Sirona Biochem (SBM:tsxv) Announces Keloid Data Accepted for Presentation to the Society of Investigative Dermatology
Sirona Biochem Announces Keloid Data Accepted for Presentation to the Society of Investigative Dermatology (SID)
Sirona Biochem Corp. (TSX VENTURE: SBM) (FRANKFURT: ZSB) (XETRA: ZSB) (the “Company“) announced today that it has been accepted to present recent data at the 76th Annual Society of Investigative Dermatology (SID) Meeting, April 26-29 in Portland, Oregon. Sirona’s abstract, titled, Novel glycopeptide potential in keloid formation prevention and recurrence, will be presented as a poster during the 4-day conference.
The presentation outlines initial study results on the compound KEL-01. KEL-01 has been tested on normal human dermal fibroblasts (NF) and keloid fibroblasts (KF) for gene expression and protein expression.
In NF gene expression, KEL-01 downregulated genes involved in extracellular matrix (ECM) synthesis, collagen I, III and elastin, while it upregulated genes involved in ECM degradation, namely MMP1 and MMP3. In protein expression studies, the addition of KEL-01 significantly decreased the levels of collagen I and collagen III in KF. When KEL-01 was added to the KF, the ratio of collagen I/III was regulated to that of NF. An additional assay done showed activation of the Nrf2 pathway via KEL-01, which is down-regulated in keloids.
“We are pleased with the early results of KEL-01 on keloid fibroblasts,” said Dr. Howard Verrico, CEO. “Keloid scars are difficult to treat and there remains a significant unmet need for those prone to their development. We are planning studies on this compound in more advanced scar models.”
About the 76th Annual SID Meeting
The Society for Investigative Dermatology was founded in 1937 to highlight and promote discovery in investigative dermatology and to better represent skin-related scientific investigation amongst medical societies. Soon after, they launched the Journal of Investigative Dermatology (JID), a source for all advancements in cutaneous biology. The first Annual Meeting was held in New York City in 1938.
The 76th Annual Meeting, like those before it, will bring together researchers, lecturers, and industry leaders in dermatology. Throughout the four-day conference, cutting-edge research, findings and trends in skin health and disease will be shared. All abstracts will be published in upcoming editions of the JID.
Alongside lectures from leading experts in the field and poster presentations, there will be opportunities to talk to representatives from global companies about partnerships and collaborations.
For more information, please visit the conference website at http://www.sidnet.org/.
About Sirona Biochem Corp.
Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential.
Sirona’s compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and ongoing royalty payments. Sirona’s laboratory, TFChem, is located in France and is the recipient of multiple French national scientific awards and European Union and French government grants. For more information, please visit www.sironabiochem.com.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
- Published in Bio technology, Life Sciences, News Home, Sirona Biochem
Tetra Bio-Pharma (TBP:CSE) Appoints Edward Miller as Vice President, Investor Relations & Corporate Communications
Tetra Bio-Pharma Appoints Edward Miller as Vice President, Investor Relations & Corporate Communications
– Momentum Public Relations –
Press Release: March 27, 2017
Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF), today announced that it entered into an employment agreement with Edward Miller as Vice President, Investor Relations and Corporate Communications effective today.
Mr. Miller has over a decade of experience in the Biotech/Pharma industry. Most recently, he served as Director, Investor Relations and Corporate Communications at IntelGenx Corp. where he successfully built their shareholder communications program, resulting in substantial growth in their website traffic and social media hits. Mr. Miller joined Paladin Labs in 2001 where he held various positions including Manager, Investor Relations where he successfully built their investor relations program. Following his tenure at Paladin Labs he moved into the role as an investor relations consultant working for Christensen IR, heading their life science practice and as an independent where he has built award winning investor relations programs. Mr. Miller is the Past President of CIRI (Canadian Investor Relations Institute) Quebec Chapter where he served two terms (2009 – 2012) and (2005 – 2007). Mr. Miller will be contributing to improving the company’s visibility in the capital markets and leveraging his international experience at broadening its shareholder base.
“We are most pleased to welcome Edward to the team as we are focused on building Tetra as a leading bio-pharmaceutical organization,” said Andre Rancourt, CEO of Tetra Bio-Pharma. “Mr. Miller has built award winning investor relations programs that have driven shareholder value and visibility for several organizations in the market place. We look forward to expanding our communications outreach as we build an even stronger shareholder base moving forwards.”
