Amgen Highlights the Versatility of the BiTE® Immuno-Oncology Platform in Multiple Tumour Types at ASCO 2019
Updated Phase 1 Data of Investigational AMG 420 in Relapsed and/or Refractory Multiple Myeloma Highlighted in Oral Presentation and Accepted for Best of ASCO®
Investigational AMG 212 (Pasotuxizumab) Phase 1 Study Explores Use of BiTE Platform in a Solid Tumour
MISSISSAUGA, ON, June 5, 2019 /CNW/ - Amgen (NASDAQ:AMGN) today announced new data from Phase 1 studies evaluating investigational bispecific T cell engager (BiTE®) molecules were presented at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago. Data presented included updated investigational AMG 420 results in patients with relapsed and/or refractory multiple myeloma (R/R MM), as well as initial results from the investigational AMG 212 (pasotuxizumab) first-in-human trial in patients with metastatic castration-resistant prostate cancer (mCRPC). BiTE technology is a targeted immuno-oncology platform that is designed to engage patients' own T cells to a tumour-specific antigen, activating the cytotoxic potential of T cells. Both products are investigational only and are not currently approved in any country.
"Our BiTE immuno-oncology platform offers unique versatility, with the potential to treat various tumours through targeting tumour-associated antigens," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "As a leader in the development of targeted immuno-oncology therapies, we continue to investigate and advance more than a dozen BiTE molecules across a broad range of hematologic malignancies and solid tumours. These data at the ASCO Annual Meeting reinforce the potential of BiTE technology for difficult-to-treat cancers like multiple myeloma and prostate cancer."
ASCO Annual Meeting Abstract #8007: Evaluation of AMG 420, An Anti-BCMA Bispecific T Cell Engager (BiTE) Immunotherapy, In R/R Multiple Myeloma (MM) Patients: Updated Results of a First-in-Human (FIH) Phase 1 Dose-Escalation Study
Updated results from a Phase 1, first-in-human dose-escalation trial of investigational AMG 420, a B-cell maturation antigen (BCMA)-targeting BiTE molecule, in patients with R/R MM were shared during an oral presentation at the ASCO Annual Meeting. This abstract was also selected for inclusion in the Best of ASCO® educational program. The objectives of the study included assessment of the safety, tolerability and anti-tumour activity of AMG 420 per International Myeloma Working Group 2006 Uniform Response Criteria for Multiple Myeloma. In the study, 42 patients with R/R MM who had progression after at least two prior lines of treatment (including a proteasome inhibitor and an immunomodulatory drug) received AMG 420 at varying doses [0.2 to 800 µg/day (d)]. Of the doses tested in this study, 400 µg/d was the maximum tolerated dose (MTD).
As of the latest readout, AMG 420 induced clinical responses in 13 of 42 patients across the dosing cohorts. Of the six patients that achieved a minimal residual disease (MRD)-negative complete response (CR), five were treated at the 400 µg/d dose. In addition, at the 400 µg/d dose, one patient achieved a very good partial response, and one achieved a partial response. The overall response rate at 400 µg/d was 70 per cent (7/10). The median duration of response was nine months (range 5.8-13.6 months). Median time to response was one month, with 11 of 13 patients responding in the first cycle.
Serious adverse events (AEs) were reported in 19 patients (45 percent). Sixteen required hospitalization and four had prolonged hospitalization. No grade 3 or 4 central nervous system toxicities were observed. Serious AEs occurring in more than one patient included infections (n=13) and peripheral polyneuropathy (n=2). Treatment-related serious AEs included polyneuropathy (n=2, both grade 3) and edema (n=1, grade 3). Grade 3 cytokine release syndrome (CRS) was seen in one patient. Two patients died during the study from AEs not considered treatment-related. One patient died from acute respiratory distress due to concurrent flu and aspergillosis. The second patient died from liver failure secondary to a viral infection during the course of treatment.
ASCO 2019 Abstract #5034: Phase 1 Study of Pasotuxizumab (BAY 2010112), a PSMA-targeting BiTE (Bispecific T Cell Engager) Immunotherapy for Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Initial results from a Phase 1 dose-escalation study of investigational AMG 212 (pasotuxizumab, formerly known as BAY 2010112), in patients with mCRPC who are refractory to standard therapy were presented in a poster at the ASCO Annual Meeting. AMG 212 is an investigational BiTE molecule which is designed to target prostate-specific membrane antigen (PSMA), a promising target in mCRPC. In the trial, 16 patients with mCRPC were enrolled into five dosing cohorts, with a target dose range of 5 to 80 µg/d delivered by continuous intravenous infusion. The primary objective was to determine safety and MTD and secondary objectives included pharmacokinetics (PK), biomarkers and tumour response. Antitumour activity as indicated by decline in serum level of prostate-specific antigen (PSA) was dose dependent. PSA decreases of ≥ 50 percent occurred in three patients (n=1 each in 20 µg/d, 40 µg/d and 80 µg/d cohorts). One long-term responder was treated for 14 months (40 µg/d) and one for 19.4 months (80 µg/d). The latter patient showed a complete regression of soft-tissue metastases and regression of bone metastases, as well as an improvement in disease-related symptoms. Recruitment in the trial was stopped before MTD was reached to facilitate initiation of a new study sponsored by Amgen.
