Optimi Health Finalizes Planned Build-Out of Mushroom Production and Research Facility
Awards contracts for interior finishing and technology installation
VANCOUVER, British Columbia, April 27, 2021 (GLOBE NEWSWIRE) -- Optimi Health Corp. (CSE: OPTI) (OTC: OPTHF) (FRA: 8BN) (“Optimi” or the “Company”), developers of a vertically integrated functional mushroom brand focused on the health and wellness sector, is pleased to offer an activity update at its 20,000 sq. ft. production and research facility in Princeton, British Columbia.
Optimi is advancing rapidly to final build-out of its two adjacent 10,000 square foot facilities which began construction in August of 2020. With the return of milder weather, final touches to exterior services, perimeter and access controls are well underway. The Company utilized the winter season to assess construction progress and to finalize a short list of contractors best suited for the critical interior layout. The entire process from engineering to tender process is now complete with all tenders graded through a fair percentile grading process including reference checks. For security purposes the tender winners’ names will be withheld but have met or exceeded the requirements per our engineering, responsiveness, and cost criteria.
All required building related permits have been obtained, and some materials have begun arriving onsite for inventory storage until required by the respective trades. Advanced HVAC equipment and controls, fire suppression, and 700kw backup electrical power systems have been contracted and are, or soon will be in transit to Princeton. Security systems play a major role to meet regulatory compliance for the companies stated goal to produce both functional and psychoactive mushroom products in-house. Perimeter intrusion detection incorporates a “smart” fence consisting of a robust chain-link fencing system which in conjunction with an integrated camera system and fence disturbance sensors, combines with wireless gate access including contact sensors and magnetic locks controlled by dual verification card readers and video intercom stations.
Agricultural production will be enhanced through the professional installation of an advanced Argus control system which provides software and hardware features such as secured local and remote connections, multiple user profiles, real-time monitoring and alarming of all critical environmental and system parameters, data recording, graphing, logging, exporting and data import for climate simulation, in a user-friendly, scalable control environment specifically designed for horticulture.
In addition, and in accordance with Health Canada protocols, the facility will include a Region III, Level 8 product vault with a projected capacity to initially secure a licensed 50kg of Psilocybin with the ability, subject to future licensing, to easily scale up to a maximum allowable level 8 capacity of 1,250kg. The company, in accordance with the respective physical security directives, has developed a comprehensive security plan and assigned responsibility for 24/7 management to its chief of security. This includes facility-wide personnel verification and tracking, intrusion or emergency notifications, CCTV monitoring and video archive of all secure areas, and further includes active response coordination with local emergency, fire and police services located nearby.
City of Princeton, Director of Economic Development, Mr. Gary Schatz notes, “I am excited to welcome Optimi Health into the Town of Princeton Industrial Park. The addition of such a cutting-edge company will help to further diversify the Princeton Economic landscape and create quality employment opportunities for our community. Optimi Health’s investment into the town is another example of the renaissance the Town of Princeton is experiencing and fits perfectly into the Town’s overall revitalization strategy. In my opinion they are doing an excellent job introducing this alternative business venture into our community and we are pleased to have them as a member of our business community.”
Optimi Health COO and Director, Bryan Safarik comments, “Activities are moving ahead rapidly, and every day brings us another step closer to moving in and getting to work. We are extremely excited by the interest in our venture and pleased by the response to our commitment to all-natural products. We aim to become the leading supplier of natural mushroom-based goods to the health & wellness community, as well as a future developer of clinically proven therapeutic psilocybin formulations for discerning users who understandably prefer a non-synthetic solution for what are very personal care solutions. Mental health care options are going to change with the advent of innovative products, and we believe the finest products come from nature – naturally. We are passionate about delivering the best and we plan to build our brand based on that. This is what this entire facility in Princeton is dedicated to, and we are committed to a plan of action designed to deliver a simple outcome; the very finest Canadian made and naturally optimized mushroom products available.”
On Behalf of the Board of Directors, Optimi Health Corp.
Mike Stier President, Chief Executive Officer and Director
ABOUT OPTIMI (CSE: OPTI) (OTC: OPTHF) (FRA: 8BN) Optimi is developing a sophisticated mushroom brand that focuses on the health and wellness markets. With a vertically integrated approach, Optimi intends to cultivate, extract, process and distribute high quality functional mushroom products at its two facilities comprising a total of 20,000 square feet nearing completion in Princeton, British Columbia. To fully investigate the science of mushrooms, the Company has received a research exemption under Health Canada Food and Drug Regulations (FDR) for the use of Psilocybin and Psilocin for scientific purposes via its wholly owned subsidiary Optimi Labs Inc. Optimi has also applied for a dealer’s license under Canada’s Narcotic Control Regulations governing possession, distribution, sale, laboratory analysis of and research and development of Psilocybin and Psilocin formulations. Optimi is committed to expert cultivation and quality production subject to and in accordance with the terms of all applicable laws and governing regulations to ensure safe, superior Canadian fungi production.
FORWARD‐LOOKING STATEMENTS This news release contains forward‐looking statements and forward‐looking information within the meaning of Canadian securities legislation (collectively, "forward‐looking statements") that relate to Optimi’s current expectations and views of future events. Any statements that express, or involve discussions as to, expectations, beliefs, plans, objectives, assumptions or future events or performance (often, but not always, through the use of words or phrases such as "will likely result," "are expected to," "expects," "will continue," "is anticipated," "anticipates," "believes," "estimated," "intends," "plans," "forecast," "projection," "strategy," "objective," and "outlook") are not historical facts and may be forward‐looking statements and may involve estimates, assumptions and uncertainties which could cause actual results or outcomes to differ materially from those expressed in such forward‐looking statements. No assurance can be given that these expectations will prove to be correct and such forward‐looking statements included in this news release should not be unduly relied upon. These statements speak only as of the date of this news release. In particular and without limitation, this news release contains forward‐ looking statements pertaining to the dealer’s license application, activities proposed to be conducted under the Company’s research exemption and associated business related to Psilocybin and Psilocin and Optimi’s plans, focus and objectives.
