ST. PETERSBURG, FL, October 09, 2013 /24-7PressRelease/
-- Eleison Pharmaceuticals LLC, a specialty pharmaceutical company developing life-saving therapeutics for rare cancers, announced the European Commission has granted Orphan Drug Designation to ILC (Inhaled Lipid-complexed Cisplatin), for the treatment of osteosarcoma. The designation follows the earlier positive opinion and recommendation of the European Medicines Agency (EMA) Committee of Orphan Medical Products. The Orphan Drug Designation provides Eleison access to protocol assistance and certain financial incentives from the EMA, as well as 10 years marketing exclusivity for ILC upon the receipt of marketing approval.
Dr. Forrest Anthony, Chief Medical Officer of Eleison Pharmaceuticals
commented, "We are very pleased to receive Orphan Drug Designation by the European Commission, as ILC is potentially a breakthrough in the treatment of children and young adults with osteosarcoma, an often deadly cancer with little improvement in survival over the past 25 years. Our global phase II clinical for ILC remains ongoing with interim results expected in the middle of next year."
About Pediatric Osteosarcoma
In the U.S., 500 children and young adults are diagnosed with osteosarcoma each year, a type of bone cancer. Standard therapy includes a combination of surgery and chemotherapy, although 30-35% of patients will experience a recurrence, most often in the lungs and only in the lungs. The prognosis for relapsed patients with pulmonary metastases is particularly grim, with five year survival of less than 25%.
Eleison has an exclusive worldwide license to ILC, a novel, sustained release formulation of cisplatin in a nanoscale lipid based complex administered via inhalation. ILC was designed to deliver high levels of sustained release cisplatin targeted to the lung, without systemic-related toxicities. ILC is currently being evaluated in a Phase II clinical trial at leading medical centers in the United States. Please visit www.clinicaltrials.gov
for more information about this on-going clinical study.About Eleison Pharmaceuticals
Eleison's mission is to acquire, develop, and commercialize clinical stage drug candidates for "orphan" oncology indications, providing new hope for patients with rare life-threatening diseases. In addition to ILC, Eleison is developing Glufosfamide, a Phase III drug candidate for the treatment of patients with pancreatic cancer, and is in discussions to acquire other promising candidates for rare cancers. Eleison was founded in 2009 and is headquartered in St. Petersburg, FL.
Forward Looking Statements
Except for statements of historical fact, the statements in this news release are forward-looking statements, including statements regarding Eleison's product candidates, their uses and potential benefits and clinical trial results and plans. These statements involve risks and uncertainties that can cause actual results to differ materially from those in such forward-looking statements. Potential risks and uncertainties include, but are not limited to, Eleison's ability to enroll and complete its current and anticipated clinical trials, the time and expense required to conduct such clinical trials and analyze data, the possibility that results from these trials will not be confirmed, potential adverse side effects, issues arising in the regulatory or manufacturing process and the results of such clinical trials (including product safety issues and efficacy results). Eleison does not intend to update any forward-looking statement made in this news release.
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