Cancer treatment – MJ Shareholders https://mjshareholders.com The Ultimate Marijuana Business Directory Thu, 30 Sep 2021 16:38:45 +0000 en-US hourly 1 https://wordpress.org/?v=6.5.4 Cannabics Announces New Corporate Logo, New Website and New Company Presentation https://mjshareholders.com/cannabics-announces-new-corporate-logo-new-website-and-new-company-presentation/ Thu, 30 Sep 2021 16:38:45 +0000 https://www.cannabisfn.com/?p=2935380

Ryan Allway

September 30th, 2021


TEL AVIV, Israel and BETHESDA, Md., Sept. 30, 2021 /PRNewswire/ — Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based medicine and a pioneer in the development of psychedelic inspired medicine, announced today that it has updated its corporate image with a new logo and a new website. In addition, the company announced that a new corporate presentation is now available on its new website.

Cannabics Pharmaaceuticals logo
Cannabics Pharmaaceuticals logo

These updates more fully reflect the company’s strategic shift from a pre-clinical stage company towards now becoming a clinical stage development corporation focused primarily on FDA regulatory compliance.

The updated site, www.cannabics.com, provides current details on each of the company’s drug candidates and their corresponding clinical path. As always, the site offers current news and investor information, including press releases, SEC filings and the newly updated company presentation featuring the latest on Cannabics development.

About Cannabics Pharmaceuticals:

Cannabics Pharmaceuticals Inc. (OTCQB: CNBX) is a U.S. public company and a global leader in the development of cancer related cannabinoid-based medicine. The Company’s R&D is based in Israel, where it is licensed by the Ministry of Health to conduct scientific and clinical research on cannabinoid formulations and cancer. For more information, please visit www.cannabics.com. For the latest updates on Cannabics Pharmaceuticals follow the Company on Twitter @Cannabics, Facebook @CannabicsPharmaceuticals, LinkedIn, and on Instagram @Cannabics_Pharmaceuticals.

Read more:

Recent expansion of Cannabics Pharmaceuticals’ Board of Advisors to include: Prof. Caroline Robert (MD, Ph.D.), a Melanoma expert, and, Dr. Sigal Tavor (MD), a Hematology expertalong with Prof. Amos Toren (MD), Prof. Zamir Halpern (MD), Prof. Noam Shomron (Ph.D.), Dr. Erez Scapa (MD), Dr. Dana Ben-Ami Shor (MD), Dr. Sigalit Arieli-Portnoy (Ph.D.) and Dr. Tal Mofkadi (Ph.D.).

Recent expansion of Cannabics Pharmaceuticals’ Board of Directors to include: Dr. Inbar Maymon-Pomeranchik (Ph.D.), and Dr. Gil Feiler (Ph.D.) as Independent Directors.

Disclaimer:

Certain statements contained in this release may constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other U.S. Federal securities laws. Such statements include but are not limited to statements identified by words such as “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “targets,” “projects” and similar expressions. The statements in this release are based upon the current beliefs and expectations of our Company’s management and are subject to significant risks and uncertainties. Actual results may differ from those outlined in the forward-looking statements. Numerous factors could cause or contribute to such differences, including, but not limited to, results of clinical trials and other studies, the challenges inherent in new product development initiatives, the effect of any competitive products, our ability to license and protect our intellectual property, our ability to raise additional capital in the future that is necessary to maintain our business, changes in government policy and regulation, potential litigation by or against us, any governmental review of our products or practices, as well as other risks discussed from time to time in our filings with the Securities and Exchange Commission including, without limitation, our latest 10-Q Report filed July 14th, 2021. We undertake no duty to update any forward-looking statement or any information contained in this press release or other public disclosures at any time. Finally, the investing public is reminded that the only announcements or information about Cannabics Pharmaceuticals Inc., which are condoned by the Company, must emanate from the Company itself and bear our name as its source.

