BEVERLY, MA–(Marketwired – Mar 16, 2015) – Cellceutix Corporation ( OTC : CTIX ) (the “Company”), a analytic date biopharmaceutical aggregation developing avant-garde therapies with oncology, dermatology, and antimicrobial applications, is admiring to acquaint shareholders that added to the Company’s columnist absolution on March 2, 2015, Cellceutix is this anniversary appointment a appeal with the U.S. Food and Biologic Administration for a pre-Investigational New Biologic (IND) affair to admit a analytic abstraction for one of the Company’s Host Defense Proteins (HDPs) for the assay of hidradenitis suppurativa (HS).
Hidradenitis suppurativa (also accepted as abscess inversa) is a abiding and debilitating anarchic bark ache characterized by alternate abscesses and accumulation of atrium tracts, about breadth bark rubs together, such as the armpits, groin, amid the ocks and beneath the s. Although the aboriginal appear case was 176 years ago, the assay of HS, which causes cogent concrete and psychosocial ache to both men and women, charcoal abundantly accepted with no cure and alone bound able assay options. Reports of prevalence ambit broadly from about one-half a percent up to about four percent of the accepted population.
“Our aggregation continues to assay absolute able abstracts on our HDP artful for HS and we are aflame to be affective advanced with this indication,” commented Dr. Krishna Menon, Chief Scientific Officer at Cellceutix. “HS presents in abounding altered forms and it is cryptic the exact role of bacilli in the pathogenesis of HS, but a cardinal of hard-to-treat bacilli breed (i.e. Staphylococcus, Streptococcus, enterobacteriaceae) are frequently abandoned in HS lesions, abounding of which our atypical HDPs accept been apparent to be alive against. We attending advanced to a affair with the FDA in alertness for an IND filing and analytic abstraction to amusement this action that plagues so abounding people.”
In added accumulated developments, Cellceutix is additionally admiring to acquaint shareholders that Nasdaq has responded to the Aggregation with a “request for added information” apropos Cellceutix’s appliance to be listed on the Nasdaq exchange. Cellceutix admiral and acknowledged admonition are advancing the requisite advice as requested as allotment of the move to uplist to Nasdaq.
With account to the Phase 1 analytic balloon of Kevetrin for solid tumors actuality conducted at Harvard’s Dana-Farber Blight Institute and Beth Israel Deaconess Medical Center, the third and final accommodating in the tenth accomplice is now enrolled and actuality brash with 450 mg/m2. Two patients accept completed the dosing agreement with no austere adverse contest appear to date. Further, samples accept been taken from these capacity and beatific to the class for assay of added levels of the protein p21, a key biomarker for action of p53, a protein generally referred to as the “Guardian Angel of the Human Genome” because of its role as a adept corpuscle regulator and bump suppressor.
“We are agitated for our aggregation and shareholders as the brawl is now rolling with account to our move to Nasdaq. Our aggregation is agilely putting calm the requested advice to acknowledge as bound as possible,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “As far as the Kevetrin trial, we believed that the astringent acclimate altitude afresh in the Boston breadth would accept a added abstruse appulse on alleviative patients. We are absolute blessed to be brash that two patients accept completed the assay per agreement and the final accommodating in the accomplice has been enrolled. We are aiming for a above advance to amusement assertive types of blight and abundantly attending advanced to abstracts on the p21 biomarker for patients brash at these college dosing levels, which we are hopeful will abutment beforehand abstracts from the balloon assuming that accretion levels of p21 are dosage dependent.”
Elsewhere in the pipeline, Cellceutix is additionally now affianced in ascent up the accomplishment of its advance Gram-negative admixture for alleviative Klebsiella breed and Escherichia coli (E. coli). Grant money studies are advancing and abstracts is accepted in about one month, which will be acclimated for planning analytic research. To accelerate the Company’s Gram-negative program, Cellceutix is convalescent the accomplishment action of this absolute different HDP mimetic.
Cellceutix intends to accommodate shareholders with a absolute amend on all analytic trials and development of compounds in the activity afterward the end of the quarter.
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About Cellceutix:Headquartered in Beverly, Massachusetts, Cellceutix is a about traded aggregation beneath the attribute “CTIX”. Cellceutix is a analytic date biopharmaceutical aggregation developing avant-garde therapies in oncology, dermatology and antimicrobial applications. Cellceutix believes it has a world-class portfolio of compounds and is now affianced in advancing its compounds and gluttonous cardinal partnerships. Cellceutix’s anti-cancer biologic Kevetrin is currently in a Phase 1 analytic balloon at Harvard Blight Centers’ Dana Farber Blight Institute and Beth Israel Deaconess Medical Center. In the class Kevetrin has apparent to abet activation of p53, generally referred to as the “Guardian Angel Gene” due to its acute role in authoritative corpuscle mutations. Cellceutix will anon activate a Phase 2 analytic balloon with its atypical admixture Brilacidin-OM for the blockage of Articulate Mucositis in patients with arch and close cancer. Brilacidin-OM, a defensin artful compound, has apparent in an beastly archetypal to abate the accident of astringent ulcerative articulate mucositis by added than 94% compared to placebo. Cellceutix’s anti-psoriasis biologic Prurisol has afresh completed a Phase 1 analytic balloon and is actuality readied for a Phase 2 trial. Prurisol is a baby atom that acts through allowed accentuation and PRINS reduction. Cellceutix’s advance antibiotic, Brilacidin, has completed a Phase 2b balloon for Acute Bacterial Bark and Bark Structure Infections, or ABSSSI. Top-line abstracts accept apparent a distinct dosage of Brilacidin to bear commensurable analytic outcomes to the FDA-approved seven-day dosing dieting of daptomycin. Brilacidin has the abeyant to be a single-dose analysis for assertive multi-drug aggressive bacilli (Superbugs). Cellceutix has formed analysis collaborations with world-renowned analysis institutions in the United States and Europe, including MD Anderson Blight Center, Beth Israel Deaconess Medical Center, and the University of Bologna. Added advice is accessible on the Cellceutix web armpit at www.cellceutix.com.
Forward-Looking StatementsThis columnist absolution contains advanced statements fabricated pursuant to the safe anchorage accoutrement of the Private Securities Litigation Reform Act of 1995 that absorb risks, uncertainties and assumptions that could account Cellceutix’s absolute after-effects and acquaintance to alter materially from advancing after-effects and expectations bidding in these advanced attractive statements. Cellceutix has in some cases articular advanced statements by application words such as “anticipates,” “believes,” “hopes,” “estimates,” “looks,” “expects,” “plans,” “intends,” “goal,” “potential,” “may,” “suggest,” and agnate expressions. Among added factors that could account absolute after-effects to alter materially from those bidding in advanced statements are Cellceutix’s charge for, and the availability of, abundant basic in the approaching to armamentarium its operations and analysis and development; including the bulk and timing of the auction of shares of accepted banal to Aspire Capital; the actuality that Cellceutix’s compounds may not auspiciously complete pre-clinical or analytic testing, or be accepted authoritative approval to be awash and marketed in the United States or elsewhere. A added complete description of these accident factors is included in Cellceutix’s filings with the Securities and Barter Commission. You should not abode disproportionate assurance on any advanced statements. Cellceutix undertakes no obligation to absolution about the after-effects of any revisions to any such advanced statements that may be fabricated to reflect contest or affairs afterwards the date of this columnist absolution or to reflect the accident of hasty events, except as appropriate by applicative law or regulation.
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