Myeloma Canada Co-founder Aldo Del Col Addresses Karyopharm Meeting in Boston
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Myeloma Canada co-founder Aldo Del Col addressing Karyopharm all-employee meeting in Boston
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On the occasion of its New Drug Application (NDA) for selinexor to the US Food and Drug Administration (FDA), Karyopharm, a
clinical-stage pharmaceutical company based in Newton, Massachusetts, invited our co-founder to address an all-employee meeting to share his personal journey and insights as a long-term myeloma survivor. The key messages were that new drugs have enabled myeloma patients to live longer, productive lives but that innovative approaches are needed to overcome relapses resulting from the myeloma cells becoming resistant (non-responsive) over time.
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As myeloma patients live longer, new classes of drugs with innovative mechanisms targeting different pathways and biomarkers are needed to address the ongoing challenges of drug resistance. Despite numerous advances in myeloma treatment, currently available therapies are insufficient to address the increasing number of patients with highly resistant myeloma, where the disease has ultimately become unresponsive to approved therapy.
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Clinical trial data have shown that selinexor, a first-in-class, oral selective inhibitor of nuclear export (SINE) compound, is potentially an effective new treatment option for difficult-to-treat penta-refractory* myeloma patients. Selinexor has received both Orphan Drug and Fast Track designations from the FDA for this indication. The FDA submission was based on data from the Phase 2b STORM clinical trial. Generally, Health Canada will only accept data from randomized Phase 3 trials when evaluating a drug for approval. Dr. Nizar Bahlis from the University of Alberta in Calgary is the Principal Investigator for BOSTON (MCRN 005), which is the pivotal selinexor Phase 3 trial currently recruiting patients across Canada and worldwide.
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Diagnosed 16 years ago at a time when treatment options were very limited, Aldo has witnessed a transformational shift in the growing number of choices available to myeloma patients and their doctors, from proteasome inhibitors (bortezomib [Velcade®], carfilzomib [Kyprolis®] and ixazomib [Ninlaro®]) to immunomodulatory drugs (thalidomide, lenalidomide [Revlimid®] and pomalidomide [Pomalyst®]), and monoclonal antibodies (daratumumab [Darzalex®]). Thousands of Canadian myeloma patients have benefitted from the research leading to the discovery of new classes of drugs that have attacked the myeloma cells from different angles, thereby helping overcome resistance and doubling overall survival.
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Our co-founder, Aldo Del Col with Michael G Kauffman, MD, PhD, Chief Executive Officer and Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer
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Continued advances, however, are contingent upon patient participation in clinical trials. Both selinexor and another first-in-class molecule, daratumumab, are presently recruiting eligible patients across Canada.
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Selinexor:
The BOSTON Trial (MCRN 005)
- Principal Investigator: Dr. Nizar Bahlis, University of Calgary
- Locations: Calgary, Edmonton, Halifax, Montreal, Quebec City, Toronto, Regina, Saskatoon, Sudbury, Vancouver
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Daratumuab (Darzalex®):
The LAURENTIANS Trial (MCRN 004)
- Principal Investigator: Dr. Michael Sebag, McGill University, Montreal
- Locations: Calgary, Edmonton, Halifax, Hamilton, Ottawa, Saint John (NB), Saskatoon, Surrey, Thunder Bay, Toronto, Winnipeg
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Myeloma Canada thanks Karyopharm for inviting our co-founder to speak at this milestone event and for bringing potential new treatment options and hope to myeloma patients.
*Patients with penta-refractory myeloma have previously received the two proteasome inhibitors (PIs), Velcade® (bortezomib) and Kyprolis® (carfilzomib), the two immunomodulatory drugs (IMiDs), Revlimid® (lenalidomide) and Pomalyst® (pomalidomide), and the anti-CD38 monoclonal antibody Darzalex® (daratumumab), and their disease is refractory to at least one PI, at least one IMiD, daratumumab and their most recent therapy.
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