Forward‐looking statements are based on a number of assumptions and are subject to a number of risks and uncertainties, many of which are beyond Optimi’s control, which could cause actual results and events to differ materially from those that are disclosed in or implied by such forward‐looking statements. Such risks and uncertainties include, but are not limited to, the impact and progression of the COVID‐19 pandemic and other factors set forth under “Forward‐Looking Statements" and “Risk Factors” in the Company’s Final Prospectus dated February 12, 2021. Optimi undertakes no obligation to update or revise any forward‐looking statements, whether as a result of new information, future events or otherwise, except as may be required by law. New factors emerge from time to time, and it is not possible for Optimi to predict all of them or assess the impact of each such factor or the extent to which any factor, or combination of factors, may cause results to differ materially from those contained in any forward‐looking statement. Any forward‐looking statements contained in this news release are expressly qualified in their entirety by this cautionary statement.
No More Sugar Coating It - New Book, No Sugar In Me™, Takes on Sugar and Delivers Better Health!
TORONTO, April 27, 2021 /CNW/ - People across the globe are consuming more sugar than ever before! The fallout of this worldwide added, processed, and refined sugar addiction comes at a very high price—our health. Brad Woodgate, self-made, serial entrepreneur and nutrition industry expert is taking on sugar with his first book: No Sugar In Me™, available for purchase on May 3rd, 2021.
"Sugar consumption is out of control and has become a health concern for everyone—it's addictive and completely detrimental to our health," says Woodgate. "This book is my effort to help people struggling with their sugar dependency. In my 21 years in the health and nutrition industry, I've never seen anything worse than refined sugar."
No Sugar In Me™ isn't an all-or-nothing detox or a quick-fix diet. This book is about changing your lifestyle by eliminating refined sugar from your diet and embracing better nutrition to gain better health. In his debut book, Woodgate details what sugar really does to your body, how it is hidden in the foods you eat every day, and the cold hard truth about refined sugars. He also arms readers with important and shocking information, such as 72 variants of refined sugar included in our food, and how to watch out for them. Big culprits include: No Fat Yogurt (often loaded in sugar) and bread.
"Refined sugars are like a modern-day cigarette — their negative effects are finally being publicized and it's only a matter of time before they become regulated," says Woodgate. "But until then, consumers can take the power into their own hands and fight for their health. I feel strongly that the No Sugar In Me lifestyle will be one of the biggest health movements to date."
Also included are simple, but delicious, No Sugar Food Swaps, a special section on how to crush cravings and how to bring your kids into the no sugar lifestyle with you.
If Woodgate has his way, we'll start to scroll down the nutritional labels past the fat content on our food to see what sugars are hiding in plain sight.
Brad Woodgate is a self-made serial entrepreneur, who turned a thirty-thousand-dollar investment into over a billion dollars in sales. Having launched several successful companies over the past 21 years in the health and wellness space, he managed over 500 employees, launched over 700 products, and distributed to more than 50 countries. Through all of this, he learned what works in this space and what doesn't. Over the years, Brad also helped many people and celebrities reach their wellness goals. In 2015, based on his own health concerns, Brad took a very strong interest in the effects of refined sugar on our health. This led to the establishment of the No Sugar Company in early 2019, which has quickly disrupted the global food industry and is now one of the fastest growing food companies in North America.
SOURCE Brad Woodgate
CHPCA is inviting Canadians to shine a light on the people and issues that matter most
National Hospice Palliative Care Week 2021
OTTAWA, ON, April 27, 2021 /CNW/ - May 2nd – 8th , 2021, marks National Hospice Palliative Care Week. It is a time to celebrate and share the achievements of Hospice Palliative Care throughout the nation, look at shortcomings, and create bridges for these gaps. This year, the Canadian Hospice Palliative Care Association (CHPCA) will be taking a moment to memorialize those who have passed, as well as appreciate those who have made this hard year a little brighter by shining a light on those who matter to us most.
Whether it is our loved ones or those working and volunteering in the hospice palliative care field, CHPCA recognizes the efforts made this year and aims to shine a light on those who matter most. To brighten up these dark days, CHPCA is inviting Canadians to light their candlelight, porch light, or spotlight on May 7th between 7–8 PM in honour of the light of their lives.
From access, funding, advocacy, and awareness, CHPCA is bringing hospice palliative care issues to light with the help of their 2019–2022 Strategic Plan. CHPCA is inviting all Canadians to join them in writing a letter to a Member of Parliament about what issues matters to them most when it comes to hospice palliative care in Canada. Participants can download CHPCA's letter template here as well as resources to help draft a letter here.
Laurel Gillespie, CEO of CHPCA states that "Our loved ones, essential workers, volunteers, and hospice palliative care workers have been the shining lights throughout this dark year of uncertainty. As Canadians, we are coming together this National Hospice Palliative Care Week to show our gratitude for the sacrifices made, as we continue to advocate for progress in the field of hospice palliative care. By casting a light on people and issues that matter most to us, we are one step closer to making a difference. Alone we can light up a room—together we can light up the whole nation."
CHPCA has created a downloadable poster and a fact sheet that helps bring hospice palliative care issues to light. To continue the conversation online, social media users are invited to share the light of their lives by engaging with CHPCA's Facebook (CanadianHospicePalliativeCare) and Twitter (@CanadianHPCAssn) with the hashtag #TheLightOfMyLife.
National Hospice Palliative Care Week is coordinated by CHPCA. Funding for National Hospice Palliative Care Week is provided by GSK, Purdue, and Innovative Medicines Canada. For more information and downloadable resources for National Hospice Palliative Care Week, please visit chpca.ca/week.
