the Company’s research and development in the psychedelics space and the development of the Supersmart business . This forward-looking information reflects the Company’s current beliefs and is based on information currently available to the Company and on assumptions the Company believes are reasonable. These assumptions include, but are not limited to the ability of the Company to successfully execute on its plans for the Company and its affiliated entities; the ability to obtain required regulatory approvals and the Company’s continued response and ability to navigate the COVID-19 pandemic being consistent with, or better than, its ability and response to date.
Forward-looking information is subject to known and unknown risks, uncertainties and other factors that may cause the actual results, level of activity, performance or achievements of the Company to be materially different from those expressed or implied by such forward-looking information. Such risks and other factors may include, but are not limited to: general business, economic, competitive, political and social uncertainties; general capital market conditions and market prices for securities; the actual results of the Company’s future operations; competition; changes in legislation affecting the Company; the ability to obtain and maintain required permits and approvals, the timing and availability of external financing on acceptable terms; lack of qualified, skilled labour or loss of key individuals; risks related to the COVID-19 pandemic including various recommendations, orders and measures of governmental authorities to try to limit the pandemic, including travel restrictions, border closures, non-essential business closures, service disruptions, quarantines, self-isolations, shelters-in-place and social distancing, disruptions to markets, economic activity, financing, supply chains and sales channels, and a deterioration of general economic conditions; and a deterioration of financial markets that could limit the Company’s ability to obtain external financing.
A description of additional risk factors that may cause actual results to differ materially from forward-looking information can be found in the Company’s disclosure documents on the SEDAR website at www.sedar.com. Although the Company has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking information, there may be other factors that cause results not to be as anticipated, estimated or intended. Accordingly, readers should not place undue reliance on forward-looking information. Readers are cautioned that the foregoing list of factors is not exhaustive. Readers are further cautioned not to place undue reliance on forward-looking information as there can be no assurance that the plans, intentions or expectations upon which they are placed will occur. Such information, although considered reasonable by management at the time of preparation, may prove to be incorrect and actual results may differ materially from those anticipated.
The Company’s securities have not been registered under the U.S. Securities Act of 1933, as amended (the “U.S. Securities Act”), or applicable state securities laws, and may not be offered or sold to, or for the account or benefit of, persons in the United States or “U.S. Persons”, as such term is defined in Regulations under the U.S. Securities Act, absent registration or an applicable exemption from such registration requirements. This press release shall not constitute an offer to sell or the solicitation of an offer to buy nor shall there be any sale of the securities in the United States or any jurisdiction in which such offer, solicitation or sale would be unlawful.
Forward-looking information contained in this press release is expressly qualified by this cautionary statement. The forward-looking information contained in this press release represents the expectations of the Company as of the date of this press release and, accordingly, are subject to change after such date. However, the Company expressly disclaims any intention or obligation to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as expressly required by applicable securities law.
References:
PharmaDrug Provides Research Results and Initiates IND-Enabling Studies for Cepharanthine in the Treatment of Multiple Cancers Study Results in the Prestigious Journal Cell Research Demonstrate Broad Antiviral Potential of Cepharanthine in Zika, Ebola and Multiple Variants of Covid-19. PharmaDrug Advances Psychedelics Program with Analogue DMT Formulations to Treat Eye Diseases PharmaDrug Expands Product Offering to Prepare for Potential Adult Use Market in Germany PharmaDrug Commences Trading on the OTCQB Market in the United States PharmaDrug Announces Positive Research Results for Cepharanthine in the Treatment of Multiple Cancers When Used Alone and in Combination with Chemotherapy PharmaDrug Announces pre-IND Meeting Request Granted by FDA for Oral Antiviral Drug Cepharanthine for the Treatment of COVID-19 Infection PharmaDrug Announces Clinical Research Collaboration with The Johns Hopkins University to Evaluate DMT in a Comparative Clinical Study PharmaDrug Forms Research Collaboration with Terasaki Institute for Novel Ocular Drug Formulation Program to Deliver DMT and Other Tryptamines to Treat Eye Disease PharmaDrug Announces Stock Ticker Symbol Change to (CSE: PHRX) Pharmadrug Announces Positive Research Results of Cepharanthine to Treat Multiple Cancers
Vancouver, B.C., November 18, 2021 – Pure Extracts Technologies Corp. (CSE: PULL) (OTC: PRXTF) (XFRA: A2QJAJ) (“Pure Extracts” or the “Company”), a plant-based extraction company focused on cannabis, hemp, functional mushrooms and the rapidly emerging psychedelic sector, is pleased to announce that its wholly owned subsidiary, Pure Extracts Manufacturing Corp., has now processed over 2,200 lbs of cannabis dry flower and over 3,300 lbs of hemp biomass using its state-of-the-art CO2 and Co-Solvent Injection extraction systems.
The bulk of the extracted oil has been used in the Company’s branded products, especially for its popular 1 gram vape carts which retail for $39.99 as well as for its white label customers. We currently have 24 SKUs listed across 4 provinces (British Columbia, Alberta, Saskatchewan and Ontario) in the recreational cannabis space and 9 SKUs in the medical cannabis space. To-date, we have manufactured approximately 50,000 vape carts and approximately 100,000 gummie packs.
Pure Pulls branded line of full spectrum oil (FSO) THC and CBD vape products and our unique, blister-packaged gummie products, including our high potency 100 mg CBD Pure Chews, continue to receive a strong reception from the marketplace with re-orders increasing in frequency.
Pure Extracts’ CEO, Ben Nikolaevsky, commented, “We are pleased to have reached this extraction processing milestone and proud of the quality we have achieved and maintained. Our reputation as a reliable producer of high-quality cannabis products is constantly growing.”
ON BEHALF OF THE BOARD
“Ben Nikolaevsky”
Ben Nikolaevsky
CEO and Director
About Pure Extracts (CSE: PULL) (OTC: PRXTF) (XFRA: A2QJAJ)
Pure Extracts Technology Corp. features an all-new, state-of-the-art processing facility located just 20 minutes north of world-famous Whistler, British Columbia. The bespoke facility has been constructed to European Union GMP standards aiming towards export sales of products and formulations, including those currently restricted in Canada, into European jurisdictions where they are legally available. Pure Extracts was granted its Standard Processing License by Health Canada under the Cannabis Act on September 25, 2020, and its Sales Amendment on July 19, 2021. The Company’s stock began trading on the Canadian Securities Exchange (CSE) on November 5, 2020.
Find out more at https://pureextractscorp.com/
Or contact:
Pure Extracts Investor Relations
Tel: +1 604 493 2052
This news release contains forward-looking statements relating to the future operations of Pure Extracts,
and the other statements are not historical facts. Forward-looking statements are often identified by terms such as “will”, “may”, “should”, “anticipate”, “expects” and similar expressions. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding the future plans and objectives of Pure Extracts’, are forward-looking statements and involve risks and uncertainties. A number of factors could cause actual events, performance or results to differ materially from what is projected in forward looking statements. Although we believe that the assumptions underlying these statements are reasonable, they may prove to be incorrect, and we cannot assure that actual results will be consistent with these forward-looking statements. Given these risks, uncertainties and assumptions, investors should not place undue reliance on these forward-looking statements. Whether actual results, performance or achievements will conform to the Company’s expectations and predictions is subject to a number of known and unknown risks, uncertainties, assumptions and other factors, including those listed under “Risk Factors” in the Company’s Annual Information Form. The Company does not undertake to update any forward-looking information, except as, and to the extent required by, applicable securities laws.
This news release contains information about potential sales revenue from supply agreements, which may be considered as disclosure of financial outlook under applicable securities laws. Such information is subject to the same assumptions, risk factors, limitations, and qualifications as set forth in the above paragraph. Specifically, estimated sales revenue which may be derived from supply contracts has been calculated based on current wholesale prices and assume, among other things, that the Company will be able to find buyers for its products. The financial outlook contained in this news release was made by management as of the date of this news release and was provided for the purpose of providing readers with an understanding of the potential revenue which may be derived from any agreements recently entered into by the Company, and are not an estimate of profitability or any other measure of financial performance. Readers are cautioned that the financial outlook contained in this document should not be used for purposes other than for which it is disclosed herein.
The CSE has neither approved nor disapproved the contents of this press release.
Englewood Cliffs NJ, Nov. 18, 2021 (GLOBE NEWSWIRE) — Silo Pharma, Inc. (OTCQB: SILO) a development-stage biopharmaceutical company focused on the use of psychedelics as a therapeutic, today announced that their joint venture partner Zylo Therapeutics received its first ketamine shipment and initiated loading ketamine into their Z-Pod® transdermal technology.
Eric Weisblum, CEO of Silo Pharma stated “The commencement of Novel Ketamine loaded Z-Pods is a pivotal advancement for administering Ketamine as a therapeutic with the patented Z-Pod® technology. This important milestone for Silo will help us study the benefits of slow-release transdermal release of Ketamine. The delivery and loading accelerates the development to deliver Ketamine as a therapeutic and potentially Psilocybin in a time-released or dosage-controlled manner.”
About Silo Pharma
Silo Pharma is a developmental stage biopharmaceutical company focused on merging traditional therapeutics with psychedelic research for people suffering from indications such as depression, PTSD, Alzheimer’s, Parkinson’s, and other rare neurological disorders. Silo’s mission is to identify assets to license and fund the research which we believe will be transformative to the well-being of patients and the health care industry. For more information, visit www.silopharma.com .
Safe Harbor and Forward-Looking Statements
This news release contains “forward-looking statements” within the meaning of the “safe-harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements are identified by the use of words “could”, “believe”, “anticipate”, “intend”, “estimate”, “expect”, “may”, “continue”, “predict”, “potential” and similar expressions that are intended to identify forward-looking statements. Such statements involve known and unknown risks, uncertainties, and other factors that could cause the actual results of Silo Pharma, Inc. (“Silo” or “the Company”) to differ materially from the results expressed or implied by such statements, including changes to anticipated sources of revenues, future economic and competitive conditions, difficulties in developing the Company’s technology platforms, retaining and expanding the Company’s customer base, fluctuations in consumer spending on the Company’s products and other factors. Accordingly, although the Company believes that the expectations reflected in such forward-looking statements are reasonable, there can be no assurance that such expectations will prove to be correct. The Company disclaims any obligations to publicly update or release any revisions to the forward-looking information contained in this presentation, whether as a result of new information, future events, or otherwise, after the date of this presentation or to reflect the occurrence of unanticipated events except as required by law.
Investor Relations Contact:
Hayden IR
Brett Maas 646-536-7331
Email: brett@haydenir.com
— Pasithea Clinics to offer ketamine infusion therapy for the treatment of mental health disorders —
— First mobile clinics launch in New York City, Los Angeles, San Diego, and San Francisco, with expansion to additional U.S. cities in coming months —
— Treatments conducted by board-certified medical professionals —
MIAMI BEACH, Fla., Nov. 17, 2021 (GLOBE NEWSWIRE) — Pasithea Therapeutics Corp. (Nasdaq: KTTA) (“Pasithea” or the “Company”), a novel biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders, today announced that its wholly owned subsidiary, Pasithea Clinics, commenced clinical operations, offering in-home intravenous (“IV”) ketamine therapy to patients suffering from treatment-resistant mental health issues. Initially, the treatment will be offered in New York City, Los Angeles, San Diego, and San Francisco and will expand nationwide in the coming months.
“The need for more effective treatment options for patients with mental health disorders has never been greater. Ketamine, when used at sub-anesthetic doses, has been shown to be highly effective in treating some psychiatric disorders. Still, we need to broaden access to this treatment to a larger patient population in a safe and convenient way. Through our mobile clinics, patients benefit from receiving the ketamine therapy in the privacy and comfort of their own homes. With patient safety as our top priority, all ketamine treatments will be delivered by board-certified medical professionals. This launch is an important stepping stone in expanding our international footprint in this space,” stated Dr. Tiago Reis Marques, CEO of Pasithea Therapeutics.