"Metastatic castrate-resistant prostate cancer is considered a heterogenous disease and despite advances made over the last few years, the majority of patients face a poor outlook1," said Horst-Dieter Hummel, M.D., University Hospital of Wuerzburg, Germany, and AMG 212 clinical study investigator. "In the first clinical study investigating the potential of a BiTE molecule in solid tumours, AMG 212 showed clinical activity, including two long-term responders. We look forward to studying AMG 212 further in this patient population."
The most common drug-related AEs were fever (94 percent, n=15) and chills (69 percent, n=11). A drug-related serious AE (fatigue) was reported in one patient. CRS was reported for three patients (19 percent); two were grade 2 and one was grade 3. No grade 5 AEs occurred.
Additional Updates on Amgen's BiTE Immuno-Oncology Platform at ASCO 2019
Amgen continues to investigate the BiTE immuno-oncology platform across a broad range of solid and hematologic malignancies. Amgen is investigating more than a dozen BiTE molecules across a range of solid and hematologic malignancies, with an additional two trials-in-progress being presented at the ASCO Annual Meeting.
During poster sessions, researchers shared information on the studies of AMG 596, an investigational BiTE molecule targeting epidermal growth factor receptor variant III (EGFRvIII) in glioblastoma (GBM), and AMG 757, an investigational BiTE molecule targeting delta-like ligand 3 (DLL3) in small-cell lung cancer (SCLC). GBM and SCLC are both aggressive and difficult-to-treat forms of cancer where there is a significant unmet medical need for patients.
Forty-three percent of GBM tumours test positive for amplification or mutation of the EGFR, the most common of which is the EGFRvIII gain-of-function mutation.2 A Phase 1, first-in-human, open-label, sequential dose-escalation and dose-expansion study is ongoing for investigational AMG 596, evaluating its safety, tolerability, and PK and pharmacodynamics in patients with EGFRvIII-postive glioblastoma. The study is expected to enroll 82 patients in two groups: one with recurrent GBM and a second in newly diagnosed patients in the maintenance treatment phase following standard of care treatment.
DLL3 is an inhibitory ligand of notch receptors that is expressed in most SCLC tumours but minimally expressed in normal tissues.3 An ongoing open-label, ascending, multiple-dose, Phase 1 study is evaluating investigational AMG 757 in adult patients with SCLC which has progressed or recurred after at least one platinum-based chemotherapy regimen. Primary objectives are to evaluate safety and tolerability and to determine the MTD or recommended Phase 2 dose. Secondary objectives are to characterize PK and evaluate preliminary anti-tumour activity.
For more information on these and other ongoing clincial trials, visit www.AmgenTrials.com.
About BiTE® Technology
BiTE® (Bispecific T cell engager) technology is a targeted immuno-oncology platform that is designed to engage patients' own T cells to any tumour-specific antigen, activating the cytotoxic potential of T cells with the goal of eliminating detectable cancer. The BiTE immuno-oncology platform has the potential to treat different tumour types through tumour-specific antigens. The BiTE platform has the goal of off-the-shelf solutions, which have the potential to make innovative T cell treatment available to all providers when their patients need it. Amgen is advancing more than a dozen BiTE molecules across a broad range of solid and hematologic malignancies, further investigating BiTE technology with the goal of enhancing patient experience and therapeutic potential.
About Amgen Canada
As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ont.'s vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new ways of using existing medicines in partnership with many of Canada's leading health-care, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca.
Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen Inc. and its subsidiaries. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen Inc., including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products (including products of our wholly-owned subsidiaries) are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to acquire other companies or products and to integrate the operations of companies we have acquired may not be successful. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. We are increasingly dependent on information technology systems, infrastructure and data security. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock.
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by the U.S. Food and Drug Administration, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.
References
1.
Moreira DM, Howard LE, Sourbeer KN, et al. Predicting time from metastasis to overall survival in castration-resistant prostate cancer: Results from SEARCH. Clin Genitourin Cancer. 2017;15(1):60–66.
2.
Westphal M, Maire CL, Lamszus K. EGFR as a target for glioblastoma treatment: An unfulfilled promise. CNS Drugs. 2017;31(9):723-735.
3.
Saunders LR, Bankovich AJ, Anderson WC, et al. A DLL3-targeted antibody-drug conjugate eradicates high-grade pulmonary neuroendocrine tumour-initiating cells in vivo. Sci Transl Med. 2015;7(302):1-13.
SOURCE Amgen Canada
Amgen Announces First Clinical Data Evaluating Investigational KRAS(G12C) inhibitor AMG 510 at ASCO 2019
AMG 510 is the First KRASG12C Inhibitor to Reach Clinical Stage After Three Decades of RAS Research
First-In-Human Results Show Preliminary Data and Anti-Tumour Activity in KRAS Mutant Solid Tumours
MISSISSAUGA, ON, June 5, 2019 /CNW/ - Amgen (NASDAQ: AMGN) today announced the first clinical results from a Phase 1 study evaluating investigational AMG 510, the first KRASG12C inhibitor to reach the clinical stage. In the trial, there were no dose-limiting toxicities at tested dose levels. AMG 510 showed anti-tumour activity when administered as a monotherapy in patients with locally-advanced or metastatic KRASG12C mutant solid tumours. These data were presented during an oral session at the 55th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
"KRAS has been a target of active exploration in cancer research since it was identified as one of the first oncogenes more than 30 years ago, but it remained undruggable due to a lack of traditional small molecule binding pockets on the protein. AMG 510 seeks to crack the KRAS code by exploiting a previously hidden groove on the protein surface," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "By irreversibly binding to cysteine 12 on the mutated KRAS protein, AMG 510 is designed to lock it into an inactive state. With high selectivity for KRASG12C, we believe investigational AMG 510 has potential as both a monotherapy and in combination with other targeted and immune therapies."
The Phase 1, first-in-human, open-label multicenter study enrolled 35 patients with various tumour types (14 non-small cell lung cancer [NSCLC], 19 colorectal cancer [CRC] and two other). Eligible patients were heavily pretreated with at least two or more prior lines of treatment, consistent with their tumour type and stage of disease. The primary endpoint is safety, and key secondary endpoints include pharmacokinetics, objective response rate (assessed every six weeks), duration of response and progression-free survival. Patients were enrolled in four dose cohorts - 180 mg, 360 mg, 720 mg and 960 mg, taken orally once a day.
Five out of 10 evaluable patients with NSCLC experienced a partial response (PR), and another four had stable disease (SD), for a disease control rate (DCR) of 90 per cent (9/10).1 All five patients with response to therapy had a treatment duration of 7.3-27.4 weeks at data cutoff and remain active on treatment. One patient with PR improved further to a complete response of the target lesions at week 18, post data cutoff.
In addition, 13 of 18 evaluable patients with CRC achieved SD, with the majority of CRC patients treated at the first two dose levels. Twenty-six patients remain on study and nine have discontinued.
Treatment-related adverse events (AEs) were primarily grade 1 events (approximately 68 per cent). Two grade 3 treatment-related AEs were reported (anemia and diarrhea). No grade 4 treatment-related AEs and no serious treatment-related AEs were reported. Enrollment into dose expansion is underway.
"While there's been significant progress in treating solid tumour cancers overall with targeted therapies, patients with the KRASG12C mutation have not benefited from these advances," said Marwan G. Fakih, M.D., clinical study investigator and co-director of the Gastrointestinal Cancer Program, City of Hope, Duarte, Calif. "In this early Phase 1 trial, investigational AMG 510 showed anti-tumour activity. We look forward to further investigating AMG 510 with the goal of closing the treatment gap for patients with this type of mutation."
About KRAS
The subject of more than three decades of research, the RAS gene family are the most frequently mutated oncogenes in human cancers.2,3 Within this family, KRAS is the most prevalent variant and is particularly common in solid tumours.3 A specific mutation known as KRASG12C accounts for approximately 13 per cent of non-small cell lung cancers, three to five per cent of colorectal cancers and one to two per cent of numerous other solid tumours.4 Amgen is exploring the potential of KRASG12C inhibition across a broad variety of tumour types.
About Amgen Canada
As a leader in innovation, Amgen Canada understands the value of science. With main operations located in Mississauga, Ont.'s vibrant biomedical cluster, and its research facility in Burnaby, B.C., Amgen Canada has been an important contributor to advancements in science and innovation in Canada since 1991. The company contributes to the development of new therapies and new ways of using existing medicines in partnership with many of Canada's leading health-care, academic, research, government and patient organizations. To learn more about Amgen Canada, visit www.amgen.ca.
Forward-Looking Statements
This news release contains forward-looking statements that are based on the current expectations and beliefs of Amgen Inc. and its subsidiaries. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results or practices, customer and prescriber patterns or practices, reimbursement activities and outcomes and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission reports filed by Amgen Inc., including our most recent annual report on Form 10-K and any subsequent periodic reports on Form 10-Q and Form 8-K. Unless otherwise noted, Amgen is providing this information as of the date of this news release and does not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.
No forward-looking statement can be guaranteed and actual results may differ materially from those we project. Our results may be affected by our ability to successfully market both new and existing products domestically and internationally, clinical and regulatory developments involving current and future products, sales growth of recently launched products, competition from other products including biosimilars, difficulties or delays in manufacturing our products and global economic conditions. In addition, sales of our products (including products of our wholly-owned subsidiaries) are affected by pricing pressure, political and public scrutiny and reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by regulatory, clinical and guideline developments and domestic and international trends toward managed care and healthcare cost containment. Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify safety, side effects or manufacturing problems with our products after they are on the market. Our business may be impacted by government investigations, litigation and product liability claims. In addition, our business may be impacted by the adoption of new tax legislation or exposure to additional tax liabilities. Further, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors, or we may fail to prevail in present and future intellectual property litigation. We perform a substantial amount of our commercial manufacturing activities at a few key facilities, including in Puerto Rico, and also depend on third parties for a portion of our manufacturing activities, and limits on supply may constrain sales of certain of our current products and product candidate development. In addition, we compete with other companies with respect to many of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. The discovery of significant problems with a product similar to one of our products that implicate an entire class of products could have a material adverse effect on sales of the affected products and on our business and results of operations. Our efforts to acquire other companies or products and to integrate the operations of companies we have acquired may not be successful. We may not be able to access the capital and credit markets on terms that are favorable to us, or at all. We are increasingly dependent on information technology systems, infrastructure and data security. Our stock price is volatile and may be affected by a number of events. Our business performance could affect or limit the ability of our Board of Directors to declare a dividend or our ability to pay a dividend or repurchase our common stock.
