XOMA's (XOMA) Proposed XOMA 358 Phase 2 in CHI Accepted by U.K. MHRA
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OMA Corporation (Nasdaq: OMA) announced the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) has accepted in principle the Company’s proposal to initiate a multi-dose Phase 2 clinical study of XOMA 358 in children two years and older diagnosed with Congenital Hyperinsulinism (CHI).
“MHRA officials clearly recognize the importance and complexity of conducting a clinical program in CHI, an orphan disease that affects children and infants for whom few effective treatment options are available. The comments resulting from our national advice meeting with the MHRA officials, regarding its requirements to support expedited clinical development for XOMA 358, were clear and thorough,” commented Paul Rubin, MD, Senior Vice President Research and Development and Chief Medical Officer of XOMA. “Upon their formal review and acceptance of our protocol, XOMA will be able to launch its first multi-dose extended treatment clinical study for XOMA 358 in CHI patients over the age of two.”
“Today’s announcement reflects the priority we have placed on our regulatory efforts. Opening our clinical program to younger patients and offering multi-dose studies is a critical step to accelerate XOMA 358 development and reach the patients we believe are most likely to benefit from this first-in-class monoclonal antibody. Additionally, the regulatory body in Germany recently approved our plan to conduct a repeat-dose clinical study in CHI patients over the age of 12. Our first German site has begun enrolling patients and has already contributed to a substantial acceleration in enrollment in our XOMA 358 studies,” stated John Varian, Chief Executive Officer of XOMA. “We look forward to continuing our conversations with the MHRA, the European Medicines Agency (EMA), and the US Food & Drug Administration (FDA) to advance the development of XOMA 358, enabling us to get this important treatment to children in need as expeditiously as possible.”
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