Patients with mental health disorders often struggle to complete day-to-day activities, and even small tasks can take extra effort. In disorders such as depression and post-traumatic stress disorder, symptoms such as fatigue, social isolation, lack of motivation, and high levels of anxiety are frequent. The effort to go to a physical clinic can be overwhelming. By providing this treatment at the patient’s home, Pasithea aims to broaden access to this important therapy.
“We are pleased to commence our U.S. rollout in major cities in New York and California, with plans to scale our business in other cities over the coming months. Although ketamine is a very safe drug to administer, there are still some risks. Patient safety is of paramount importance, and we are providing a network of highly trained medical professionals to administer this treatment in the comfort of the patient´s home. Our medical team ensures that our patients receive state-of-the-art support throughout their treatment experience. We believe we can become the best-in-class and largest provider of IV ketamine treatments in the United States. We will use our at-home model to expand our reach in the U.S. in a fast and accessible way,” said Dr. Adam Nadelson, Managing Director of Pasithea Clinics in the United States.
Ketamine is a U.S. Food and Drug Administration (“FDA”) approved drug introduced to the medical community as an anesthetic more than 50 years ago. It has recently been repurposed for the treatment of psychiatric disorders using significantly lower doses than in anesthesia and is now gaining ground as a promising treatment for mental health disorders. In certain psychiatric conditions, such as treatment-resistant depression (“TRD”) and post-traumatic stress disorder (“PTSD”), it has shown remarkable efficacy and a rapid and sustained effect, and up to 70% of those who receive this treatment can eventually show a clinical response. While the number of treatments suggested is done on a case-by-case basis, a typical treatment plan consists of up to six infusions in the interval of two to three weeks.
About Pasithea Therapeutics Corp.
Pasithea Therapeutics Corporation is a U.S. biotechnology company focused on the research and discovery of new and effective treatments for psychiatric and neurological disorders. With an experienced team of experts in the fields of neuroscience and psychopharmacology, Pasithea is developing new molecular entities for the treatment of psychiatric and neurological disorders. Pasithea is also focused on addressing the needs of patients currently suffering with mental illness by providing access to IV ketamine infusions both in clinics and in-home settings.
Forward Looking Statements
This press release contains statements that constitute “forward-looking statements.” Forward-looking statements are subject to numerous conditions, many of which are beyond the control of the Company. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to the Company on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including, without limitation, those set forth in the Company’s filings with the SEC. Thus, actual results could be materially different. The Company undertakes no obligation to update these statements whether as a result of new information, future events or otherwise, after the date of this release, except as required by law.
Pasithea Therapeutics Corp. Company Contact
Dr. Tiago Reis Marques
Chief Executive Officer
E: tiago@pasithea.com
Pasithea Therapeutics Corp. Investor Relations
Lisa M. Wilson
In-Site Communications, Inc.
T: 212-452-2793
E: lwilson@insitecony.com
A study discovered that psilocybin can reduce the odds of alcohol relapse!
How does it work? Alcohol reduces a protein in the brain called mGluR2. In a rat model, researchers found that the more protein lost, the more alcohol the rats craved, creating an addictive cycle.
Psilocybin was able to restore protein levels, thus decreasing relapses.
OSOYOOS, British Columbia, Nov. 17, 2021 (GLOBE NEWSWIRE) — via InvestorWire — Way2Grow Biopharma Corp. (“W2G” or the “Company”), a privately held therapeutic corporation existing under the laws of British Columbia, is pleased to announce approval of a Health Canada Dealer’s Licence Application, in which Health Canada issued notice to W2G to complete the construction of a Level 8 Secure Environ and Psilocybin Production Campus. A Health Canada Dealer Licence and production facility will allow W2G to procure psychedelics as well as propagate, cultivate, harvest and sell psychedelics to pharmacies, clinics and other licenced research facilities for allowable research purposes pursuant to the Controlled Drugs and Substances Act (the “CDSA”).
