Celsion Corporation, a fully-integrated oncology company focussed on the development of a portfolio of innovative cancer treatments, announced that it has signed a licence and distribution agreement with myTomorrows to implement an Early Access Program for ThermoDox, its proprietary heat-activated liposomal encapsulation of doxorubicin, in all countries of the European Union (EU) territory plus Switzerland for the treatment of patients with recurrent chest wall (RCW) breast cancer.

RCW breast cancer is difficult to treat and has a poor prognosis with a significant impact on a patient's quality of life.  Patients with highly resistant tumours found on the chest wall often see their cancer progress despite previous treatment attempts including chemotherapy, radiation therapy and hormone therapy.  There are approximately 25,000 to 35,000 incidence of RCW breast cancer in the EU alone and thermal therapy is a well-accepted strategy for treating patients.  Recent findings from two phase I studies and an ongoing open label phase II study indicate that when combined with thermal therapy, ThermoDox can demonstrate significant overall response rates and tumor control in post mastectomy, refractory patients.

Early Access Program (EAP) allow bio-pharmaceutical companies to provide eligible patients with ethical access to investigational medicines for unmet medical needs within the scope of the existing early access legislation.  Access is provided in response to physician requests in a fully compliant manner, where no alternative treatment options are available to these patients.  Celsion will provide ThermoDox to centers of excellence in the EU and Switzerland through its Early Access Program with myTomorrows, at prices that are comparable to chemotherapeutics used to treat this and other aggressive form of cancer. The Company expects to have ThermoDox available for the EAP in the second quarter of 2015.

"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," stated Dr. Nicolas Borys, Celsion's Senior vice president and chief medical officer.  "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."

"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 Programme emphasises our commitment to addressing refractory RCW breast cancer and to providing patients and their physicians with early access to our promising therapeutic approach," said Michael H. Tardugno, Celsion's Chairman, president and chief executive Officer. "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."

ThermoDox is a proprietary heat-activated liposomal encapsulation of doxorubicin, an approved and frequently used oncology drug for the treatment of a wide range of cancers.  ThermoDox is being evaluated in a phase III clinical trial for primary liver cancer and a phase II clinical trial for recurrent chest wall breast cancer.  Localised mild hyperthermia (39.5 - 42 degrees Celsius) releases the entrapped doxorubicin from the liposome.  This delivery technology enables high concentrations of doxorubicin to be deposited preferentially in a targeted tumour.