Krakow, Poland – October 7, 2017 – Selvita S.A. (WSE:SLV), a clinical stage drug discovery and development company focused on innovative medicines for patients with blood cancers, announced today that the FDA has placed a full clinical hold on the phase I/II clinical trial of SEL24 in patients with relapsed/refractory (R/R) AML, being conducted in the United States. Selvita received a clinical hold letter from the FDA on October 6 and plans to work diligently with the agency and seek the release of the clinical hold.
The FDA’s decision follows a Suspected Serious Unexpected Adverse Reaction Report that a fatal stroke in Patient in Cohort 5 receiving the 150 mg dose of SEL24 has been evaluated by investigator as possibly related to the study treatment. Under this clinical hold, no new patients will be enrolled, and enrolled patients shall not receive SEL24 until the FDA lifts the full clinical hold. As part of this process, Selvita will provide the FDA with the requested additional data and analysis on patients treated with SEL24 as well as a proposed protocol amendment.
The current open-label, single-agent, dose escalation Phase 1 study of SEL24 was initiated in the first quarter of 2017 in patients with relapsed and refractory acute myeloid leukemia. The study is designed to determine the maximum tolerated dose (MTD) and recommended dose of SEL24 using a continuous, once-daily treatment schedule. The studies were initiated with a 25 mg daily dose which was then escalated following cohort reviews. One AML patient who initiated the treatment with a 150 mg dose of SEL24 as the third patient in this cohort and received four doses of the drug developed a life-threatening grade 4 venous thrombus in the brain with subsequent intracerebral hemorrhage, that required hospitalization. The patient died in hospice four days later due to the cerebral event. The patient’s death was subsequently evaluated as possibly related to SEL24. The safety report and a review of data by the Data Monitoring Committee were submitted to the FDA. The agency has placed a clinical hold on the trial and requested more safety data on the patients who have received SEL24, specific protocol changes and additional guidance to the study staff.
Selvita plans to comply with the requests formulated by the FDA regarding the amendment of the study protocol, and to provide additional information to the Agency and to the clinical trial centers in a timely manner, in collaboration with the Menarini Group, its global development partner for SEL24. By regulation, the FDA has 30 days from receipt of Selvita’s response to notify the company whether the clinical hold is lifted.
– Selvita remains steadfast in our commitment to improve outcomes for patients with acute myeloid leukemia, and will work closely with the FDA to address the agency’s concerns and resume the clinical studies on SEL24 – said Pawel Przewiezlikowski, the Chief Executive Officer of Selvita.
Selvita will host a conference call to discuss today’s announcement on Monday, October 9 at 8:00 CET. Conference call will be available to all participants at https://selvita.clickmeeting.com/konferencja-selvita
About Selvita
Selvita is a drug discovery company, developing breakthrough therapies in the area of oncology. The company’s most advanced program, SEL24, has been licensed to Menarini Group and is currently in Phase I studies in AML. Other projects include SEL120, a first-in-class small molecule inhibitor of CDK8 in preclinical studies, several drug discovery platforms in immuno-oncology, immunometabolism and cancer metabolism, as well as epigenetics, performed independently or in collaboration with global pharma and biotech companies.
Selvita also offers a broad range of integrated drug discovery services, helping biotech and pharma partners discover and develop new drugs.
The company has alliances and partnerships with more than fifty large and medium-sized pharmaceutical and biotechnology companies from USA and Europe, including R&D partnerships with Menarini, Leukemia and Lymphoma Society, Merck, H3 Biomedicine, and Nodthera.
The company was established in 2007 and currently employs over 400 scientists, among which 30% are PhDs. Selvita is headquartered in Krakow with second research site in Poznan, Poland and international offices located in Cambridge, MA and San Francisco Bay Area, in the US, as well as in Cambridge, UK. Selvita is listed on the Warsaw Stock Exchange (WSE:SLV).
More information: https://selvita.com/
About SEL24
SEL24 is a Selvita-developed first-in-class dual PIM/FLT3 kinase inhibitor with a unique activity profile in oral formulation. It is intended for the treatment of patients with relapsed/refractory (R/R) AML. The major goal for treatment of R/R AML is to achieve remission or to significantly prolong life, with acceptable quality. In March 2017, the first patient was dosed with SEL24 in a Phase I/II clinical trial. On March 28, 2017, Selvita S.A. and Menarini Group, entered into a global license agreement for SEL24. Selvita remains the sponsor of the study during the transition period to Menarini.