(Release 5 December- Stockholm, Sweden) PledPharma (STO:PLED) today announced positive results of PledOx in a preclinical model. The chemotherapy drug oxaliplatin caused an 80% drop in the number of white blood cells. The white blood cell drop was only 30% after pretreatment with PledOx. This difference was statistically significant (p=0.0012). Moreover, the anticancer effect of oxaliplatin was enhanced following pretreatment with PledOx.
The efficacy of PledPharma’s new PLED-derivative, PledOx, to reduce serious side-effects of oxaliplatin has been compared with that of another PLED-derivative, mangafodipir, in a preclinical model. The anticancer treatment oxaliplatin is a commonly used drug in colorectal cancer. Mangafodipir has previously been used in the clinic as an MRI contrast agent. We have earlier found that mangafodipir reduces oxaliplatin induced white blood cell drop in preclinical and clinical studies. The present preclinical results indicate that the protective potential of PledOx is higher than that of mangafodipir.
”The positive results of PledOx in the preclinical setting are very encouraging since they support our goal of offering cancer patients undergoing chemotherapy a strongly sought after supportive care. The preclinical studies are part of the ongoing work ahead of the initiation of our clinical phase IIb study, which is expected to start mid 2012. In addition, the new PLED-derivative composition, PledOx, and the new results will strengthen our intellectual property position”, says CEO Jacques Näsström.
About PledOx®
PledOx, a PLED-derivative, is developed as a treatment against the side-effects of chemotherapy treatment of cancer. PLED-derivatives reduce oxidative stress by mimicking the naturally occurring superoxide dismutase enzyme. The side effects of chemotherapy treatment often lead to a reduction of the planned chemotherapy dose or in worst case, treatment discontinuation. In a clinical study where we administered a similar PLED-derivative (mangafodipir) to colorectal cancer patients undergoing chemotherapy treatment, a reduced number of serious adverse events was observed.
The primary focus of the company is to document the PledOx reduction of FOLFOX (FOLinate, 5-Fluorouracil (5-FU), and OXaliplatin) induced side effects in the treatment of colorectal cancer patients. The clinical phase IIb study, which is expected to start mid 2012, will be done in patients with advanced colorectal cancer where chemotherapy treatment is given to prolong survival and for palliative purposes. The primary objective will be to evaluate the reduction of side effects related to a drop of white blood cells (i.e. neutrophils), and sensory nerve disturbances (sensory neuropathy).
About PledPharma
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