My Fellow CTIX Shareholders,
We are very pleased to inform you today of two new developments with Brilacidin. The first is the acceptance of an oral poster at the Joint 55th Interscience Conference on Antimicrobial Agents & Chemotherapy. The second is the extension of a Material Transfer Agreement with a division of a leading pharmaceutical company for additional testing of Brilacidin for preventing infection in implants. We first disclosed this agreement last November and we are very encouraged by the company’s desire to continue evaluating Brilacidin in this application.
We would also like to address in this alert the concern of some shareholders regarding the recent press releases by legal firms. To our knowledge, these headlines all pertain to the lawsuit filed by Rosen Law Firm. We are not aware of any additional lawsuits and view these releases as simply attorneys fishing for work. As we’ve stated, we consider the Rosen suit frivolous and we are taking the appropriate actions to defend our company against Rosen’s ridiculous allegations.
The press release issued this morning is as follows:
Cellceutix Announces Brilacidin Data to be Presented by ICPD at The Joint 55th Interscience Conference on Antimicrobial Agents & Chemotherapy (ICAAC)
Material Transfer Agreement Being Extended for Additional Research of Brilacidin to Prevent Infection in Implants
BEVERLY, MA–(Marketwired – Sept 16, 2015) – Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology and antimicrobial applications, is pleased to report that results of its recently completed pharmacokinetic/pharmacodynamic (PK/PD) model entitled “Population Pharmacokinetics (PPK)” of Brilacidin (BRI) in Healthy Subjects and Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) will be presented as a “poster walk” at the Joint 55th Interscience Conference on Antimicrobial Agents & Chemotherapy and 28th International Congress of Chemotherapy from 12:00 to 2:00 pm PDT on September 18 in San Diego, CA. The oral presentation will be given by the lead author of the poster, Dr. Scott Van Wart, of the Institute for Clinical Pharmacodynamics (ICPD). The poster will be available on the Cellceutix website beginning 12:00 pm PDT Friday, September 18, 2015.
Using data from three Phase 1 and two Phase 2 studies in acute bacterial skin and skin-structure infection (ABSSSI) patients, a population pharmacokinetic (PPK) model for BRI was developed to describe the time-course of BRI in plasma and to identify significant predictors of BRI PK. “We are pleased that this important information has been accepted for an oral poster presentation”, said Dr. Daniel Jorgensen, Chief Medical Officer at Cellceutix. "This way, the audience has an opportunity to participate in an interactive question and answer discussion. More importantly, the audience will learn about state-of-the art modeling techniques that have informed the selection of Brilacidin doses in past Phase 2 studies and future Phase 3 studies.”
Dr. Jorgensen added, “There is an urgent need for new classes of antibiotics that are effective in this era of increasing drug resistance. We believe our defensin-mimetics, including Brilacidin, can address this need. The laboratory and clinical data presented at previous academic meetings, along with the newer PK/PD data to be presented at ICAAC, support the continued development of this promising class of compounds. We look forward to sharing these data at the ICAAC meeting.”
Separately, Cellceutix is pleased to provide and update on the Material Transfer Agreement (MTA) disclosed in November 2014 with a division of one of the largest U.S. pharmaceutical companies (the “Pharma”) for testing Brilacidin as a component of certain implanted devices as a means to prevent infection. Cellceutix has been advised that initial testing is encouraging. The Pharma has requested an extension to the MTA with an additional order to conduct further analysis of Brilacidin for this prophylactic application. The MTA 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 feel the MTA extension and add-on order for additional research by such an esteemed organization is further validation of the potential of Brilacidin. These types of collaborations are important in expanding our defensin-mimetic drug discovery program in new verticals and we look forward to results from their testing in the future,” concluded Dr. Jorgensen.
Alerts:
Sign-up for Cellceutix email alerts is available at http://cellceutix.com/email-alerts/#sthash.CRfqSmmY.dpbs
Cellceutix clinical trials on Clinicaltrials.gov:
https://clinicaltrials.gov/ct2/results?term=c...rch=Search
We are very pleased to inform you today of two new developments with Brilacidin. The first is the acceptance of an oral poster at the Joint 55th Interscience Conference on Antimicrobial Agents & Chemotherapy. The second is the extension of a Material Transfer Agreement with a division of a leading pharmaceutical company for additional testing of Brilacidin for preventing infection in implants. We first disclosed this agreement last November and we are very encouraged by the company’s desire to continue evaluating Brilacidin in this application.
