BEVERLY, MA--(Marketwired - December 11, 2015) - Cellceutix Corporation (
The Company is now completing all the necessary steps to move Brilacidin for ABSSSI into Phase 3, including working with vendors in selecting international sites for the planned study.
Approximately one year ago, we disclosed, "Cellceutix has signed an agreement with a division of one of the largest U.S. pharmaceutical companies for testing Brilacidin as a component of certain implanted devices as a means to prevent infection. This potential prophylactic use was not part of Cellceutix's strategic plans for Brilacidin, but given the compilation of clinical and laboratory data, it is a logical application that could potentially add millions of dollars of revenue to the Company. The material transfer does not cover the pharmaceutical use of Brilacidin for treatment of infections or other diseases. A final contract can only be entered into if and when Brilacidin receives Food and Drug Administration (FDA) approval." We are pleased to report that this pharmaceutical company recently ordered additional Brilacidin for further testing. We interpret this as a positive sign and remain optimistic about this application for Brilacidin.
Although other companies have announced plans to enter the ABSSSI market, we believe their intention for doing such is primarily to use ABSSSI as a gateway for treating other diseases. When comparing their drug to approved ABSSSI drugs, we believe they are uncompetitive due to dosing regimens and other factors. However, at Cellceutix we view ABSSSI as a huge commercial opportunity for Brilacidin, possibly as much as hundreds of millions of dollars per annum for an approved single dose treatment, as well as a gateway to other diseases.
Brilacidin is the first in a new class of immunomodulatory antibiotics known as Host Defense Protein (HDP) mimics. The intravenous formulation of Brilacidin has the potential to treat a variety of infections, including ABSSSI caused by drug-sensitive or drug-resistant strains of Staphylococcus aureus, including Methicillin-Resistant Staphylococcus aureus (MRSA), and by other Gram-positive bacteria.
Although several companies are targeting ABSSSI, the Company believes that Brilacidin has several advantages over therapies; these include:
1) Brilacidin can be given as a single IV dose. At present, there is only one approved drug -- and no generics -- that can be given a single time for treating ABSSSI.
2) Because it is the first in a new class of antibiotics, there is no expected cross-resistance. In contrast, all of the newly approved ABSSSI drugs have come from existing classes of antibiotics that have been marketed for years, if not decades. This means resistance has already developed to older members of that class, and when bacteria are exposed to the new members of the same class, cross-resistance is likely to occur.
3) Brilacidin is effective against the stationary phase of bacteria. Most bactericidal antibiotics require bacteria to be in an "active growth phase" in order for rapid killing to occur. However, Brilacidin is active against bacteria in both the rapid growth phase and the stationary phase, and it has been shown to disrupt biofilms. By killing bacteria in both phases, this decreases the opportunity for a "persistent bacteria" to evolve into a "resistant bacteria." This is yet another way that Brilacidin could reduce the burden of resistance.
4) Brilacidin has immunomodulatory activity, including anti-inflammatory activity. This is not surprising, as Brilacidin was created to mimic key properties of our innate immune system. This is the immune system that protects our barriers surfaces, such as skin and mucous membranes. These immunomodulatory properties may help accelerate the healing of infections.
5) Because of its many attributes, Brilacidin could be used for other infectious or inflammatory conditions. The combination of antibacterial, anti-inflammatory, and anti-biofilm properties is unlike any other antibiotic, and we believe it can be used to treat biofilm-related infections of artificial joints, which is a growing problem in our aging population. In this space, we are currently conducting a Phase 2 trial assessing the effect of Brilacidin on oral mucositis, an inflammatory condition in cancer patients undergoing chemoradiation therapy."
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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 oncology, dermatology and antimicrobial applications. 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.
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Cellceutix Corporation
Leo Ehrlich