Prurisol (abacavir gylcolate) / Innovation Pharma - LARVOL DELTA

"Hope 4 #psoriasis sufferers Phase 2B #Clinicaltrial Oral #Prurisol @Cellceutix_News $IPIX #biotech @US_FDA @KarinCAtrades interim results Q3" (@CoastCabCritic)

P2 data • Biosimilar • Immunology • Psoriasis

FDA schedules meeting with Cellceutix on new psoriasis drug (Marketwire) - Cellceutix Corporation announced that it has received a response from FDA related to its pre-IND submission & meeting request on Prurisol (KM-133); The FDA has confirmed mid-June 2012 for a pre-IND meeting focused on Prurisol to offer guidance on the Cellceutix initiatives to advance development of this new drug for treating psoriasis

Anticipated FDA meeting • Psoriasis

Efficacy and Safety of Prurisol Administered Orally for Active Moderate to Severe Chronic Plaque Psoriasis (clinicaltrials.gov) - P2; N=189; Recruiting; Sponsor: Cellceutix Corporation; Not yet recruiting ➔ Recruiting

Enrollment open • Biosimilar • Immunology • Psoriasis

Cellceutix reports on Kevetrin clinical trials and Prurisol manufacturing (Cellceutix) - "Cellceutix...is pleased to provide shareholders an update on...Prurisol™, the Company’s anti-psoriasis drug in development set to commence mid-stage clinical trials....Dr. Reddy’s has completed the process development of Prurisol and is now in the formulation stage for the manufacturing of Prurisol for the upcoming clinical trials in Europe planned for the second quarter of 2013."

Anticipated trial initiation date • Pipeline update • Psoriasis

Final patient completes treatment in Innovation Pharmaceuticals phase 2b study of oral Prurisol for psoriasis (GlobeNewswire) - P2b, N=199; NCT02949388; Sponsor: Innovation Pharmaceuticals; “Innovation Pharmaceuticals…today announces that the last patient has completed study treatment in the Company’s Phase 2b trial of Prurisol for the treatment of psoriasis.”

Enrollment closed • Immunology • Psoriasis

Cellceutix completes patient enrollment in clinical trial of Prurisol (Cellceutix Press Release) - P1, N=18; Sponsor: Cellceutix; NCT02101216; P1 study enrollment completed; "Cellceutix expects lab results, pharmacokinetic studies, and analysis to take approximately two months. If the data shows bioequivalence of Prurisol with Abacavir Sulfate, the Company will then schedule a meeting with the U.S. Food and Drug Administration regarding initiating a Phase 2/3 trial of Prurisol through the 505(b)(2) regulatory pathway."

Anticipated FDA event • Anticipated P1 data • Enrollment closed • Psoriasis

Cellceutix finishes last patient visit in mid-stage Prurisol study in plaque psoriasis; top-line data expected in May (SeekingAlpha) - P2, N=NA; NCT02494479; Sponsor: Cellceutix; "Cellceutix announces that the last patient visit has been concluded in its Phase 2 clinical trial assessing orally-administered Prurisol (abacavir acetate) for the treatment of mild-to-moderate plaque psoriasis. The unblinding of the study and top-line data are expected in May."

Anticipated P2 data • Trial status • Psoriasis

Cellceutix Institutes "Database Soft Lock" on its phase 2 psoriasis clinical trial, top line results anticipated in May; Additional company updates (Cellceutix Press Release) - P2, N=NA; NCT02494479; Sponsor: Cellceutix; "Cellceutix Corporation...is pleased to inform shareholders that the clinical database for Prurisol’s Phase 2 FDA trial for mild-to-moderate chronic plaque psoriasis has instituted a 'Database Soft Lock'...the Quality Assurance staff will review all the data points to ensure statistical accuracy in preparation of the dataset’s final analysis and confirm that all data points, including PK data, are in-line with the Statistical Analysis Plan."

Anticipated P2 data • Trial status • Psoriasis

Cellceutix submits Investigational New Drug Application (IND) for clinical trial of new anti-psoriasis drug, enrollment underway in phase 2b clinical trials of brilacidin (Cellceutix Press Release) - "Cellceutix Corporation...announces today that the Company has submitted an Investigational New Drug Application ('IND') to the U.S. Food and Drug Administration ('FDA') for the clinical development of Prurisol as a potential new treatment for psoriasis. Per regulatory protocol, the FDA has 30 days to review the IND. If the FDA in that time frame raises no questions, the first clinical trial of Prurisol is allowed to begin."