We would also like to address in this alert the concern of some shareholders regarding the recent press releases by legal firms. To our knowledge, these headlines all pertain to the lawsuit filed by Rosen Law Firm. We are not aware of any additional lawsuits and view these releases as simply attorneys fishing for work. As we’ve stated, we consider the Rosen suit frivolous and we are taking the appropriate actions to defend our company against Rosen’s ridiculous allegations.
The press release issued this morning is as follows:
Cellceutix Announces Brilacidin Data to be Presented by ICPD at The Joint 55th Interscience Conference on Antimicrobial Agents & Chemotherapy (ICAAC)
Material Transfer Agreement Being Extended for Additional Research of Brilacidin to Prevent Infection in Implants
BEVERLY, MA–(Marketwired – Sept 16, 2015) – Cellceutix Corporation (OTC: CTIX) (the “Company”), a clinical stage biopharmaceutical company developing innovative therapies with oncology, dermatology and antimicrobial applications, is pleased to report that results of its recently completed pharmacokinetic/pharmacodynamic (PK/PD) model entitled “Population Pharmacokinetics (PPK)” of Brilacidin (BRI) in Healthy Subjects and Patients with Acute Bacterial Skin and Skin Structure Infections (ABSSSI) will be presented as a “poster walk” at the Joint 55th Interscience Conference on Antimicrobial Agents & Chemotherapy and 28th International Congress of Chemotherapy from 12:00 to 2:00 pm PDT on September 18 in San Diego, CA. The oral presentation will be given by the lead author of the poster, Dr. Scott Van Wart, of the Institute for Clinical Pharmacodynamics (ICPD). The poster will be available on the Cellceutix website beginning 12:00 pm PDT Friday, September 18, 2015.
Using data from three Phase 1 and two Phase 2 studies in acute bacterial skin and skin-structure infection (ABSSSI) patients, a population pharmacokinetic (PPK) model for BRI was developed to describe the time-course of BRI in plasma and to identify significant predictors of BRI PK. “We are pleased that this important information has been accepted for an oral poster presentation”, said Dr. Daniel Jorgensen, Chief Medical Officer at Cellceutix. "This way, the audience has an opportunity to participate in an interactive question and answer discussion. More importantly, the audience will learn about state-of-the art modeling techniques that have informed the selection of Brilacidin doses in past Phase 2 studies and future Phase 3 studies.”
Dr. Jorgensen added, “There is an urgent need for new classes of antibiotics that are effective in this era of increasing drug resistance. We believe our defensin-mimetics, including Brilacidin, can address this need. The laboratory and clinical data presented at previous academic meetings, along with the newer PK/PD data to be presented at ICAAC, support the continued development of this promising class of compounds. We look forward to sharing these data at the ICAAC meeting.”
Separately, Cellceutix is pleased to provide and update on the Material Transfer Agreement (MTA) disclosed in November 2014 with a division of one of the largest U.S. pharmaceutical companies (the “Pharma”) for testing Brilacidin as a component of certain implanted devices as a means to prevent infection. Cellceutix has been advised that initial testing is encouraging. The Pharma has requested an extension to the MTA with an additional order to conduct further analysis of Brilacidin for this prophylactic application. The MTA 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 feel the MTA extension and add-on order for additional research by such an esteemed organization is further validation of the potential of Brilacidin. These types of collaborations are important in expanding our defensin-mimetic drug discovery program in new verticals and we look forward to results from their testing in the future,” concluded Dr. Jorgensen.
Alerts:
Sign-up for Cellceutix email alerts is available at http://cellceutix.com/email-alerts/#sthash.CRfqSmmY.dpbs
Cellceutix clinical trials on Clinicaltrials.gov:
https://clinicaltrials.gov/ct2/results?term=c...rch=Search
