Krakow, Poland, April 8, 2021 – Ryvu Therapeutics (WSE:RVU), a clinical stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, announced today that the U.S. Food and Drug Administration, FDA, has placed a partial clinical hold on the first in human phase Ib, dose escalation clinical trial of RVU120 (also known as SEL120) in patients with relapsed/refractory (R/R) AML and high-risk MDS, being conducted in the United States. Patients who are currently taking RVU120 may continue treatment in the study. No new patients may be enrolled in the study until the partial clinical hold is lifted by the FDA.
Ryvu received the clinical hold letter from the FDA on April 8th and plans to work diligently with the agency to address the comments and request, in order to resolve the partial clinical hold.
The partial clinical hold was initiated following Ryvu’s recent report to the FDA of a Serious Adverse Event involving a patient death that may possibly be related to RVU120. One of the two patients enrolled in Cohort 5, 110 mg dose level, of RVU120 experienced a fatal incidence of “Worsening Pancreatitis. The other patient in the same study cohort, completed the 1st treatment cycle without any serious adverse events (SAE) reported by the investigational site and entered Cycle 2. There are currently two patients continuing to receive treatment with RVU120 in the study.
“Patient safety is Ryvu’s priority,” said Pawel Przewiezlikowski, CEO of Ryvu. “Based on the totality of the data we have for RVU120, we believe that it continues to be a promising treatment option for cancer patients, and we will continue to work closely with the FDA to resolve the partial clinical hold with the objective of resuming enrollment in the study. We remain on track to present detailed interim safety and efficacy data at upcoming scientific conferences.”
Ryvu will host a conference call to discuss today’s announcement for addressing investor’s questions, on Friday, April 9th 2021, at 8:00am CET. The conference will be open for everyone to participate: https://zoom.us/j/96738371669?pwd=MG01dDA3Zk9qVnN1ZWc1NjV4ZVlhZz09
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Safe Harbor Statement
Certain statements in this press release, including, but not limited to, those concerning additional data for RVU120 and the safety and efficacy of RVU120 as a treatment for acute myeloid leukemia and myelodysplastic syndromes are considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, that are subject to risks, uncertainties and other factors that could cause actual results to differ materially from those referred to in the forward-looking statements and, therefore, the reader should not place undue reliance on them. These risks, uncertainties and other factors include, without limitation, the inherent risks associated with clinical trials, product development activities and regulatory approval requirements, including the risk that data from the ongoing clinical programs may not support continuation of the study due to safety, efficacy or other reasons in AML or MDS. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. The forward-looking statements contained herein are based on management’s current expectations and beliefs and speak only as of the date hereof and Ryvu undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise.