PledPharma Presents New In-Depth Follow-Up Data From Pliant Study - Pledox Shown To Reduce Chemotherapy-Induced Peripheral Neuropathy By 75 Percent
At the Redeye Investor Forum tonight in Stockholm, PledPharma AB’s (Publ) CEO Jacques Näsström will present new in-depth long-term data from a preliminary interim analysis of the ongoing follow-up phase of the company’s pivotal Phase IIb study PLIANT of PledOx®. Importantly, this data show that 24 weeks after completion of treatment PledOx® reduces the incidence and intensity of chemotherapy induced neuropathy by 75 percent compared with placebo. The difference was statistically significant (p <0.01).
Earlier this year, PledPharma presented results from PLIANT showing that PledOx® reduces the appearance of nerve damage symptoms by 43 percent compared to placebo during treatment. These results were based on the treating doctor's assessment of the severity of the symptoms. However, the long-term data now being presented are based on the patients' own assessments of symptoms and show that the effect of pretreatment with PledOx® is even more pronounced at 24 weeks post treatment.
Treatment by PledOx® with a 5 µmol / kg dose was found to keep the symptoms stable at a low level during the first 24 weeks after completion of treatment, while the placebo group showed increased neuropathy. Patients in this dosage group estimated the magnitude of neuropathy to be 62 percent lower than patients in the placebo group at week 12, and 75 percent lower at 24 weeks after completion of chemotherapy. The difference is statistically significant (p<0.01 at 24 weeks and p<0.05 at 12 weeks). For the group receiving the placebo the incidence and severity of symptoms increased significantly until week 12 and then levelled out at a high level.
"These new and more detailed long-term results from PLIANT study increase the possibility of establishing PledOx® as a future standard treatment to avoid permanent nerve damage due to cytotoxic therapy in colorectal cancer. This can lead to more effective cancer treatment and a better quality of life for these long-suffering patients", said CEO Jacques Näsström.
A detailed presentation of the above results is provided on the PledPharma webpage. A recording of the presentation on Redeye Investor Forum will be available on Redeye website, www.redeye.se
Earlier this year, PledPharma presented results from PLIANT showing that PledOx® reduces the appearance of nerve damage symptoms by 43 percent compared to placebo during treatment. These results were based on the treating doctor's assessment of the severity of the symptoms. However, the long-term data now being presented are based on the patients' own assessments of symptoms and show that the effect of pretreatment with PledOx® is even more pronounced at 24 weeks post treatment.
Treatment by PledOx® with a 5 µmol / kg dose was found to keep the symptoms stable at a low level during the first 24 weeks after completion of treatment, while the placebo group showed increased neuropathy. Patients in this dosage group estimated the magnitude of neuropathy to be 62 percent lower than patients in the placebo group at week 12, and 75 percent lower at 24 weeks after completion of chemotherapy. The difference is statistically significant (p<0.01 at 24 weeks and p<0.05 at 12 weeks). For the group receiving the placebo the incidence and severity of symptoms increased significantly until week 12 and then levelled out at a high level.
"These new and more detailed long-term results from PLIANT study increase the possibility of establishing PledOx® as a future standard treatment to avoid permanent nerve damage due to cytotoxic therapy in colorectal cancer. This can lead to more effective cancer treatment and a better quality of life for these long-suffering patients", said CEO Jacques Näsström.
A detailed presentation of the above results is provided on the PledPharma webpage. A recording of the presentation on Redeye Investor Forum will be available on Redeye website, www.redeye.se