The Canadian Hospice Palliative Care Association – the national voice for hospice palliative care in Canada – is dedicated to the pursuit of excellence in care for persons approaching death so that the burdens of suffering, loneliness and grief are lessened. The CHPCA operates in close partnership with provincial hospice palliative care organizations and other national organizations and continues to work to ensure "that all Canadians have access to quality hospice palliative care."
SOURCE Canadian Hospice Palliative Care Association
Shock and Denial Consume Parents of Addicts
“About Natalie is groundbreaking. It doesn’t preach or pretend to offer a panacea. Instead, it offers a refreshing, authentic look at one family’s struggle with addiction, easily the most powerful book published on the subject in the 21st century.”— Dr. Maryel McKinley PhD, Addictions Expert, Former Co-Host, “All Talk Recovery Radio,” Los Angeles, Arbitron rated No. 1 in Southern California
Pittsburgh, PA, April 27, 2021 — Like the band that played on as the Titanic sank, Christine Naman unpacked the groceries and made a meatloaf — the simple act of normalcy distracting her from an unthinkable reality: addiction was pulling her daughter under.
“Even with the picture of the situation coming more clearly into focus, I clung to denial like a kayaker who has been thrown from his boat would cling to a branch lying across the water,” Christine says. “It is amazing how deep into denial a person can go and how strongly they can hang onto it before reality smacks them around enough so that they let go.”
Christinetraces her daughter's years-long battle with addiction in About Natalie, a gripping, cautionary tale of how, in spite of a loving family and a comfortable life, a child can end up on the wrong path, meet the wrong people and get lost in the unthinkable.
About Natalie takes readers deep inside Christine’s emotional and mental turmoil as she grows into her new, unfortunate role as the parent of an addict. She steps on syringes left on the floor and wrestles one from the family dog’s mouth. She lives the nightmare of finding an unresponsive child on the floor and uses Narcan to revive her. She chases away a drug dealer and stays up all night waiting for her missing child to come home. She rejoices during periods of recovery and hope and is devastated during relapses. When her daughter suffers, Christine suffers right along with her.
Interwoven with Christine’s reflections are Natalie’s compelling poems that share her personal pain and the unvarnished truth of her struggle.
At its core, About Natalie is a story of fighting for — and right alongside — the ones we love, no matter how difficult the circumstances. It is a story of keeping the faith, battling hard and never giving up.
Bestselling author Christine Pisera Naman is a wife to a beautiful man named Peter and a mother to three fantastic kids named Jason, Natalie and Trevor. In her free time, she enjoys crocheting, which she does poorly; painting, again poorly; and volunteering at her local hospital, which she hopes she does well. She is the author of the Faces of Hope series of books that are now housed in the 9/11 Memorial Museum in New York City. Her other works include Caterpillar Kisses, Christmas Lights, The Novena and The Believers.About Natalie is her heart poured onto paper.
She hopes that by sharing her family’s difficult story she can bring understanding and knowledge to those who do not know the problem firsthand as well as provide comfort to those who know the nightmare of addiction all too well.
Revive Therapeutics Files for FDA Orphan Drug Designation for Psilocybin in Traumatic Brain Injury
TORONTO, April 27, 2021 (GLOBE NEWSWIRE) -- Revive Therapeutics Ltd. (“Revive” or the “Company”) (CSE: RVV, USA: RVVTF), a specialty life sciences company focused on the research and development of therapeutics for medical needs and rare disorders, is pleased to announce it has filed an application with the U.S. Food and Drug Administration ("FDA") to receive Orphan Drug Designation ("ODD") for Psilocybin to treat moderate to severe traumatic brain injury (“TBI”).
There are no FDA approved treatments for cognitive impairments due to TBI. Moderate to severe TBI is a subset of TBI and can lead to a physical, cognitive, emotional, and behavioral changes over the course of a person’s life. These changes may affect a person’s ability to function in their everyday life. Approximately 50% of people with severe TBI will experience further decline in their daily lives or die within 9 years of their injury. People with TBI are fifty times more likely to die from seizures and six times more likely to die from pneumonia.[1]
Psilocybin offers a potential solution to manage moderate to severe cases of TBI. Psilocybin has the potential with its neuroreparative effect to improve loss of cognitive function after TBI lessening disability. The clinical effect of psilocybin appears to be related to its attenuation of traumatically-induced glutamate excitotoxicity during the early post-injury period. In preclinical studies conducted at the National Health Research Institutes, which was part of the research program acquired from PharmaTher Holdings Ltd. (CSE: PHRM) (OTCQB: PHRRF), characterized the potential neuroreparative effect of psilocybin compared to being treated with a vehicle (saline) using a TBI mouse model. Adult mice were randomly assigned to 4 groups: (1) control, (2) TBI+vehicle, (3) TBI+low dose psilocybin, and (4) high dose psilocybin. Cognitive function was examined by the Morris water maze test after the injury. It was found that psilocybin, given after injury, improved cognitive function in TBI mice. Also, there were no adverse effects observed with psilocybin.
Michael Frank, CEO of Revive commented: “The FDA orphan drug application for psilocybin to treat moderate to severe TBI is an important milestone for Revive as we focus on building a robust product pipeline focused on novel uses and delivery forms of psilocybin to treat significant unmet medical needs. We are currently seeking to evaluate psilocybin in a clinical trial for moderate to severe TBI and advancing our development of a proprietary oral thin film psilocybin product for the potential treatment of certain neurological disorders, such as brain damage caused by all forms of TBI and stroke, and other related mental health and substance abuse disorders.”
The Orphan Drug Act grants special status to a drug or biological product to treat a rare disease or condition upon request of a sponsor. This status is referred to as orphan designation (or sometimes "orphan status"). The FDA grants ODD status to products that treat rare diseases, providing incentives to sponsors developing drugs or biologics. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States at any given time. ODD would qualify psilocybin for certain benefits and incentives, including seven years of marketing exclusivity if regulatory approval is ultimately received for the designated indication, potential tax credits for certain clinical drug testing costs, activities, eligibility for orphan drug grants, and the waiver of the FDA New Drug Application filing fee of approximately USD $2,400,000.