About Tetra Bio-Pharma:
Tetra Bio Pharma is a multi subsidiary publicly traded company (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF) engaged in the development of Bio Pharmaceuticals and Natural Health Products containing Cannabis and other medicinal plant based elements.
Tetra Bio Pharma is focused on combining the traditional methods of medicinal cannabis use with the supporting scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators physicians and insurance companies. More information is available about the company at: www.tetrabiopharma.com.
- Published in Bio technology, Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Aphria Exercises Warrants for Gross Proceeds of $1.3 Million to Further Fund Tetra’s (TBP:CSE) Clinical Trials
Aphria Exercises Warrants for Gross Proceeds of $1.3 Million to Further Fund Tetra’s Clinical Trials
– Momentum Public Relations –
Press Release: March 20, 2017
Tetra Bio-Pharma Inc. (“Tetra Bio” or “the Company”) (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF) is pleased to announce that Aphria Inc. (TSX VENTURE:APH)(OTCQB:APHQF) has exercised their 5,000,000 warrants for aggregate gross proceeds of $1,300,000. The proceeds from the warrant exercise will be used to advance the clinical trials being developed in PhytoPain Pharma Inc., a subsidiary of Tetra.
“We would like to thank Aphria for their continued support and investment in the research and development being conducted by the science team at Tetra,” said Andre Rancourt, CEO of Tetra Bio-Pharma Inc. “By exercising their warrants ahead of schedule, this further confirms Aphira’s commitment to accelerate Tetra’s development work. I am pleased to report to shareholders that Tetra is in a solid financial position with over $4 million to continue advancing its strategic plan of becoming a leading bio-pharma organization focused on cannabis.”
About Aphria:
Aphria Inc., one of Canada’s lowest cost producers, produces, supplies and sells medical cannabis. Located in Leamington, Ontario, the greenhouse capital of Canada. Aphria is truly powered by sunlight, allowing for the most natural growing conditions available. We are committed to providing pharma-grade medical cannabis, superior patient care while balancing patient economics and returns to shareholders. We are the first public licensed producer to report positive cash flow from operations and the first to report positive earnings in consecutive quarters. For more information, visit www.Aphria.com.
About Tetra Bio-Pharma:
Tetra Bio-Pharma is a multi subsidiary publicly traded company (CSE:TBP) engaged in the development of Bio Pharmaceuticals and Natural Health Products containing Cannabis and other medicinal plant based elements.
Tetra Bio-Pharma is focused on combining the traditional methods of medicinal cannabis use with the supporting scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators physicians and insurance companies. More information is available about the company at: www.tetrabiopharma.com.
- Published in Bio technology, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma (TBP:CSE) Enters into Binding Term Sheet for Two Products with Panag Pharma
Tetra Bio-Pharma Enters into Binding Term Sheet for Two Products with Panag Pharma
– Momentum Public Relations –
Press Release: March 14, 2017
Tetra Bio-Pharma Inc. (“Tetra” or the “Company“) (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF), announced today it has entered into a binding term sheet with Panag Pharma Inc. for the development and commercialization of novel cannabinoid based formulations for the treatment of pain and inflammation. Combined total market potential of both products in the USA in 2014 is estimated over US$5.5 billion.
Per the binding term sheet, Tetra will have exclusive access to sell the ocular and topical drug products in North America with right of first negotiation for outside U.S. and Canadian territories. In addition, Tetra will have a right of first negotiation for future products.
Tetra will be working in close collaboration with Panag’s team of experts to ensure a rapid and successful development. Tetra shall be responsible for 100{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} of the research and development of the Licensed Products. Tetra will own and control all regulatory approvals in the Territory, including the application and any other marketing authorizations within the Territory and shall be responsible for all aspects of commercializing the drug products.
Panag has developed potential new cannabinoid-based therapies for ocular and topical anti-inflammatory and pain markets. The total ocular anti-inflammatory market was estimated at over $3 billion in the USA in 2014 and includes conditions such as post-op inflammation, allergic conjunctivitis and inflammatory dry eye. Panag also developed a cannabinoid topical drug product for the treatment of local neuropathic and non-neuropathic pain. In 2014, the over the counter sales of topical analgesics were estimated at over $2.5 billion according to IMS.