For more information about Cannabics:
Cannabics Pharmaceuticals Inc.
Phone: +1-(877)-424-2429
[email protected]
http://www.Cannabics.com

Related Links
https://www.cannabics.com

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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Can-Fite Reports Second Quarter 2021 Financial Results & Provides Clinical Update https://mjshareholders.com/can-fite-reports-second-quarter-2021-financial-results-provides-clinical-update/ Fri, 27 Aug 2021 01:43:19 +0000 https://www.cannabisfn.com/?p=2931727

Ryan Allway

August 26th, 2021


PETACH TIKVA, Israel, August 26, 2021–(BUSINESS WIRE)–Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, today announced financial results for the quarter ended June 30, 2021.

Corporate and Clinical Development Highlights Include:

Can-Fite Entered into Development and Commercialization Agreement in $3 Billion Veterinary Osteoarthritis Market – Can-Fite entered into a development and commercialization agreement with Vetbiolix, a France-based veterinary biotech company, for the development of Piclidenoson for the treatment of osteoarthritis in companion animals including dogs and cats. Vetbiolix will have the exclusive right to Piclidenoson in the veterinary osteoarthritis market for two years, during which time Vetbiolix will conduct proof-of-concept studies and cover all associated costs. If the studies yield positive data and Vetbiolix exercises its option to obtain the license from Can-Fite, then Vetbiolix will be obligated to pay Can-Fite upfront and milestone payments, in addition to royalties on sales upon regulatory approval for veterinary use. The canine osteoarthritis market is projected to reach $3 billion by 2024.

Can-Fite Received a Notice Allowance in China for its NASH Patent – During the second quarter, Can-Fite received a Notice Allowance in China for its patent titled “An A3 Adenosine Receptor Ligand For Use In Treating Ectopic Fat Accumulation”. This patent, which has subsequently been issued to Can-Fite, addresses the use of the A3 Adenosine Receptor (A3AR) ligand, the target receptor for Can-Fite’s drug platform technology, to reduce liver fat particularly in patients with NASH.

Patent Filed for A3AR-based Cannabis Compounds in the Treatment of Liver Diseases – Can-Fite’s preclinical studies of cannabis compounds found CBD rich T3/C15 induced inhibition of liver cancer cell growth and also had an inhibitory effect on liver fibrosis, which is associated with NAFLD/NASH, cirrhosis, and liver cancer. Can-Fite has filed patent applications to protect its discovery of cannabinoid-based therapies where the A3AR target is overexpressed.

Phase III Psoriasis Study Nears Completion of Enrollment – The Phase III Comfort™ study completed enrollment of 75% of planned patients during the second quarter, with full enrollment expected in the coming weeks. The study is designed to establish Piclidenoson’s superiority compared to placebo and non-inferiority compared to Apremilast (Otezla®) in patients with moderate to severe plaque psoriasis. Topline results are expected Q1 2022.

Phase II COVID-19 Study Expands into Europe – Can-Fite’s ongoing Phase II study, under a U.S. FDA protocol, has been enrolling patients in Israel and expanded enrollment into Europe during the second quarter. The randomized, double blind, placebo-controlled study is evaluating the benefits of treatment with Piclidenoson plus standard supportive care (SSC) vs. placebo plus SSC in 40 patients hospitalized with moderate to severe COVID-19, as defined by the U.S. National Institutes of Health Coronavirus Disease 2019 (COVID-19) Treatment Guidelines.

Phase IIb NASH Study Receives Clearance from Israeli Ministry of Health – Can-Fite received clearance from the Israeli Ministry of Health to commence a Phase IIb study of its drug candidate Namodenoson in the treatment of NASH. Patient enrollment is expected to commence Q3 2021, ahead of the prior expected start date of Q4 2021. The Company expects to expand the study to additional clinical sites in Europe. A prior Phase IIa clinical trial of Namodenoson in the treatment of NASH met study endpoints showing anti-steatotic, anti-inflammatory, and anti-fibrotic effects.