About Revive Therapeutics Ltd.
Revive is a life sciences company focused on the research and development of therapeutics for infectious diseases and rare disorders, and it is prioritizing drug development efforts to take advantage of several regulatory incentives awarded by the FDA such as Orphan Drug, Fast Track, Breakthrough Therapy and Rare Pediatric Disease designations. Currently, the Company is exploring the use of Bucillamine for the potential treatment of infectious diseases, with an initial focus on severe influenza and COVID-19. With its recent acquisition of Psilocin Pharma Corp., Revive is advancing the development of Psilocybin-based therapeutics in various diseases and disorders. Revive’s cannabinoid pharmaceutical portfolio focuses on rare inflammatory diseases and the company was granted FDA orphan drug status designation for the use of Cannabidiol (CBD) to treat autoimmune hepatitis (liver disease) and to treat ischemia and reperfusion injury from organ transplantation. For more information, visit www.ReviveThera.com.
Neither the Canadian Securities Exchange nor its Regulation Services Provider has reviewed or accepts responsibility for the adequacy or accuracy of this release.
Cautionary Statement
This press release contains ‘forward-looking information’ within the meaning of applicable Canadian securities legislation. These statements relate to future events or future performance. The use of any of the words “could”, “intend”, “expect”, “believe”, “will”, “projected”, “estimated” and similar expressions and statements relating to matters that are not historical facts are intended to identify forward-looking information and are based on Revive’s current belief or assumptions as to the outcome and timing of such future events. Forward looking information in this press release includes information with respect to the the Company’s cannabinoids, psychedelics and infectious diseases programs. Forward-looking information is based on reasonable assumptions that have been made by Revive at the date of the information and is subject to known and unknown risks, uncertainties, and other factors that may cause actual results or events to differ materially from those anticipated in the forward-looking information. Given these risks, uncertainties and assumptions, you should not unduly rely on these forward-looking statements. The forward-looking information contained in this press release is made as of the date hereof, and Revive is not obligated to update or revise any forward-looking information, whether as a result of new information, future events or otherwise, except as required by applicable securities laws. The foregoing statements expressly qualify any forward-looking information contained herein. Reference is made to the risk factors disclosed under the heading “Risk Factors” in the Company’s annual MD&A for the fiscal year ended June 30, 2020, which has been filed on SEDAR and is available under the Company’s profile at www.sedar.com.
Memoir Details Author’s Journey with Mental Illness and Disability
Long Island, NY, April 27, 2021 – As we enter Mental Health Awareness month, one author and artist is sharing her coming-of-age story through the lenses of mental illness, disability and steadfast determination. Long Island native Ruth Poniarski’s first book, Journey of the Self: Memoir of an Artist, published by Charlotte, North Carolina-based Warren Publishing, is a stunning and unflinchingly-honest memoir that challenges the stigmas placed on mental illness. The book has received glowing reviews, including a Kirkus Star review.
It started as a college prank; a friend offered Ruth Poniarski a brownie that, unbeknownst to her, was laced with angel dust. What resulted was a debilitating accident, and the first of many mental breakdowns that spiraled into diagnoses of psychosis, schizophrenia, severe anxiety and bipolar disorder.
For years, Poniarski struggled to cope with her new reality as she undertook a rigorous architectural program, sought out new friends (and the perfect mate) and battled through the depths of mental illness. Her journey led her in all directions as she sought comfort, solace, stability and love.
Now an accomplished artist, Poniarski considers her memoir to be a portrait of sorts.
“This book, like many of my paintings, is about introspection,” she says. “So many of us, particularly when we’re young, seek definition through labels or through what others think of us. It’s so easy to say, ‘I have bipolar disorder, therefore, X,’ or, ‘So and so doesn’t love me the way I love him, therefore, Y.’ But none of that is who we truly are.”
The release of Poniarski’s memoir is particularly timely in light of the coronavirus pandemic and social distancing orders.
“A lot of people are stuck at home right now. This kind of isolation forces a person to examine themselves; what makes them unique beyond who they are to society,” says Poniarski. “That kind of self-reflection allows us to become more available to others. You have to know yourself first.
“So, who am I?” Poniarski laughs. “Well … you’ll just have to read the book!”
For more information about Ruth Poniarski or her book, please visit: ruthponiarski.com.
Roasted Bean Box Launches World's First Data-driven Coffee Subscription in Montreal
Coffee lovers can get the flavors of the world customized to their exact taste preferences and delivered right to their door with Roasted Bean Box’s new subscription service.
MONTREAL, April 27, 2021 (GLOBE NEWSWIRE) -- Roasted Bean Box, a hot new subscription coffee delivery startup, has launched and is brewing up a storm of caffeinated flavor for its members by offering organic data-driven taste personalization.
Coffee consumers who want to enjoy fresh new coffee varieties without having to hunt for exactly the tastes they most like can leverage Roasted Bean Box’s proprietary preference analysis tools. These work their magic to let each customer enjoy scheduled deliveries of asserted roasts and blends matched to what they most enjoy without the need to mix and match on their own.
A customer's journey begins online with questions about their preferred coffee quantity, roast preferences, bean preparation and whether they want their deliveries on a Wednesday or a Friday.
From there, each customer’s exploratory journey continues with the delivery of 2 single origin coffees in 170g or 340g bag choices offered each month. As they receive their coffees, customers rate each through their personalized dashboard that lets Roasted Bean Box map out the clients own coffee profile. Within 3 to 4 months, this refinement lets customers receive only single origin and personalized blend arabica beans that they’re sure to fall in love with.
Roasted Bean Box uses its data-driven analysis and ratings tools that are created from customers feedback to lead towards what they’ll enjoy most. The unique customer dashboard develops organically over time based on their own ratings of their increasingly refined coffee profile. In-house roasters use these same data points and tools to create their world-spanning selections of unique and refined flavors.
