Halneuron—currently in Phase III clinical trials for neuropathic pain brought on by chemotherapy—is also being studied for additional pain indications, with more than 700 patients having been previously treated by the drug.

Tetrodotoxin (TTX), Halneuron’s active ingredient, is a sodium channel blocker that prevents pain signals from reaching the brain without the negative effects of opioids, the current gold standard for treating moderate to severe pain.

While opioids have substantial drawbacks and hazards when used long-term, including adverse effects on the respiratory, gastrointestinal, and central nervous systems, and putting patients at risk for addiction and tolerance, Halneuron promises to revolutionize how the brain perceives both short- and long-term pain.

A subsidiary of CK Life Sciences Int’l., (Holdings) Inc., a publicly traded company in Hong Kong, WEX is headed by CEO Walter Korz, who has a distinguished background in the healthcare industry, including experience with concerns such as rheumatoid arthritis, cancer, multiple sclerosis, and now pain management.

“I’m also pleased to say we have a strong management team,” says Korz of the focused group of nine people who understand the core of the business and drive its research, manufacturing, and business development.

“We stay lean by relying on a strong network of competent contractors from animal studies to manufacturing, spending a high percentage of our money on the actual drug development rather than on overhead,” he explains.

WEX is also a long-time member of Life Sciences BC, a non-profit, non-governmental organization, and an important element of the healthcare biosphere, providing networking events and continuing education, and serving as a conduit to government services and other pharmaceutical companies and agencies.

“They’re the glue that keeps this sector here in BC attached and a vibrant community,” says Korz.

While numerous factors set WEX apart from others in the pain management field, it’s the company’s unique technology that has truly made it stand out, says Korz. “We’re succeeding where others have failed.”

Pain is a “very subjective” area of research, he explains, compared with cancer, for instance, where a CT scan can measure the size of a tumour and, after a drug is administered, doctors can accurately establish whether the tumour has shrunk. “That’s a very good surrogate marker of efficacy, and you measure how long somebody lives without their disease coming back,” he says.

With pain, he says, it’s more nebulous. You’re taking something that’s not quantifiable, that’s subjective, and you’re trying to quantify it.

“We try to take something subjective and turn it into objective data,” Korz says. “You use pain scales and try to have patients answer questionnaires about how their pain is progressing, and then you try to see whether your drug is doing something compared to a placebo.”

Placebo effects are real, he adds, and response can be as high as 30 to 40 percent. Sometimes when doctors or nurses ask patients to assess their pain score on a scale, patients tend to say “better” so as not to disappoint their doctors.

“It’s hard to prove [the efficacy of] a drug when you get 30 percent of the people on placebo saying they’re better,” Korz says. “So that’s one of the challenges we have.”

WEX employs technology to capture patients’ data more effectively—for example, using cell phones to more accurately record pain scores in real time. “But it comes down to our technology with our drug itself and how it’s working,” he says. “The pain drugs we’re routinely using today are no different than 30 years ago. There are different ways of delivering it; you can put fentanyl in a lollipop and give that to a patient, as an example, but essentially, they’re the same kind of drugs.”

WEX’s Halneuron, however, is a non-opioid drug designed to address moderate to severe pain indications with no evidence of addiction or withdrawal symptoms and doesn’t cross the blood-brain barrier, a vital distinction.

“Many of these drugs being used today are absorbed into the brain where they relieve the pain,” says Korz. “But at the same time, you may experience side effects such as confusion, somnolence, respiratory depression, euphoria. And before you know it, evidence tells us some patients are abusing these drugs.”

A worldwide opioid crisis points to the undeniable fact that new ways of treating pain are desperately needed. Halneuron, administered through an injection twice a day for four days, has resulted in some patients reporting pain relief, not for hours or days, but for weeks and months, a truly remarkable effect.

“Despite everything the government is doing, deaths from drug use are increasing, not decreasing,” says Korz. There has been a 26 percent increase in the number of drug deaths since 2020, despite more treatments and detox facilities, better control of prescription drugs, and limiting the types and number of doses per patient.

“The sad truth is those people that are on the street didn’t decide one day to get up in the morning and become addicted to an opioid. In fact, 70 percent of people who abuse these drugs started from a doctor’s prescription—an athlete who got injured, or a routine surgery that ended up needing analgesics. There are many, many reasons that everybody in their life will at some point need an analgesic.”

While media reports are rife with celebrity addictions and overdoses, Korz stresses it’s mainly everyday, ordinary people who are suffering.

