Celsion Corporation has announced it signed an agreement with myTomorrows to implement an Early Access Program for ThermoDox in European Union countries along with Switzerland, to be used in the treatment of recurrent chest wall (RCW) breast cancer patients.
This type of breast cancer is considered hard to treat and is associated with a poor prognosis. RCW breast cancer patients that have very resistant tumors will often suffer with metastasis and will not be sensitive to chemotherapy, radiotherapy or hormone therapy.
Two recent Phase I clinical trials along with a current Phase II trial have shown that upon combination with thermal therapy, ThermoDox has the potential to significantly improve the overall response rates in refractory patients who have undergone mastectomy.
ThermoDox is Celsion’s proprietary therapy, consisting of intravenously delivered doxorubicin enhanced with lysolipid thermally sensitive liposomes that upon heating change structure, creating openings in the liposomes to release doxorubicin directly into the targeted tumor. This therapy is currently being investigated in a Phase II clinical trial for recurrent chest wall breast cancer.
“We are very excited to make ThermoDox® available to patients with breast cancer who have few options once the tumors have progressed to the chest wall. Patients with highly resistant tumors found on the chest wall often see their cancer progress despite treatment which typically involves chemotherapy, radiation therapy and hormone therapy,” Dr. Nicolas Borys, Celsion’s Senior Vice President and Chief Medical Officer, said in a press release. “ThermoDox® coupled with mild hyperthermia therapy appears to be active in these heavily pre-treated patients with RCW breast cancer. I look forward to working with prescribing physicians and myTomorrows to bring this promising and innovative medicine to the European medical community.”
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Early Access Programs (EAP) can enable companies to supply patients with access to investigational drugs for unmet medical needs, when there are no alternative options available.
“Celsion is honored and proud to be part of this important Early Access Program that affects the lives of thousands of women each year. This Early Access Program emphasizes our commitment to addressing refractory RCW breast cancer and to providing patients and their physicians with early access to our promising therapeutic approach,” Michael H. Tardugno, Celsion’s Chairman, President and Chief Executive Officer, added. “In addition to the Early Access Program, we are expanding our development efforts in this indication and plan to initiate a European-based Phase II clinical trial in RCW breast cancer patients. Our common goal is to develop and provide the most effective therapies to improve and prolong the quality of life.”