“This announcement further demonstrates Tetra’s commitment to shareholders to add future products to our product portfolio in an effort of building a leading bio- pharmaceutical organization,” said Andre Rancourt, CEO of Tetra Bio-Pharma. “This will further allow Tetra to generate revenues in 2017 through its partnership with Panag. Tetra is going to work closely with Panag to exploit its innovative technology that indirectly acts on the CB2 receptor with the goal of launching several products in the retail market. This is in-line with Tetra’s goal of commercializing products pending legalization.”
According to Guy Chamberland, Chief Scientific Officer of Tetra Bio-Pharma, “We are going to prioritize the development of the ocular therapy as this is a promising innovative product and the potential financial reward will be significant. Tetra had already positioned itself to become a leader in topical pain relief with its PPTGR technology. With the Panag partnership, Tetra is going to modify its development plans to accelerate bringing an innovative cannabinoid topical drug product to the market. The Panag team is going to strengthen Tetra’s overall scientific knowledge and expertise base making it one of the leading biotechnology companies developing cannabinoid-based therapies.”
About Panag Pharma:
Panag Pharma Inc. is a Canadian based bio-tech company focused on the development of novel cannabinoid based formulations for the treatment of pain and inflammation. Panag believes that pain relief should be safe, non-addictive and above all; effective. The Panag Pharma team of PhD scientists and medical doctors are among the world’s leading researchers and clinicians in the area of pain treatment and management. They bring a combined experience of over 100 years in research and clinical care of people dealing with chronic pain and inflammatory conditions. Panag’s current pipeline of pain relief products include formulations for the topical application to the skin, the eye and other mucous membranes. Recently approved by Health Canada and currently undergoing clinical trials, Panag Pharma’s Topical AOTC provides a new approach to the treatment of chronic pain and inflammation.
About Tetra Bio-Pharma:
Tetra Bio Pharma is a multi subsidiary publicly traded company (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF) engaged in the development of Bio Pharmaceuticals and Natural Health Products containing Cannabis and other medicinal plant based elements.
Tetra Bio Pharma is focused on combining the traditional methods of medicinal cannabis use with the supporting scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators physicians and insurance companies. More information is available about the company at: www.tetrabiopharma.com.
- Published in Bio technology, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma Announces that the Delay in Legalization of Marijuana Does Not Affect its Drug Development & Commercialization Plans
Tetra Bio-Pharma (TBP:CSE) Announces that the Delay in Legalization of Marijuana Does Not Affect its Drug Development & Commercialization Plans
– Momentum Public Relations –
Press Release: March 9, 2017
Tetra Bio-Pharma Inc. (“Tetra”, “TBP” or the “Company”) (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF), a biotechnology company specialized in the development and commercialization of Cannabis-based prescription drugs announced that the delay in legalization of marijuana does not affect its commercialization plans for 2017. AgroTek Health (AGT) for the over-the-counter self-care consumer markets is on schedule for the launch of its first Cannabis-derived (THC- and CBD-free) product in 2017.
Based on Tetra’s experience in government affairs, the Company had anticipated delays in the legalization due to the complexity associated with this endeavour. Subsequent to this assessment, Tetra had initiated a plan to commercialize THC- and CBD-free Cannabis derived products. In addition, Tetra entered into a partnership with McGill University and Ford’s Family Pharmacy and Wellness Centre to ensure timely commercialization of these products. Tetra is also discussing with several Licensed Producers to ensure a supply of Cannabis and or to enter into a partnership with AGT.
“Tetra is making tremendous progress in the execution of its strategy to become a leading biopharmaceutical company in developing and commercializing cannabis prescription drugs,” said Mr. Andre Rancourt, CEO of Tetra Bio-Pharma Inc. “I am proud to report to shareholders that AGT is on schedule to bring cannabis-derived products to the OTC market after it strategically developed its commercialization plans to partner with Drs. Peter Ford and Stan Kubow after anticipating delays in the legalization of marijuana. We look forward to keeping shareholders updated on our future plans of strengthening Tetra into a bio-pharmaceutical organization.”
All TBP partners and any future partners or suppliers of Cannabis will be subject to regular quality audits to ensure compliance with Canadian regulations and that the Cannabis raw material conforms to quality standards for an oral pharmaceutical product. The quality audit includes third party independent testing for impurities such as pesticides. All of these Licensed Producers will be subject to potential inspections by Health Canada’s Inspectorate or the USA Food and Drug Administration. TBP and its partners recognize that this is part of the responsibility of bringing quality safe products to consumers.
In autumn 2016, TBP announced that it had entered into a partnership with Dr. Stan Kubow, School of Nutrition and Dietetics, McGill University after obtaining an NSERC ENGAGE grant for the development of proprietary Cannabis-extracts for the development and commercialization of nutritional and heath care supplements as well as topical natural products and cosmetics. In February 2017, Controlled Drug Substances, Health Canada, issued the exemption required for the development of these proprietary extracts. This innovative project is expected to deliver at least one commercial nutritional supplement later this year. AGT is also working with Ford’s Family Pharmacy and Wellness Centre to commercialize one or more topical THC- and CBD-free products.
About Tetra Bio-Pharma:
Tetra Bio Pharma is a multi subsidiary publicly traded company (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF) engaged in the development of Bio Pharmaceuticals and Natural Health Products containing Cannabis and other medicinal plant based elements.
Tetra Bio Pharma is focused on combining the traditional methods of medicinal cannabis use with the supporting scientific validation and safety data required for inclusion into the existing bio pharma industry by regulators physicians and insurance companies. More information is available about the company at: www.tetrabiopharma.com.
- Published in Bio technology, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma (TBP:CSE) Announces the Initiation of its Phase I Trial of PPP001 (dried Cannabis)
Tetra Bio-Pharma Announces the Initiation of its Phase I Trial of PPP001 (dried Cannabis)
– Momentum Public Relations –
Press Release: February 23rd, 2017
PhytoPain Pharma (PPP), a subsidiary of Tetra BioPharma Inc. (“Tetra” or the “Company”) (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF), a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain is pleased to announce the launch of its Double-Blind Phase I Study to Assess Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Multiple Daily Ascending Doses of Cannabis (Delta-9-tetrahydrocannabinol/ Cannabidiol) by Smoking/Inhalation in Healthy Male and Female Volunteers.
The Phase I clinical research is a classical pharmaceutical study in the development of a new drug. The trial activities will occur over a 3 to 4-month period and involve site initiation, subject recruitment and enrolment, a single daily ascending dose phase and a 7-day multiple daily ascending dose phase, followed by study termination. Algorithme Pharma has already begun recruiting subjects for the Phase I trial. This study is a pivotal safety trial as it will allow Tetra to understand the adverse effects of smoking Cannabis and associate the outcomes, such as cognitive function, to plasma levels of THC and CBD. The study will provide Tetra with the data necessary to discuss with Health Canada and FDA the potential risks in patient populations and discuss marketing requirements for specific indications.
The pharmacokinetic profile and safety data generated by the Phase I trial will allow Tetra to finalize the design of its Phase II-III clinical trial that will assess the safety and efficacy of PPP001 in cancer patients with uncontrolled pain. PPP001 is being developed for cancer patients with moderate-to-severe pain and that are not adequately controlled with the standard of care. Approximately 50{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} of cancer patients suffer from pain and more than 600,000 of these patients suffer from moderate-to-severe pain. In the USA, there are over 4 million cancer patients and this pain market is valued at over $5 billion USD.
“We are very pleased to announce that the start of the Phase I clinical trial activities as this keeps the company on track in its development of PPP001”, commented Mr, Andre Rancourt. “With PPP001 and the mucoadhesive AdVersa® controlled-release tablet, Tetra is positioning itself to become a major player in the cancer pain therapy market,” added Mr. Rancourt.
The Canadian Securities Exchange (“CSE”) has not reviewed this news release and does not accept responsibility for its adequacy or accuracy.
- Published in Bio technology, Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma Reports Approval by Health Canada of its Phase I Trial of PPP001 (dried Cannabis)
Tetra Bio-Pharma Reports Approval by Health Canada of its Phase I Trial of PPP001 (dried Cannabis)
– Momentum Public Relations –
Press Release: February 16, 2017
PhytoPain Pharma Inc. (PPP), a subsidiary of Tetra Bio-Pharma Inc. (“Tetra” or the “Company”) (CSE:TBP)(CSE:TBP.CN), a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain is pleased to announce that the Therapeutic Products Directorate (TPD) of Health Canada has approved its Phase I clinical study of smoked cannabis.
Tetra has worked with Algorithme Pharma, an Altasciences company, for the preparation of the Clinical Trial Application (CTA) for the conduct of a Double-Blind Phase I Study to Assess Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Multiple Daily Ascending Doses of Cannabis (Delta-9-tetrahydrocannabinol/ Cannabidiol) by Smoking/Inhalation in Healthy Male and Female Volunteers. The CTA was submitted to Health Canada and the research ethics review board in December 2016. On January 3, 2017, the clinical trial received approval from the Institutional Review Board. TPD issued a Letter of Authorization for the conduct of the Phase I clinical trial on February 16, 2017. Algorithme Pharma will be initiating the clinical trial activities in the coming weeks.
“We are very pleased to announce the authorisation of the Phase I clinical trial by TPD. This is an important milestone in the clinical development of smoked Cannabis in North America and we are proud to be working with Algorithme pharma, a Clinical Research Organization with many years of experience and expertise in the conduct of Phase I clinical studies,” said Dr. Chamberland, Chief Science Officer.
“This trial is part of Tetra’s commitment to develop medical Cannabis as a prescription drug for patients. The outcome of this trial is going to have significant implications in medical Cannabis research as it is a first pharmaceutical clinical trial assessing the effects of smoked Cannabis on cognitive function in healthy volunteers” said Mr. Rancourt, Chief Executive Officer
Earlier this month, Tetra and IntelGenx announced the co-development of Dronabinol AdVersa® Mucoadhesive controlled-release tablet for the management of Breakthrough Cancer Pain. The significant advantage of the Mucoadhesive technology was demonstrated in a Phase I clinical trial. The study demonstrated the delayed-release of THC avoids a rapid increase in the blood. ²With both of these products in clinical development, Tetra is on track with its objective to bring Cannabis-based prescription drugs to the market. Both of these products are promising alternatives in the battle for the reduction of opioids and improving quality of life in patients with chronic pain², added Dr. Chamberland.
- Published in Bio technology, Life Sciences, Medical Marijuana, News Home, Tetra Bio Pharma
Tetra Bio-Pharma (TBP:CSE) Moves Closer to Clinical Trials
Tetra Bio-Pharma Moves Closer to Clinical Trials
By: Ryan Allway – February 14th, 2017
View Original: CFN Media Group
Medical marijuana may be legal for roughly 60{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} of the U.S. population, but the cost of the drug remains prohibitive for many patients in need. Tetra Bio-Pharma Inc. (CSE: TBP) (OTC: GRPOF) aims to undergo FDA-sanctioned clinical trials for dried medical marijuana to secure prescription drug coverage from insurance companies. If successful, the company could potentially reach a large patient population with a unique option.
CFN Media recently spoke with Chief Science Officer Dr. Guy Chamberland about the company’s progress:
Click Here for Video Interview
In this article, we will take a closer look at some of the company’s recent milestones and why investors may want to consider the stock for their portfolios.
FDA Clears Way for Phase I Trials
Tetra Bio-Pharma held a pre-Investigational New Drug (“IND”) meeting with the U.S. Food and Drug Administration (“FDA”) in late January to advance its PPP001 clinical trial. During the meeting, the FDA provided all the necessary guidance on the design of a Phase I clinical trial on healthy volunteers and its overall development program. The meeting further demonstrates the agency’s willingness to continue the clinical trial to develop a dried marijuana prescription drug.
“We could not be more pleased, as the FDA guidance gave us a clear path to progress from early to late phase clinical development,” said Dr. Chamberland, M.Sc., Ph.D., Chief Scientific Officer and Regulatory Affairs. “Adhering to the U.S. FDA regulations is part of Tetra Bio-Pharma’s dedication to the commercialization of cannabis as a prescription controlled drug and the corporation’s plan to seek reimbursement by insurers for patients.”
PPP001 is a dried cannabis product with 9.5{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} tetrahydrocannabinol (“THC”) and 2{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} cannabidiol (“CBD”) that is being developed as a prescription drug that will meet the FDA’s high bar for quality and manufacturing. The company’s goal is to be the first to achieve reimbursement from insurance companies for the cost of the prescription, which could prove to be a game-changer for would-be medical marijuana patients that cannot afford the drug.
Enhancing the Odds of Success
Tetra Bio-Pharma recently partnered with Sante Cannabis in Montreal to assist in developing its clinical trials. As a leading private medical marijuana clinic, the organization has years of experience in educating patients and ensuring the optimal benefits. The company aims to leverage this expertise to ensure that its clinical trials are properly designed to achieve desired outcomes while helping achieve the organization’s goal of lowering costs for patients.
“Our clinic has provided services to almost 2,000 patients referred by over 1,500 physicians across Québec,” said Erin Prosk, Director of Santé Cannabis. “It is clear that both the medical community and the Quebec patient population are in desperate need of information about the potential benefits and risks of medical cannabis treatments … Of the 2,000 patients that we have seen, there is not one who is not burdened by [the cost of medical marijuana].”
These efforts are supported by an exceptional Scientific Advisory Board comprised of experts in clinical research, pain management, cancer, and neurological product drug development. Recently, the company expanded the board to include Dr. Gilles Chamberland, MD,FRCPC (no relation to Dr. Guy Chamberland) who will provide critical guidance on PPP’s clinical development program with regards to the safety of cannabis drug products and the potential mental health risks associated with marijuana.
Looking Ahead
Tetra Bio-Pharma Inc. (CSE: TBP) (OTC: GRPOF) continues to advance towards clinical trials for its PPP001, which aims to become the first dried marijuana prescription drug. After a successful pre-IND meeting and new partnership with the Sante Cannabis clinic, the company has assembled the right conditions to properly execute a clinical trial, significantly lower the cost of medical marijuana for patients, and unlock significant value for shareholders.
For more information, visit the company’s website
- Published in Bio technology, Blog, Tetra Bio Pharma
The 2017 Standards of Medical Care in Diabetes: an update from the ADA
The 2017 Standards of Medical Care in Diabetes: an update from the ADA
The American Diabetes Association (ADA) has released the 2017 update to its Standards of Medical Care in Diabetes (Standards).1 The document is reviewed each year by a multidisciplinary committee of experts in diabetes care, which examines relevant research that informs the revisions.
“The most recent update to the ADA Standards of Medical Care addresses many new and important issues regarding the management of patients with diabetes,” said Kevin M. Pantalone, DO, staff endocrinologist and director of clinical research at the Cleveland Clinic Foundation. The 2017 Standards contain the usual guidelines pertaining to type 2 diabetes prevention and the diagnosis and treatment of type 1, type 2, and gestational diabetes. Additionally, Dr Pantalone identified several of the most notable updates.
One recommendation suggests considering metabolic surgery for patients with obesity and uncontrolled type 2 diabetes who have a body mass index (BMI) as low as 30 kg/m2 (27.5 kg/m2for Asian Americans). This update is based on a growing body of research showing that metabolic surgery — previously referred to as bariatric surgery — leads to improved glycemic control and reduced cardiovascular disease (CVD) risk in this patient population compared with other medical and lifestyle interventions.2 The committee also noted that the safety of metabolic surgery has significantly improved in the past 2 decades: Related mortality rates are 0.1{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} to 0.5{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce}, which are similar to the rates associated with hysterectomy or cholecystectomy.2
Another update recommends considering 2 specific glucose-lowering therapies (glucagon-like peptide-1 [GLP-1] receptor agonists or sodium-glucose cotransporter-2 [SGLT2] inhibitors) for high-risk patients with CVD who have type 2 diabetes, which is in line with the findings of recently published clinical trials, including the EMPA-REG OUTCOME (ClinicalTrials.gov identifier: NCT01131676) and LEADER (ClinicalTrials.gov identifier: NCT01179048) trials.
The EMPA-REG OUTCOME study examined the effects of the SGLT2 inhibitor empagliflozin vs placebo and usual care in high-risk patients with CVD who have diabetes.3 The findings show that the drug led to a 14{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} reduction in the composite outcome of myocardial infarction (MI) and stroke, and a 38{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} reduction in CV death over a median follow-up period of 3.1 years.3 As a result, the US Food and Drug Administration (FDA) added a new indication for empagliflozin to reduce CV mortality risk in adults with type 2 diabetes and heart disease.4 In a similar manner, results from the LEADER trial showed that the GLP-1 receptor agonist liraglutide resulted in fewer MI, stroke, or CV deaths compared with placebo (13{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} vs 14.9{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce}) over a median follow-up period of 3.8 years.5
The committee also sought to further define hypoglycemia. The update indicates that a level of lower than 54 mg/dL (3.0 mmol/L) should be considered serious, clinically important hypoglycemia, even in the absence of symptoms. It is recommended that values below this level be reported in clinical trials and practice. Previous recommendations defined hypoglycemia in hospitalized patients as blood glucose levels <70 mg/dL (3.9 mmol/L) and severe hypoglycemia as levels <40 mg/dL (2.2 mmol/L). Severe hypoglycemia is now defined as “that associated with severe cognitive impairment regardless of blood glucose level,” and a level ≤70 mg/dL “is considered an alert value and may be used as a threshold for further titration of insulin regimens,” according to the Standards.
“Also, and perhaps most important, is the Standards’ acknowledgment and addressing of the socioeconomic aspects of diabetes management: medication cost and self-management support,” Dr Pantalone added. “These areas had been inadequately addressed by earlier versions of the guideline.”
The new version includes 2 detailed tables that provide the estimated monthly cost of various glucose-lowering medications, and the section on reducing disparities in diabetes care states that community health workers, peers, and lay leaders can facilitate the delivery of diabetes self-management education (DSME) and support services. “Strong social support leads to improved clinical outcomes, a reduction in psychosocial issues, and adoption of healthier lifestyles,” the committee noted.
Other notable additions include recommendations pertaining to screening and mental health referrals for patients with depression, anxiety, diabetes distress, eating disorders, and other psychological issues; greater emphasis on assessing comorbidities in patients with diabetes, and an expanded list of such comorbidities, including mental disorders as well as autoimmune disease and HIV; a new physical activity recommendation to break up sedentary behavior every 30 minutes to reduce associated behaviors illuminated by recent research; and increased options for both glucose management and hypertension treatment.
“The ADA has done a fantastic job of remaining on top of the new advances in diabetes management, incorporating new findings and recommendations into the guidelines in a timely manner, but doing so only after a thorough and vigorous review of the recently published medical literature,” said Dr Pantalone.
References
- American Diabetes Association. Standards of medical care in diabetes–2017. Diabetes Care. 2017;40(Suppl. 1):S6-S10.
- Rubino F, Nathan DM, Eckel RH, et al. Metabolic surgery in the treatment algorithm for type 2 diabetes: a joint statement by international diabetes organizations. Diabetes Care. 2016;39(6):861-77.
- Zinman B, Wanner C, Lachin JM, et al; EMPA-REG OUTCOME Investigators. Empagliflozin, cardiovascular outcomes, and mortality in type 2 diabetes. N Engl J Med. 2015; 373:2117-2128.
- FDA approves Jardiance to reduce cardiovascular death in adults with type 2 diabetes [news release]. Silver Spring, MD: FDA; December 2, 2016. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm531517.htm. Accessed January 18, 2017.
- Marso SP, Daniels GH, Brown-Frandsen K, et al.; LEADER Steering Committee; LEADER Trial Investigators. Liraglutide and cardiovascular outcomes in type 2 diabetes. N Engl J Med. 2016;375:311-322.
- Published in Bio technology, Blog, Life Sciences, Sirona Biochem
Sirona Biochem Announces Convertible Note Financing
VANCOUVER, BC–(Marketwired – January 31, 2017) – Sirona Biochem Corp. (TSX VENTURE: SBM) (FRANKFURT: ZSB) (XETRA: ZSB) announced today a non-brokered private placement (the “Private Placement”) of convertible notes (“Notes”) for gross proceeds of up to $600,000. Each Note will be convertible at the option of the holder into one common share of the company at a conversion price of $0.18 per share during the 18 month term of the Notes.