Pivotal Phase III Liver Cancer Study Expected to Commence Q4 2021 – Can-Fite has completed preparatory work for its pivotal Phase III study and plans to submit its study protocol and plans to Institutional Review Boards (IRBs) at potential clinical sites. The double blind, placebo-controlled trial will enroll 450 patients diagnosed with HCC and underlying Child Pugh B7 (CPB7) through clinical sites worldwide. Patients will be randomized to oral treatment with either 25 mg Namodenoson or matching placebo given twice daily. The primary efficacy endpoint of the trial is overall survival.

Fortified Balance Sheet

On June 30, 2021 Can-Fite had approximately $7.5 million in cash, cash equivalents, and short-term deposits. The Company closed an additional $10 million registered direct offering in August 2021.

“We expect multiple milestones in the coming months including topline results from our Phase III psoriasis study, in addition to the commencement of our pivotal Phase III in liver cancer and Phase IIb in NASH. We believe positive topline results may lead to further expansion of our global distribution strategy which has included significant non-dilutive funding,” stated Can-Fite CEO Dr. Pnina Fishman.

Financial Results

Revenues for the six months ended June 30, 2021 were $0.39 million compared to revenues of $0.40 million during the six months ended June 30, 2020. The decrease is considered immaterial.

Research and development expenses for the six months ended June 30, 2021 were $3.81 million compared with $7.05 million for the same period in 2020. Research and development expenses for the first half of 2021 comprised primarily of expenses associated with two studies for Piclidenoson, a Phase II study in COVID-19 and a Phase III study in the treatment of psoriasis. The decrease is primarily due to costs incurred in the first six months of 2020 associated with Phase II studies for Namodenoson in the treatment of liver cancer and NASH, and a Phase III study of Piclidenoson for the treatment of rheumatoid arthritis, partially offset by the two ongoing studies of Piclidenoson in the first six months of 2021. We expect research and development expenses will increase through 2021 and beyond.

General and administrative expenses were $1.89 million for the six months ended June 30, 2021 compared to $1.45 million for the same period in 2020. The increase is primarily due to the increase in salaries and related benefits due to the distribution of bonuses to employees. We expect general and administrative expenses will remain at the same level through 2021.

Financial income, net for the six months ended June 30, 2021 was $0.20 million compared to financial expense, net of $0.12 million for the same period in 2020. The decrease in financial expense, net was mainly due to finance income recorded from revaluation of our short-term investment.

Can-Fite’s net loss for the six months ended June 30, 2021 was $5.09 million compared with a net loss of $8.23 million for the same period in 2020. The decrease in net loss was primarily attributable to a decrease in research and development expenses which were partly offset by an increase in general and administrative expenses and a decrease in finance expenses, net.

As of June 30, 2021, Can-Fite had cash, cash equivalents and short-term deposits of $7.53 million as compared to $8.26 million at December 31, 2020. The decrease in cash during the six months ended June 30, 2021 is due to an aggregate of $2.74 million in net proceeds received through warrant exercise transactions during the first quarter of 2021 and from an advance payment of $2.25 million from a distribution agreement with Ewopharma which were offset by Company’s operating activity.

The Company’s consolidated financial results for the six months ended June 30, 2021 are presented in accordance with US GAAP Reporting Standards.