“We’re trying to provide a tool for physicians that is safe, efficacious, and gives them some additional drugs they can use, and introduce something novel,” he says. “This is a drug that interrupts the pain signal from the periphery, meaning from your external to your central nervous system, and prevents the pain signal from reaching the brain. If it does that, then there’s no perception of pain.”

WEX has conducted 15 clinical trials to date and has administered the drug to late-stage cancer patients and healthy volunteers at the same dose, showing a patient can take a dose of the drug and go back to work without feeling sleepy or confused. “We’ve shown we can reduce pain even in some of those patients that had intractable pain and were not responding anymore to opioids or couldn’t tolerate them. There was a statistically significant reduction of pain in this patient group,” Korz says. “That’s compelling evidence.”

WEX has also demonstrated that, when introducing its drug, the amount of opioids used decreases. “Our drug is safe, and our clinical evidence to date supports that,” he says. “We’re changing the way the brain is perceiving long-term chronic pain.”

WEX is also looking at chemo-induced neuropathic pain, a peripheral neuropathy caused by chemotherapy damaging the nerves, sometimes permanently. When this occurs, chemo is usually stopped, as there is currently no drug that can treat the condition, including opioids. WEX is investigating methods of treating this and has been developing and conducting clinical trials, recently launching a Phase Two trial in Korea, Taiwan, the U.S., and Canada.

“The difference between our company and others who have tried and failed, again, comes down to the way our drug works,” says Korz. “Nature produces drugs for us. This is part of pharmacy called pharmacognosy, taking active ingredients from plants and animals, refining them, and making them into pharmaceutical drugs that are useful to humans.”

This group of drugs includes penicillin from mould, heroin from poppy plants, insulin from the pancreas of a pig, and Taxol, from the bark of yew trees, one of the most successful chemotherapeutic agents. In fact, 70 percent of drugs used today had their genesis in plant or animal chemistry, says Korz. Tetrodotoxin is also extracted from nature: a toxin found in puffer fish used as a defence against predators.

“It’s a complicated molecule. It’s a gift from nature in that it’s very efficient in blocking a channel critical for the sensation of pain. People have tried to emulate that molecule from chemistry and haven’t been successful,” Korz says. “Our success is that this chemical that nature has produced is very efficient at targeting sodium channels. We use this chemical, refine it, purify it, and make it into a drug.”

While tetrodotoxin is a toxin, WEX has shown it can be used and handled safely and is far less dangerous than many analgesics being used today, but that process hasn’t been easy, with the company overcoming “hurdle after hurdle” to prove its safety.

“We’re faced with this challenge all the time,” Korz says. “We have a potent drug, and it becomes a question of educating even the companies that normally manufacture drugs. We need to work with them closely to convince them of the safety profile of our drug for their workers.”

Due to this, the number of manufacturers that will work with WEX is limited, he adds. Of course, it’s not just a matter of educating manufacturers, but also preclinical and regulators about the use and safety profile of the drug.

Despite all the challenges faced, from production to manufacturing, trials, and ongoing education, WEX remains dedicated to its goal of helping people fight pain in new and safer ways.

“Everybody at one point in their life will need to take some sort of painkiller,” Korz says. “Not everybody’s going to be touched by cancer or heart disease or some other [severe] affliction, but everybody will experience pain of some sort that needs help,” he says.

“There’s a ‘heart’ factor in the people involved in this development,” Korz says. “This isn’t just a job to them; they’re committed to seeing this being put in the hands of doctors to alleviate pain and suffering in the people that really need it.”

The post Perfecting the Science of Pain Management<p class="company">WEX Pharmaceuticals</p> appeared first on Manufacturing In Focus.

The system tests for a wide range of biomarkers including Troponin I, CK-MB, Myoglobin, NT-proBNP, D-dimer, and Procalcitonin. These RAMP tests assist in the diagnosis of conditions such as acute myocardial infarction, heart failure, and sepsis for effective and efficient patient management.

Response designs, develops, and manufactures a platform technology that can be used to detect environmental, viral vectors, and disease biomarkers from a small volume of fluid in just 15 minutes, aiding in the diagnosis of life-threatening conditions for both the laboratory and near-patient testing markets in more than 40 countries worldwide.

