7 October 2014
PHOSPHAGENICS ANNOUNCES SUCCESSFUL RESULTS FROM ITS PHASE 2 TPM®/TRETINOIN GEL STUDY ON ACNE PATIENTS
Phosphagenics Limited today announced results from its Phase 2 study examining the effectiveness of its TPM®/Tretinoin topical gel formulation in the treatment of acne vulgaris. The study demonstrated that the Company’s proprietary TPM® technology provides a topical tretinoin formulation with several key advantages in overcoming limitations of the market leading topical formulation for acne, Retin-A®.
- TPM®/Tretinoin gel better than Retin-A® in treating inflammatory acne lesions
- TPM®/Tretinoin gel produces less erythema and dryness than Retin-A®
- TPM®/Vehicle gel shows encouraging anti-acne effects
11 August 2014
PHOSPHAGENICS COMPLETES FIRST IND ENABLING STUDY FOR TPM®/OXYMORPHONE PATCH
Phosphagenic announces that the first of its additional studies designed to further characterise the TPM®/Oxymorphone patch, in support of an Investigational New Drug (IND) application with the FDA, has been completed. The study was conducted on 15 healthy volunteers at Linear Clinical Research’s facility in Perth. It assessed additional pharmacokinetic parameters associated with the safety and elimination profile that were not addressed in the previous multiple dose Phase 1 study. The data generated will be used to help design the upcoming Phase 2 study, support the IND application and inform the eventual product label.
- Single dose pharmacokinetic (PK) study reproduces earlier results
- Therapeutic oxymorphone blood levels achieved in all 15 subjects
- Drug elimination indicates favourable safety profile