VANCOUVER, Aug. 15, 2018 /CNW/ - The Acne and Rosacea Society of Canada has just launched "Skin Confident", a 1-hour, healthy skin and acne education program for Canadian high school students with proven, positive results.

In a recent study ⁽¹⁾, Skin Confident was shown after one month to bring about improvements in acne-related self-perception, social and emotional well-being and acne symptoms in teens. The program is freely available for teachers, school nurses and anyone interested in presenting it to high school students via the not for profit society's website https://www.acneaction.ca/skin-confident/

"It appears there is no formal teaching about acne at high schools despite the fact that about 90% of students have it," says Dr. Shannon Humphrey, a Vancouver dermatologist and spokesperson for the Acne and Rosacea Society of Canada. "This is particularly concerning since acne has been shown to affect self-esteem and may cause significant emotional distress," added Dr. Humphrey, co-developer of the program.

"Skin Confident gives us an opportunity to provide teens with scientific, independent information to help with this common condition and its emotional effects," she said.

Aside from acne, Skin Confident covers the biology of the skin, skin care and self-esteem as it relates to acne. The program is aimed at students in grades 10 and 11 but can be shown to any high school grade.

"We are hoping physical education teachers in particular, many of whom now have an added role to provide health education, will be among the top users of the program," Dr. Humphrey said. Educators and health personnel are encouraged to present the program.

Developed by Dr. Angela Burleigh, resident physician, and Dr. Humphrey, the fully scripted program is available in English and French.

A search for similar high school acne education programs worldwide did not turn up any results, pointing to Skin Confident as the first program of its kind in the world.

⁽¹⁾ Burleigh A, Yousefi M, Humphrey S, Skin Confident: A skin health and acne educational intervention to improve Acne Quality of Life measures in adolescents, Journal of the American Academy of Dermatology (2018), doi: 10.1016/j.jaad.2018.06.052.

About the Acne and Rosacea Society of Canada:
The society, a national, not for profit organization, offers hope and help to those with acne by providing independent, reputable and current information and raising awareness. For more, visit www.AcneAction.ca

Acne Awareness Month, September 2018 was designated by the Acne and Rosacea Society of Canada / La Société canadienne de l'acné et de la rosacée to raise awareness about acne, a common skin condition affecting 5 million Canadians that can cause significant physical and emotional effects.

TORONTO, Aug. 14, 2018 /CNW/ - The Ontario Pharmacists Association (OPA) applauds the Ontario government on its initiative to consult with Ontarians towards the creation of a new retail model for the sale and distribution of recreational cannabis. Since pharmacists are the medication experts on a patient's healthcare team, OPA welcomes this approach as an opportunity to advise the government during its period of consultation specifically on the sale and distribution of medicinal cannabis, and how patient safety and appropriate use can be assured and monitored in Ontario.

With recreational cannabis being the sole focus of the government announcement, OPA remains concerned on the process by which medicinal cannabis is currently dispensed in Ontario and on the lack of medication safety measures that need to be in place to ensure patient safety and appropriate use.  During the period of consultation, OPA will be urging the government to reconsider its current approach for the sale and distribution of medicinal cannabis and enable it to be dispensed through pharmacies, while using the existing pharmacy supply management systems, where patients are able to receive the care, advice and education they need and want. In a recent poll of approximately 600 pharmacy professionals, nearly 60% indicated that their patients are currently using cannabis for medicinal purposes, and 40% said they receive questions from patients at least once a month about cannabis. In an earlier survey of 800 adults, seven out of ten Ontarians said patients should be able to obtain cannabis for medical purposes from their pharmacist – like they do with all prescription products – so that they have increased access to the advice, guidance and information they need and want.

Pharmacists have access to a patient's full medication history, know their allergies and serve as a patient's last line of defence against harmful drug-drug interactions – licensed producers do not have this access or knowledge of a patient's medication profile.

"We're pleased to see that the government is creating opportunities for discussion about medicinal cannabis. We've been asking for this for some time. It's critical that medicinal cannabis is dispensed through pharmacies. Medicinal cannabis is the only medication that requires a prescription that is not dispensed through pharmacies, and this is a potential safety risk and a missed healthcare opportunity," says Mike Cavanagh, Chair, OPA Board of Directors.

Currently, an Ontario patient must obtain cannabis for medical purposes through a federally licensed producer via mail order pursuant to a prescription issued by a prescriber. Furthermore, with Ontario in the midst of an opioid crisis that shows no signs of abating, there is a growing body of evidence that suggests that cannabis for medicinal purposes can be a suitable alternative to opioid therapy in the management of pain. This underscores the incredible importance of capturing the dispensing of all prescription drugs on the patient's medication profile in the pharmacy. The province has the legislative power to make cannabis for medicinal purposes available to patients through their pharmacist.

"This in the best interests of Ontarians' continued health and safety, and it is also what Ontarians want," says Cavanagh.

As the medication experts on a patient's healthcare team, pharmacy professionals play a critical role in managing a patient's overall health. Ontario's pharmacists are driven by their commitment to provide patient-centred care in local communities across the province, and as a result should be the primary point of contact for the controlled dispensing of medicinal cannabis in the province. OPA looks forward to working with the Ontario government and other healthcare providers on ensuring that medicinal cannabis is introduced in our province in a safe and effective manner.

About the Ontario Pharmacists Association

The Ontario Pharmacists Association is committed to evolving the pharmacy profession and advocating for excellence in practice and patient care. With more than 10,000 members, OPA is Canada's largest advocacy organization, and professional development and drug information provider for pharmacy professionals across Ontario. By leveraging the unique expertise of pharmacy professionals, enabling them to practise to their fullest potential, and making them more accessible to patients, OPA is working to improve the efficiency and effectiveness of the healthcare system. The pharmacy sector plays a strong role in Ontario with an economic impact of more than $6.3 billion across 4,500 pharmacies, employing 60,000 Ontarians.

HEMLIBRA is the first new treatment in almost 20 years for this most severe form of hemophilia¹
and the only medicine that is self-injected once weekly

MISSISSAUGA, ON, Aug. 7, 2018 /CNW/ - Hoffmann-La Roche Limited (Roche Canada) announced today that Health Canada has approved HEMLIBRA^® (emicizumab injection) for hemophilia A (congenital factor VIII deficiency) patients with factor VIII inhibitors as routine prophylaxis to prevent bleeding or reduce the frequency of bleeding episodes.² (Please see HEMLIBRA Product Monograph for full prescribing information.)

In two of the largest clinical studies for people with hemophilia A with inhibitors (HAVEN 1 and HAVEN 2), HEMLIBRA was shown to substantially reduce bleeds in adults and children compared to prior episodic (on demand) treatment with bypassing agents.^3,4

"Preventing bleeds in patients with hemophilia A can be extremely challenging, usually requiring patients to self-infuse medications multiple times a week, or even daily," says Dr. Jayson Stoffman, Associate Professor, Department of Pediatrics and Child Health, University of Manitoba, and Medical Director of the Manitoba Bleeding Disorders Program. "The development of inhibitors adds a significant challenge, with more demanding treatments that are often less effective. Hemlibra offers these patients the chance to effectively reduce the frequency of their bleeds with a once weekly injection at home. This could significantly improve the quality of life for inhibitor patients, and particularly children and their families."

Hemophilia A is a rare bleeding disorder affecting approximately 3,000 Canadian males.⁵ People with hemophilia A have significantly lower than normal levels of factor VIII (FVIII) in their blood, which lowers the ability of their blood to clot.⁶ Nearly one-in-three people with severe hemophilia A can develop inhibitors to factor VIII replacement therapies, putting them at greater risk of life-threatening bleeds or repeated bleeding episodes that can cause long-term joint damage.⁷

"Many people with severe hemophilia A face an ongoing struggle to control their bleeds, live with pain caused by joint damage and their lives revolve around treatment infusions. Until now, treatment options have been limited for those with inhibitors to factor VIII and there hasn't been a new medicine in the past 20 years," says Paul Wilton, President, Canadian Hemophilia Society. "Hemlibra is a significant innovation for people with inhibitors and we are pleased that it is now approved for Canadian patients."

About the Health Canada Approval
The Health Canada approval of HEMLIBRA is based on data from two pivotal clinical studies for people with hemophilia A with inhibitors, the phase III HAVEN 1 and HAVEN 2 studies.

HEMLIBRA prophylaxis was evaluated in a randomized, multicenter, open-label clinical study in 109 adolescent and adult males (aged 12 to 75 years old) with hemophilia A with FVIII inhibitors who had previously received either episodic (on-demand) or prophylactic treatment with bypassing agents.  In the study, patients received weekly HEMLIBRA prophylaxis (Arms A and C) — 3 mg/kg once weekly for 4 weeks followed by 1.5 mg/kg once weekly thereafter — or no prophylaxis (Arm B).⁸

Below is a summary of key data from the HAVEN 1 study:⁹

• The primary endpoint showed a statistically significant reduction in treated bleeds of 87% (risk rate [RR]=0.13, p<0.0001) with HEMLIBRA prophylaxis compared to no prophylaxis.
  • In addition, 62.9% (95% CI: 44.9; 78.5) of patients who received HEMLIBRA prophylaxis experienced zero treated bleeds compared to 5.6% (95% CI: 0.1; 27.3) of patients who received no prophylaxis.
• In a first-of-its-kind intra-patient analysis, HEMLIBRA prophylaxis resulted in a statistically significant reduction in treated bleeds of 79% (RR=0.21, p=0.0003) compared to previous treatment with BPA prophylaxis collected in the NIS prior to enrolment.
  • Additionally, 70.8% (95% CI: 48.9; 87.4) of patients experienced zero treated bleeds with HEMLIBRA prophylaxis compared to 12.5% (95% CI: 2.7; 32.4) with previous treatment with BPA prophylaxis during the NIS.
• Improvements in bleed rate with HEMLIBRA prophylaxis compared to no prophylaxis included:
  • 80% (RR=0.20, p<0.0001) reduction in all bleeds
  • 92% (RR=0.08, p<0.0001) reduction in treated spontaneous bleeds
  • 89% (RR=0.11, p=0.0050) reduction in treated joint bleeds
  • 95% (RR=0.05, p=0.0002) reduction in treated target joint bleeds.
• HEMLIBRA prophylaxis showed a statistically significant and clinically meaningful improvement in the Haemophilia-specific Quality of Life (Haem-A-QoL) Total Score and Physical Health scale compared to no prophylaxis. This was measured at week 25 after the start of treatment in adults 18 years of age and older and evaluated hemophilia-related symptoms and physical function.

HAVEN 2 was a single-arm, multicenter, open-label clinical study in pediatric patients (age < 12 years old, or 12 to 17 years old weighing < 40 kg) with hemophilia A with factor VIII inhibitors.  Patients received HEMLIBRA prophylaxis at 3 mg/kg once weekly for the first four weeks followed by 1.5 mg/kg once weekly thereafter.

The study evaluated the pharmacokinetics, safety, and efficacy of weekly HEMLIBRA prophylaxis, including the efficacy of weekly HEMLIBRA prophylaxis compared with previous episodic (on-demand) and prophylactic bypassing agent treatment in patients who had participated in the non-interventional study (NIS) BH29768 prior to enrollment (intra-patient comparison).

At the time of the interim analysis, the clinical study had enrolled 60 male patients.  Thirty-eight patients aged 6 to < 12 years, 17 patients aged 2 to < 6 years, two patients aged < 2 years and three patients aged ≥ 12 years.¹⁰

Below is a summary of the interim results of HAVEN 2:⁴

• After a median observation time of 38.1 weeks, the interim analysis showed that 87% (95% CI: 66.4; 97.2) of children who received HEMLIBRA prophylaxis experienced zero treated bleeds. Interim data also showed:
  • 34.8% (95% CI: 16.4; 57.3) of children experienced zero bleeds overall, which includes all treated and non-treated bleeds.
  • 95.7% (95% CI: 78.1; 99.9) of children experienced zero treated spontaneous bleeds.
  • 95.7% (95% CI: 78.1; 99.9) of children experienced zero treated joint bleeds.
  • 100% (95% CI: 85.2; 100) of children experienced zero treated target joint bleeds.
• In an intra-patient analysis, 13 children who had participated in the NIS had an annualised bleeding rate (ABR) for treated bleeds of 17.2 (95% CI: 12.4; 23.8) on previous treatment with a BPA either as prophylaxis (n=12) or on-demand (n=1) compared to 0.2 (95% CI: 0.1; 0.8) on HEMLIBRA prophylaxis, corresponding to a 99% (RR=0.01, 95% CI: 0.004; 0.044) reduction in bleed rate. On HEMLIBRA prophylaxis, 11 children (84.6%) experienced zero treated bleeds.⁴

The most common adverse drug reactions (ADRs) from pooled clinical studies of people treated with HEMLIBRA were injection site reactions, headache, arthralgia, pyrexia, diarrhea, myalgia and thrombotic microangiopathy. The most serious adverse drug reactions reported from the clinical trials with HEMLIBRA were TMA and thrombotic events, including cavernous sinus thrombosis and superficial vein thrombosis contemporaneous with skin necrosis.¹¹

In the HAVEN 1 study, three people experienced thrombotic microangiopathy (TMA) events and two people experienced serious thrombotic events when on average, a cumulative amount of more than 100 U/kg/24 hours of activated prothrombin complex concentrate (aPCC) (FEIBA^®) was administered for 24 hours or more while receiving HEMLIBRA prophylaxis.¹²

About Hemophilia A
Hemophilia A is an inherited, serious disorder in which a person's blood does not clot properly, leading to uncontrolled and often spontaneous bleeding. Hemophilia A affects around 3,000 Canadian males,⁵ approximately 40 per cent of whom have a severe form of the disorder.¹³

People with hemophilia A either lack or do not have enough of a clotting protein called factor VIII. Depending on the severity of their disorder, people with haemophilia A can bleed frequently, especially into their joints or muscles.¹⁴ These bleeds can present a significant health concern as they often cause pain and can lead to chronic swelling, deformity, reduced mobility, and long-term joint damage.¹⁵ A serious complication of treatment is the development of inhibitors to factor VIII replacement therapies.¹⁶ Inhibitors are antibodies developed by the body's immune system that bind to and block the efficacy of replacement factor VIII,¹⁷ making it difficult, if not impossible to obtain a level of factor VIII sufficient to control bleeding.

About HEMLIBRA^® (emicizumab injection)
HEMLIBRA is an engineered humanized monoclonal modified immunoglobulin G4 (IgG4) antibody that bridges activated factor IX and factor X to restore the natural function of missing activated factor VIII that is needed for effective blood clotting. It has no structural relationship to FVIII and, as such, does not induce or enhance the development of direct inhibitors to FVIII.^18,19

HEMLIBRA is a prophylactic (preventative) treatment that can be administered by an injection of a ready-to-use solution under the skin (subcutaneously) once weekly.²⁰

HEMLIBRA was created by Chugai Pharmaceutical Co., Ltd. and is being co-developed by Chugai, Roche and Genentech. It is currently approved in the United States and Europe for people with hemophilia A with factor VIII inhibitors.

