Brilacidin Lyophilized as Cellceutix Prepares to Bring First New Class of Antibiotic to Phase 3 Trials in More Than 20 Years
http://finance.yahoo.com/news/brilacidin-lyop...31869.html
BEVERLY, MA--(Marketwired - January 14, 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 inform shareholders that manufacturing, lyophilization and filling of vials is now complete in preparation for the planned Phase 3 trials of Brilacidin for Acute Bacterial Skin and Skin Structure (ABSSSI) infections caused by Gram-positive bacteria. The vials of Brilacidin are now in the inspection and quality control (QC) stage. The Company is preparing for submission the final protocol for the trial per guidance from the U.S. Food and Drug Administration (FDA) received at the end-of-phase 2 meeting.
With the vials being filled, a global Contract Research Organization (CRO) selected, and the final protocol nearing completion, the vast majority of the work has been finished in preparation for the pivotal Phase 3 trials of Brilacidin for ABSSSI. Cellceutix is almost ready to make history by becoming the first new class of antibiotic to enter a Phase 3 clinical trial for ABSSSI in more than two decades.
"I'd also like to address the amended complaint by The Rosen Law Firm, pertaining to the ABSSSI Phase 3 trials," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "Using Durata Therapeutics as an example, Rosen alleges that costs for the trial will be a grotesquely over-estimated $145 million. It's a completely inappropriate example. Investors should remember that we have former Durata executive Dr. Ronald Trust as a consultant for the trial, and our Head of Clinical Operations, Edward Walters, is experienced in taking drugs through Phase 3 and getting drugs FDA approved. Many may be unaware that Cellceutix did not use a full service CRO for our Phase 2 ABSSSI study nor the Phase 2 psoriasis study now nearing completion. This likely saved Cellceutix millions of dollars compared to other companies. For the Phase 3 ABSSSI study we will use a global CRO. To that point, we have completed negotiations with a highly recognized global CRO and have a contractual proposal for costs that are many multiples less than that amount Rosen incredibly asserts. With our cash on hand, our commitment from Aspire Capital, and our shelf registration, we believe we have the funding options subject to market conditions, to not only complete the Phase 3 trial of Brilacidin for ABSSSI, but also continue other clinical trials and pre-clinical research. Investors are encouraged to read Cellceutix budgets as they appear in our filings. We have always operated at a very minimal burn rate compared to peers. I will not go into more detail at this point regarding Rosen's complaint as it is in litigation, but I assure you that Cellceutix and our counsel consider it extremely frivolous and feel that there is a strong case for dismissal, sanctions and other legal actions against Rosen and the plaintiff for filing this lawsuit."
http://finance.yahoo.com/news/brilacidin-lyop...31869.html
BEVERLY, MA--(Marketwired - January 14, 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 inform shareholders that manufacturing, lyophilization and filling of vials is now complete in preparation for the planned Phase 3 trials of Brilacidin for Acute Bacterial Skin and Skin Structure (ABSSSI) infections caused by Gram-positive bacteria. The vials of Brilacidin are now in the inspection and quality control (QC) stage. The Company is preparing for submission the final protocol for the trial per guidance from the U.S. Food and Drug Administration (FDA) received at the end-of-phase 2 meeting. With the vials being filled, a global Contract Research Organization (CRO) selected, and the final protocol nearing completion, the vast majority of the work has been finished in preparation for the pivotal Phase 3 trials of Brilacidin for ABSSSI. Cellceutix is almost ready to make history by becoming the first new class of antibiotic to enter a Phase 3 clinical trial for ABSSSI in more than two decades.
"I'd also like to address the amended complaint by The Rosen Law Firm, pertaining to the ABSSSI Phase 3 trials," commented Leo Ehrlich, Chief Executive Officer at Cellceutix. "Using Durata Therapeutics as an example, Rosen alleges that costs for the trial will be a grotesquely over-estimated $145 million. It's a completely inappropriate example. Investors should remember that we have former Durata executive Dr. Ronald Trust as a consultant for the trial, and our Head of Clinical Operations, Edward Walters, is experienced in taking drugs through Phase 3 and getting drugs FDA approved. Many may be unaware that Cellceutix did not use a full service CRO for our Phase 2 ABSSSI study nor the Phase 2 psoriasis study now nearing completion. This likely saved Cellceutix millions of dollars compared to other companies. For the Phase 3 ABSSSI study we will use a global CRO. To that point, we have completed negotiations with a highly recognized global CRO and have a contractual proposal for costs that are many multiples less than that amount Rosen incredibly asserts. With our cash on hand, our commitment from Aspire Capital, and our shelf registration, we believe we have the funding options subject to market conditions, to not only complete the Phase 3 trial of Brilacidin for ABSSSI, but also continue other clinical trials and pre-clinical research. Investors are encouraged to read Cellceutix budgets as they appear in our filings. We have always operated at a very minimal burn rate compared to peers. I will not go into more detail at this point regarding Rosen's complaint as it is in litigation, but I assure you that Cellceutix and our counsel consider it extremely frivolous and feel that there is a strong case for dismissal, sanctions and other legal actions against Rosen and the plaintiff for filing this lawsuit."
