Eleison Announces the Approval from the CFDA to Expand Enrollment to China of Eleison's Ongoing Phase III Glufosfamide Study in Pancreatic Cancer

    ST. PETERSBURG, FL, May 16, 2016 /24-7PressRelease/ -- Eleison Pharmaceuticals LLC, a specialty pharmaceutical company developing life-saving therapeutics for rare cancers, has announced it has received approval from the China Food and Drug Administration (the "CFDA") to enroll patients in China under Eleison's ongoing Phase III clinical trial of Glufosfamide.

"We are very pleased to have received approval from CFDA to commence enrollment of patients in China, which represents a significant milestone for us and our development partner in China, and is indicative of the unmet need for new therapeutics for pancreatic cancer in China and worldwide," commented Dr. Guangtao Zhang, VP and head of Business Development in China for EleisonPharmaceuticals. "New clinical sites will be added in China in the coming months to complement the approximately 20 sites now enrolling the U.S." added Dr. Zhang.

About Glufosfamide

Glufosfamide, a new chemical entity, is a third-generation alkylating agent designed for greater specificity and tumor uptake, with reduced systemic toxicities and side effects. Eleison is currently enrolling patients in a pivotal multi-national Phase III study of Glufosfamide as second-line therapy for patients with metastatic pancreatic cancer. This pivotal trial is enrolling patients with relapsed or refractory pancreatic cancer following prior chemotherapy treatment. The randomized, open-label trial is being conducted to evaluate the safety and efficacy of Glufosfamide, with a target enrollment of 480 patients. The primary endpoint is overall survival with a number of pre-specified secondary endpoints. The trial will exclude insulin-treated diabetic patients. Eleison has an agreement with the U.S. Food and Drug Administration (FDA) on a Special Protocol Assessment (SPA) for this Phase III study.

For more information about this Phase III clinical trial, please visit this link from ClinicalTrials.gov.

Eleison possesses worldwide exclusive rights to Glufosfamide, and has entered into marketing and development agreements with partners in Asia.

About Pancreatic Cancer

Pancreatic cancer is the fourth leading cause of death by cancer in the United States. More than 46,000 Americans are diagnosed with pancreatic cancer annually, resulting in 40,000 deaths each year. There exist few effective therapeutic options to treat this disease, as five year survival rates are typically less than 5%.

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. 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.

# # #