The scientific information discussed in this news release related to our product candidates is preliminary and investigative. Such product candidates are not approved by Health Canada, and no conclusions can or should be drawn regarding the safety or effectiveness of the product candidates.
References
1.
Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: Revised RECIST guideline (version 1.1). European Journal of Cancer. 2009;45:228-247.
2.
Cox A, et al. Drugging the undruggable RAS: Mission Possible? Nature Reviews Drug Discovery. 2014;13(11):828-851.
3.
Fernandez-Medarde A, Santos E. Ras in Cancer and Developmental Diseases. Genes Cancer. 2011;2(3):344-358.
4.
Lipford, JR. Pre-clinical development of AMG 510: the first inhibitor of KRASG12C in clinical testing. Oral presentation at AACR 2019; Atlanta, GA. March 29-April 3, 2019.
SOURCE Amgen Canada
Finalists announced in competition that will recognize top innovators in Canada's technology and aging sector
Events will showcase innovative solutions to support healthy aging
TORONTO, June 5, 2019 /CNW/ - Fifteen Canadian startups have been selected to compete in the AGE-WELL National Impact Challenge: Startup Edition, it was announced today.
The competition is for startups whose technologies or services can improve quality of life for older adults or their caregivers. Finalists will be challenged to explain how their technology-based solution can positively impact older Canadians and/or caregivers.
Five finalists will compete in each of three regional pitch events held in Montreal, Vancouver and Toronto. The winner of each regional competition will receive $15,000 in cash plus in-kind prizes.
"We're thrilled to be hosting this competition that will recognize top startups in Canada's technology and aging sector, and support entrepreneurship," says Dr. Alex Mihailidis, Scientific Co-Director and CEO of the AGE-WELL Network of Centres of Excellence.
"AGE-WELL thanks all the startups who submitted applications and congratulates the finalists. We can't wait to see which ones emerge as winners and to welcome them to our network where their innovations will be nurtured in order to have the greatest impact possible."
AGE-WELL, Canada's Technology and Aging Network, brings together researchers, older adults, caregivers, partner organizations and future leaders to accelerate the delivery of technology-based solutions that make a meaningful difference in the lives of Canadians.
"As Canada's aging population grows, AGE-WELL is connecting inventive minds to work together to deliver real-world solutions to support seniors and caregivers―and to build Canada's capacity as a global leader in technologies for healthy aging," says Dr. Mihailidis.
Finalists in the AGE-WELL National Impact Challenge: Startup Edition were selected by a panel drawn from AGE-WELL's business development team, Core Facility in Entrepreneurship and Older Adult and Caregiver Advisory Committee.
Sponsors of the competition are: CARP, Fasken, Hacking Health, The Impact Centre at the University of Toronto, MEDTEQ, Ontario Brain Institute, and YouAreUNLTD.
About AGE-WELL:
AGE-WELL NCE Inc. (https://www.agewell-nce.ca/, @AGEWELL_NCE) is a pan-Canadian network that brings together researchers, older adults, caregivers, partner organizations and future leaders to accelerate the delivery of technology-based solutions that make a meaningful difference in the lives of Canadians. AGE-WELL researchers are producing technologies, services, policies and practices that improve quality of life for older adults and caregivers, and generate social and economic benefits for Canada. AGE-WELL is funded through the federal Networks of Centres of Excellence program.
SOURCE AGE-WELL Network of Centres of Excellence (NCE)
For further information:
Margaret Polanyi, Senior Communications Manager, AGE-WELL: margaret@agewell-nce.ca 416-597-3422, ext. 7710
Ontario Sets New Record for Organ Donors in April
TORONTO, June 5, 2019 /CNW/ - Today, Trillium Gift of Life Network announced a record high number of organ donors during BeADonor Month in April 2019. Thirty-seven generous donors and their families gave the gift of life – more than any previous BeADonor Month, and the third highest number in a single month in Ontario's history.
"This new record reflects our power to save lives when we rally together to raise the decibel on registering for organ and tissue donation," says Ronnie Gavsie, President and CEO, Trillium Gift of Life Network. "But we must continue to work together year-round to accentuate the importance of registering. Today 1,600 of our own family members, friends and colleagues are waiting for a medically urgent life-saving transplant. Their lives are depending on us."
During BeADonor Month, the number of families giving their consent for donation grew from the previous month, contributing to the record number of organ donors in April. "When Ontarians register and speak to their families about their wish to donate, they relieve their family of the burden of making a decision. Families respect and honour their loved one's wishes if the opportunity to donate arises," says Gavsie.
Trillium Gift of Life Network's efforts during BeADonor Month also contributed to an increase in the number of registered donors. The first annual Green Shirt Day on April 7 bolstered efforts, which honoured the legacy of Logan Boulet, the young man who donated his organs following the Humboldt tragedy a year ago. Logan gave the gift of life to six Canadians in need.