The RAMP platform is based on gold standard immunochromatography technology coupled with highly sensitive fluorescent detection; the system delivers quantitative results from a small drop of blood that aids and enables healthcare providers to rapidly triage patients in a wide range of settings and helps improve operational efficiency. Historically, the value of traditional point-of-care testing (POCT) has been limited due to the visual inspection needed for the rapid tests commonly used, their qualitative nature leading to subjective interpretation, and the lack of data storage capabilities for integration of test results into Electronic Medical Records. To overcome these numerous challenges, the RAMP instrument was designed for ease of use, lab-quality quantitative results, connectivity, compliance, and the ability to be networked to all major laboratory and hospital information systems. In fact, Response has global regulatory clearances for a wide range of tests that aid in the diagnosis of multiple life-threatening conditions caused by cardiovascular disease, infectious disease, or sepsis.

The original platform and diagnostic biomarker testing strategy was defined in the late ‘90s, and while the company was focused on developing cardiac biomarker tests, Response was unfortunately hit by the downturn that followed the 9/11 tragedy.

Starting in 2002, in a post 9/11 world, Response launched its RAMP platform into the biodefense market with the introduction of a test for on-site detection of Anthrax; subsequent tests for Ricin, Botulism toxin, and Small Pox were launched in the following months. Response expanded its offering into infectious agents when it introduced a West Nile Virus (WNV) test for the detection of the virus in mosquitos, the primary vector for the virus. In fact, even today, this ability of the team to be agile and pivot to market shifts in such a successful and continual fashion remains a key element of the company’s culture today.

While the commercial launch of the RAMP biodefense and WNV tests helped gain traction in non-clinical settings, Response’s focus remained on the near-patient diagnostic testing market with the aim of improving diagnosis at the point of need. Response received Health Canada and FDA clearance for its first acute care test (Myoglobin) on the first generation RAMP Reader in 2004 followed by the launch of Troponin I and CK-MB tests; together, these cardiac markers positioned Response to aid in the diagnosis of heart attacks. In 2007, in close collaboration with Roche Diagnostics, another key test was developed for aid in the diagnosis of congestive heart failure (NT-proBNP).

Response later developed a higher capacity instrument, the RAMP200, with the ability to run up to six tests in parallel; the system was configured to meet the needs of a wide range of settings from small physician’s office labs to high-volume laboratory settings. This directly addressed a market need where competitive systems had a throughput of a single test at a time. Due to its unique modular design where one, two, or three testing modules could be connected to a central control module, the RAMP200 is able to increase capacity without the need to purchase a new system. This allows the RAMP system to grow as the customer’s testing needs increase.

The RAMP200 control module also addresses common connectivity issues with near-patient testing and data storage / transmission. The system boasts enhanced security features as well as the ability to connect to any Laboratory Information System (LIS).

Response has validated its ability to develop, manufacture, and sell point-of-care solutions in a very competitive and complex global diagnostic market. While committing to maintaining all production in British Columbia (B.C.), the company differentiates itself by integrating its development, manufacturing, and regulatory teams to produce high-quality solutions at a low cost. Further, Response has established a worldwide network of channel partners that act as an extension of itself in their individual market. With a shared commitment to deliver the best global customer experience and trusted, high-quality tests, Response can be competitive against significantly larger competitors.

The clinical laboratory testing world is constantly evolving; many cutting-edge technologies common over the past 10 or 15 years have become old-fashioned and obsolete. Response must not only be dynamic but constantly pivot to bring new technology to market. To that end, the company routinely recruits the best and brightest talent from today’s technology space in B.C. by collaborating, teaching, and engaging various academic institutions; this allows the company to reach out directly to students and faculty interested in diagnostics. The company looks broadly for talent in the U.S., Canada, Europe, and beyond.

The company also understands the importance of investing in R&D growth since it has received more than $6 million in government grants, subsidies, and sponsorships over the past five years while continuing to explore options across the U.S. and Canada. Growing its people and promoting talent from within is a cornerstone of any company’s evolution; Response believes that to grow, the company must improve team skills and experiential leadership training.

Response knows that clinical testing continues to migrate from the core laboratory to more near-patient applications. If COVID-19 taught the industry anything, it’s that rapid diagnostic testing does work in the immediate hands of patients and doctors. As such, Response must continually stay abreast of practices and procedures utilized in emergency departments and Intensive Care Units so that RAMP products become the obvious choice for hospitals around the world. This means educating employees, customers, suppliers, and collaborators on the company’s products and how adaptation is necessary to stay relevant in today’s market and tomorrow’s clinical world.

Being a proud and active part of B.C.’s life sciences and biomanufacturing community means Response can leverage its expertise and learn from local life sciences teams on best practices in its industries. Life Sciences BC, a not-for-profit organization, ensures that best practices and key relevant topics are discussed and provides networking opportunities to support the growth of the community.

