Laurent Levy, CEO of Nanobiotix said: "As planned, we should start the pivotal phase before the end of the year, the association of PharmaEngine to the trial is an excellent news. This reinforced collaboration will allow us to pool resources and data leading to a more impactful study for this first key indication. Moreover PharmaEngine's direct collaboration to the last phase of development of NBTXR3 is a new plan that should allow a faster access to the Asian market."
Soft Tissue Sarcoma
Following the very positive pilot Phase I results for advanced soft tissue sarcoma (STS) recently presented at the American Society of Clinical Oncology (ASCO) annual meeting, PharmaEngine and Nanobiotix have decided to accelerate the clinical development of NBTXR3 in the Asia-Pacific region.
The planned European pivotal trial for NBTXR3 in soft tissue sarcoma will be broadened to Asia-Pacific where PharmaEngine will open additional clinical centers in multiple countries. Nanobiotix is sponsoring the global trial and PharmaEngine is co-sponsoring for the Asia-Pacific territory. The partners will bear the costs of the trial in their respective territories.
The expanded soft tissue sarcoma trial will provide additional clinical centers in multiples countries in Asia-Pacific, a larger cohort of enrolled patients and a more efficient study as Nanobiotix and PharmaEngine will share patient data. This may lead to faster market approval in the Asia-Pacific region than originally anticipated. An ongoing pivotal trial in the Asia-Pacific region could also facilitate the pathway for other indications in this region due to the available clinical data from patients in soft tissue sarcoma.
Nanobiotix plans to begin this pivotal trial and the patient recruitment before the end of 2014. Market authorization in Europe is expected in 2016.
Other NBTXR3 indications
PharmaEngine is progressing its development in the rectal cancer indication in Taiwan and is in discussions with the Taiwanese regulatory agency. NBTXR3 could also be developed in other indications as the potential is broad especially for head and neck cancer, esophagus cancer, glioblastoma, cervix cancer, etc.
In addition, Nanobiotix and PharmaEngine are conducting pre-clinical studies in parallel to enable the two companies to start clinical studies in primary liver cancer in their respective territories. Liver cancer is a major health problem in Asia that causes one of the greatest number of deaths each year worldwide (695,000 deaths per annum). Moreover, countries like Taiwan, Japan, Korea, and China have a large prevalence of this disease.
Financials
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Soft Tissue Sarcoma