Members of the new subscription service can keep their relationship with Roasted Bean Box flexible at all times, being able to manage their deliveries directly from their online account.
The rating system itself is as simple and easy as can be, letting customers select each coffee they receive as “perfect”, “great”, “good” or “dislike”. Roasted Bean Box takes over from this to keep refining personalized recommendations for each customer.
Happy client reviews for the young company's coffee and service are already piling up on Trustpilot, with one example among many showing typical satisfaction:
“Love it so far, can't wait to see my taste profile and understand exactly what it is I like with every coffee.”
Roasted Bean Box, or RBB, also shows its commitment to the environment through its local delivery, green packaging and reusable option for its shipping box. Currently, the startup’s service area covers much of the Greater Montreal Area, including Montreal Island, Brossard, Laval and Longueuil. Members receive their locally and freshly roasted coffees - the roast date is indicated on the package - in fully compostable bags, and subscribers who return their delivery box for reuse get a $1 discount per return off their monthly subscription. On Earth Day 2021, Roasted Bean Box made an additional commitment to show its care for nature by pledging 1% of its annual sales to fund the science-based environmental projects of the David Suzuki Foundation.
Roasted Bean Box’s vision to offer a highly personalized experience while being environmentally-friendly wouldn’t have been complete without offering an affordable price to consumers, with subscriptions starting at just $16.95 for their “One person” option, or 2 x 170g bags of coffee. The e-commerce startup made this possible by roasting coffees in-house and delivering directly to consumers.
Coffee lovers in Montreal who want to sign up and explore the flavorful coffee roasts crafted just for them by Roasted Bean Box can sign up at any time through the website. No long-term commitment is needed.
AA Pharma Strengthens its Support of Canadian Clozapine Patients With Exclusive Rights to Blood Analyzer
Health Canada Approval Enables Quick and Accurate Blood Testing
TORONTO, April 27, 2021 /CNW/ - AA Pharma, a Canadian company focused on legacy pharmaceutical products, has secured the exclusive Canadian rights for the use of a blood analyzer for patients prescribed Clozapine. This medication, indicated for patients with Treatment Resistant Schizophrenia, requires regular blood monitoring. Blood Analyzer Complete Blood Count Blood Diagnostics
Sight DiagnosticsⓇ received Health Canada approval for its Sight OLOⓇ analyzer, which performs Complete Blood Count (CBC) tests, the most commonly ordered blood test because it offers insight into the status of a patient's overall health. The analyzer leverages a patented method of "digitizing" blood samples and is built with high-powered microscopes, computer vision, and artificial intelligence, providing accurate results in minutes with only two drops of blood. It is also the first CBC analyzer that is FDA 510(k) cleared for blood taken directly from either a finger prick or a venous sample.
AA Pharma is collaborating with Inter Medico, a distributor of medical devices, to place Sight OLO analyzers in labs across Canada. "There is significant underutilization in this patient population because of barriers to treatment, including the requirement for regular blood monitoring," said Geoffrey Johnson, AA Pharma's Director, Sales & Marketing. "We are pleased to help bring Sight OLO to Canadian patients which requires less blood than traditional methods and delivers lab-grade results rapidly, enabling health care providers to make quick and informed treatment decisions."
The results can be securely transferred to healthcare providers and both Electronic Health and Medical Records. Results can also be securely shared with AA Pharma's patient registry, a Health Canada requirement, to ensure ongoing monitoring of patients' health while taking clozapine. AA Pharma's AASPIRE Patient Care Network, also provides tools and resources to further support Canadian Schizophrenia patients and their caregivers.
About AA Pharma AA Pharma is a Canadian company focused on legacy pharmaceutical products. Legacy pharmaceuticals are drug products with well-established efficacy and safety profiles and years of real-world experience. AA Pharma manufacturers over 80 treatments in a range of therapeutic areas. Learn more at www.aapharma.ca
About Sight Diagnostics
Founded in 2011, Sight Diagnostics aims to transform health systems and patient outcomes through fast, accurate and convenient blood diagnostic testing. Sight's technology, developed over a decade of research, represents breakthrough innovations in diagnostic methodology. The company has a rapidly growing presence in the UK, the US and Israel. Learn more at www.SightDX.com
About Inter Medico Inter Medico specializes in providing leading edge instrumentation and reagent solutions to Canadian customers with over 40 years of experience. The company is positioned to offer products from multiple strategic partners to provide creative and effective solutions. Learn more at http://www.inter-medico.com
SOURCE AA Pharma Inc.
Alberta sites join network of certified centres to deliver CAR-T therapy, Kymriah® (tisagenlecleucel)
Expansion of treatment centre network includes two specialized centres in Alberta certified to deliver Kymriah to Canadian patients with relapsed/refractory (r/r) pediatric and young adult B-cell ALL and adult r/r DLBCL
Alberta joins Quebec and Ontario to reimburse Kymriah therapy for these life-threatening cancers for patients who are in critical needii
Kymriah indication now extended for pediatric patients younger than 3 years of age for the treatment of r/r B-cell ALLi
DORVAL, QC, April 28, 2021 /CNW/ - Novartis Pharmaceuticals Canada Inc. is pleased to announce that two centres in Alberta have been certified in accordance with applicable requirements, making Kymriah® (tisagenlecleucel) available to certain leukemia and lymphoma patients. Patients with relapsed/refractory (r/r) pediatric and young adult B-cell acute lymphoblastic leukemia (ALL) and adult r/r diffuse large B-cell lymphoma (DLBCL) will be eligible for treatment with Kymriah, the first of its kind chimeric antigen receptor T cell (CAR-T) therapy. This news follows a decision by the Alberta government to reimburse Kymriah; the third Canadian province to implement funding for Kymriah, following Quebec and Ontario.