Licensing
W2G is pioneering a comprehensive Life Science Therapeutic Production Campus with the goal of researching, advancing and manufacturing life science therapeutics. W2G’s Therapeutic Production Campus supports small room, closed-loop, evidence-based therapeutic research and production. The Company’s pure cultivation approach is rooted in science, is empirically based, organically grown and evidence driven. W2G’s approach uses standardized tissue culture and micropropagation to cultivate and extract pure organic cannabis and psychedelic therapeutics. Completion of the Level 8 Controlled Substances Dealer’s Licence will allow W2G to cultivate, extract and store up to $30 million in value of psychedelics compounds, including psilocybin/psilocin (magic mushrooms), N, N-Dimethyltryptamine (DMT), Ololiuqui (Morning Glory), mescaline and peyote.
W2G will be the first comprehensive Life Science Therapeutic Production Campus specializing in psychedelic and cannabis production, micropropagation, organic cultivation, processing and therapeutic manufacturing in North America. Approval of the Controlled Substances Dealer’s Licence allows W2G to procure controlled substances by synthesis, propagation, cultivation and harvesting of psychedelic substances. W2G will be permitted to sell psychedelic compounds to other licenced dealers, authorized hospitals, research facilities and academic institutions until such time that psychedelics are prescribed by authorized physicians.
To fulfill W2G’s innovative research plans in psychedelic formulations, the Company’s plans include EU-GMP-compliant facility construction to allow for the import and export of psychedelics therapeutics to expand evidence-based psychedelics research through global partnerships. W2G’s research plans include improving breeding programs, standardizing psilocybin production, and the examination of psychedelics’ combinative efficacy on treating certain health conditions.
W2G’s cultivation relies on a small, closed room approach to growing consistent organic medical psilocybin. Each W2G cultivar or spore starts with a consistent germplasm developed though natural breeding and tissue culture. The future of W2G germplasm development will integrate the use of advanced genomic and genetic engineering to produce novel biotechnologies. Each cultivation room operates under specific growing conditions to maintain optimal production and consistent quality of medicinal compounds.
W2G has pioneered a new and strategic comprehensive Life Science Therapeutic Production Campus by combining its expertise in organic cultivation technology with an experienced genetic advancement team, innovative pharmaceutical research plans and intellectual property development, coupled with the highest level of security.
“We are excited to enter this next phase of life science therapeutics, and we believe this unique combination will lead to the highest-quality targeted organic therapeutic products. As we enter this next phase of our company’s evolution, we will focus on building strategic partnerships to help disseminate our psychedelics research and to expand our distribution,” stated W2G CEO Jamie Filipuzzi.
About W2G
W2G is a privately held therapeutic company in the life science industry. W2G began with a vision to help patients gain better access to high-quality, consistent, organic therapeutics. To achieve this vision, W2G has developed a consistent growth plan using tissue culture and molecular biology. These methods allow for the standardization of the procedures used to ensure quality and consistency of W2G’s therapeutics.
W2G’s extensive research and intellectual property approach are focused on the development of several new plant-based cultivation techniques, hybrid cultivar development, genetic profiling and tissue culture. By developing a molecular breeding and genetics program, we can identify new bioactive compounds to determine interaction with specific genes responsible for chronic diseases.
W2G is located in Osoyoos, British Columbia, and is federally regulated in Canada under the Cannabis Act (S.C. 2018, c. 16) and the Cannabis Regulations (SOR/2018-144)).
FORWARD-LOOKING STATEMENTS
This news release may contain “forward-looking statements.” These statements relate to future events or future performance of Way2Grow. Statements which are not purely historical are forward-looking statements and include any statements regarding beliefs, plans, outlook, expectations or intentions regarding the future, including words or phrases such as “anticipate,” “may,” “will,” “might,” “should,” “could,” “can,” “intend,” “expect,” “believe,” “plan,” “project,” “continue” or similar expressions that suggest future outcomes or the negative thereof or similar variations. Such forward-looking statements include, but are not limited to, statements concerning W2G’s research, development and expansion plans, including its Health Canada application for the Dealer Licence and Section 56 Exemption, and the potential results from such Licensing.
Forward-looking statements are based on management’s current expectations and may materially differ from actual results. Further, such forward-looking statements are subject to risks and uncertainties that could negatively affect our business, operating results and financial condition, including, without limitation, risks arising from a delay in Licensing and financing risks. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based, except as required by law.
