Selvita Announces First Patient Dosed in Phase I/II Clinical Trial of SEL24 in Acute Myeloid Leukemia

Kraków, Poland, 17 March 2017 – Selvita (WSE:SLV), a clinical stage drug discovery and development company focused on innovative medicines for patients with blood cancers, announced today that the first patient was dosed with SEL24 in a Phase I/II clinical trial, for acute myeloid leukemia (AML).

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.

This Phase I/II study is the first clinical trial initiated by Selvita, demonstrating the significant progress achieved in the Company’s pipeline of proprietary product candidates. The SEL24 clinical program is anticipated to provide important safety, tolerability and biomarker efficacy data for SEL24 to support its clinical potential in AML, other hematological malignancies as well as solid tumors.

I am both proud and appreciative of the Selvita team and our clinical investigators in the USA, who have helped to make this key milestone possible – said Krzysztof Brzozka, Chief Scientific Officer at Selvita. This is an important step toward Selvita’s biggest goal – bringing to market a potentially life-saving treatment for patients suffering from aggressive AML.

The preliminary data established in the first part of the study will include the recommended dose and evaluation of SEL24 pharmacokinetic profile.


About AML
Leukemia is cancer of the blood cells. Leukemia begins when healthy blood cells change and grow out of control. Acute myeloid leukemia (AML) is a disorder of the process that normally produces neutrophils, red blood cells, and/or platelets, which are types of healthy blood cells. It develops quickly and needs immediate treatment. AML occurs in people of all ages but is most common in adults older than 65. Despite progress in the understanding of leukemia pathophysiology, the treatment of AML remains challenging. AML has the lowest survival rate of all adult leukemias. Approximately 20,000 patients have been diagnosed with AML with greater than 10,000 AML patient deaths in the United States only during 2016. While complete response rates can be as high as 80% in patients undergoing initial induction cytotoxic chemotherapy, the majority of AML patients will ultimately be diagnosed with relapsed or refractory disease.  Patients with relapsed or refractory AML (RR-AML) have, in general, a poor prognosis. These patients represent a population that is difficult to treat, having a very dismal outcome with approximately 10% of patients surviving. There is no current standard of care for adult R/R AML other than offering referral to an appropriate clinical trial.

Selvita Oncology Pipeline
In its internal research and development efforts, Selvita focuses on oncology. The company’s most advanced R&D program is SEL24, a dual PIM/FLT3 kinase inhibitor currently in Phase I/II clinical study. The second most advanced program is SEL120, a first-in-class small molecule inhibitor of CDK8 with potential use in hematological malignancies, colorectal cancer and breast cancer. Several Selvita programs have been partnered with Merck/EMD Serono, H3 Biomedicine/Eisai and Nodthera/Epidarex. Selvita Early Discovery programs include: Immunooncology platform, Eptheron – an oncology platform with an aim to develop novel molecules specifically targeting certain epigenetic and metabolic abnormalities in cancer, as well as an early discovery stage immunometabolism program and project targeting novel kinase targets.

Disclaimer:
This announcement may include statements that are, or may be deemed to be “forward-looking statements”. Such statements are based upon the current beliefs and expectations of Selvita’s management and are subject to significant risks relating to future events, general industry conditions, uncertainties inherent in the initiation and completion of clinical trials or relating to Selvita’s business. Forward-looking statements speak only as of the date they are made. Selvita disclaims any obligation or undertaking to update or revise any forward-looking statement, whether as a result of new information, future developments or otherwise.

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