THROMBIN PEPTIDE TP508

THROMBIN PEPTIDE TP508

A pilot, randomized, double-blind, placebo-controlled clinical trial to determine safety and potential benefit of TP508 was recently completed.

In this pilot trial, complete healing of foot ulcers was achieved in 4 of 13 of the saline placebo controls (31%) compared with 9 of 12 (75%) and 7 of 10 (70%) in the 1 and 10-ug TP508-treatment groups, respectively. Median time to closure in the placebo group was not reached by 140 days but was Reached in 94 days in the 1-ug group and 72 days in the 10-ug group (p = 0.033). Thus, treatment with 10-ug of TP508 twice weekly almost doubled the rate of Foot ulcer closure. Moreover, this data shows that treatment with TP508 nearly Doubled the probability of complete ulcer closure within 60 days. Interestingly, in a subset analysis of the most critical and most difficult to heal ulcers (those Located on the heel of the foot), TP508 treatment resulted in closure of.7 out of B ulcers (87%), while placebo treatment resulted in no closures, or 0 out of 6 Ulcers (%). This significant effect suggests that the cellular effects of proteo-Lytically inactive thrombin-derived peptides may stimulate a cascade of events That are highly active in reversing defects associated with some of the most Severe chronic wounds There are a number of theories for why diabetic foot ulcers do not heal. These Ulcers seem to be caught in an inflammatory phase of healing, with elevated Proinflammatory cytokines, elevated metalloproteinases (MMPs), and no apparent Progression of angiogenesis or epithelialization (Trengove et al. 1999; Mi et al 2007).

Two clinical trials have now been completed to determine the effect of TP508 on Repair of distal radius fractures. TP508 was tested in a phase ½ prospective, double Blind, randomized, placebo-controlled distal radius fracture study. In this study, a A single injection of TP508 or saline vehicle alone was injected into the fracture site. Radiographic evaluation showed that the median time to healing was 23.5 days in Subjects treated with 10-ug TP508 vs. 31 days in subjects treated with placebo (Ryaby et al. 2006). Thus, fractures healed on average 25-30% faster when treated With TP508. Clinically, the time required for 50% of the fractures to heal was 10.6 Days faster for subjects treated with TP508 than for those treated with placebo, and the time required for 70% to heal occurred 13.1 days faster (Ryaby et al. 2006). The Second trial Demonstrated significant improvement in cortical bridging and decreased Healing time in subjects with extra-articular fractures, but nO overall reduction in Time tO fixation removal (presented at the 2007 meeting of the American Academy Of Orthopedic Surgeons Meeting 2007; Ladd et al. 2007). Interestingly, this study Also evaluated at-risk-populations such as those with Osteopenia who demonstrated Delayed fracture healing- In this population, significant effects of TP508 were seen in Time to immobilization removal and in time to overall radiographic fracture healing.

Product intended for research purposes

Additional informations:

• The product (substance) isn't a food or diet supplement and is not suitable for human consumption.
• Keep out of children's reach
• Keep container tightly closed.
• Store in a dry, cool and shaded place; protect from moisture.
• Store only in the original container.
• Avoid contact during pregnancy and breast feeding.
• Consult a doctor in the event of feeling unwell or having adverse effects related to the contact with the substance.