Bergen, Norway and Schiphol, the Netherlands (8 August 2019) – Cytovation AS (“Cytovation”) and Specialized Medical Services-oncology BV (“SMS-oncology”) today announce that SMS-oncology has been selected as the CRO to conduct the phase I/II clinical trial with CyPep-1 in patients with advanced solid cancers.
In recent months, Cytovation has progressed through preclinical and toxicology studies with its lead candidate CyPep-1, a first-in-class lytic agent. Through its unique pharmacological properties, CyPep-1 selectively targets and lyses tumor cell membranes based on their altered molecular composition. This mode of action kills cancer cells, releases tumor antigens, and potentially induces a tumor-specific immune response by in-situ immunization.
Cytovation is currently initiating a first-in-human trial with intratumoral injection of CyPep-1 and aims to reach first in patient (FPI) milestone by the end of 2019. An agreement is now concluded with the oncology dedicated CRO SMS-oncology in Schiphol, the Netherlands.
The study is designed as an open-label, dose escalation phase I/II trial to evaluate the safety, efficacy and pharmacokinetics of intratumoral CyPep-1 in patients with advanced solid cancers. The multicenter trial in Europe will enroll approximately 18 patients. SMS-oncology is developing the protocol and giving guidance regarding patient inclusion criteria and investigational sites for a best-fit and seamless transition to clinic. This will be followed by full conduct of the trial, expected to commence in Q4 2019.
Mr. Kjell-Inge, CEO of Cytovation: “We are excited CyPep-1 is now progressing to the next phase of development, which is an important step for our company. We are pleased with selecting SMS-oncology as our partner in this transition to clinic. From the initial discussions, they lived up to their reputation as experts in the field of early phase and immuno-oncology trials. Preparations of the trial are moving forward in a fast pace, and we feel confident our trial will be conducted in an optimal and valuable matter with our goals is mind.”
Ms. Philine van den Tol, CEO of SMS-oncology: “We are delighted to support Cytovation and look forward to jointly make the CyPep-1 trial a great success. It is exactly these type of innovative projects SMS-oncology leverages great experience in, and beyond all, is passionate
about. The enthusiasm of Cytovation is catching and our team can’t wait to see results of this promising first-in-class lytic compound.”
CyPep-1, in a cream formulation for topical application, is currently being evaluated in a phase I trial in patients with HPV-induced cutaneous tumors (warts).