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Cellceutix acquires PolyMedix assets; plans to advance Brilacidin phase IIb trial for ABSSSI
Beverly, Massachusetts | Wednesday, September 18, 2013, 14:00 Hrs  [IST]

Cellceutix Corporation, a clinical stage biopharmaceutical company, has acquired all the remaining assets of PolyMedix. The company also decided to immediately advance Brilacidin compound portfolio asset by bringing in all of the research data from the PolyMedix pipeline, including the phase IIa clinical data from the antibiotic Brilacidin.

Early September, Cellceutix had 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 plan to advance Brilacidin immediately into a phase IIb 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 US Food and Drug Administration (FDA) and was near completion of an Investigational New Drug application to move the drug into a phase II 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 II 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.”

Cellceutix is focused on developing and commercializing its pipeline of compounds for novel therapies in areas of serious unmet medical need, including cancer, psoriasis and antibiotic applications.

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