About Roche in Hematology
For more than 20 years, Roche has been developing medicines that redefine treatment in hematology. Today, we are investing more than ever in our effort to bring innovative treatment options to people with diseases of the blood. In addition to approved medicines MabThera^®/Rituxan® (rituximab), Gazyva^®/Gazyvaro^® (obinutuzumab), and Venclexta™/Venclyxto™ (venetoclax) in collaboration with AbbVie, Roche's pipeline of investigational hematology medicines includes Tecentriq^® (atezolizumab), an anti-CD79b antibody drug conjugate (polatuzumab vedotin/RG7596) and a small molecule antagonist of MDM2 (idasanutlin/RG7388). Roche's dedication to developing novel molecules in hematology expands beyond malignancy, with the development of Hemlibra (emicizumab injection), a bispecific monoclonal antibody for the treatment of hemophilia A.

About Roche
Headquartered in Basel, Switzerland, Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people's lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world's largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Roche Canada was founded in 1931. The company employs over 1,000 people across the country, with its pharmaceuticals head office located in Mississauga, Ontario, and diagnostics division based in Laval, Quebec. Roche Canada is actively involved in local communities, investing in charitable organizations and partnering with healthcare institutions across the country. For more information, visit www.rochecanada.com.

All trade-marks mentioned are the property of their respective owners.

© Copyright 2018; Hoffmann-La Roche Limited

REFERENCES

TORONTO and CAMBRIDGE, MA, Aug. 14, 2018 /CNW/ - ProMIS Neurosciences, Inc. (TSX: PMN; OTCQB: ARFXF), a biotechnology company focused on the discovery and development of antibody therapeutics targeting toxic oligomers implicated in the development of neurodegenerative diseases, today announced its operational and financial results for the three and six months ended June 30, 2018.

"Over the first half of 2018, we focused on three key priorities to advance our business," stated ProMIS Executive Chairman, Eugene Williams. "First, to continue to push toward our goal of initiating the  first clinical trial of PMN310 in the second half of 2019; second, to differentiate the oligomer selectivity of PMN310 as best in class profile for the treatment of Alzheimer's disease (AD) versus other amyloid-beta directed therapies in development; and third, to expand our portfolio by developing therapeutic antibodies targeting toxic oligomers of alpha-synuclein for Parkinson's disease (PD) and toxic aggregates of Tar-DNA binding protein (TDP43) for ALS. We are pleased to be on target to meet our objectives for the year and look forward to communicating our accomplishments."

Recent Corporate Highlights

• On May 1, we announced completion of a private placement of 19,306,668 common share units at a price of $0.375 per unit, for gross proceeds of approximately $7,240,000. Each unit consisted of one common share and one-half of a common share purchase warrant. Each whole warrant is exercisable into one common share at a price of $0.48 per share for a 60-month exercise period, subject to earlier expiry on 30 days' notice if, at any time after four months from closing, the 20-day volume-weighted average trading price of the Company's common shares is greater than CDN$1.00. Net proceeds from the private placement will be used for working capital and general corporate purposes.
• During the second quarter of 2018, we received proceeds of $1,550,204 related to the exercise of common stock warrants and stock options. The warrants were exercisable at $0.17, $0.20 and $0.30.
• On April 10, we announced publication of a peer reviewed scientific paper describing a novel target on toxic oligomers of amyloid-beta in AD.
• On June 12, we announced the initiation of producer cell line development for PMN310, our lead therapeutic antibody candidate for treatment of AD. Selexis, SA will carry out this critical first step in the manufacturing of antibody therapeutics using their proprietary Selexis SUREtechnology Platform™.
• On June 26, we announced that our unique discovery platform generated potential new antibody therapeutic candidates targeting toxic oligomers implicated in the development and progression of PD and ALS.
• On June 28, we announced results of the Annual Meeting of Shareholders, whereby all of the resolutions announced in the Management Proxy Circular and placed before the Meeting were overwhelmingly approved by the shareholders.

Financial Results

Results of Operations – Three months ended June 30, 2018 and 2017
The net loss for the three months ended June 30, 2018 was $2,214,861, compared to a net loss of $1,903,396 for the three months ended June 30, 2017.  The increased loss in the current period reflects the costs associated with operating the Company's AD therapeutics program, increased contract research and consultant salaries and associated costs, supporting its patent portfolio and general corporate expenditures.