In April 2019, nearly 20,000 Ontarians registered for donation.
"It is tremendously encouraging to see Ontarians showing their support during BeADonor Month by registering for organ and tissue donation," says Gavsie. "The simple act of registering can affect so many people – one organ donor has the power to save up to eight lives and enhance as many as 75 more through the gift of tissue."
Today, 34 per cent of Ontarians are registered, but research suggests 85 per cent of the population support donation. Visit www.BeADonor.ca to register or learn more.
Quick facts:
Today, more than 1,600 people are waiting for a lifesaving organ transplant, and every three days someone dies waiting because there aren't enough organs to meet the need.
Everyone has the potential to be an organ and tissue donor. To date, the oldest Canadian organ donor was 92, and the oldest tissue donor was over 100.
Trillium Gift of Life Network is the Government of Ontario agency responsible for planning, promoting, coordinating and supporting organ and tissue donation and transplantation across the province and for continually improving the system so that more lives can be saved.
SOURCE Trillium Gift of Life Network
PrescribeIT™ Welcomes Intrahealth as New EMR Vendor
TORONTO, June 5, 2019 /CNW/ - Canada Health Infoway (Infoway) is pleased to announce that it has signed an agreement with Intrahealth Canada Limited (Intrahealth), an electronic medical record (EMR) provider, bringing the total number of PrescribeIT™ EMR vendors to 11.
"EMRs are critical to the success of PrescribeIT™, so we are very excited to have Intrahealth onboard," said Michael Green, President and CEO of Infoway. "EMRs enable prescribers to send electronic prescriptions directly to a patient's pharmacy of choice, making prescribing safer and more secure, easier and more convenient, and eliminating the use of paper or faxed prescriptions."
Intrahealth, which is based in Vancouver, serves primary care markets in New Brunswick and British Columbia, as well as community health clinics in Ontario.
"We are thrilled to begin offering PrescribeIT™ through our EMR," said Silvio Labriola, General Manager, Intrahealth. "This e-prescribing service is a perfect fit for our patient-first approach to using technology to reduce costs and improve convenience, while also improving services for the health care provider community."
"We launched PrescribeIT™ in New Brunswick last fall as part of our ACCESS Atlantic initiative to improve health outcomes by improving access to care," Green said. "There is tremendous opportunity to scale the PrescribeIT™ service in the province, so we look forward to working with Intrahealth on those plans."
In addition to New Brunswick, PrescribeIT™ is also operating in Ontario and Alberta. There are agreements in place with seven other provinces and territories and roll-out plans are being developed. In addition, PrescribeIT™ works with 32 community pharmacy companies representing more than 3,400 pharmacies, as well as 11 EMR vendors and four Pharmacy Management System (PMS) vendors.
Learn more about PrescribeIT™ at www.PrescribeIT.ca. Prescribers and pharmacists interested in implementing the service are invited to submit an application of interest.
About Intrahealth Canada Limited Incorporated in 2005, Intrahealth Canada provides medical software solutions to general practitioner clinics and public health authorities. Privately owned and founded by two New Zealand medical doctors, the company offers robust, secure, and scalable solutions via innovative technology that keeps pace with today's mobile lifestyles. The platform functions across multiple community-based practice types — primary care, specialist physician, community care, home care, residential care, and more. Our solutions meet the needs of front-line professionals by delivering core information to coordinating hubs, implementing programs more rapidly, and reducing the compliance burden on physicians and other clinicians. We help our customers capture structured data that holds context, meaning, and can be analyzed and processed automatically.
About PrescribeIT™ Canada Health Infoway is working with Health Canada, the provinces and territories, and industry stakeholders to develop, operate and maintain the national e-prescribing service known as PrescribeIT™. PrescribeIT™ will serve all Canadians, pharmacies and prescribers and provide safer and more effective medication management by enabling prescribers to transmit a prescription electronically between a prescriber's electronic medical record (EMR) and the pharmacy management system (PMS) of a patient's pharmacy of choice. PrescribeIT™ will protect Canadians' personal health information from being sold or used for commercial activities.
About Canada Health Infoway Infoway helps to improve the health of Canadians by working with partners to accelerate the development, adoption and effective use of digital health across Canada. Through our investments, we help deliver better quality and access to care and more efficient delivery of health services for patients and clinicians. Infoway is an independent, not-for-profit organization funded by the federal government.
