STOCKHOLM, May 8, 2017 /PRNewswire/ -- Cantargia AB ("Cantargia") today announced that the company has finalised the GLP safety studies of the product candidate CAN04 prior to the start of clinical trials. The toxicity study showed good tolerability with no adverse findings that would indicate potential serious safety concerns in patients. Also, a tissue cross reactivity study showed very limited binding of CAN04 to normal human tissues.
Cantargia's proprietary antibody CAN04 directed towards the molecular target IL1RAP has undergone the final tests prior to applying for the start of clinical trials in patients with non-small cell lung cancer and pancreatic cancer. In accordance with regulatory guidelines, two important safety studies have been conducted under Good Laboratory Practice (GLP).
The first study investigated toxicity at three different dose levels. The highest dose level was 100 mg/kg, i e the same as in the previously reported study but in a larger number of animals. This is in the order of ten times higher than the anticipated human dose level. The study investigated weekly dosing of CAN04 for four weeks followed by a four weeks recovery period. In addition to the safety evaluation during treatment, a histological examination was performed at the end of the study. CAN04 was well tolerated and no toxicity issues were reported during treatment or in the analysis of potential pathological changes. Thus, the new study confirms the very attractive safety properties of CAN04 previously seen in toxicity studies of smaller size.
In a second study, the binding of CAN04 to human tissues from healthy donors was examined using a full FDA/EMA tissue panel. In general, the binding of CAN04 to normal human tissues was very low and in accordance with a previous non-GLP study. This further confirms Cantargia's expectation that CAN04 will be associated with a good safety in patients.
"We are very pleased with the clear results from these studies, confirming our view that CAN04 may be a very safe compound for treatment of patients with cancer", Göran Forsberg, CEO of Cantargia, says. "As we now have all parts ready, including CAN04 produced under GMP, the application to start the phase I/IIa trial will be submitted as quickly as possible, with the goal to start the clinical trial in June 2017".
For further information, please contact:
Göran Forsberg, CEO
Telephone: +46 (0)46-275 62 60
This constitutes information that Cantargia is required to publish under the EU's Market Abuse Regulation. The information was submitted for publication through the above contact person at 08.30CET on 8 May 2017.
Cantargia AB (publ), reg.no. 556791-6019, is a biotech company that is developing an antibody-based cancer treatment, which aims to attack cancer cells and arrest the inflammation of the tumour. The original discovery by the research team behind Cantargia was the overexpression of a specific target molecule, interleukin 1 receptor accessory protein "IL1RAP", in cancer stem cells in patients with leukemia that is not found in normal stem cells in the bone marrow. In preclinical studies (in vitro and in vivo) the antibody, targeted at IL1RAP, has been shown to have two potential mechanisms of action, which are complementary. The Company has selected a product candidate, CAN04, for future studies in humans and development activities have been focused on non-small cell lung cancer and pancreatic cancer.
Cantargia is listed on Nasdaq Stockholm First North (ticker: CANTA). Sedermera Fondkommission is the company's Certified Adviser. More information about Cantargia is available at http://www.cantargia.com.
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SOURCE Cantargia AB