Pacylex Pharmaceuticals Announces Progress on Early Phase Clinical Trials of PCLX-001 in Patients

Edmonton, Alberta--(Newsfile Corp. - September 29, 2022) - Pacylex Pharmaceuticals has dosed 16 patients in the early phase clinical trials of the company's new cancer drug, PCLX-001. PCLX-001 is an N-myristoyltransferase (NMT) inhibitor that targets the lipid modification of proteins that initiate the signaling pathways for the proliferation and survival of cancer cells, especially in leukemia and lymphoma. The drug ^[1]is a once-per-day capsule that has been dosed in 16 solid tumor and non Hodgkin's lymphoma patents to date without any dose limiting toxicities.

In September 2021, Pacylex Pharmaceuticals began a Phase 1 open label, dose escalation clinical trial of PCLX-001 at the University of Alberta Cross Cancer Institute to examine the safety and tolerability of the drug and determine the dose to be used in initial efficacy studies. In December 2021, Pacylex announced the results of the first patients dosed with PCLX-001 at the American Society of Hematology (ASH) Annual meeting and Exposition. An abstract of the clinical study was also published online in the November supplemental issue of 'Blood'.

Pacylex has safely completed 4 dose cohorts reaching target drug exposure levels in patients expected to provide benefit in leukemia and lymphoma. The study has confirmed that once-per-day oral administration of PCLX-001 is sufficient to achieve target drug exposure. The company has started a 5th dose level and will continue to escalate doses as long as they are well tolerated by patients. The study is continuing to enroll patients at four Canadian cancer centers, the University of Alberta Cross Cancer Institute^[2], Princess Margaret Hospital^[3] in Toronto, Center Hospitalier de l'Université de Montréal (CHUM)^[4] and the BC Cancer Agency in Vancouver^[5]. The plan is to enroll 20-30 patients in the initial phase.

Pacylex Pharmaceuticals has presented its progress in the development of this new drug at professional conferences like the American Society of Hematology (ASH) Annual Meeting in December 2021 and the American Association for Cancer Research Annual Meeting in April 2022. The results of its studies and clinical trials have been published in industry journals like 'Nature Communications', and 'Breast Cancer Research and Treatment'.

What makes PCLX-001 different from other drugs used for the treatment of cancer is that it targets the origin of the signaling process used by cancer cells to rapidly proliferate and survive. By inhibiting and stopping this process right at the beginning, oral administration of the drug induces apoptosis, or cell death, in just a few days.

Commenting on the company's ambitious plans for the future, CEO of Pacylex, Dr. Michael Weickert, said, "Cancer has many different origins and causes and no silver bullet has been developed to defeat them all. But as each cancer mechanism is discovered, new strategies are developed to defeat it. Pacylex has discovered a new cancer mechanism and is developing PCLX-001 to defeat it. In in-vitro tests, PCLX-001 has been shown to eliminate leukemia and lymphoma tumors. We found that in many animal models, it also inhibits lung and breast cancer tumors. Our focus is now on proving the efficacy and safety of the drug through human clinical studies. We have already achieved our goal of drug exposure in phase one clinical trials so we will seek Series B investors to support two Phase 2 programs in leukemia (AML) and lymphoma (DLBCL), and an expansion study in solid tumor patients. The end goal is to file for initial regulatory approval in at least one indication by 2025 and make this drug widely available to indicated cancer patients worldwide at an affordable cost. The convenience of an oral, once-per-day pill also stands out in the current environment of immunotherapies and cell-based treatment strategies."

About Pacylex PharmaceuticalsPacylex is a pharmaceutical firm based in Edmonton, Canada, that is developing a new first-in-class therapeutic drug for hematologic and solid cancers. Pacylex began clinical studies of the drug in Canada in September 2021 and is currently seeking funds for Phase 2 of clinical trials.

Media contactName: Michael J. WeickertEmail address: michael.weickert@pacylex.com^[6]

To view the source version of this press release, please visit https://www.newsfilecorp.com/release/138904^[7]

References

1. ^{^} The drug (www.newsfilecorp.com)
2. ^{^} University of Alberta Cross Cancer Institute (www.newsfilecorp.com)
3. ^{^} Princess Margaret Hospital (www.newsfilecorp.com)
4. ^{^} Center Hospitalier de l'Université de Montréal (CHUM) (www.newsfilecorp.com)
5. ^{^} BC Cancer Agency in Vancouver (www.newsfilecorp.com)
6. ^{^} michael.weickert@pacylex.com (www.newsfilecorp.com)
7. ^{^} https://www.newsfilecorp.com/release/138904 (www.newsfilecorp.com)