Repost from other board might be harder to read without the bold and colored text.
Some DD on Placebo effect during Psoriasis trials.
At week 26 and across both studies for subjects receiving placebo, the PASI 75 was 9% (48/506) and the PASI 50 (proportion of subjects who achieved at least 50% improvement from baseline) was 27% (135/506)
CONCLUSION:
While these large-scale, robust studies demonstrated that rosiglitazone is not active in psoriasis, they also showed that for a large proportion of subjects receiving placebo, the expectation of a successful treatment, the favorable adverse effect profile of the drug, and the supportive environment of a clinical study conferred beneficial effects. These results may have implications for the design of future placebo-controlled studies in patients with psoriasis.
http://www.ncbi.nlm.nih.gov/pubmed/17428114
TRIAL DESIGN
THREE OF THE FOUR ARMS ARE PRURISOL
Active Comparator: 50mg of Purisol daily
One (1) 50 mg tablet of Prurisol and one (1) matching placebo tablet given AM and two (2) matching placebo tablets given PM for 84 (± 3) days
Drug: Prurisol
50mg tablet
Other Name: Purisol, 50mg tablet
Active Comparator: 100mg of Purisol daily
One (1) 50 mg tablets of Prurisol and one (1) matching placebo tablet given twice daily (AM and PM) for 84 (± 3) days
Drug: Prurisol
50mg tablet
Other Name: Purisol, 50mg tablet
Active Comparator: 200mg of Purisol daily
Two (2) 50 mg tablets of Prurisol given twice daily (AM and PM) for 84 (± 3) days
Drug: Prurisol
50mg tablet
Other Name: Purisol, 50mg tablet
Placebo Comparator: Placebo daily
Two (2) placebo tablets given twice daily (AM and PM) for 84 (± 3) days
Drug: Placebo
Sugar pill designed to match Purisol tablet
Other Name: Matching Placebo to Purisol tablet
Status
News
Enrollment Approximately 50 Percent Complete in Cellceutix Phase 2 Clinical Trial of Prurisol for Chronic Plaque Psoriasis
BEVERLY, MA–(Marketwired – Sept 30, 2015) – Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology and antimicrobial applications, today announces that the Company’s Phase 2 clinical trial of the oral drug candidate Prurisol for psoriasis has now enrolled approximately 50 percent of the planned number of patients. The trial was designed to enroll 100 patients with active mild to moderate chronic plaque psoriasis.
http://cellceutix.com/enrollment-approximatel...7bTUE.dpbs
What we should/could expect from the clinical responses. Based on the Lab summary.
Prurisol (10 mg/kg PO twice/ day x 21 days)
» 84% reduction in lesion appearance
» 99% reduction in lesions based on histology
» 96% reduction in serum PRINS
» 87% reduction in serum IL-20
» No reoccurrence of lesions within 180 days
- See more at: http://cellceutix.com/prurisol/#sthash.pgq6pZrb.dpuf
Summary:
A minimum of 50 Patients have completed the entire 84 days to end of treatment.
5 should have 75% clearance (9%)
15 should have 50% clearance (27%)
3 of the 4 arms are Prurisol
If Prurisol is ineffective ~30 of the 50 should show less than 50% clearance. Really none (or very very few) should have greater than 75% clearance.
If they are seeing "complete responses" or if more than the numbers referenced above are showing high percentage clearance than they will have some pretty good clues that Prurisol is a winner. Might not be to hard to get, say 50 million in up front payment for a ~500 million dollar a year orally available psoriasis treatment with predictable side effects.
A good visual PASI reference.
http://www.dermnetnz.org/scaly/pasi.html
Some DD on Placebo effect during Psoriasis trials.
At week 26 and across both studies for subjects receiving placebo, the PASI 75 was 9% (48/506) and the PASI 50 (proportion of subjects who achieved at least 50% improvement from baseline) was 27% (135/506)
CONCLUSION:
While these large-scale, robust studies demonstrated that rosiglitazone is not active in psoriasis, they also showed that for a large proportion of subjects receiving placebo, the expectation of a successful treatment, the favorable adverse effect profile of the drug, and the supportive environment of a clinical study conferred beneficial effects. These results may have implications for the design of future placebo-controlled studies in patients with psoriasis.
http://www.ncbi.nlm.nih.gov/pubmed/17428114
TRIAL DESIGN
THREE OF THE FOUR ARMS ARE PRURISOL
Active Comparator: 50mg of Purisol daily
One (1) 50 mg tablet of Prurisol and one (1) matching placebo tablet given AM and two (2) matching placebo tablets given PM for 84 (± 3) days
Drug: Prurisol
50mg tablet
Other Name: Purisol, 50mg tablet
Active Comparator: 100mg of Purisol daily
One (1) 50 mg tablets of Prurisol and one (1) matching placebo tablet given twice daily (AM and PM) for 84 (± 3) days
Drug: Prurisol
50mg tablet
Other Name: Purisol, 50mg tablet
Active Comparator: 200mg of Purisol daily
Two (2) 50 mg tablets of Prurisol given twice daily (AM and PM) for 84 (± 3) days
Drug: Prurisol
50mg tablet
Other Name: Purisol, 50mg tablet
Placebo Comparator: Placebo daily
Two (2) placebo tablets given twice daily (AM and PM) for 84 (± 3) days
Drug: Placebo
Sugar pill designed to match Purisol tablet
Other Name: Matching Placebo to Purisol tablet
Status
News
Enrollment Approximately 50 Percent Complete in Cellceutix Phase 2 Clinical Trial of Prurisol for Chronic Plaque Psoriasis
BEVERLY, MA–(Marketwired – Sept 30, 2015) – Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology and antimicrobial applications, today announces that the Company’s Phase 2 clinical trial of the oral drug candidate Prurisol for psoriasis has now enrolled approximately 50 percent of the planned number of patients. The trial was designed to enroll 100 patients with active mild to moderate chronic plaque psoriasis.
http://cellceutix.com/enrollment-approximatel...7bTUE.dpbs
What we should/could expect from the clinical responses. Based on the Lab summary.
Prurisol (10 mg/kg PO twice/ day x 21 days)
» 84% reduction in lesion appearance
» 99% reduction in lesions based on histology
» 96% reduction in serum PRINS
» 87% reduction in serum IL-20
» No reoccurrence of lesions within 180 days
- See more at: http://cellceutix.com/prurisol/#sthash.pgq6pZrb.dpuf
Summary:
A minimum of 50 Patients have completed the entire 84 days to end of treatment.
5 should have 75% clearance (9%)
15 should have 50% clearance (27%)
3 of the 4 arms are Prurisol
If Prurisol is ineffective ~30 of the 50 should show less than 50% clearance. Really none (or very very few) should have greater than 75% clearance.
If they are seeing "complete responses" or if more than the numbers referenced above are showing high percentage clearance than they will have some pretty good clues that Prurisol is a winner. Might not be to hard to get, say 50 million in up front payment for a ~500 million dollar a year orally available psoriasis treatment with predictable side effects.
A good visual PASI reference.
http://www.dermnetnz.org/scaly/pasi.html
