Oxaliplatin in combination with a fluoropyrimide/leucovorin to form the FOLFOX regimen is an important component of adjuvant and palliative therapy for colorectal cancer. Oxaliplatin treatment causes an acute neurotoxicity that manifests as rapid onset of cold-induced distal dysesthesia and/or paresthesia that occurs shortly after drug infusion. This acute reaction occurs in almost all patients but quickly resolves.  However, approximately 50-60% of patients who complete a full 12-cycle course of FOLFOX treatment for colorectal cancer develop a chronic peripheral neuropathy characterized by impaired sensation, sensory ataxia, and/or deficits in fine sensory-motor coordination. The symptoms may be severe enough to limit patients from performing their activities of daily living. Currently there are no approved therapies for the treatment of CIPN.

 

PeriphaGen's PGN-503 is a new investigational drug designed to protect and treat peripheral nerves from the damaging toxicity of chemotherapeutic agents.  Oxaliplatin (as part of the FOLFOX regimen) is the most common chemotherapeutic agent used in the treatment of colorectal cancer. In preclinical studies, animals pretreated with a single dose of PGN-503 demonstrated significant protection against the development of chronic CIPN. PGN-503 did not interfere with the anti-neoplastic activity of oxaliplatin.

 

PeriphaGen will soon assess the efficacy of PGN-503 in clinical trials. Our first trial will test if PGN-503 can protect patients from developing CIPN. Patients who will undergo adjuvant therapy for colon cancer will be eligible for this study. A single dose of PGN-503 will be given to patients prior to the initiation of FOLFOX chemotherapy. Patients will be carefully monitored during their treatment, and for a short follow-up period, in order to determine if PGN-503 reduces the incidence and/or severity of peripheral neuropathy. Future clinical studies will determine if PGN-503 is capable of reversing peripheral neuropathy in patients who already suffer from CIPN and if PGN-503 can prevent or reverse CIPN in chemotherapy treatment of metastatic colon cancer.

 

If you would like more information about PGN-503 or our upcoming clinical trials please contact us using the form below