Innovation Pharmaceuticals Inc (IPIX)

[BooDog]

News: Cellceutix Submits Briefing Book for Phase 2 Trial of p53 Targeting Drug for Ovarian Cancer



BEVERLY, MA–(Marketwired – January 19, 2016) - Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to inform shareholders that the briefing book with data collected during the Phase 1 clinical trial of Kevetrin for various advanced solid tumors has already been submitted to the U.S. Food and Drug Administration (FDA). This briefing book submission is in advance of the FDA meeting to discuss the planned Phase 2 clinical trial of Kevetrin for advanced ovarian cancer. Cellceutix is developing Kevetrin for ovarian cancer under an FDA Orphan Drug designation.

48 advanced-stage cancer patients were enrolled in the Phase 1 trial and received at least one dose of Kevetrin. 11 of the 48 patients in the trial had advanced ovarian cancer.

Kevetrin has a unique mechanism of action that enhances activity of p53, a key tumor suppressor protein, in both wild type and mutant p53-expressing tumors. In the Phase 1 trial, p53 activity is measured by increased expression of the protein p21, a downstream biomarker of p53, in peripheral blood lymphocytes. p21 increased by ≥ 10% in 48% of the 31 evaluable patients to date. Importantly, with respect to the planned Phase 2 trial for ovarian cancer, 8 of 11 subjects (73%) with advanced ovarian cancer had increases in p21 expression, indicative of activation of p53.

No evidence of adverse effects on liver, kidney or hematologic function related to Kevetrin was observed, regardless of dose. Therapeutic efficacy was not an endpoint in the Phase 1 trial. However, RECIST (Response Evaluation Criteria In Solid Tumors) criteria were used and several subjects had stable disease for several months during a Kevetrin treatment cycle of one dose per week for three weeks and then one week off. The longest enrolled subject has completed 15 cycles and remains enrolled in the trial.

In the planned Phase 2 ovarian cancer trial, Cellceutix intends to leverage the short half-life and strong pharmacokinetic profile of Kevetrin to change Kevetrin dosing from a single dose weekly to multiple doses weekly. The company expects that this will further increase p53 activity.

Ovarian cancer is a disease with a large unmet medical need and represents one of the fastest paths for approval for a clinically successful drug.

About Cellceutix:
Headquartered in Beverly, Massachusetts, Cellceutix is a publicly traded company under the symbol “CTIX”. Cellceutix is a clinical stage biopharmaceutical company developing innovative therapies in multiple diseases. Cellceutix believes it has a world-class portfolio of compounds and is now engaged in advancing its compounds and seeking strategic partnerships. Cellceutix’s anti-cancer drug Kevetrin is currently in a Phase 1 clinical trial at Harvard Cancer Centers’ Dana Farber Cancer Institute and Beth Israel Deaconess Medical Center. In the laboratory Kevetrin has shown to induce activation of p53, often referred to as the “Guardian Angel Gene” due to its crucial role in controlling cell mutations. Cellceutix is in a Phase 2 clinical trial with its novel compound Brilacidin-OM for the prevention of Oral Mucositis in patients with head and neck cancer. Brilacidin-OM, a defensin mimetic compound, has shown in an animal model to reduce the occurrence of severe ulcerative oral mucositis by more than 94% compared to placebo. Cellceutix’s anti-psoriasis drug Prurisol is in a Phase 2 trial. Prurisol is a small molecule that acts through immune modulation and PRINS reduction. Cellceutix’s lead antibiotic, Brilacidin, has completed a Phase 2b trial for Acute Bacterial Skin and Skin Structure Infections, or ABSSSI. Top-line data have shown a single dose of Brilacidin to deliver comparable clinical outcomes to the FDA-approved seven-day dosing regimen of daptomycin. Brilacidin has the potential to be a single-dose therapy for certain multi-drug resistant bacteria (Superbugs). Cellceutix has formed research collaborations with world-renowned research institutions in the United States and Europe, including MD Anderson Cancer Center, Beth Israel Deaconess Medical Center, and the University of Bologna. More information is available on the Cellceutix web site at www.cellceutix.com.

Forward-Looking Statements
This press release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 that involve risks, uncertainties and assumptions that could cause Cellceutix’s actual results and experience to differ materially from anticipated results and expectations expressed in these forward looking statements. Cellceutix has in some cases identified forward-looking statements by using words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and similar expressions. Among other factors that could cause actual results to differ materially from those expressed in forward-looking statements are Cellceutix’s need for, and the availability of, substantial capital in the future to fund its operations and research and development; including the amount and timing of the sale of shares of common stock to Aspire Capital; the fact that Cellceutix’s compounds may not successfully complete pre-clinical or clinical testing, or be granted regulatory approval to be sold and marketed in the United States or elsewhere. A more complete description of these risk factors is included in Cellceutix’s filings with the Securities and Exchange Commission. You should not place undue reliance on any forward-looking statements. Cellceutix undertakes no obligation to release publicly the results of any revisions to any such forward-looking statements that may be made to reflect events or circumstances after the date of this press release or to reflect the occurrence of unanticipated events, except as required by applicable law or regulation.
- See more at: http://cellceutix.com/cellceutix-submits-briefing-book-for-phase-2-trial-of-p53-targeting-drug-for-ovarian-cancer/#sthash.aT6kI7bK.dpuf


Just awesome.

Also want to keep this in the forefront:


F1ash Wednesday, 01/13/16 06:36:57 PM
Re: KarinCA post# 136777
Post # of 137447

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
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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

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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-approximately-50-percent-complete-in-cellceutix-phase-2-clinical-trial-of-prurisol-for-chronic-plaque-psoriasis/#sthash.JvK7bTUE.dpbs
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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
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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