LIDDS receives approval from MPA to start Phase I study NZ-DTX-001

The Swedish Medical Product Agency has approved a first-in-human study, NZ-DTX-001, in which solid tumors will be treated with NanoZolid combined with docetaxel. This is LIDDS' second clinical project and will initially include patients at Karolinska University Hospital in Sweden.

The Phase I study will assess the safety and tolerability of intratumoral treatment of patients with advanced cancer with an injection of NanoZolid with docetaxel. The injection provides a controlled release with a high and lasting drug concentration for the local treatment of tumors, avoiding the severe side effects of chemotherapy. Cytotoxic drugs often cause severe side effects which limit the dosage and the clinical effect, as the entire body is subjected to the treatment.

An earlier reported placebo controlled preclinical trial in an aggressive lung cancer model compared intratumoral and systemic administration of docetaxel with a placebo. The trial showed that an intratumoral injection with NanoZolid in combination with docetaxel had equal tumoral effects to systemic docetaxel treatment but avoided the severe side effects that occurred in systemically treated mice.

"This is another important step in the development of NanoZolid and demonstrates the wide-range of different drug formulations where NanoZolid can potentially be used," says Monica Wallter, CEO LIDDS.

LIDDS already has an ongoing clinical project for prostate cancer in Phase IIb and several preclinical development projects for treating solid tumors, for example with STING-agonists.

For more information, please contact:
Monica Wallter, CEO LIDDS, +46 (0)737 07 09 22, monica.wallter@liddspharma.com

LIDDS is required to disclose the information in this press release under the European Union's Market Abuse Regulation and the Securities Market Act. The information was submitted through the agency of the aforementioned contact person for publication on 13 November 2018 at 08.45 CET.
                 
LIDDS AB (publ) is a Swedish-based pharmaceutical company with a unique drug delivery technology: NanoZolid®. NanoZolid is superior to any drug delivery technology in its ability to provide a controlled and sustained release of active drug substances for up to six months. Lidds has licensing agreements where NanoZolid is combined with antiandrogens and in-house development projects in preclinical phase for cytostatics and immunoactive agents. LIDDS shares are listed on Nasdaq First North (LIDDS). For more information, please visit www.liddspharma.com