BEVERLY, MA–(Marketwired – May 31, 2016) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, antibiotic, and anti-inflammatory applications, is pleased to announce that the pharmacokinetics (PK) data on the recently completed Phase 2 trial of Prurisol as a novel oral treatment for plaque psoriasis has been received and is starting to be analyzed.
PK Data Complements Efficacy Data
The PK data complements the efficacy data reported last week by showing a dose-dependent increase in exposure and maximum plasma concentration of the drug. Further, the elimination half-life was similar in each of the three dosing levels (50mg, 100mg, 200mg), with an average of 1.3 hours. The clearance of the drug was also similar across dosing levels, with an average of 80.1 liters per hour.
Of particular note, the half-life of Prurisol is shorter than that of apremilast (Otezla®) (1.3 hours vs. 6 to 9 hours). This suggests Prurisol, which acts through immunodulatory mechanisms, may not be dependent upon long-term exposure in the body to exhibit activity. A shorter half-life also may play a role in minimizing side effects commonly observed with other psoriasis treatments. The longer the drug remains in the body, the greater potential for adverse interactions with other medications and foods.
Low Patient Dropout Rates
Patient withdrawals (also called discontinuance) from study arms, whether active or placebo, are often an indicator of general patient satisfaction or dissatisfaction of the drug under study. Additional data analyses revealed a higher dropout rate among patients on placebo compared to patients receiving Prurisol. The Company interprets this as a clear indicator of patient satisfaction.
Coupled with Prurisol’s strong safety profile, minimal-to-no side effects, this insight reinforces qualitative endorsements expressed by many trial participants who reported feeling that their skin was moist, and not as dry, during the trial, as compared to before — an insight providing rationale for possible expansion of Prurisol into other dermatological areas, including atopic dermatitis, or eczema.
Cellceutix clinical trials on Clinicaltrials.gov: