Leo: "To see such a strong response among patients
Post# of 72446
Posted On: 05/24/2016 10:12:48 AM
Leo: "To see such a strong response among patients, achieving clear to almost clear skin without serious side effects—the downside of biologics—in such a short period of time, is exceptional."
Excerpt from the PR:
"Cellceutix would also like to share some observations and comments from Principle Investigators (PIs) overseeing different participating clinical sites in the trial. Numerous PIs noted patients expressed a desire to have access to Prurisol following the study’s conclusion. Moreover, the Company learned that some patients were previously unsuccessfully treated with other therapies, including biologics and apremilast (Otezla®).
Included below is a sampling of responses that were authorized to be published:
“Well designed study, patients were pleased, minimal to no side effects.”
“Good tolerability was shown with very few AEs reported. Good compliance and good patient satisfaction.”
“Overall impression of the study is very positive, as well as the patients’ satisfaction.”
When asked, “Why would you choose Prurisol (should it be approved) over another oral compound for psoriasis?” and “Why would you choose Prurisol over an injectable biologic?” responses included:
“Because [Prurisol] does not cause any severe side effects. Patients dislike needles and injections because they cause pain and discomfort.”
“Patients overall prefer oral medications over injectable medication. Our experience with injectable studies for other indications has been that many subjects do not like taking them and those studies tend to be difficult compared to oral medications to recruit subjects.”
“Because of [Prurisol’s] low side effect profile.”
“Patients prefer oral treatments.”
Sponsor Comments
Cellceutix believes that the results from the Prurisol Phase 2 trial are extremely encouraging, especially for the 80 percent of psoriasis sufferers exhibiting milder symptoms of the condition. These people are more likely to switch between therapies or be off treatment altogether. Planning is underway to explore Prurisol’s potential in the treatment of moderate to severe psoriasis and eczema, a skin condition experienced by up to 30 percent of children and 10 percent of adults. The Company is hopeful Prurisol may one day become a leading treatment for psoriasis regardless of disease severity.
Leo Ehrlich, Chief Executive Officer of Cellceutix, commented: “We had always wanted to explore Prurisol’s clinical merit, as it had excellent results in laboratory studies. We put it to the test under some of the most demanding conditions, with respect to the IGA versus PASI scoring systems; short treatment duration; low dosing levels; enrollment that included patients who were previously treated with biologics; and evaluation in mild to moderate psoriasis patients, where it can be more difficult to achieve a meaningful therapeutic effect. To see such a strong response among patients, achieving clear to almost clear skin without serious side effects—the downside of biologics—in such a short period of time, is exceptional. We would like to thank patients and investigators who participated in the study. Prurisol has taken a key step towards potentially becoming only the second oral treatment approved by the FDA for psoriasis in decades.”
Excerpt from the PR:
"Cellceutix would also like to share some observations and comments from Principle Investigators (PIs) overseeing different participating clinical sites in the trial. Numerous PIs noted patients expressed a desire to have access to Prurisol following the study’s conclusion. Moreover, the Company learned that some patients were previously unsuccessfully treated with other therapies, including biologics and apremilast (Otezla®).
Included below is a sampling of responses that were authorized to be published:
“Well designed study, patients were pleased, minimal to no side effects.”
“Good tolerability was shown with very few AEs reported. Good compliance and good patient satisfaction.”
“Overall impression of the study is very positive, as well as the patients’ satisfaction.”
When asked, “Why would you choose Prurisol (should it be approved) over another oral compound for psoriasis?” and “Why would you choose Prurisol over an injectable biologic?” responses included:
“Because [Prurisol] does not cause any severe side effects. Patients dislike needles and injections because they cause pain and discomfort.”
“Patients overall prefer oral medications over injectable medication. Our experience with injectable studies for other indications has been that many subjects do not like taking them and those studies tend to be difficult compared to oral medications to recruit subjects.”
“Because of [Prurisol’s] low side effect profile.”
“Patients prefer oral treatments.”
Sponsor Comments
Cellceutix believes that the results from the Prurisol Phase 2 trial are extremely encouraging, especially for the 80 percent of psoriasis sufferers exhibiting milder symptoms of the condition. These people are more likely to switch between therapies or be off treatment altogether. Planning is underway to explore Prurisol’s potential in the treatment of moderate to severe psoriasis and eczema, a skin condition experienced by up to 30 percent of children and 10 percent of adults. The Company is hopeful Prurisol may one day become a leading treatment for psoriasis regardless of disease severity.
Leo Ehrlich, Chief Executive Officer of Cellceutix, commented: “We had always wanted to explore Prurisol’s clinical merit, as it had excellent results in laboratory studies. We put it to the test under some of the most demanding conditions, with respect to the IGA versus PASI scoring systems; short treatment duration; low dosing levels; enrollment that included patients who were previously treated with biologics; and evaluation in mild to moderate psoriasis patients, where it can be more difficult to achieve a meaningful therapeutic effect. To see such a strong response among patients, achieving clear to almost clear skin without serious side effects—the downside of biologics—in such a short period of time, is exceptional. We would like to thank patients and investigators who participated in the study. Prurisol has taken a key step towards potentially becoming only the second oral treatment approved by the FDA for psoriasis in decades.”
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