Inquiries about PrescribeIT™: Tania Ensor Group Director, PrescribeIT™ Marketing Strategy & Stakeholder Relations, Canada Health Infoway 416.595.3411 tensor@infoway-inforoute.ca Follow @PrescribeIT_CA
Inquiries about Intrahealth: Silvio Labriola General Manager, Intrahealth Canada Limited 604.980.5577 ext. 112 Silvio.Labriola@intrahealth.com
SOURCE Canada Health Infoway
Popular Japanese Goku “Sleeping Time Machine” Spa Opens First Location In The US
Head massage specialist salon Goku no Kimochi may be the most sought-after massage establishment in Japan. Since they opened their first shop in Kyoto in 2008, their waiting list across all branches now exceeds 436,000 people. This popular spa officially opened in New York City (18 W 38th St. / 2nd floor) on May 20th. One of Goku most requested services is their “Zeccho Sleep.'' Aligning the hands and fingers to provide perfect pressure on the scalp, a Japanese head massage therapist releases tension in muscles around the head and eye areas, promoting good blood circulation. As a result, the mind and brain become totally relaxed, leading to improved health, focus, and lower stress levels. When it’s over, individuals will emerge with a euphoric feeling, released from stress. The quality of your sleep may also improve for the next few nights after the treatment. This massage is especially beneficial for people with brain tiredness caused by: stress, over-work, worry and/or constant computer use. Another service offered at Goku is “The Kamiwaza Technique.” This head massage technique was developed and refined over with the help of Japan’s top health care professionals, from diverse fields including: neuroscience, acupuncture, psychology, and massage therapy. This is a dry treatment, no water, lotion, or oils are used. “Zeccho Sleep has been satisfying people especially who suffer stress and insomnia in Japan. As New York is the city that never sleeps as well as the world capital of finance and business, we are thrilled to open our spa here.” For more information about Goku spa, please call (929) 336-3088 and visit: https://www.gokusleep.com/ For all interviews please call Ryan McCormick of Goldman McCormick Public Relations (www.goldmanmccormick.com) at 516-901-1103 / 919-377-1200
Affinity Living Group launches daily exercise campaign utilizing National Institute on Aging resources
Hickory, NC, June 5, 2019 – Affinity Living Group (ALG) has launched a physical activity and exercise program across its more than 120 communities this month, using the science-based information from Go4Life®, an outreach initiative developed by the National Institute on Aging, part of the National Institutes of Health. The Hickory, North Carolina-based senior housing company will be tracking participation in its Go4Life® campaign this summer, leading up to National Go4Life Month in September.“We are excited that ALG, a Go4Life® partner, is launching this national campaign in all of its communities,” said Stephanie Dailey, director of Go4Life® at the National Institute on Aging (NIA). “ALG recognizes that physical activity is key to the health and well-being of its residents, and we are delighted that Go4Life® resources will be the cornerstone of this innovative campaign.” This week, ALG’s more than 7,000 residents began the daily exercise and physical activity campaign, while team members at the company’s headquarters in Hickory, N.C. joined together with shake weights, resistance bands and strength-training teddy bears to show support.“The healthier that we are, the better life we live,” said Julie Walker, Director of Dementia Care for ALG who has worked to launch the campaign across the company. “As we age, we tend to lose our balance, our flexibility, and our endurance is not as great. By doing these choreographed movements, we can help our residents have better days, we can help reduce their falls, we can help them have more mobility and a better range of motion.”The Go4Life® campaign focuses on four key areas – endurance, strength, balance and flexibility. NIA offers a guide to types of exercises in each of these areas, and ALG teams have trained community leaders on a variety of movement-centered activities as well. ALG communities are also tracking resident participation in the daily exercise activities, using an application created specifically for the campaign. Throughout June, July and August, the designated Go4Life® leader at each community will be awarded a prize based on the highest number of residents participating for the month. In September, a “grand champion” will be named, and they will win a trip to Washington, D.C. The goal of the incentives, Walker said, is to encourage the teams to get residents excited about participating in the exercise programs. Team members from the company’s home office will also be joining in and tracking participation with group exercises three days each week.For more information on ALG, visit algcommunities.com or follow @ALGcommunities on social media.For more information on this press release, contact Tiffany Fields, Communications Specialist, at tfields@affinitylivinggroup.com or (828) 442-3621. *********************With more than 120 communities in 6 states, Affinity Living Group, based in Hickory, NC, is the largest senior housing provider in the southeastern United States. Affinity’s mission is to provide a full continuum of housing and care services for older adults, delivered by a team of passionate and respectful professionals, at locations throughout the United States. We strive daily to create the best life for all we serve. Mason Gray, right, with Affinity Living Group's partner organization Broad River Rehab, works with a resident at The Landings of Mills River while she exercises on a seated elliptical machine at the community. Daily exercise has become part of the routine for residents at Mills River and other ALG communities, as they launched their Go4Life® campaign this month. Residents across ALG's more than 120 communities joined in on a daily exercise and physical activity campaign this month, with exercise guidance from the National Institute on Aging's Go4Life® program.Mason Gray, right, with Affinity Living Group's partner organization Broad River Rehab, works with a resident at The Landings of Mills River on strength training in the dedicated exercise and physical therapy room at the community. Daily exercise has become part of the routine for residents at Mills River and other ALG communities, as they launched their Go4Life® campaign this month.
The Cornucopia Institute Examines Plant-Based Beverages
Advertising Promotes Them as a Health Food—But Are They?
https://www.cornucopia.org/2019/06/plant-based-beverage-report-release/ Cornucopia, WI — Cornucopia’s new report, “Pouring” Over Plant-Based Beverages, takes an in-depth look at what these beverages really offer consumers, how they are marketed, and how they compare to cow’s milk. Amid health concerns and dire climate crisis predictions, more consumers are buying plant-based beverages than ever before. But are they the right choice for everyone?
