Approximately 230,000 women will be diagnosed with breast cancer each year. Over half, or about 120,000 women, will develop peripheral neuropathy as a consequence of chemotherapy treatment. This peripheral neuropathy will last for 5 years or longer for a quarter of the women. The development of CIPN may result in dose reduction of the chemotherapy agents or a switch to less efficacious agents or even cessation of treatment when the severity of CIPN becomes unbearable. 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.  Paclitaxel is the most common chemotherapeutic agent used in adjuvant breast cancer treatment and is espcially prone to cause CIPN. In preclinical studies, animals pretreated with a single dose of PGN-503 did not develop peripheral neuropathy in response to paclitaxel and animals with existing CIPN recovered. PGN-503 did not interfere with the anti-neoplastic activity of paclitaxel.

 

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. Women who will undergo adjuvant therapy for breast cancer will be eligible for this study. A single dose of PGN-503 will be given to patients prior to the initiation of paclitaxel chemotherapy. Patients will be carefully monitored during their paclitaxel 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 breast cancer.