Luzitin kicks off clinical trials for LUZ112014-07-23 in Press Release Luzitin | LPM
Following approval by the authorities, Luzitin has initiated a clinical trial with its new medicine, which has an extremely promising potential in the treatment of several types of cancer. Head and neck cancer will be the focus of this first clinical trial. This new medicine – code name: LUZ11 – is potentially the first Portuguese oncological medicine to reach the clinical trial stage and may in fact be in a position to reach the market within 5 years.
Luzitin focuses on investigating and developing innovative compounds to be used in Photodynamic Therapy (PDT). The selected lead compound on the cancer development program (LUZ11) represents a high potential opportunity as it overcomes current limitations usually associated with PDT. Luzitin goes beyond PDT’s traditional approach by highlighting how its lead compound presents pivotal advantages over the existing photosensitizers currently in clinical use, namely its improved cost-benefit relation.
Photodynamyc Therapy is an extremely promising technique for the treatment of cancer, consisting of the administering of a light-sensitve drug (photosensitizer), followed by its light-activation. The light has an effect only on the desired area, i.e. the tumor.
Photoactivation is done through a laser light, which has a wave-length specifically designed for the drug. Following this activation, the tumor cells are destroyed with minimum side effects to the organism. This constitutes a crucial advantage over other cancer treatments.
Currently at phase IIa for advanced Head & Neck cancer, the attributes recognized to LUZ11 constitute important advantages over other photosensitizers as well as to other therapeutic procedures currently available for cancer treatment. The next steps include broadening LUZ11 to other types of solid tumors, Cervical, Lung and Gastric cancer.
Luzitin’s lead compound - LUZ11 - was specifically designed to improve efficacy/safety/ convenience over the existing photosensitisers of systemic use.
The lead compound was selected among a series of compounds covered by international patents on novel derivatives of porphyrins, namely chlorins and bacteriochlorins and uses thereof in PDT, as well as the drug substance manufacturing process (which assure protection up to at least 2029), and/or at least 10 years data protection granted post registration.
Among its advantages, emphasis should be placed on:
- Better efficacy: Activation by light of longer wavelength, with deeper action in tissues
- Better tolerability and safety: Less skin photosensitivity
- Improved convenience: Shorter time interval between photosensitizer administration and light irradiation
- Improved Pharmacoeconomics: sophisticated, yet easy-to-use and cost-effective system.
LUZ11’s Clinical Trial
The approval of LUZ11’s first clinical trial by the authorities is the result of 3 years of intensive labor, which included, among other stages, the successful scale-up of the LUZ11’s API under GMP conditions and of the respective finished product, the development of the medical device for irradiation, the non-clinical studies under GLP conditions and all the necessary regulatory process. All the detailed information about the clinical trial, might be found in the FDA and EU websites: