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As cancer continues to plague global health in all its various forms, new methods are constantly being strategized to tackle the various versions of the disease. So far, newer therapies have lowered the mortality of many cancers but are still not able to offer cures for a stubbornly high percentage of patients, particularly those caught late in their development. Pacylex Pharmaceuticals is bringing new options to cancer treatment with its innovative therapy, developed by a virtual team.

Cancer is one of the leading causes of death worldwide, and it is estimated that 1 in 2 men and 1 in 3 women in the US will develop a version of this disease during their lifetime. In light of such statistics, breakthrough drugs like PCLX-001, the new anti-cancer pill that can be taken once per day, that Pacylex Pharmaceuticals has developed, provide a ray of hope.

Pacylex
Pacylex

During the pandemic, Pacylex Pharmaceuticals and its microteam accomplished what many big pharmaceutical companies take years to do. The company was already functioning virtually with team members in Canada and the US and with key partnerships that include DavosPharma and Ozmosis coordinating manufacturing and clinical trials, respectively, so the pandemic had little impact on operations. Even participation in academic and business conferences, as well as collaborations with academic researchers, testing laboratories, hospitals, and government agencies like Health Canada and the FDA, were virtual.

Through outsourcing almost all the activities related to drug development, despite the challenges of the pandemic, their core 6-person team, with over 100 years of combined experience, pioneered a first-in-class drug for a brand new cancer target that had never been tested in patients before.

They managed the animal safety and toxicology studies conducted by a contractor, worked with DavosPharma to file the Clinical Trial Application (CTA) necessary to start clinical trials in Canada, and, with Ozmosis, started testing PCLX-001 on non-Hodgkin's lymphoma and solid tumor cancer patients at 4 Canadian hospitals in 2021. Clinical results are very encouraging so far, and the team was successful in obtaining Orphan Drug and Fast Track Designations from the United States Food and Drug Administration (FDA) for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with PCLX-001 and getting a grant from the US Department of Defense to fund this new study in the US on AML, which will start soon.

Dr. Luc. G. Berthiaume, a founder of Pacylex, is a professor of Cell Biology at the University of Alberta. The research in his laboratory revealed ways in which a process called myristoylation might be important in certain cancers, and that arresting that process in cancer cells halted the signaling required for cancer cells to grow and spread. He identified a drug candidate, a molecule we now call PCLX-001, and licensed it from the University of Dundee in Scotland.

Another co-founder of Pacylex is John Mackey, a medical oncologist and Professor of Oncology at the University of Alberta who has overseen more than 100 clinical trials. John Mackey helped Pacylex partner with Ozmosis Research Inc., based in Toronto, for conducting and overseeing phase I clinical trials.

Ryan Heit, the third co-founder of the company, manages the complex operations of the company, monitoring and coordinating relationships with consultants and contractors. Ryan is the Vice-President of Operations and is based in Edmonton, Canada. He has extensive experience sourcing capital and establishing startups.

The company's CEO, Michael Weickert, is based in the San Francisco Bay area and has over 30 years of experience overseeing all aspects of drug development. He was brought in by the founders to develop the company strategy, finance company operations, but also help the company transition into full drug development, where he was instrumental in establishing many of the necessary partnerships that allow this small team to achieve such significant progress.

Commenting on the success that Pacylex Pharmaceuticals has achieved so far through its virtual model, Michael Weickert said, "During the pandemic, a virtual model of doing business became commonplace. The complexity and regulatory compliance required for pharmaceutical research and development makes it challenging to conduct everything remotely. Coordinating Dr. Berthiaume's team of researchers, Ozmosis, Davos Pharmaceuticals, regulatory agencies, and hospitals for the clinical trials, and other consultants has been our route, and our very small team has proven that it is possible for companies to thrive in clinical development of a pharmaceutical with a virtual model. What matters is not the infrastructure or being in the office every day. It is important to have a team of experienced professionals who know what they are doing and the right partners with industry experience. This model is definitely one that many startups can replicate successfully."

About Pacylex Pharmaceuticals

Pacylex Pharmaceuticals is a pharmaceutical firm based in Edmonton, Canada, that has developed a new first-in-class, oral, once-per-day drug for the treatment of cancer. Pacylex began clinical studies of the drug in Canada in September 2021 and based on the success of those initial studies, is currently seeking funds for the expansion of clinical trials and the commercialization of the drug.

Media Contact

Name: Michael J. Weickert

Email address: michael.weickert@pacylex.com

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