Research and development expenses for the three months ended June 30, 2018 were $1,531,075, as compared to $1,132,258 in the three months ended June 30, 2017.  Costs were higher in the current period due to higher research program costs for the AD therapeutics program, recruiting expenses and higher costs to support its patent portfolio, offset by lower stock-based compensation.

General and administrative expenses for the three months ended June 30, 2018 were $683,786, as compared to $768,696 in the three months ended June 30, 2017.  The decreased in expenditures in the current period reflect reduced investor relations expenses and foreign exchange expense, offset by higher consultant salaries and associated costs, other professional fees, and stock-based compensation.

Results of Operations – Six months ended June 30, 2018 and 2017
The net loss for the six months ended June 30, 2018 was $3,771,733, compared to a net loss of $3,275,599 for the six months ended June 30, 2017.  The increased loss in the current period reflects the costs associated with operating the Company's AD therapeutics program, increased contracted research and consultant salaries and associated costs, supporting its patent portfolio and general corporate expenditures.

Revenues for the six months ended June 30, 2018 and 2017 were nominal and relate to legacy technologies.

Research and development expenses for the six months ended June 30, 2018 were $2,229,082, as compared to $1,851,360 in the six months ended June 30, 2017.  Costs are higher in the current period due to higher research program costs for the AD therapeutics program, recruiting expenses and higher costs to support its patent portfolio, offset by lower stock-based compensation.

General and administrative expenses for the six months ended June 30, 2018 were $1,542,656, as compared to $1,420,056 in the six months ended June 30, 2017.  The increased expenditures in the current period reflect increased consultant salaries and associated costs and higher stock-based compensation, offset by foreign exchange gains.

Outlook
The Company plans to further advance its AD portfolio, with a focus on development of PMN310 for clinical trial initiation in the second half of 2019. Based on the highly selective binding of PMN310 to the toxic Aβ oligomers and lack of off-target binding to non-toxic forms of Aβ (monomer, plaque), the ProMIS AD program will continue to develop data further supporting potential best in class safety and efficacy versus other Aβ-directed therapies currently in development.

Finally, using its unique technology platform, we will advance work to identify and validate selective antibody therapies for the toxic oligomers of alpha synuclein in PD and TDP43 in ALS, with a view to partnering these assets.

About ProMIS Neurosciences
ProMIS Neurosciences, Inc. is a development stage biotechnology company focused on discovering and developing antibody therapeutics targeting toxic oligomers implicated in the development and progression of neurodegenerative diseases, in particular Alzheimer's disease (AD), amyotrophic lateral sclerosis (ALS) and Parkinson's disease (PD). The Company's proprietary target discovery engine is based on the use of two complementary techniques. The Company applies its thermodynamic, computational discovery platform—ProMIS™ and Collective Coordinates — to predict novel targets known as Disease Specific Epitopes on the molecular surface of misfolded proteins. Using this unique precision medicine approach, the Company is developing novel antibody therapeutics for AD, ALS and PD.  ProMIS is headquartered in Toronto, Ontario, with offices in Cambridge, Massachusetts. ProMIS is listed on the Toronto Stock Exchange under the symbol PMN, and on the OTCQB Venture Market under the symbol ARFXF.
For further information please consult the Company's website at:  www.promisneurosciences.com

Follow us on Twitter
Like us on LinkedIn

The TSX has not reviewed and does not accept responsibility for the adequacy or accuracy of this release. This information release contains certain forward-looking information, including about the timing and completion of the Offering, the receipt of TSX approval and the expected use of proceeds from the Offering. Such information involves known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those implied by statements herein, and therefore these statements should not be read as guarantees of future performance or results. All forward-looking statements are based on the Company's current beliefs as well as assumptions made by and information currently available to it as well as other factors. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Due to risks and uncertainties, including the risks and uncertainties identified by the Company in its public securities filings, actual events may differ materially from current expectations. The Company disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.