On March 13, 2019 LIDDS AB reported that first patient has now been enrolled in the Phase I NanoZolid-docetaxel study where NanoZolid combined with docetaxel will be injected into solid tumors (Press release, Lidds, MAR 13, 2019, View Source [SID1234555908]). The first injection was administered at Karolinska University Hospital.
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-The potential usefulness of this product is that it allows for higher drug concentrations to be achieved in the local treatment of cancer. These are probably drug concentrations that cannot be achieved with oral or intravenous treatments, says Dr Jeffrey Yachnin, Section Head Phase-I Unit, Center for Clinical Cancer Studies, Karolinska University Hospital.
-So far the treatment is without complications, says Dr Yachnin.
The first part of the Phase I study (NZ-DTX-001) will enroll patients for dose escalation after which patients will be treated intratumorally at a fixed dose to confirm tolerability. The primary objective is to study tolerability of NanoZolid-docetaxel and a secondary objective is to assess efficacy on tumor regression.
NZ-DTX is a key project for LIDDS as most types of cancer tumors can benefit from the intratumoral delivery of cytotoxic drugs. The cancers of greatest interest to LIDDS are lung, head & neck, prostate and breast cancer, but other tumors may also benefit from treatment using NanoZolid loaded with cytotoxic drugs.
An intratumorally sustained release of cytotoxic drugs can result in substantial tumor regression and facilitate subsequent curative surgery or radiation therapy and may prevent the tumor from metastasizing during the diagnostic lag period. Depending on the cancer indication, intratumoral treatment can also be combined with systemic drugs.
Around four million people are diagnosed with solid-tumor cancers each year and a very large number undergo diagnostic biopsies. LIDDS aim is that a significant proportion of patients undergoing diagnostic biopsies will be offered an injection of NanoZolid combined with docetaxel.
-LIDDS has had very promising results with docetaxel in the preclinical trial which gives us confidence that tumor regression will also be observed during Phase I. If so, it is likely that a substantial number of patients could benefit from this new form of treatment, says Monica Wallter, CEO LIDDS.
-Our objective is that NanoZolid combined with docetaxel will be regularly used to treat solid tumors, including at the tumor biopsy phase, to decrease the tumor size and improve surgery and radiation therapy outcomes. This will also benefit cancer patients that often have to wait many weeks before their treatment plan is decided, says Monica Wallter.
LIDDS docetaxel strategy is to prove tolerability and tumor regression for a number of different types of cancer. LIDDS has combined NanoZolid with docetaxel as it is indicated for a large number of common types of cancer types. When proof of concept is reached, LIDDS objective is to divest or license the project to one or several pharmaceutical companies.
-The NanoZolid technology has patent coverage until 2037, which is an important asset when out-licensing NanoZolid with cytotoxic drugs, says Monica Wallter.