Solasia Initiates Phase III Program for Cancer Treatment Effect Med in Japan

Solasia Pharma K.K. (TOKYO:4597, Headquarters: Tokyo, Japan, President & CEO: Yoshihiro Arai, hereinafter “Solasia”) announced the initiation of Phase III clinical trial for PledOx® in Japan.

In November 2017, Solasia acquired exclusive development and commercialization rights for PledOx® in Japan, China, Hong Kong, Macau, South Korea and Taiwan from PledPharma.

This Phase III clinical trial in Asia (Japan, South Korea, Taiwan and Hong Kong) is an expansion of the Global Phase III trial led by PledPharma in the rest of the world where the first patient was included in the United States in November. The Asian region including Japan is now officially part of this Global Phase III clinical trial.
Following Japan, Solasia will also initiate in South Korea, Taiwan and Hong Kong successively.

This trial is for colorectal cancer patients treated with mFOLFOX6 ^(*1) which contains antioxidant drug “oxaliplatin” and to examine the effect of suppressing the development of peripheral neuropathy by administering PledOx®. Oxaliplatin is a platinum-based drug and is indicated for colorectal cancer, pancreatic cancer, gastric cancer etc.
Peripheral neuropathy is known as one of the serious side effects caused by administration of oxaliplatin, and one of the causes is that neurons develop by being damaged due to oxidative stress induced by the drug. Peripheral neuropathy is also known as the main side effect of other platinum-based drugs such as cisplatin. There are currently no drugs approved for the treatment of chemotherapy induced peripheral neuropathy. PledOx® is a superoxide dismutase analogue that is an enzyme that degrades active oxygen generated in cells and has the effect of protecting nerve cells from damage caused by drug-induced oxidative stress.
The initiation of this trial is a significant milestone for Solasia as this trial is positioned as a registration trial and its success is expected to contribute to patients suffering from peripheral neuropathy due to cancer chemotherapy.

Study description:

• Phase III, International, multicenter, double-blind, randomized, placebo-controlled study

Purpose of the study:

• The effect of reduce the peripheral neuropathy associated with administration of oxaliplatin by PledOx® administration compared with placebo.

Study design:

• POLAR-M study: Colorectal cancer patients who undergo mFOLFOX6 therapy with distant metastases are included.
• POLAR-A study: Colorectal cancer patients who undergo mFOLFOX6 therapy as an adjuvant therapy for postoperative surgery are included.

Primary outcome measures:

• Both the POLAR-M and POLAR-A studies will evaluate the proportion of patients with moderate or severe chronic peripheral neuropathy at 9 months after (first day of FOLFOX therapy) the initial administration of PledOx®.

Estimated enrollment:

• POLAR-M study: 420 patients (of which 120 patients in Asian region)
• POLAR-A study: 280 patients (of which 80 patients in Asian region)

Solasia is a specialty pharmaceutical company based in Asia, with a mission of “Better Medicine for a Brighter Tomorrow”. In order to address the unmet medical needs within the oncology area, we develop innovative medicines to contribute to the patient’s healthy living and to provide treatment options for the healthcare providers. Additional information is available at http://www.solasia.co.jp/en/

https://www.marketscreener.com/news/Solasia-Initiates-Phase-III-Program-for-PledOx-in-Japan–27829608/