SP-04:PledOx®

Initial indication: Chemotherapy Induced Peripheral Neuropathy (CIPN)

    • Pipeline Code
    • Estimated Initial indication
    • Originator
  • Pre-
    clinical
  • Clinical Study
    Phase 1
  • Clinical Study
    Phase 2
  • Clinical Study
    Phase 3
  • NDA
  • App-
    roval
  • Lau-
    nch
  • Partner
  • SP-04

    Chemotherapy Induced Peripheral Neuropathy (CIPN)

    PledPharma AB
  • Japan, Korea, Taiwan, HK (Phase III preparation)
    China
    US and EU (PledPharma)
Pipeline Code
SP-04
Estimated Initial indication
Chemotherapy Induced Peripheral Neuropathy (CIPN)
Originator
PledPharma AB
  • Pre-
    clinical
  • Clinical Study
    Phase 1
  • Clinical Study
    Phase 2
  • Clinical Study
    Phase 3
  • NDA
  • App-
    roval
  • Lau-
    nch
Japan, Korea, Taiwan, HK (Phase III preparation)
China
US and EU (PledPharma)
Partner
SP-04

In November 2017, Solasia acquired the rights to SP-04 (PledOx) from PledPharma AB for Japan, China, Hong Kong, Macau, South Korea and Taiwan. SP-04 is a product pipeline for Chemotherapy Induced Peripheral Neuropathy. The side-effects of chemotherapy can lead to a reduction of the planned dose or, in worst case, treatment discontinuation. Unfortunately, it appears that the chemotherapy can induce permanent nerve damage. Patients may, for example, experience discomfort and numbness in the hands and feet, difficulty with balance with risk of falling and problems with sensation that can last for the rest of their lives. The results from a completed Phase IIb trial, where patients with metastatic colorectal cancer were treated with the chemotherapy combination FOLFOX and PledOx®, indicates that the patients who received PledOx® had a lower risk than the placebo group to suffer from nerve damage during the chemotherapy.

Development Strategy:Preparing Global Phase III study (Japan, Korea, Taiwan, Hong Kong)

Phase I study in Japanese and Caucasian Healthy Volunteers completed in February 2018 in US by PledPharma.

Based on the consultation with the Pharmaceuticals and Medical Devices Agency (PMDA), Asian region including Japan will now be part of Phase III International joint clinical trial.

Phase III clinical trials in Asian region will start in the second half of 2018 as an extension of the Phase III clinical trial that will be conducted under the initiative of PledPharma.

Expected Target Indications

Chemotherapy Induced Peripheral Neuropathy (CIPN)
Peripheral neuropathy symptoms are caused by damages to sensory nerves, most commonly in hands and feet. Certain chemotherapies, including oxaliplatin, can cause such damages, which is then called chemotherapy induced peripheral neuropathy (CIPN). This can be a debilitating adverse reaction to the cancer treatment and may occur at any time after the initiation of chemotherapy. The symptoms often increase as the chemotherapy treatment continues and may often cause discontinuation of the chemotherapy. In many patients, the symptoms are resolved after discontinuing the chemotherapy, but up to 85-95% of the patients have sustained symptoms such as numbness, tingling and pain in hands and feet in case of FOLFOX therapy including oxaliplatin. Discontinuation of chemotherapy contributes improvement of a part of symptoms in 80% of patients and recovered in 40% of patients 6-8 months after discontinuation of chemotherapy. However, discontinuation of chemotherapy sometimes means withdrawal from treatment or change of treatment strategy and it is a clinically significant issue. There is currently no approved drug to prevent or treat CIPN.

Information for use of our pruducts

The site you are about to access is intended to provide information for medical professionals in Japan. It is designed to allow users to better understand Solasia's products.

I have read and understood above

Page Top

SELECT YOUR LANGUAGE