PledPharma Presents Additional Results From A Phase IIb Study With Pledox At The Scientific Conference MASCC
June 26, 2015: PledPharma AB (publ) presents additional topline results from PLIANT – a Phase IIb study with the drug candidate PledOx® – at the scientific conference MASCC (Multinational Association of Supportive Care in Cancer) in Copenhagen, Denmark. The results confirm that PledOx® can reduce the risk of symptoms caused by sensory nerve damage associated with chemotherapy treatment of advanced colorectal cancer in a clinically relevant manner.
The study results presented at MASCC show that patients treated with PledOx® have a lower risk than the placebo group to suffer from nerve damage. As previously reported, the incidence of symptoms caused by sensory nerve damage (neuropathy) was 43 percent lower in the group of patients treated with PledOx® at a dose of 5 µmol/kg, compared to the placebo group. New data from three different test methods consistently show a positive effect of the treatment. The data also clearly confirms that the anti-cancer effect of chemotherapy was not negatively impacted by PledOx® treatment. It was concluded PledOx® had a benign safety profile and was not associated with any serious adverse effects.
Moreover, the additional results revealed that symptoms occur later and disappear faster after pretreatment with PledOx®. The findings were presented by Associate Professor Devalingam Mahalingam, M.D., Ph.D., University of Texas Health Science Center, San Antonio, Tx, USA and principal investigator for the PLIANT study in the United States.
"To our knowledge, this is the first controlled study to show a clinically significant prevention of chemotherapy-induced sensory nerve damage, with no apparent negative impact on the efficacy of the chemotherapy," said Jacques Näsström, CEO PledPharma.
Neuropathy in conjunction with chemotherapy can cause debilitating problems, for example hypersensitivity to cold, disruption of fine motor skills and severe pain especially in the hands and feet. This is one of the most common serious side effects in the treatment of colorectal cancer with the FOLFOX chemotherapy combination. These side effects often require reduction of the prescribed chemotherapy dose and in the most severe cases treatment must be discontinued.
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The study results presented at MASCC show that patients treated with PledOx® have a lower risk than the placebo group to suffer from nerve damage. As previously reported, the incidence of symptoms caused by sensory nerve damage (neuropathy) was 43 percent lower in the group of patients treated with PledOx® at a dose of 5 µmol/kg, compared to the placebo group. New data from three different test methods consistently show a positive effect of the treatment. The data also clearly confirms that the anti-cancer effect of chemotherapy was not negatively impacted by PledOx® treatment. It was concluded PledOx® had a benign safety profile and was not associated with any serious adverse effects.
Moreover, the additional results revealed that symptoms occur later and disappear faster after pretreatment with PledOx®. The findings were presented by Associate Professor Devalingam Mahalingam, M.D., Ph.D., University of Texas Health Science Center, San Antonio, Tx, USA and principal investigator for the PLIANT study in the United States.
"To our knowledge, this is the first controlled study to show a clinically significant prevention of chemotherapy-induced sensory nerve damage, with no apparent negative impact on the efficacy of the chemotherapy," said Jacques Näsström, CEO PledPharma.
Neuropathy in conjunction with chemotherapy can cause debilitating problems, for example hypersensitivity to cold, disruption of fine motor skills and severe pain especially in the hands and feet. This is one of the most common serious side effects in the treatment of colorectal cancer with the FOLFOX chemotherapy combination. These side effects often require reduction of the prescribed chemotherapy dose and in the most severe cases treatment must be discontinued.
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