CONDENSED CONSOLIDATED BALANCE SHEETS

U.S dollars in thousands (except for share and per share data)

June 30, December
2021 31, 2020
Unaudited Audited
ASSETS
CURRENT ASSETS:
Cash and cash equivalents $ 1,025 $ 8,268
Short-term deposits 6,512
Other receivable and prepaid expenses 1,745 1,057
Short-term investment 271 75
Total current assets 9,553 9,400
NON-CURRENT ASSETS:
Operating lease right of use assets 77 73
Property, plant and equipment, net 50 50
Total long-term assets 127 123
Total assets $ 9,680 $ 9,523

CONDENSED CONSOLIDATED BALANCE SHEETS

U.S dollars in thousands (except for share and per share data)

June 30, December
2021 31, 2020
Unaudited Audited
LIABILITIES AND SHAREHOLDERS’ EQUITY
CURRENT LIABILITIES:
Trade payables $ 1,005 $ 561
Current maturity of operating lease liability 43 43
Deferred revenues 1,002 334
Other accounts payable 309 331
Total current liabilities 2,359 1,269
NON-CURRENT LIABILITIES:
Long – term operating lease liability 25 24
Deferred revenues 3,341 2.156
Total long-term liabilities 3,366 2,180
CONTINGENT LIABILITIES AND COMMITMENTS
SHAREHOLDERS’ EQUITY:
Ordinary shares of NIS 0.25 par value – Authorized: 5,000,000,000 and 1,000,000,000 shares at June 30, 2021 and December 31, 2020, respectively; Issued and outstanding: 515,746,293 shares as of June 30, 2021; 463,769,463 shares as of December 31, 2020 37,008 33,036
Additional paid-in capital 96,386 97,380
Accumulated other comprehensive income 1,127 1,127
Accumulated deficit (130,566 ) (125,469 )
Total equity 3,955 6,074
Total liabilities and shareholders’ equity $ 9,680 $ 9,523

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS

U.S dollars in thousands (except for share and per share data)

Six months ended

June 30,

2021 2020
Unaudited
Revenues $ 398 $ 402
Research and development expenses (3,810 ) (7,054 )
General and administrative expenses (1,892 ) (1,455 )
Operating loss (5,304 ) (8,107 )
Total financial income (expenses), net 207 (128 )
Net loss (5,097) (8,235 )
Total comprehensive loss (5,097 ) (8,235 )
Deemed dividend (715 )
Net loss attributed to ordinary shareholders $ (5,097 ) $ (8,950 )
Basic and diluted net loss per share (0.01 ) (0.04 )
Weighted average number of ordinary shares used in computing basic and diluted net loss per share 500,010,114 254,940,675

About Can-Fite BioPharma Ltd.

Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE: CFBI) is an advanced clinical stage drug development Company with a platform technology that is designed to address multi-billion dollar markets in the treatment of cancer, liver, inflammatory disease and COVID-19. The Company’s lead drug candidate, Piclidenoson, is currently in a Phase III trial for psoriasis and a Phase II study in the treatment of moderate COVID-19. Can-Fite’s liver drug, Namodenoson, is headed into a Phase III trial for hepatocellular carcinoma (HCC), the most common form of liver cancer, and a Phase IIb trial for the treatment of non-alcoholic steatohepatitis (NASH). Namodenoson has been granted Orphan Drug Designation in the U.S. and Europe and Fast Track Designation as a second line treatment for HCC by the U.S. Food and Drug Administration. Namodenoson has also shown proof of concept to potentially treat other cancers including colon, prostate, and melanoma. CF602, the Company’s third drug candidate, has shown efficacy in the treatment of erectile dysfunction. These drugs have an excellent safety profile with experience in over 1,500 patients in clinical studies to date. For more information please visit: www.can-fite.com.

Forward-Looking Statements

This press release may contain forward-looking statements, about Can-Fite’s expectations, beliefs or intentions regarding, among other things, market risks and uncertainties, its product development efforts, business, financial condition, results of operations, strategies or prospects. In addition, from time to time, Can-Fite or its representatives have made or may make forward-looking statements, orally or in writing. Forward-looking statements can be identified by the use of forward-looking words such as “believe,” “expect,” “intend,” “plan,” “may,” “should” or “anticipate” or their negatives or other variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical or current matters. These forward-looking statements may be included in, but are not limited to, various filings made by Can-Fite with the U.S. Securities and Exchange Commission, press releases or oral statements made by or with the approval of one of Can-Fite’s authorized executive officers. Forward-looking statements relate to anticipated or expected events, activities, trends or results as of the date they are made. Because forward-looking statements relate to matters that have not yet occurred, these statements are inherently subject to risks and uncertainties that could cause Can-Fite’s actual results to differ materially from any future results expressed or implied by the forward-looking statements. Many factors could cause Can-Fite’s actual activities or results to differ materially from the activities and results anticipated in such forward-looking statements. Factors that could cause our actual results to differ materially from those expressed or implied in such forward-looking statements include, but are not limited to: our history of losses and needs for additional capital to fund our operations and our inability to obtain additional capital on acceptable terms, or at all; uncertainties of cash flows and inability to meet working capital needs; the impact of the COVID-19 pandemic; the initiation, timing, progress and results of our preclinical studies, clinical trials and other product candidate development efforts; our ability to advance our product candidates into clinical trials or to successfully complete our preclinical studies or clinical trials; our receipt of regulatory approvals for our product candidates, and the timing of other regulatory filings and approvals; the clinical development, commercialization and market acceptance of our product candidates; our ability to establish and maintain strategic partnerships and other corporate collaborations; the implementation of our business model and strategic plans for our business and product candidates; the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates and our ability to operate our business without infringing the intellectual property rights of others; competitive companies, technologies and our industry; statements as to the impact of the political and security situation in Israel on our business; and risks and other risk factors detailed in Can-Fite’s filings with the SEC and in its periodic filings with the TASE. In addition, Can-Fite operates in an industry sector where securities values are highly volatile and may be influenced by economic and other factors beyond its control. Can-Fite does not undertake any obligation to publicly update these forward-looking statements, whether as a result of new information, future events or

otherwise.

Contacts

Can-Fite BioPharma
Motti Farbstein
[email protected]
+972-3-9241114

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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Pharmadrug Announces Positive Research Results of Cepharanthine to Treat Multiple Cancers https://mjshareholders.com/pharmadrug-announces-positive-research-results-of-cepharanthine-to-treat-multiple-cancers/ Wed, 28 Jul 2021 16:33:03 +0000 https://www.cannabisfn.com/?p=2927623

Ryan Allway

July 28th, 2021


  • Validates Cepharanthine’s potential in treating various cancers with unsatisfactory treatment options
  • Positions Cepharanthine’s ‘pipeline in a pill’ strategy focusing on esophageal, colorectal, liver and skin cancers
  • Advance to FDA IND-enabling studies to support human clinical studies

Toronto, Ontario–(Newsfile Corp. – July 28, 2021) – PharmaDrug Inc. (CSE: BUZZ) (OTC Pink: 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 the completion of their preclinical cancer study which evaluated cepharanthine-2HCl, the active pharmaceutical ingredient in PD-001, the Company’s patented oral formulation of cepharanthine. The results from the study validate cepharanthine’s potential in treating different types of cancer including esophageal, colorectal, liver and skin. The results also provide confidence in the Company’s plan to dedicate resources to advance PD-001 through FDA IND-enabling studies to support Phase 1 and 2 clinical studies. The study was conducted by a respected contract research organization with deep expertise in preclinical oncology model development and drug testing and data corresponding to all studied cancer cell lines have now been reported to the Company.

PharmaDrug was pleased to find that twenty of the sixty cancer cells lines screened showed growth inhibition of at least fifty percent when exposed to cepharanthine levels previously determined to be well tolerated in a human clinical population. Additionally, there were several instances in which cepharanthine displayed growth inhibition which was comparable or superior to current gold standard treatments, including colorectal, liver and skin cancers. More notably, results of the current study demonstrated that esophageal cancer was the most highly responsive of all sixty cancers examined; with cepharanthine showing 99.96% growth inhibition at the top concentration tested and displayed approximately 5-times greater potency (at IC50) than cisplatin, a chemotherapy commonly used to treat esophageal cancer despite the fact that development of chemoresistance to this family of agents is common. Previously the Company announced that it had secured FDA Orphan Drug Designation for cepharanthine in the treatment of esophageal cancer. However, prior to committing to a substantial clinical program for that indication, PharmaDrug looked to further expand on the body of existing supportive data for esophageal cancer, while also potentially revealing new, promising cancer indications. Based on these promising findings, PharmaDrug reiterates that it remains committed to the clinical development of PD-001 for the treatment of patients suffering from esophageal cancer.