The Notes will mature in 18 months from the date of issuance and bear interest at the rate of 12{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} per annum, payable quarterly, until the Notes are converted or repaid. The company will be entitled to repay the principal amount of the Notes, together with accrued and unpaid interest, at any time commencing four months after the date of issuance, subject to giving the holders prior notice thereof to permit holders to convert during the notice period. The Notes are unsecured and transferable, subject to resale restrictions under applicable securities laws and TSX Venture Exchange requirements.
Sirona Biochem intends to use the net proceeds from the Private Placement for general working capital, and to support the company’s efforts to secure a licensing agreement for its skin lightening compound, TFC-1067. The company is expecting to receive a term sheet for a licensing transaction for TFC-1067 in Q1 2017 but there can be no assurances that a licensing agreement will be entered into on terms acceptable to Sirona Biochem or at all. The Company may pay fees of 7{92d3d6fd85a76c012ea375328005e518e768e12ace6b1722b71965c2a02ea7ce} in cash to qualified finders.
All securities issued in connection with the private placement will be subject to a statutory hold period of four months commencing from the date of issuance of the Notes. Closing of the private placement is subject to customary conditions, including TSX Venture Exchange acceptance.
This news release does not constitute an offer to sell or a solicitation of an offer to buy nor shall there be any sale of any of the Shares in any jurisdiction in which such offer, solicitation or sale would be unlawful. The Shares have not been and will not be registered under the United States Securities Act of 1933, as amended (the “U.S. Securities Act”) or any state securities laws and may not be offered or sold within the United States or to, or for the benefit of, U.S. persons (as defined in Regulation S under the U.S. Securities Act) unless registered under the U.S. Securities Act and applicable state securities laws or pursuant to an exemption from such registration requirements.
In addition, the Company announces an extension to the term of 8,865,970 common share purchase warrants (the “Warrants”) originally issued on March 6, 2014. The warrants were issued as part of a private placement. The expiry dates will be extended as follows:
March 6, 2014
Number of Warrants: | 8,865,970 |
Original Expiry Date of Warrants: | March 6, 2017 |
New Expiry Date of Warrants: | April 30, 2017 |
Exercise Price of Warrants: | $0.20 |
All other terms of the Warrants will remain unchanged.
About Sirona Biochem Corp.
Sirona Biochem is a cosmetic ingredient and drug discovery company with a proprietary platform technology. Sirona specializes in stabilizing carbohydrate molecules with the goal of improving efficacy and safety. New compounds are patented for maximum revenue potential.
Sirona’s compounds are licensed to leading companies around the world in return for licensing fees, milestone fees and ongoing royalty payments. Sirona’s laboratory, TFChem, is located in France and is the recipient of multiple French national scientific awards and European Union and French government grants. For more information, please visit www.sironabiochem.com.
Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.
Sirona Biochem cautions you that statements included in this press release that are not a description of historical facts may be forward-looking statements. Forward-looking statements are only predictions based upon current expectations and involve known and unknown risks and uncertainties. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of release of the relevant information, unless explicitly stated otherwise. Actual results, performance or achievement could differ materially from those expressed in, or implied by, Sirona Biochem’s forward-looking statements due to the risks and uncertainties inherent in Sirona Biochem’s business including, without limitation, statements about: a third party potential licensees of TFC-1067 may not deliver a term sheet to the company in Q1 2017 or at all; the company may not be able to negotiate a license agreement with a potential licensees of TFC-1067 on terms acceptable to Sirona Biochem; the progress and timing of its clinical trials are uncertain; difficulties or delays in development, testing, obtaining regulatory approval, producing and marketing products; unexpected adverse side effects or inadequate therapeutic efficacy of the company’s or licensed products that could delay or prevent product development or commercialization; the scope and validity of patent protection for the company’s or licensed products; competition from other pharmaceutical or biotechnology companies; and its ability to obtain additional financing to support its operations. Sirona Biochem does not assume any obligation to update any forward-looking statements except as required by law.
CONTACT INFORMATION
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For more information regarding this press release, please contact:
Christopher Hopton
CFO
Sirona Biochem Corp.
Phone: 1.604.282.6064
Email: chopton@sironabiochem.com
- Published in Bio technology, News Home, Sirona Biochem