Health Canada is changing regulations. Experts hope this could mean good news for reproductive healthcare

Health Canada is changing regulations. Experts hope this could mean good news for reproductive healthcare

Signs point to potential for early Canadian access to new endometriosis diagnostics and male contraceptives

New strides in reproductive healthcare, like male contraceptives and endometriosis diagnostic tools, may not be far away for Canadians — especially in light of regulatory changes announced by Health Canada last month.

Two rapid diagnostic tests for endometriosis, a painful and underdiagnosed medical condition that affects at least 1 in 10 women of reproductive age in Canada, were recently approved for use in the UK for a pilot period of three years.

Meanwhile, this year, a number of new male birth control options — like oral pills and topical and injectable gels — are entering later stages of development around the world.

In the wake of these developments, last month, Health Canada published a new Ministerial Order that lets the department fast-track certain parts of new drug submissions if they have already been approved by a handful of foreign regulatory bodies, like the US Food and Drug Administration. This is draft guidance that Health Canada is seeking feedback on from healthcare professionals and industry until September 12.

As of July 29, the federal health regulatory body issued new clinical trial framework, “removing red tape to encourage more companies to bring their clinical trials to Canada with the aim of improving access to new and innovative therapies for people in Canada while maintaining strong safety protections for participants,” Health Canada said in a statement emailed to PressProgress.

Though Health Canada specified that the new orders don’t currently include drug submissions for “anatomical therapeutic chemical classifications that would most likely capture male contraceptive drugs,” nor do they include medical devices for diagnostics, experts and researchers are still watching the changes closely.

“We were very excited to see that announcement,” said Dr. Darlene Walley, CEO of NEXT Life Sciences Inc., the company behind Vasalgel, a non-hormonal long-acting injectable gel to block sperm that is currently undergoing clinical trials including in Canada, in an interview with PressProgress.

“It protects the consumer, but then it also allows for innovation, so we are really excited about Canada.”

For Shay Freger, a McMaster University PhD candidate who has researched endometriosis clinical sciences and policy for a decade, the latest announcements will “create some changes for sure.”

“We know that endometriosis doesn’t have a cure. That remains universally true worldwide. Surgery is not a cure. There’s a 50% chance of reoccurrence,” Freger told PressProgress.

But having attended the latest World Congress on Endometriosis in Australia last year and regularly hearing from experts, Freger said there is work being done to repurpose medications for cancer and certain immunotherapies for use in treating endometriosis.

“We’ll see how effective those are in the context of endometriosis, and hopefully, those regulatory pathways make it easier for us to test these things and corroborate the findings,” Freger said.

In terms of diagnostics, however, the latest technologies available in the UK appear to already be circulating in Canada, though in limited and unclear ways.

“Health Canada does not regulate testing services,” the authority told PressProgress. “Provinces and territories are responsible for the delivery, administration, and oversight of health care services, including testing services.”

Are rapid endometriosis tests already available in Canada?

The two endometriosis rapid diagnostic tests now covered in the UK are called EndoSure and Endotest. The processes by which they are performed differ vastly.

EndoSure is a test that uses electrical signals obtained from sensor pads placed on the abdomen to measure any inflammation caused by endometriosis. It takes 30 to 45 minutes and results are available immediately afterwards.

It is shown online as being available for sale at a private clinic in Alberta, a fertility clinic in Ontario, and more recently, a ‘women’s health’ clinic in BC that is run by a nurse practitioner and advertises naturopathy, physiotherapy and Traditional Chinese Medicine.

The company markets EndoSure on its website as “the only rapid, non-invasive, highly accurate tier-1 test for endometriosis authorized for sale by Health Canada.”

“I do know it’s quite pricey. I’ve spoken to them before at a meeting,” Freger said, referring to EndoSure. “It is quite interesting, but bold statements to make.”

According to Dr. Paul Yong, Canada Research Chair in Endometriosis and Pelvic Pain at the University of British Columbia, the science behind EndoSure “makes sense physiologically, but this one I think needs more testing.”

The rapid diagnostic tool that has the most evidence backing it up at the moment, Yong said, is Endotest — a biological marker test that uses saliva samples from women to detect microRNAs to indicate the presence (or absence) of endometriosis.

Developed by French medical technology company Ziwig, the test has a validation study published by a journal within the New England Journal of Medicine Group which finds that it has an overall accuracy rate of 96.6%, after enrolling 971 symptomatic women aged 18 to 43 years across 17 public and private hospitals.

“That one probably has the best evidence so far, but has not been validated in Canada. I think a validation study in Canada will be necessary,” Yong told PressProgress.

According to an emailed statement from the president and founder of Ziwig, Yahya El Mir, Endotest can already be distributed in Canada.

“The saliva collection kit used for Endotest is manufactured by a Canadian company, and we have already successfully tested the logistics required for its deployment,” El Mir wrote.

“Our current focus is therefore on selecting the right local partner. We are in discussions with potential partners who can help us build the most appropriate model for Canada, with one key objective: making Endotest as widely accessible as possible to Canadian patients across the country.”

Freger said he is aware of a number of patients in Canada who have used Endotest.

“I know a bunch of people have gotten their hands on it — a lot of patients have, and I’m not exactly sure how,” Freger said. “[Maybe] they went to the UK, or maybe there is some kind of availability here in our markets that they just happened to come across.”

Finally, a third diagnostic tool that also relies on biomarkers, this time obtained via a blood test, is entirely homegrown, called ‘EndomiR’ by Afynia, a biotech company from Hamilton, Ontario.

“There is currently a funded multi-centre national trial going on at the moment, headed by McMaster and Afynia, and we at UBC are one of the recruitment sites where we’re attempting to validate this blood test for microRNA as a non-invasive test for endometriosis,” Yong said.

There are three types of endometriosis diagnoses: superficial, deep infiltrating, and ovarian. The latter two are easier to diagnose with accuracy using ultrasounds and MRIs. But superficial endometriosis is the most common form affecting about 80% of women worldwide, as established by multiple studies over the years.

“It’s virtually impossible to diagnose superficial endometriosis, so typically comes down to laparoscopic surgery, where we can directly visualize it,” Freger said.

Though the rapid tests being developed cannot tell which type of endometriosis is affecting the patient or where exactly the tissue is located, a simple “yes” or “no” diagnosis can be useful for a chronic disease with variable symptoms that often gets overlooked by physicians who are less versed in its pathogenesis.

“There aren’t many specialists who are able to diagnose endometriosis on imaging… Ultimately, it comes down to a lot of these tests,” Freger said.

“It does get [patients] through the door faster, especially when GPs don’t take you seriously. It’s at least a fighting, working chance for them to get the care that they need, get through those doors of the GP, and start their journey.”

For Yong, the UK’s model of approving Endotest and EndoSure for a period of three years to evaluate their efficacy is the same thing Canada should be doing.

“In my opinion, any deployment of these tests needs close monitoring. Ideally, like a research study that’s attached to it to really rigorously evaluate how the tests do,” he said.

The race for male contraceptives

This year, international developers for two types of male contraceptives announced some promising results via clinical trials.

A non-hormonal male contraceptive pill meant to be taken once a day, just like women’s oral contraceptives, called YCT-529 created by YourChoice Therapeutics at the University of Minnesota, entered phase two of development this year.

Its first phase of clinical trials with 16 volunteers found it safe enough — with no adverse effects on heart rates, hormone, inflammatory biomarker levels, sexual desire, or mood — to advance to the next stage.

Another product, a topical hormonal gel called NES/T developed by Contraline, announced completion of a global Phase 2b clinical trial with 462 couples. This gel formula includes Nestorone, an already-approved gel that suppresses sperm creation in men, and combines it with testosterone.

Co-developed by international NGO, Population Council, the product is said to have shown “strong potential for safety, efficacy, reversibility, and patient acceptability,” in trials so far.

“Contraline has begun actively planning a pivotal Phase 3 clinical program, which is expected to be the first Phase 3 trial of a hormonal male contraceptive in history,” reads a press release from Population Council earlier this year.

In an emailed statement to PressProgress, Contraline CEO Kevin Eisenfrats said current clinical trials are mostly being planned in the US, but the company sees a “significant opportunity to bring the product to men in other countries, including Canada,” after a commercial launch in the US.

For its part, a spokesperson for YourChoice Therapeutics told PressProgress that the company is “open to including at least one Canadian site in its upcoming clinical trials [for YCT-529] but the final decision on which countries and sites to choose has not been made yet.”

The one product that will undergo a six-month-long clinical trial in Canada is the long-acting injectable gel called Plan A or Vasalgel, developed by NEXT Life Sciences. This gel requires an outpatient procedure to inject, and is expected to be reversible, also requiring a clinic visit.

“Next year we’ll do what’s called a pivotal trial… It’s just a larger version of what we’re going to do in Canada,” said CEO Dr. Darlene Walley in an interview with PressProgress. “After [regulatory] approval we’ll do post-market studies. Hundreds of men will be using our product for many years. We’ll be using sites from the US, Canada, probably Australia and Europe as well.”

The science behind Vasalgel was pioneered by a Bengali man from India, Dr. Sujoy Kumar Guha, who has been working on this male contraceptive as an alternative to vasectomies since the 1970s.

His process is revealed in a documentary called ‘The Scientist Who Runs at Night’, and his product called ‘RISUG’ (or ‘Reverse Inhibition of Sperm Under Guidance’) underwent several phases of multicentre clinical trials that showed high efficacy and no adverse side-effects.

According to NEXT Life’s website, “RISUG and Vasalgel are both hydrogels with slight proprietary differences.”

“That product was effective for over 13 years,” before needing to be re-upped, said Walley. “Really good safety and really good efficacy, so we have every reason to believe that Plan A [Vasalgel] will be very long lasting.”

Research surveys conducted across multiple countries and thousands of people have shown growing interest in additional forms of male contraceptive options.

Walley said her company has seen some of this demand bear out in real time.

“We have 50,000 men who’ve come into our website without us marketing to them or asking for it,” she said. “So when we do clinical trials, we look at that database and it helps us recruit in different areas where they’re located.”

The demand comes from physicians as well, she said, who are increasingly encountering patients who seek reversible contraception that is less invasive than a vasectomy.

“I think that’s a really big change in young men today that maybe we didn’t see in my generation,” Walley said.

“Young men want to participate in family planning, and I think that’s going to be a great inflection point in society.”

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