Response’s CEO, Dr. Barb Kinnaird, currently serves as Chair of the Board of Acetech, a local not-for-profit organization designed by CEOs to help CEOs grow and scale tech businesses. This stimulates the economy through job creation and global expansion. Dr. Kinnaird also sits on the Advisory Committee for Genome BC, a not-for-profit organization that invests in local start-ups and SMEs to drive commercialization activities. Finally, Response has been an active partner in collaboration with B.C.-based colleges, universities, and industrial partners.

Under Dr. Kinnaird’s leadership, Response established a “big hairy audacious goal” (BHAG) of being the “diagnostic brand of choice where lives are at risk.” The company has systematically moved forward by establishing annual milestones toward that goal, and this year, Response’s immediate vision was to expand its menu in some of the biggest markets in the world. There has also been a strong push to complete clinical trials on key products to help solidify its offering in these markets and beyond.

Expansion into other key markets in addition to growth in its current markets requires a continued focus on the customer experience and evolving the product menu. For example, Response has leveraged its more than 20 years of experience in cardiac testing to make excellent progress on the development of a high sensitivity Troponin I assay that can meet American Heart Association (AHA) guidelines. Response believes these steps over the next three years will help establish the company as a dominant player globally in this emerging space.

Beyond 2025, there will be continued migration of current core laboratory testing to other channels in the health care space, while technologies that can be adaptable to doctors’ offices, ambulances, pharmacies, and specialized care centers will thrive. This will lead to a crowded diagnostic space as many companies envision this same migration. Companies that can offer higher value testing—multiplexing, faster assays, simpler sample collection, lower costs—will be most attractive and consequently thrive. For this reason, Response is focused on adding this type of value for its next-generation technologies that expand upon its current legacy offering.

There are challenges, of course. The menu of the RAMP platform includes key assays—Troponin I, D-dimer, PCT, NT-proBNP, Myoglobin, CK-MB, and Total β-hCG—that have regulatory clearance in most international markets and are in widespread use. There are, however, some assays that require more extensive clinical trials to achieve clearance in new territories, including extensive clinical trials at the point-of-care. These clinical trials can be cost-prohibitive when performed; however, with a shift in the market from contemporary Troponin testing to new high sensitivity Troponin assays, Response has the opportunity to provide one of the few point-of-care assays with this capability. This positions Response extremely well in its existing markets and revolutionizes the point-of-care testing paradigm for chest pain and patients suspected of heart attack.

Along with these challenges there are many goals that have been set by the company including the development of a focused strategy on the acute care market and completing the product test menu to accommodate the needs of those customers. Response will need to implement key industry-standard manufacturing processes to ensure RAMP continues to deliver reliable test results as the company continues to scale. This will ensure that healthcare providers achieve highly accurate results in high-stress medical environments where lives are at risk.

Finally, Response continues to build a culture empowering innovation, thinking, and open communication. It does this by driving commercial growth through a partner-focused strategy in emerging markets, streamlining operations to maintain high efficiency that maintains manufacturing in Canada, developing a brand promise around responsive service, and utilizing a team of subject matter experts that support customers with immediate information and answers.

The post Accurate Diagnostics – When Every Minute Counts<p class="company">Response Biomedical Corp.</p> appeared first on Manufacturing In Focus.

StressMarq Biosciences’ tools include antibodies and fibrilized proteins that improve the speed, ease, and consistency of scientific research that has led to the discovery of new information about neurodegenerative diseases, their progression, and treatment options for improved patient outcomes.

When President and CEO Ariel Louwrier founded StressMarq, after time spent at a public drug discovery company, he had two goals: to go his own way and achieve autonomy; and to advance the resources available for the treatment of illness, as he, personally, had experienced the toll that neurodegenerative disease took on individuals, their families, and the healthcare system.

Success under stress
Louwrier chose a volatile economic period to found StressMarq Biosciences. The global financial crisis of 2007-2008 and the U.S.-Canadian currency value reversal that followed might have been the worst possible time to launch an export-based operation. However, the company weathered the storm through the relationships that Louwrier had established over the years and the high standard of products and support it provided.

“We survived all that and managed to grow, and it was really a question of two things: we were providing quality products; and, because we’re an unregulated industry, it’s a question of trust with whomever you’re selling to,” says Louwrier. “If that trust isn’t backed up with something then you have a problem.”

Trust is the foundation of StressMarq’s relationships with its distributors and end users. As Louwrier confirms, “They knew the technical side would be supported and the products would work. That allowed us to get the products into the hands of companies that had confidence in us.”