"This is the news Western Canada has been waiting for. The patients who can be treated with Kymriah are the Canadians who have run out of options and are desperate for hope. This is wonderful news for them," said Dr. Mona Shafey, hematologist-oncologist, Alberta Health Services, Calgary. "We are delighted our institution has received certification and are thrilled to be part of the CAR-T treatment network. Patients can now also be treated closer to home which is what anyone would want."
Joining the specific network of Canadian treatment centres to offer Kymriah are Alberta Children's Hospital, Tom Baker Cancer Centre and Foothills Medical Centre in Calgary. Novartis is committed to build a strong Canadian network of certified, FACT-accredited (Foundation for the Accreditation of Cellular Therapy) sites and provide equity of care across the country.
"Novartis welcomes the centres in Alberta to the network and applauds the Alberta government for its decision to make Kymriah accessible to patients in need. We will continue to live up to our promise to make our life changing therapies available and accessible. This means remaining focused on building a national network of certified sites and collaborating with governments in other provinces to meet the needs of more Canadians," said Christian Macher, Country President & General Manager, Oncology, Novartis Pharmaceuticals Canada Inc. "We are proud to have provided Kymriah as a treatment option to more than 100 pediatric and adult Canadians. It is so rewarding to hear the stories of hope across different age groups, and that we are reaching patients who are most in need of Kymriah."
Kymriah is a one-time treatment that uses a patient's own T cells to identify and kill cancer cells. This unique approach to fighting cancer puts the patient at the centre of the process and its delivery to patients requires collaboration among many different stakeholders.
"This truly is good news for young Canadians living in the West. If you have ever had the opportunity to drive across Canada, you know two things; our country is breathtaking and big. When you have a child with cancer, the option to be treated closer to home and your support network is an incredible gift," said Chris Collins, Chair, Ac2orn. "We were also pleased to learn that Health Canada has expanded the age for treatment with Kymriah to now include an even younger pediatric population. This is testament to the positive outcomes we are seeing with CAR-T therapy."
Due to the sophisticated and individualized nature of Kymriah, treatment sites must be qualified to perform intravenous infusion of stem cells collected from the bone marrow of a donor, also referred to as allogeneic hematopoietic stem cell transplantation (alloSCT) and have experience with cell therapies and treating leukemia and lymphoma to facilitate safe and seamless delivery of Kymriah to eligible patients.
About Kymriah® Kymriah® (tisagenlecleucel), a CD19-directed genetically modified autologous T-cell immunocellular therapy, is a one-time treatment approved to treat two life-threatening cancers that have limited treatment options and historically poor outcomes, addressing a critical need for new therapies for these patients.
Kymriah is approved by Health Canada for use in pediatric and young adult patients 25 years and younger of age with B-cell acute lymphoblastic leukemia (ALL) who are refractory, have relapsed after allogenic stem cell transplant (SCT) or are otherwise ineligible for SCT, or have experienced second or later relapse; and for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphomai.
Kymriah® (tisagenlecleucel) Important Safety Information The full prescribing information for Kymriah® can be found at: www.novartis.ca
Novartis Leadership in Cell and Gene Therapy Novartis is at the forefront of investigational immunocellular therapy and was the first pharmaceutical company to significantly invest in CAR-T research, work with pioneers in CAR-T and initiate global CAR-T trials. Active research programs are underway targeting other hematologic malignancies and solid tumors, and include efforts focused on next generation CAR-Ts that involve simplified manufacturing schemes and gene edited cells.
About Novartis Pharmaceuticals Canada Novartis Pharmaceuticals Canada Inc., a leader in the healthcare field, is committed to the discovery, development and marketing of innovative products to improve the well-being of all Canadians. In 2020, the company invested $45 million in research and development in Canada. Located in Dorval, Quebec, Novartis Pharmaceuticals Canada Inc. employs approximately 1,000 people in Canada and is an affiliate of Novartis AG, which provides innovative healthcare solutions that address the evolving needs of patients and societies. For further information, please consult www.novartis.ca.
About Novartis Novartis is reimagining medicine to improve and extend people's lives. As a leading global medicines company, we use innovative science and digital technologies to create transformative treatments in areas of great medical need. In our quest to find new medicines, we consistently rank among the world's top companies investing in research and development. Novartis products reach nearly 800 million people globally and we are finding innovative ways to expand access to our latest treatments. About 110,000 people of more than 140 nationalities work at Novartis around the world. Find out more at https://www.novartis.com.
References
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Novartis Pharmaceuticals Canada Inc., Kymriah® Product Monograph. December 24, 2020.
Trillium Therapeutics Provides Data Update, Announces Phase 1b/2 Program Priorities Across Hematologic Malignancies and Solid Tumors, and Reports Governance Changes
TTI-622 monotherapy shows 33% objective response rate (ORR) in relapsed/refractory (R/R) lymphomas at 0.8-18 mg/kg doses, including 3 new responses (1 Complete Response (CR) + 2 Partial Responses (PRs)) since last data disclosure;
TTI-621 monotherapy shows 18-29% ORR in R/R T- and B-cell lymphomas at 0.2-2.0 mg/kg doses, including 3 new responses (1 CR + 2 PRs) in cutaneous T-cell lymphoma (CTCL) since last data disclosure;
TTI-622 and TTI-621 have been well tolerated at doses up to 18 mg/kg and 2.0 mg/kg weekly, respectively; neither drug candidate reached a maximum tolerated dose (MTD) level;
Phase 1b/2 program across seven hematologic and solid tumor indications has been initiated, with studies across nine patient settings to start over approximately the next twelve months;
Scott Myers joins the Board of Directors; Robert Kirkman and Tom Reynolds retire from the Board of Directors; Tom Reynolds to focus on SAB and senior advisor roles.
CAMBRIDGE, Mass., April 28, 2021 (GLOBE NEWSWIRE) -- Trillium Therapeutics Inc. (NASDAQ/TSX: TRIL), a clinical stage immuno-oncology company developing innovative therapies for the treatment of cancer, today provided a data update, announced Phase 1b/2 program priorities across seven hematologic and solid tumor indications, and reported governance changes with its Board of Directors.
“We have reached a critical milestone in Trillium’s evolution,” said Jan Skvarka, Trillium’s President and CEO. “We have built a robust foundation for advancing into a Phase 1b/2 program – a foundation of two highly differentiated CD47 assets with monotherapy proof-of-concept across several lymphoma indications. Our new data further solidify our position in the CD47 field as having potentially class-leading single agent activity with both TTI-622 and 621, as well as potentially best-in-class tolerability with TTI-622. Furthermore, we are particularly excited to observe substantial anti-tumor activity in the skin of our CTCL patients, which suggests that TTI-622 and 621 have the ability to exit blood circulation and penetrate skin tumors, thus underscoring the potential of both drug candidates to treat solid tumors. Finally, new translational data suggest that natural killer cell engagement plays a key role in what we believe is TTI-621’s mechanism of action, thus further differentiating TTI-621 in the CD47 field.”
“We are now rapidly advancing into a Phase 1b/2 program, with multiple shots on goal – two drug candidates, seven target indications, multiple drug combinations – in patients with hematologic malignancies and solid tumors,” added Ingmar Bruns, Chief Medical Officer. “Over the next twelve months, we expect to initiate studies across nine patient settings. The pipeline represents a portfolio of different risk-reward opportunities, multiple potentially accelerated regulatory paths to market, and a total addressable US patient population of over 30,000 patients in our entry settings. In parallel, we are continuing to evaluate less frequent dosing regimens than our current weekly dosing. This is supported by pharmacokinetic data, and, in the case of TTI-622, clinical experience with two CR patients who are on every three- and four-week dosing schedules.”
“On a more personal note, as we are announcing governance changes, we would like to thank Bob Kirkman for his invaluable contributions over his eight-year tenure with Trillium as a Board member, including periods when he held Chair and Executive Chair roles,” said Dr. Skvarka. “Bob has played a pivotal role in transitioning the CEO leadership in 2019, and positioning the company for our subsequent transformation program in 2020. Trillium would not be where it is today without Bob’s leadership, hands-on contributions and personal sacrifices. We will sorely miss Bob, and wish him all the best as he scales down his professional commitments.”
TTI-622 Study Update
As of the data cutoff date of April 12, 2021, a total of 42 patients have been enrolled in the ongoing open-label Phase 1 dose escalation study of TTI-622 in patients with R/R lymphoma (NCT03530683). Patients received weekly intravenous doses between 0.05 and 18 mg/kg. All dose levels were very well-tolerated and an MTD was not reached. Adverse events (AEs) were predominantly Grade 1-2; related AEs ≥Grade 3 were neutropenia (9%), thrombocytopenia (5%) and anemia (2%). Pharmacokinetic data demonstrated dose-proportional increases in drug exposure between 8 and 18 mg/kg, and support evaluating less frequent dosing. Objective responses were achieved in 9 of 27 (33%) heavily pre-treated response-evaluable patients at dose levels ≥0.8 mg/kg, and included 2 CRs and 7 PRs. Three responses (1 CR and 2 PRs) at 12 and 18 mg/kg were obtained since the last data disclosure at the American Society of Hematology (ASH) 2020 Annual Meeting. All responses occurred within the first eight weeks of treatment across multiple lymphoma indications. One CR patient (0.8 mg/kg dose level) has been on study for more than 22 months and was transitioned to monthly dosing. The second CR patient (18 mg/kg) achieved a response after receiving only two doses with a 4-week dosing interval and is being maintained on every three weeks (Q3W) dosing. The study is continuing, with 3 more patients at 18 mg/kg pending response assessments as of the April 12, 2021 cutoff date.
TTI-621 Study Update
We have provided a further update on the safety data and anti-tumor activity observed in the ongoing open-label Phase 1 dose escalation study of intravenous TTI-621 in patients with R/R hematologic malignancies (NCT02663518). The study consists of four parts: (a) “Parts 1-3” in hematologic malignancies, with dosing up to 0.5 mg/kg weekly, now complete; and (b) “Part 4” in CTCL, with dosing at 0.5 mg/kg weekly and higher, currently ongoing. As of the data cutoff date of April 12, 2021, TTI-621 was well-tolerated and an MTD in Part 4 was not reached. Across Parts 1-4, the most common treatment-related AEs ≥Grade 3 were thrombocytopenia (22%), which was transient and not dose-limiting, anemia (8%), neutropenia (6%), and infusion-related reactions (4%), which occurred mostly at the first dose and were effectively managed by prophylactic treatment. Monotherapy activity was observed in CTCL (19% ORR, n=62), peripheral T-cell lymphoma (18% ORR, n=22) and diffuse large B-cell lymphoma (DLBCL) (29% ORR, n=7). Three responses (1 CR and 2 PRs) in CTCL patients treated at 1.4 and 2.0 mg/kg were obtained since the last data disclosure at ASH 2020. Emerging translational data from patient samples suggest that NK cell activation plays a key role in the anti-tumor activity of TTI-621, in addition to inhibition of the “don’t eat me” signal and delivery of a pro-phagocytic signal. This highly differentiated proposed mode of action, together with encouraging monotherapy activity and good tolerability, prompt continued and focused further investigation of TTI-621. The study is continuing, with 3 more patients at 2.0 mg/kg pending response assessments as of the April 12, 2021 cutoff date.
Phase 1b/2 Program
Based on the strong and differentiated foundation that Trillium has built, including potentially class-leading monotherapy activity, the Company is initiating Phase 1b/2 programs with both TTI-622 and TTI-621. These programs will initially cover seven indications (four hematological cancers, three solid tumors), and study TTI-622 and TTI-621 primarily in combination with other anti-cancer agents.
Specifically, TTI-622 will be evaluated in the following settings and combination regimens:
R/R multiple myeloma, in a combination with carfilzomib + dexamethasone;
First line p53 mutant acute myeloid leukemia (AML), in a combination with azacitidine;
First line elderly or unfit p53 wild type AML patients, in a combination with azacitidine and venetoclax;
R/R DLBCL, in a combination with anti-PD-1, in an investigator-sponsored trial at Mayo Clinic;
Platinum-resistant ovarian cancer, in a combination with chemotherapy; and
A second solid tumor combination study to be announced later this year.
These studies will be initiated with 8 mg/kg weekly dosing, or potentially less frequent dosing regimens at higher doses.
The Phase 1b/2 program for TTI-622 has now been initiated with the dosing of a first multiple myeloma patient with TTI-622 in a combination with carfilzomib + dexamethasone. Both AML cohorts are open for enrollment, and we expect the first patients to be dosed this quarter.
TTI-621 will be evaluated in the following settings and combination regimens:
Second line peripheral T-cell lymphoma (PTCL), as a TTI-621 monotherapy;
R/R DLBCL, in a combination with anti-PD-1, in an investigator-sponsored trial at Mayo Clinic; and
First line leiomyosarcoma, a subtype of soft tissue sarcoma, in a combination with doxorubicin.
Initial Phase 1b/2 studies will be initiated at two dose levels (0.2 mg/kg and up to 2.0 mg/kg weekly); different levels may be chosen based on overlapping toxicities with combination agents.
In addition, bi-weekly (Q2W) and Q3W dosing schedules will be evaluated for each molecule in the ongoing monotherapy dose escalation studies.
Governance Update
Effective April 28, 2021, Scott Myers is joining the Board of Directors. Scott is an accomplished executive who brings to the Board nearly three decades of pharmaceutical and medical device industry experience. Previously, he served as CEO of AMAG Pharmaceuticals, Rainier Therapeutics, Cascadian Therapeutics, and Aerocrine AB. He currently serves on the Boards of Directors of Selecta Biosciences and Harpoon Therapeutics. We are very excited that Scott has agreed to join the Board, and look forward to benefitting from his extensive executive experience and track record of building successful biotechnology companies.
Robert Kirkman elected to retire from the Board of Directors, effective April 28, 2021. Robert has served as a director since December 2013, the Chair of the Board since March 2019, and acted as the Executive Chair from April 2019 to March 2020.
As previously announced, Tom Reynolds joined our scientific advisory board (SAB) in November 2020. Due to the resulting loss of his independent status as a Board member, Tom is now (effective April 28, 2021) retiring from the Board to focus on the SAB role, as well as to serve as a senior advisor to assist with initiation of our extensive Phase 1b/2 program and a scale-up of the clinical development organization.
Upcoming Milestones and Guidance
In 2021, Trillium expects two data updates:
TTI-622 data update from the ongoing dose escalation study in R/R lymphomas at a medical conference in 4Q 2021; and
TTI-621 data update from the ongoing dose escalation study in R/R CTCL at a medical conference in 4Q 2021.
Over approximately the next twelve months, the Company plans to initiate studies in the following indications and patient settings:
TTI-622 + azacitidine combination in p53 mutant AML patients in 2Q 2021 (enrollment open);
TTI-622 + azacitidine + venetoclax combination in elderly or unfit p53 wild type AML patients in 2Q 2021 (enrollment open);
TTI-622 + chemotherapy combination in platinum-resistant ovarian cancer patients in 2H 2021;
TTI-622 combination study in a to-be-announced solid tumor indication in 1H 2022;
TTI-622 + anti-PD-1 and TTI-621 + anti-PD-1 in DLBCL patients in 4Q 2021 to 1H 2022 (investigator-sponsored trial);
TTI-621 monotherapy study in PTCL in 3Q 2021; and
TTI-621 + doxorubicin combination in leiomyosarcoma in 3Q 2021.
As all of the above studies are open-label trials, the Company expects a robust flow of new data updates and multiple catalysts in 2022, in addition to the above mentioned updates from the continuing dose escalation studies in the fourth quarter of 2021.
As of March 31, 2021, Trillium had $276 million in cash, cash equivalents, and marketable securities, sufficient to fund operations and the above outlined clinical development priorities into 2023.
Trillium is an immuno-oncology company developing innovative therapies for the treatment of cancer. The company’s two clinical programs, TTI-622 and TTI-621, target CD47, a “don’t eat me” signal that cancer cells frequently use to evade the immune system.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and applicable United States federal securities laws and forward-looking information within the meaning of Canadian securities laws (collectively, "forward-looking statements"). The use of words such as "may," "will," "could", "should," "expects," "intends," "plans," "anticipates," "believes," "estimates," "predicts," "projects," "seeks," "endeavor," "potential," "continue" or the negative of such words or other similar expressions can be used to identify forward-looking statements. Forward-looking statements in this press release include, but are not limited to, express or implied statements regarding the therapeutic potential and monotherapy activity of our programs, our clinical development plans and our expectations with respect to the timing of clinical development milestones, including with respect to initiating Phase 1b/2 studies in hematological and solid tumor malignancies, the expected timing of the release of further data on Trillium’s TTI-622 and TTI-621 studies, and our expected cash runway. With respect to the forward-looking statements contained in this press release, Trillium has made numerous assumptions regarding, among other things: the impact of the COVID-19 pandemic on its operations, the effectiveness and timeliness of preclinical and clinical trials; and the completeness, accuracy and usefulness of the data. While Trillium considers these assumptions to be reasonable, these assumptions are inherently subject to significant scientific, business, economic, competitive, market and social uncertainties and contingencies. Additionally, there are known and unknown risk factors that could cause Trillium's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained in this press release. A discussion of risks and uncertainties facing Trillium appears in Trillium's Annual Report on Form 10-K for the year ended December 31, 2020, with the U.S. Securities Exchange Commission, each as updated by Trillium's continuous disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Trillium disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
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