BUFFALO, NY--(Marketwired - Apr 17, 2017) - Cleveland BioLabs, Inc. (NASDAQ: CBLI) today announced that the European Medicines Agency (EMA) has accepted the company's pediatric investigation plan (PIP), paving the way for submission of a Marketing Authorization Application (MAA) for entolimod as a medical radiation countermeasure.
As part of the regulatory process for submitting an MAA in the European Union, pharmaceutical companies are required to provide a PIP outlining their strategy for investigation of the new medicinal product in the pediatric population. As agreed with the EMA, existing CBLI results, when combined with future nonclinical cell culture experiments and formulation, provide a path toward product labeling for children. The future work to be performed as part of the PIP can be deferred until after an MAA submission.
Yakov Kogan, PhD, MBA, Chief Executive Officer, commented: "We are excited to have received a positive opinion from the EMA on our PIP. In addition, we have held a series of encouraging meetings with the EMA concerning our MAA submission. We look forward to continuing our discussions with the agency as we move forward with the MAA."
The next step is for CBLI to complete the MAA submission and have the documentation validated and accepted for evaluation by the EMA. Validation typically occurs approximately 30 days after submission. Thereafter, further interactions with the EMA must occur during the review process. CBLI will provide updates regarding the MAA process.
About Cleveland BioLabs, Inc.
Cleveland BioLabs, Inc. is an innovative biopharmaceutical company developing novel approaches to activate the immune system and address serious medical needs. The company's proprietary platform of Toll-like immune receptor activators has applications in radiation mitigation, immuno-oncology, and vaccines. The company's most advanced product candidate is entolimod, which is being developed as a medical radiation countermeasure for the prevention of death from acute radiation syndrome, an immunotherapy for oncology and other indications. The company conducts business in the United States and in the Russian Federation through a wholly-owned subsidiary, BioLab 612, LLC, and a joint venture with Joint Stock Company RUSNANO, Panacela Labs, Inc. The company maintains strategic relationships with the Cleveland Clinic and Roswell Park Cancer Institute. To learn more about Cleveland BioLabs, Inc., please visit the company's website at http://www.cbiolabs.com.
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