Anticipated new trial • IND • Psoriasis

Cellceutix to initiate psoriasis clinical trial (Cellceutix Press Release) - "Cellceutix...announces today that the U.S. Food and Drug Administration’s ('FDA') 30-day waiting period pertaining to the Company’s Investigational New Drug Application ('IND') for Prurisol™ has now passed....The initial clinical research will be a brief Bioequivalence crossover study expected to last approximately 45 days with the primary endpoint of demonstration that Prurisol converts to abacavir in humans, as it has been shown to do in animal models. Upon successful completion of the crossover trial, the Company will initiate a larger Phase 2/3 clinical trial..."

Anticipated new P2/3 trial • Anticipated new trial • IND • Psoriasis

Cellceutix submits application to institutional review board to commence clinical trials of anti-psoriasis drug prurisol (Cellceutix Press Release) - "Cellceutix Corporation...submitted the application to the Institutional Review Board ('IRB') responsible for the planned clinical study of the Company’s psoriasis drug Prurisol...Once IRB approval is received, Cellceutix will immediately file an Investigational New Drug (IND) Application with the FDA...the Company will move forward with initiation of a larger Phase 2/3 trial under the guidance from the FDA that a 505(b)(2) designation is an appropriate developmental pathway for Prurisol."

Anticipated IND • Anticipated new P2/3 trial • Regulatory • Psoriasis

Cellceutix to initiate phase 2b trial of Prurisol for chronic plaque psoriasis (Cellceutix Press Release) - "Cellceutix has begun preparing for a Phase 2b trial of Prurisol for patients with moderate to severe plaque psoriasis in order to better define appropriate dosing to achieve greatest clinical responses...expectations are to initiate the trial late in the third quarter or early in the fourth quarter with top-line results in the second quarter of 2017."

Anticipated new P2b trial • Anticipated P2b data • Psoriasis

Cellceutix: Dermatology Overview (Cellceutix) - "AUC values were comparable for both Prurisol and Ziagen, within 80% to 125% equivalence window, indicating equivalent systemic exposure. No serious adverse events, or other significant adverse events occurred over the course of the study"

P1 data • Psoriasis

Cellceutix: Corporate Fact Sheet (Cellceutix) - Anticipated top-line data from P2 trial (NCT02494479) for chronic plaque psoriasis in May 2016

Anticipated P2 data • Psoriasis

Cellceutix: Dermatology Overview (Cellceutix) - "Prurisol met the primary endpoint (a 2-point IGA reduction) in 35% of all patients who received a dose of 200mg per day"; "Among patients with the severest form of psoriasis, those having a baseline IGA score of 3 (“moderate”), the primary endpoint was met in 46% of patients who received 200mg per day. This data was derived from analyses of all patients"; "Patients who received any dose of Prurisol, regardless of the treatment arm, had a 1-point IGA improvement"; "Patients reported improved general skin condition, e.g., skin felt moist and smoother"; "Prurisol was well-tolerated—just one Serious Adverse Event (SAE) occurred and it was in the 50mg dose group"; "PK results showed a dose-dependent increase in exposure and maximum plasma concentration of the drug. The elimination half-life was similar in each of the three dosing levels (50mg, 100mg, 200mg), with an average of 1.3 hours. The clearance of the drug was also similar across dosing levels, with an average..."

P2 data • Psoriasis

Cellceutix: Dermatology Overview (Cellceutix) - Anticipated expiry of patents in US, Australia, Singapore, Taiwan and Europe related to pharmaceutical use and compositions in 2032

Anticipated patent expiry • Psoriasis

Cellceutix: Prurisol for psoriasis -- FDA agrees that phase 2 study may begin (Marketwire) - "...US Food and Drug Administration (FDA) has agreed that Cellceutix may begin a Phase 2 study of Prurisol (abacavir acetate)...FDA noted at the end-of-Phase 1 meeting on December 8, 2014 that, pending the full review of the Phase 1 data, long-term safety data for Prurisol in the treatment of psoriasis would not be required."

Anticipated new P2 trial • FDA event • Psoriasis

Cellceutix anti-psoriasis drug Prurisol meets primary endpoint of clinical trial (Marketwire) - P1, N=18; Sponsor: Cellceutix; NCT02101216; "Cellceutix...announce that it has just received notice that the data from its Phase 1 trial of the Company's anti-psoriasis drug candidate Prurisol...Cellceutix believes it has met the primary endpoints and objectives of the study....Upon receipt of the final report Cellceutix will schedule a meeting with the FDA to advance Prurisol into a Phase 2/3 clinical trial as quickly as possible."

Anticipated FDA event • Anticipated phase shift • P1 data • Psoriasis