The study results demonstrate that i.v. Cantrixil was well tolerated at all dose levels, with no adverse findings, no cardiovascular effects, and no signs of local irritation or toxicity at the injection site. Pharmacokinetic parameters, including blood concentration levels and half-life, were consistent with expectations and complement prior preclinical data.

“We are pleased to report that intravenous administration of Cantrixil was well tolerated and that both primary objectives were met in this exploratory study. We now have important information to complete the preclinical package needed to prepare a Phase I clinical trial in human AML, and the pharmacokinetic and safety data required to initiate a pilot study in dogs with cancer,” says Erik Kinnman, CEO of Vivesto.

In the PK/toxicology study, four dogs received increasing i.v. doses of Cantrixil in three rounds at 2, 5 and 10 mg/kg. The study design and day 7 assessments support the intended once-weekly dosing frequency for both humans and dogs.

Cantrixil was well tolerated by all dogs, with no adverse or toxicologically relevant findings. No cardiovascular adverse effects were reported, a particularly important finding as cardiovascular toxicity is a known and often dose-limiting risk for cytotoxic agents. Furthermore, there were no local signs of irritation or toxicity at the injection site.
Hematological and clinical biochemistry parameters, which were analyzed before treatment start and 7 days after each treatment administration, a common timepoint for assessing cytotoxic agents, showed no alterations.

The pharmacokinetic parameters of Cantrixil, including blood concentration levels, were in line with previous observations from the in vivo study performed in a mouse model of AML earlier last year. Drug half-life was as expected, confirming that the i.v. formulation performs as intended and is consistent with existing preclinical documentation.

Together with previous findings, these new results support the continued advancement of Cantrixil toward a Phase I clinical trial in AML in humans, in parallel with continued CMC development to produce clinical trial material.

As previously announced, Vivesto is also developing Cantrixil for dogs with cancer, building on its anti-cancer mechanism of action and synergies with the company’s existing veterinary oncology program.

For more information:
Erik Kinnman, Chief Executive Officer, Vivesto
Phone: +46 018-50 54 40
E-mail: IR@vivesto.com

About Vivesto AB
Vivesto is a Swedish development company that aims to offer new treatment options for hard-to-treat cancers where there are major medical needs and significant market potential. The project portfolio consists of Cantrixil, which is being developed for blood cancer, and the veterinary oncology program Paccal Vet (paclitaxel micellar), which is being evaluated in a pilot clinical trial in dogs with splenic hemangiosarcoma following splenectomy and in a dose-finding study in cats with solid tumors.

Vivesto’s shares are traded on Nasdaq Stockholm (ticker: VIVE). Visit www.vivesto.com for more information about Vivesto.