The Study

The Company’s study examined potential anti-cancer properties of cepharanthine (monotherapy) in a panel of sixty solid and liquid cancer cell types and does so by comparing cell growth inhibition following exposure to cepharanthine as well as current standard of care agents. Cepharanthine has been an approved drug in Japan for approximately 70 years. Generic cepharanthine has been safely and effectively delivered to patients via an intravenous route of administration, however oral administration has not received broad adoption owing to its poor bioavailability. Borrowing from what is already known about safe circulating levels in patients for generic cepharanthine, the Company’s current 60 cancer screen was designed to investigate the impact of their patented cepharanthine formulation at concentrations that are predicted to be safe to patients1. Using these criteria, PharmaDrug was pleased to find that twenty of the sixty cancer cells lines screened showed growth inhibition of at least 50 percent when exposed to cepharanthine levels previously determined to be well tolerated in a human clinical population. Additionally, there were several instances in which cepharanthine displayed growth inhibition which was comparable or superior to current gold standard treatments examined.

With these highly encouraging results, PharmaDrug is advancing its cancer program with the initiation of IND-enabling studies to support human clinical studies, such as an in vitro efficacy study to assess the potential of cepharanthine to provide additive and/or synergistic benefits in combination (combo-therapy) with current standard of care agents and in vivo efficacy studies designed to further validate cancer indication selection with a view to de-risking downstream clinical programs. The outcome of these IND-enabling studies is anticipated to strengthen and broaden the foundation of the Company’s intellectual property portfolio, as well as validate the proposed clinical development plans to be put forward to the FDA in future IND applications to conduct both Phase 1 and 2 clinical studies. These efforts will provide PharmaDrug with additional intellectual property, downstream licensing opportunities in the oncology space, but most importantly, a clear path for electing a lead cancer indication for their internal development program.

Daniel Cohen, CEO of PharmaDrug commented: “We are extremely excited with the results of this study demonstrating the potential of cepharanthine in treating multiple forms of cancer known to commonly escape response through the development of chemoresistance. Although cepharanthine is described in scientific literature as a potential cancer therapeutic, we did not expect to see the noted significant growth inhibition in difficult to treat cancers. Cepharanthine is on its way to establishing itself as a once per day, oral anti-cancer therapeutic with a well-established safety profile which will pave the way for an expedited clinical development pathway and future partnering opportunities with pharmaceutical companies. We look forward to providing continued updates on our intellectual property, research, clinical, regulatory and manufacturing activities for PD-001; our novel oral formulation of cepharanthine, with the aim of working towards a first-in-human, proof-of-concept clinical trial under an FDA IND approval.”

Next Steps

Based on the de-risked and positive results from the study, the Company has initiated the following activities:

  • Broadening intellectual property strategy with planned filing of provisional patents on cepharanthine for specific cancers. These findings will be made public after being filed with the patent office;
  • Expanding orphan drug designations in the U.S. and Europe for certain cancers based on the Company’s proprietary results;
  • Completing a second, drug combination preclinical study in September which may generate additional discoveries and facilitation a broadening of the Company’s intellectual property portfolio;
  • Pursuing FDA IND-enabling animal studies in the fall to evaluate the benefit of cepharanthine alone (monotherapy) or when combined with relevant first and second-line chemotherapy drugs to support future human clinical studies; and
  • Initiating the scale-up processes and Good Manufacturing Practice (GMP) production of PD-001 (novel oral formulation of cepharanthine) in preparation for the first-in-human proof-of-concept clinical trial.

Cepharanthine’s Rationale in Cancer

PharmaDrug’s cancer program is based on cepharanthine’s known anti-cancer activities. Cepharanthine has been shown in preclinical efficacy models to restore cancer cell sensitivity to multiple unrelated classes of chemotherapy. Multidrug resistance 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 drugs25. 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/synergistic benefit to existing treatments.

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 properties5. 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. The Company owns 80% of Pharmadrug Production GmbH, 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 EU. The Company also owns 100% of Super Smart, a Dutch company building a modern adult use psychedelic retail business with an elevated and educational focus. PharmaDrug recently acquired Sairiyo Therapeutics, a biotech company that specializes in researching and reformulating established natural medicines with a goal of bringing them through regulatory and research driven clinical trials.

For further information, please contact:

Daniel Cohen, Chairman and CEO
[email protected]
(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 timing of the proposed non-clinical and clinical manufacturing of Cepharanthine for the Company’s rare cancer and infectious diseases programs; the ability to expedite development timelines by leveraging SwRI’s existing Cepharanthine preclinical data sets and manufacturing know-how; the ability to advance clinical development of an improved oral formulation of Cepharanthine to treat rare cancers and infectious diseases; the ability to obtain applicable approval for the use of Cepharanthine to treat esophageal cancer; the timing and potential results of the Company’s plan to initiate high throughput studies to screen a large panel of additional cancers; the Company’s plans to evaluate the benefit of its novel oral formulation of Cepharanthine in an animal model of SARS-CoV-2 infection and its proposed discussions with regulators regarding same. 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 Sairiyo; the ability to complete the studies referenced herein nd the results thereto; 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:

  1. Yasuda, K., Moro, M., Akasu, M., and Ohnishi, A. (1989). Pharmacokinetic disposition of cepharanthin following single and multiple intravenous doses in healthy subjects. Jpn. J. Clin.Pharmacol. Ther. 20, 741-749.
  1. Saito T, Hikita M, Kohno K, Tanimura H, Miyahara M, Kobayashi M. Enhanced expression of the multidrug resistance gene in vindesine-resistant human esophageal cancer cells. Oncology. 1994 Sep-Oct;51(5):440-5. doi: 10.1159/000227380. PMID: 8052486.
  1. Zhou P, Zhang R, Wang Y, Xu D, Zhang L, Qin J, Su G, Feng Y, Chen H, You S, Rui W, Liu H, Chen S, Chen H, Wang Y. Cepharanthine hydrochloride reverses the mdr1 (P-glycoprotein)-mediated esophageal squamous cell carcinoma cell cisplatin resistance through JNK and p53 signals. Oncotarget. 2017 Nov 27;8(67):111144-111160. doi: 10.18632/oncotarget.22676. Erratum in: Oncotarget. 2021 Jan 05;12(1):61-62. PMID: 29340044; PMCID: PMC5762312.
  1. Huang CZ, Wang YF, Zhang Y, Peng YM, Liu YX, Ma F, Jiang JH, Wang QD. Cepharanthine hydrochloride reverses P glycoprotein-mediated multidrug resistance in human ovarian carcinoma A2780/Taxol cells by inhibiting the PI3K/Akt signaling pathway. Oncol Rep. 2017 Oct;38(4):2558-2564. doi: 10.3892/or.2017.5879. Epub 2017 Aug 4. PMID: 28791369.
  1. Zahedi P, De Souza R, Huynh L, Piquette-Miller M, Allen C. Combination drug delivery strategy for the treatment of multidrug resistant ovarian cancer. Mol Pharm. 2011 Feb 7;8(1):260-9. doi: 10.1021/mp100323z. Epub 2010 Dec 17. PMID: 21166459.

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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