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Farmas USA

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#84505

Re: Farmas USA

Cellceutix Completes Dosing in Phase 2 Trial of Prurisol for Chronic Psoriasis, Top-Line Data Anticipated in May
Marketwired Cellceutix
2 minutes ago

BEVERLY, MA--(Marketwired - March 01, 2016) - Cellceutix Corporation (CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology, anti-inflammatory and antibiotic applications, is pleased to announce that dosing has been completed in the Company's Phase 2 trial of Prurisol for the treatment of mild to moderate chronic plaque psoriasis. Approximately 7.5 million people in the U.S. are diagnosed with some form of psoriasis, a chronic immune-mediated skin disorder presenting with varying symptoms and levels of severity.

Based on compelling pre-clinical data, Cellceutix purposely set the bar high for the Phase 2 trial by targeting mild to moderate plaque psoriasis with an oral drug. By doing this, the Company is assessing Prurisol potentially for two different and very large markets in the psoriasis space. First, there are currently limited oral medications for mild to moderate chronic plaque psoriasis. Second, there is a need for new non-biologic oral treatments for moderate to severe chronic plaque psoriasis. Various trial endpoints will be studied once the trial is completed.

In the Phase 2 trial, physicians selected and evaluated a specific lesion while the patient was treated with a Prurisol or placebo tablet, as opposed to treating the lesion with a cream or gel, a common method used in clinical trials for the treatment of mild to moderate chronic plaque psoriasis.

"As the trial is a randomized, double-blind design with a placebo arm, we, nor anyone, can speculate on the outcome until all data is collected, un-blinded and analyzed." commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "Should the trial be a success, our plan is to seek a partnership through discussions with parties that have previously shown interest in Prurisol."

Cellceutix is developing Prurisol under the U.S. Food and Drug Administration's 505(b)(2) pathway, which can help expedite a drug's approval by relying, in part, on clinical data from an already approved drug.

The randomized, double-blind Phase 2 trial for chronic psoriasis is designed to evaluate the safety and efficacy of Prurisol as compared to a placebo. In a four-arm, multi-center trial, three arms of the study were administered different dosing regimens of oral Prurisol and one arm was administered an oral placebo for a period of 84 days. The subjects will now be followed for an additional 28 days without taking additional study medication. The final study visit and data collection for the last subject is expected to be completed by early April 2016, with top-line data made available approximately four weeks later. The primary endpoint to be evaluated is the percentage of subjects with greater than or equal to a 2-point improvement in Investigator's Global Assessment (IGA) rating as defined by visual inspections of patient's target lesion.

CITX

#84506

Re: Farmas USA

ONTY Dejo este comentario de Cowen (hoy tenían conferencia con ellos a las 8):

#84510

Re: Farmas USA

Me podéis mirar gráfica de CEMP y decirme dónde veis soporte? Gracias

#84511

Re: Farmas USA

Mirando CEMP en el corto plazo te diria que 15,34 a dia de hoy serian soporte. 

 

Pero si miramos en SEMANAL, la MM200 en 16,00 ha sido perforada hoy, de cerrar por abajo hay otros niveles a considerar, y un gap no muy lejos de aqui. 

 

Mejor que te aguanten los 15,43 en semanal ... sino se ira a testar los 15,00 y entre 14,48 y 14,95 esta el gap

 

edito: estos graficos no  incluyen la sesion de hoy, eh?

#84512

Re: Farmas USA

gracias Framus, yo también lo veía parecido. Entiendo que puede tocar el 52 week low en 15,43. La bajada de hoy es por un "downgrade" de buy a "hold", con un target price a $29, que es doblar el precio a día de hoy, vamos una broma, un downgrade para poder comprar barato. La semana que viene presentan en conferencia. Estoy planteando comprar al 52 week low

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