Clinical Trial for Acute Bacterial and Skin Structure Infections (ABSSSI) and Phase 2 Trial for Oral Mucositis
Beverly, MA — 09/16/13 — Cellceutix Corporation (OTCBB: CTIX) (the “Company”), a clinical stage biopharmaceutical company, is pleased to provide shareholders an update regarding the Company’s recent acquisition of the assets of PolyMedix. In the acquisition announced September 9, 2013, Cellceutix acquired substantially all of the assets of PolyMedix, including multiple compounds, two of which were in clinical trials, equipment assets at the former PolyMedix headquarters, as well as the Intellectual Property relating to drugs in the pipeline.
The Company has decided to immediately advance the Brilacidin compound portfolio asset. The Company now has in its possession all of the research data from the PolyMedix pipeline, including the Phase 2a clinical data from the antibiotic Brilacidin. The plan is to immediately advance Brilacidin into a Phase 2b clinical trial for acute bacterial skin and skin structure infections, or ABSSSI. Under the initiatives of the GAIN Act (Generating Antibiotic Incentives Now) passed in 2012, the Company intends to pursue an expedited regulatory review process, which can include Fast Track designation, for Brilacidin.
Brilacidin has also demonstrated potent activity as a potential new therapeutic for oral mucositis, an often-serious complication of chemotherapy and radiation therapy for cancer. Prior to PolyMedix’s bankruptcy, the company had communicated with the U.S. Food and Drug Administration (“FDA”) and was near completion of an Investigational New Drug application to move the drug into a Phase 2 trial for oral mucositis. Cellceutix has prioritized to complete this process and submit the application to the FDA. It is the Company’s understanding that oral mucositis is a qualifying condition under the Orphan Drug Act, a designation that Cellceutix intends to pursue.
Additionally, Cellceutix is now studying scientific data that show Brilacidin as a potential treatment for other indications. An examination of data and collaboration with researchers has shown a strong potential for Brilacidin for inflammatory bowel diseases, such as Crohn’s disease, as well as wound infections. After studies are completed at Cellceutix, the Company will update shareholders on its plan going forward, particularly on Crohn’s disease.
The Company has also started reviewing other newly acquired compounds and, in particular, sees strong possibilities in PMX-10098 for fungal infections. The Cellceutix team intends to immediately begin further research.
Chief Executive Officer of Cellceutix, Leo Ehrlich commented, “The energy at Cellceutix is very high as we believe we hit a home run with the PolyMedix acquisition, especially as it pertains to Brilacidin. The reality of owning these assets is now beginning to set in. With Brilacidin, there is very little work to be done to advance this compound into two different Phase 2 clinical trials. Brilacidin is the ‘low hanging fruit’ in this acquisition with tremendous upside potential. We believe that the clinical development of the Brilacidin franchise will firmly stamp our name in the lucrative and rapidly growing antibiotic industry. The only feeling that parallels my pride in our accomplishments to date is my excitement for the future.”