Beverages made from seeds, fruits, nuts, legumes, and cereals often contain shockingly little plant material. Manufacturers heavily sweeten the drinks to improve their flavor and add thickeners and gums, such as the gastrointestinal inflammatory agent carrageenan, to make them seem creamy.
“Astonishingly, some of these beverages advertised as ‘healthy’ alternatives to dairy have a sugar content equal to or greater than some soft drinks,” said Anne Ross, the report’s lead author and Cornucopia’s Director of International Policy.
To help consumers find the most nutritious plant-based beverages containing the fewest additives, Cornucopia developed a comprehensive scorecard rating over 300 products from 49 brands.
The global market for plant-based beverages is estimated to climb to nearly $20 billion by 2023 with an anticipated annual growth rate of 12%. Several of the country’s largest food marketers have recently acquired plant-based and alternative protein companies. Is the company that pushes Coca-Cola also making your “healthy” plant-beverage?
“Massive conglomerates are eager to get into the plant-beverage market,” observed Ross. “It is a lucrative venture because these products sometimes consist of only a handful of nuts or seeds, water, and additives, while producing high profit margins.”
Marketing suggests that plant-based beverages are equivalent substitutes for dairy milk, but nutrient profiles show these beverages are fundamentally different types of food.
For individuals without dietary restrictions, cow’s milk provides a natural source of bioavailable calcium and micronutrients, often at demonstrably higher levels than in plant-based beverages. Organic milk produced by cows that graze on pasture has nutritional qualities that are naturally superior to conventionally produced cow’s milk and plant-based beverages.
There has been a lot of debate over which “milks,” dairy or plant-based, are better for the environment. The environmental impact of any beverage depends not only on the plant or animal product itself, but how it was grown or produced, sourced, and processed. All conventional beverages have roots in the destruction of native habitat and the use of toxic chemicals.
Cornucopia’s research is a valuable tool for anyone trying to figure out which plant-based beverage is right for them or whether highly nutritious, grass-based, organic cow’s milk is the better option.
The best choice, whether it be a glass of plant-based product or cow’s milk, is always USDA certified organic.
Rapid Dose Therapeutics Appoints Vice President, Research & Innovation
BURLINGTON, ON, June 6, 2019 /CNW/ - Rapid Dose Therapeutics Corp. ("RDT" or the "Company") (CSE: DOSE), a Canadian leader in drug delivery solutions, is pleased to announce that Dr. Rina Carlini has been appointed Vice President, Research & Innovation.
Dr. Carlini is an accomplished scientist and management executive with 25 years of experience in technology innovation, product development, commercialization within the sectors of health technology, life science, IoT, artificial intelligence, advanced manufacturing, and nanotechnology.
Dr. Carlini holds a Ph.D. in Chemistry from the University of Waterloo, and in 2017 she was awarded the Faculty of Science Alumni of Honour. She also holds several certificates from MIT, Harvard University, McMaster University in the areas of Artificial Intelligence for Business Strategy and Business Model Innovation.
Rina's professional experience spans diverse industries and leadership roles, including pharma drug discovery R&D (Merck, Syntex), as Director of Nanotechnology for Xerox Innovation Group (Canada), Director of Commercialization at GreenCentre Canada, and President & CEO of Haltech Regional Innovation Centre. In addition, Rina is the inventor of over 100 US patents; co-author of 20+ peer-reviewed research articles; serves on the board for Waterloo Institute for Nanotechnology, Concordia University's Gina Cody School of Engineering, and as an expert reviewer for several Canadian funding agencies (OCE, NSERC, CFI).
"We are excited to have Rina join the RDT team and we look forward to engaging her wealth of expertise as RDT enters the next advancement of our global growth within the drug delivery technology sector," stated Mark Upsdell, President and CEO.
"I am pleased to join RDT at this time of RDT's scaleup and growth. It is an exciting time to lead science and innovation in the life science industry," said Rina Carlini.
About Rapid Dose Therapeutics Rapid Dose Therapeutics Corp. is a publicly-traded Canadian life sciences company that provides innovative, proprietary drug delivery technologies designed to improve outcomes and quality of lives. RDT offers Quick, Convenient, Precise and Discreet™ choices to consumers. RDT is focused and committed to clinical research and product development for the healthcare manufacturing industry, including nutraceutical, pharmaceutical and cannabis industries. Within the cannabis sector, RDT provides a turn-key Managed Strip Service Program which enables RDT's QuickStrip™ proprietary drug delivery technology to be licensed by select partners. RDT's service based annuity contracts drive recurring revenue which enables rapid expansion into emerging markets — generating value for consumers and shareholders. Rapid Dose Therapeutics is committed to continually create innovative solutions aimed at multiple consumer segments and future market needs — including humans, animals and plants.
CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS: Certain information in this news release may contain forward-looking information within the meaning of applicable securities laws. Any statements that are contained in this news release that are not statements of historical fact may be deemed to be forward- looking statements. Forward looking statements are often identified by terms such as "may", "should", "anticipate", "expect", "potential", "believe", "intend" or the negative of these terms and similar expressions. Statements containing forward-looking information, including, without limitation, in respect of the delivery of products using the QuickStrip™ product delivery method, express, as at the date of this news release, the plans, estimates, forecasts, projections, expectations or beliefs of RDT as to future events or results and are believed to be reasonable based on information currently available to them. Forward-looking statements necessarily involve known and unknown risks, including, without limitation, risks associated with general economic conditions; adverse industry events; marketing costs; loss of markets; future legislative and regulatory developments involving cannabis; inability to access sufficient capital from internal and external sources, and/or inability to access sufficient capital on favourable terms; the cannabis industry in Canada generally, income tax and regulatory matters; the ability to implement its business strategies; competition; currency and interest rate fluctuations and other risks. Readers are cautioned that the foregoing list is not exhaustive. There can be no assurance that statements of forward-looking information, although considered reasonable by management at the time of preparation, will prove to be accurate as there can be no assurance that the plans, intentions or expectations upon which they are based will occur. Actual results and future events could differ materially from those anticipated in such statements. Readers should not place undue reliance on forward-looking information. Forward-looking statements contained in this news release are expressly qualified by this cautionary statement.
SOURCE Rapid Dose Therapeutics Corp.
AbbVie Receives Positive Recommendation from the pan-Canadian Oncology Drug Review Expert Review Committee for the Combination VENCLEXTA® With Rituximab as a Treatment for Patients With Chronic Lymphocytic Leukemia
pERC conditionally recommends reimbursement of VENCLEXTA® (venetoclax) in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy.i
Adult patients with CLL taking VENCLEXTA in combination with rituximab can stop their therapy after a defined treatment period of 24 months on treatment.
MONTREAL, June 6, 2019 /CNW/ - AbbVie (NYSE: ABBV), a global research and development-based biopharmaceutical company, today announced that the pan-Canadian Oncology Drug Review (pCODR) Expert Review Committee (pERC) conditionally recommends reimbursement of VENCLEXTA® (venetoclax) in combination with rituximab for the treatment of adult patients with chronic lymphocytic leukemia (CLL) who have received at least one prior therapy, irrespective of their 17p deletion status, only if the following condition is met: cost-effectiveness being improved to an acceptable level.i VENCLEXTA in combination with rituximab is an effective treatment option that has the benefit of a finite treatment approach, meaning patients can able to stop their therapy after two years of treatment.
"With venetoclax plus rituximab, patients receive a highly effective treatment that leads to durable remission while having a clear defined end-date. The concept of finite treatment duration is something my patients appreciate because they have the ability to be off therapy," says Dr. Carolyn Owen, MD, MDres(UK), FRCPC, a Hematologist and associate professor at the University of Calgary.
pERC concluded in its report that VENCLEXTA plus rituximab aligns with patient values in that it provides additional treatment choice, delays disease progression, has manageable side effects, a finite treatment duration, and a partially oral route of administration.i
"The pCODR recommendation for VENCLEXTA plus rituximab is positive news for Canadians living with CLL," says Elizabeth Lye, Director of Research & Programs, Lymphoma Canada. "Receiving a diagnosis of CLL or any cancer is always shocking and overwhelming, therefore knowing that there are highly effective treatments available provides reassurance to people facing this uncertain journey."
CLL, which is typically a slow-progressing cancer of the bone marrow and bloodii, is one of the most common types of leukemia in adults. In Canada, CLL accounts for approximately 2,465 newly diagnosed cases of leukemia each year and is responsible for more than 600 deaths a year.iii The goal of treatment is to delay progression of the disease and improve quality of life.
"This is another tremendous milestone in our efforts to bring VENCLEXTA plus rituximab to Canadians living with CLL. This is a much needed treatment option as it is the first chemotherapy-free combination in CLL that allows patients a 24-month treatment duration," says Stéphane Lassignardie, General Manager of Abbvie Canada.
VENCLEXTA continues to be investigated in CLL and other hematological diseases.
VENCLEXTA is being developed by AbbVie and Roche. It is jointly commercialized by AbbVie and Genentech, a member of the Roche Group, in the U.S. and by AbbVie outside of the U.S.
About the MURANO Study A total of 389 patients with R/R CLL who had received at least one prior therapy were enrolled in the international, multicenter, open-label, randomized (1:1) MURANO study (NCT02005471). The study was designed to evaluate the efficacy and safety of VENCLEXTA in combination with rituximab (194 patients) compared with bendamustine in combination with rituximab (195 patients). The median age of patients in the trial was 65 years (range 22-85).iv
About AbbVie Care Canadians prescribed VENCLEXTA will have the opportunity to be enrolled in AbbVie Care, AbbVie's signature care program. The program is designed to provide a wide range of customized services including reimbursement and financial support, pharmacy services, lab work reminders and coordination, personalized education and ongoing disease management support throughout the treatment and beyond. For more information, please visit www.abbviecare.ca.
About AbbVie AbbVie is a global, research and development-driven biopharmaceutical company committed to developing innovative advanced therapies for some of the world's most complex and critical conditions. The company's mission is to use its expertise, dedicated people and unique approach to innovation to markedly improve treatments across four primary therapeutic areas: immunology, oncology, virology and neuroscience. In more than 75 countries, AbbVie employees are working every day to advance health solutions for people around the world. For more information about AbbVie, please visit us at www.abbvie.ca and www.abbvie.com. Follow @abbvieCanada and @abbvie on Twitter or view careers on our Facebook or LinkedIn page.