Contact Information:
JJ Filipuzzi, Investor Relations
Phone: (403) 554-5973
Email: info@w2g.ca
Website: www.w2g.ca
Wire Service Contact
InvestorWire (IW)
Los Angeles, California
www.InvestorWire.com
212.418.1217 Office
Editor@InvestorWire.com
Vancouver, B.C. – November 17, 2021: Better Plant Sciences Inc. (CSE: PLNT) (OTCQB: VEGGF) (FRA: YG3) (“Better Plant”), a wellness company that develops and sells sustainable, plant-based products that are better for health and better for the earth, is pleased to announce that it will be an exhibitor at Planted Expo Vancouver (“Planted Expo”). Better Plant will showcase products from Jusu Wellness and Jusu Bar.
Planted Expo Conference Details:
Place: Vancouver Convention Centre West Building
Date: November 20 – 21, 2021
Time: 10:00 AM to 5:00 PM Daily
Tickets: https://www.showpass.com/planted-expo-vancouver-2021/
Planted Expo is Canada’s largest plant-based event of the year where over 250 plant-based edible and lifestyle businesses gather to showcase their products and inspirational speakers from around the world share their industry insights. Proof of vaccination is required to attend.
About Better Plant Sciences Inc.
Better Plant harnesses plant intelligence and leverages modern science to offer sustainable, plant-based products that are better for health and better for the earth. It makes and sells over 75 proprietary products, all made with 100% natural ingredients, under the brands Jusu, Urban Juve and Wright & Well. Better Plant operates Jusu Bar, a quick serve restaurant alternative in Victoria, BC, which serves up fresh, healthy, and nutritious options with a focus on Jusu cold-pressed juices. Jusubar.com offers home delivery of refrigerated plant-based beverages consisting of cold-pressed juices and packaged juice cleanses. Through its Shopify enabled eCommerce sites getjusu.com and urbanjuve.com, Better Plant sells plant-based personal care products and cleaning products. Better Plant products are sold through a network of over 150 online and brick and mortar retail locations including Whole Foods Market, Pharmasave, Healthy Planet and Vitasave. Better Plant also offers operational, financial, and other services to companies with businesses that align with Better Plant’s mission to help create a better world.
For more information or to purchase Jusu Wellness products, visit getjusu.com or follow Jusu Wellness on Instagram or Facebook.
For more information or to purchase Jusu Bar products, visit jusubar.com or follow on Instagram.
For more information on Better Plant, visit betterplantsciences.com or follow on Instagram, Twitter or LinkedIn.
Penny White, President & CEO
1-833-515-2677
Investor Relations:
Alexandra Dumanski
invest@betterplantsciences.com
1-833-515-2677
Sales Inquiries:
Amber Allen, Head of Sales
604-808-8118
The Canadian Securities Exchange has not reviewed, approved or disapproved the contents of this news release.
Cautionary Statement Regarding Forward-Looking Statements
This press release includes forward-looking information and statements (collectively, “forward looking statements”) under applicable Canadian securities legislation. Forward-looking statements are necessarily based upon a number of estimates, forecasts, beliefs and assumptions that, while considered reasonable, are subject to known and unknown risks, uncertainties, and other factors which may cause actual results and future events to differ materially from those expressed or implied by such forward-looking statements. Such risks, uncertainties and factors include, but are not limited to: risks related to the development, testing, licensing, brand development, availability of packaging, intellectual property protection, reduced global commerce and reduced access to raw materials and other supplies due to the spread of COVID-19, the potential for not acquiring any rights as a result of the patent application and any products making use of the intellectual property may be ineffective or the company may be unsuccessful in commercializing them; and other approvals will be required before commercial exploitation of the intellectual property can happen. Demand for the company’s products, general business, economic, competitive, political and social uncertainties, delay or failure to receive board or regulatory approvals where applicable, and the state of the capital markets. Better Plant cautions readers not to place undue reliance on forward-looking statements provided by Better Plant, as such forward-looking statements are not a guarantee of future results or performance and actual results may differ materially. The forward-looking statements contained in this press release are made as of the date of this press release, and Better Plant 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.