This isn’t without its challenges, either. As Louwrier says, “We work really hard to get things to work in an area where there are still a lot of unknowns; we then have to provide that knowledge in a usable form to the wider scientific world because they have to be convinced that it’s useful.”

Tools for change
Initially an antibody company, StressMarq pivoted in 2016 to also produce fibrilized proteins, primarily of interest to researchers studying neurodegenerative diseases, a market that was less saturated due to the more technical, drug discovery-driven nature of the work that was taking place.

According to Louwrier, “We made antibodies and that was a very competitive space, quite cutthroat in many ways. What we did, starting in 2016, was to move a bit sideways and identify a niche in the neurodegenerative disease area that we could exploit. It’s more difficult to do than antibody work, so there are also fewer players and less competition.”

The decision was made almost overnight. StressMarq quickly moved to assert itself in that market, confident that it could have a substantive impact, not least because of its small size and savvy leadership team.

“In a field that requires lots of help and input, the faster you can do these things the better. So that’s where we ended up because no one else in the world was doing it. We became the first, and first is always good as long as you can exploit that and, of course, let people know what you’re doing. We did that and we’re now the primary company,” says Louwrier.

For fifteen years, StressMarq has worked hard to lessen the load on its distribution partners and the end users of its products by ensuring effective knowledge transfer and support, building confidence throughout the entirety of its supply chain.

Good work out there
Despite this success, Louwrier remains humble, shining a light on the good work happening in the scientific space. “There are a lot of people doing some very interesting things with our materials, and without our materials, too, but we’re enabling people to do things faster and more consistently.”

One of those organizations is the Michael J. Fox Foundation, which recently published the results of a landmark trial able to detect Parkinson’s disease by using an aggregation assay. StressMarq is working on developing the reagents to carry out this assay on a commercial scale.

As Louwrier explains, “We’re trying to create those building blocks, the brick and mortar for that assay, that on the one hand really slows down these actions that allow proteins to self-aggregate, while at the same time—if there’s something in there from the sample from the patient that would actually get this going—to accelerate that as fast as possible so we can measure it in a certain amount of time.”

Referred to as a “game changer,” the organization’s Parkinson’s Progression Markers Initiative (PPMI) has discovered a biomarker for Parkinson’s disease that could lead to new diagnostics and eventually treatments, meaning there is some element of confidence that Parkinson’s disease can be diagnosed prior to a person becoming symptomatic.

“That was termed a breakthrough because the study was done on a large scale on a very well-defined population that had been generated by the Michael J. Fox Foundation,” Louwrier says. This population was followed for a long time, enabling potential disease progression to be identified and measured, as well as obtaining biological samples including blood, urine, cerebral spinal fluid, and nucleic acid preparations.

Speeding up discovery
Neurodegeneration occurs when plaques, caused by self-catalyzing proteins that deviate from standard behaviour, build up in the brain. As Louwrier explains, “They just take more of the benevolent version of themselves and make it into a version that kills cells. What scientists do is replicate that artificially to create a model that drug discovery work is carried out on.”

These models enable drug discovery work to be completed in a much shorter time. Whereas it would take between six and 18 months to generate the model using genetic techniques, the StressMarq model can be generated in as few as 30 days. An expedited response time could facilitate more rapid diagnoses and proactive, rather than reactive treatment options, which could improve patient outcomes while reducing the systemic burden associated with these diseases.

Louwrier notes, “The brain can suffer a lot of neuronal loss in these diseases, up to fifty to sixty percent, and with that kind of cell death, you’re now talking about a rear-guard action: how do we keep this from getting worse? At that point, you already have a major problem on your hands.”

What’s next?
If the assay published by the PPMI works for Parkinson’s as a diagnostic, there is no telling what other neurodegenerative diseases could also be addressed using the same approach. While Louwrier knows that not all drugs that are deemed a success receive federal approval, it is important work that is being done at a time when it is needed the most.

“The emphasis on neurodegenerative disease is probably at its zenith right now, as far as the last thirty to forty years is concerned,” Louwrier says. There’s great opportunity to take advantage of the opportunity that StressMarq is poised to capitalize on.

He adds, “Something we develop today and launch tomorrow may well have a ten- to twenty-year lifespan, so we’re already doing things for the future even if we stop dead right now. But our mission is to make the next generation tools for the sector; we’re not engaged in doing the research that’s resulting in a drug. We’re essentially enabling things in the realm of drug discovery to happen faster and more consistently.”

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