Here is the PR :
Cellceutix Structures for Significant Growth in Upcoming Year
Teams Established for Oncology, Dermatology and Antibiotic Clinical Trials
Beverly, MA — 10/21/13 — Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company focused on discovering, developing and commercializing drugs to treat unmet medical conditions, is pleased to announce that it has expanded the infrastructure of the Company to accommodate the planned initiation of five Phase 2 clinical trials in 2014. The Cellceutix pipeline has doubled in size with promising compounds spanning several disease areas following the acquisition of PolyMedix assets in September. The Company has established teams for oncology, dermatology and antibiotics consisting of consultants and employees to facilitate conducting efficient clinical trials of multiple compounds simultaneously. With this approach we intend to save approximately $5 million dollars over the traditional Pharma model of using outside parties to conduct the trials.
The 2014 plans for clinical trials are as follows:
Kevetrin™ (oncology) for solid tumors – Initiate Phase 2
Kevetrin™ (oncology) for Acute Myelogenous Leukemia – Initiate Phase 1b/2
Brilacidin (oncology) for Oral Mucositis – Initiate Phase 2
Prurisol™ (dermatology) for Psoriasis – Initiate Phase 2/3 (Adaptive trial design)
Brilacidin (antibiotic) for Acute Bacterial Skin and Skin Structure Infections – Initiate Phase 2b
There is also the possibility that a Phase 2 trial on renal cancers will be initiated in 2014 and funded with a National Cancer Institute Specialized Programs of Research Excellence “SPORE” Grant .
Cellceutix’s strength has always been in biology expertise and resources. PolyMedix was very strong in chemistry, and extremely skilled at identifying and licensing university compounds. With the addition of the PolyMedix compounds and data, Cellceutix is a perfect fusion of chemistry and biology, a key to the highest chance of clinical success.
Cellceutix understanding of biology is best exemplified by a multi-billion dollar pharmaceutical company with thousands of employees recently coming to Cellceutix for assistance in evaluating a drug program. The pharmaceutical company recognized the skill set of Cellceutix to efficiently and effectively analyze the mechanism of action of a compound.
Currently, the teams are reviewing and finalizing regulatory filings to proceed with clinical studies. Simultaneously, the newly acquired compounds are being studied to identify the best uses and targets for additional clinical trials. Cellceutix’s biologists believe that there could be a ‘treasure chest’ of drugs waiting to be developed for several disease indications that may never have been thought of by PolyMedix.
“Cellceutix has evolved into a formidable biotechnology company with a first-class team that is laser-focused on developing drugs that can benefit from expedited programs by the U.S. Food and Drug Administration such as Fast Track and the GAINS Act, and do so on a tight budget,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “We have already paid for the manufacturing of Prurisol and the acquisition of PolyMedix, and still have approximately $5 million in cash on hand with another $1 million available from the Aspire financing that occurred last December. We are evaluating several financing proposals ranging from $10 million to $20 million that would solidify our financial strength as we move into additional clinical trials.
http://cellceutix.com/cellceutix-structures-f...ming-year/
Also pete - I am understanding it the same way that you are, that each team will be responsible for doing the day to day tactical planning and preparatory work required to commence a trial, but the trial will still be run by others outside of CTIX's actual scope. I am a bit fuzzy myself on exactly where the 5M savings comes in to play, but I'd assume something like that wouldn't be announced unless there was great confidence behind the statement.
Would also love to hear Seel's thoughts on this!
Calling Seel, Seel please report to IH headquarters
Cellceutix Structures for Significant Growth in Upcoming Year
Teams Established for Oncology, Dermatology and Antibiotic Clinical Trials
Beverly, MA — 10/21/13 — Cellceutix Corporation (OTCQB: CTIX) (the “Company”), a clinical stage biopharmaceutical company focused on discovering, developing and commercializing drugs to treat unmet medical conditions, is pleased to announce that it has expanded the infrastructure of the Company to accommodate the planned initiation of five Phase 2 clinical trials in 2014. The Cellceutix pipeline has doubled in size with promising compounds spanning several disease areas following the acquisition of PolyMedix assets in September. The Company has established teams for oncology, dermatology and antibiotics consisting of consultants and employees to facilitate conducting efficient clinical trials of multiple compounds simultaneously. With this approach we intend to save approximately $5 million dollars over the traditional Pharma model of using outside parties to conduct the trials.
The 2014 plans for clinical trials are as follows:
Kevetrin™ (oncology) for solid tumors – Initiate Phase 2
Kevetrin™ (oncology) for Acute Myelogenous Leukemia – Initiate Phase 1b/2
Brilacidin (oncology) for Oral Mucositis – Initiate Phase 2
Prurisol™ (dermatology) for Psoriasis – Initiate Phase 2/3 (Adaptive trial design)
Brilacidin (antibiotic) for Acute Bacterial Skin and Skin Structure Infections – Initiate Phase 2b
There is also the possibility that a Phase 2 trial on renal cancers will be initiated in 2014 and funded with a National Cancer Institute Specialized Programs of Research Excellence “SPORE” Grant .
Cellceutix’s strength has always been in biology expertise and resources. PolyMedix was very strong in chemistry, and extremely skilled at identifying and licensing university compounds. With the addition of the PolyMedix compounds and data, Cellceutix is a perfect fusion of chemistry and biology, a key to the highest chance of clinical success.
Cellceutix understanding of biology is best exemplified by a multi-billion dollar pharmaceutical company with thousands of employees recently coming to Cellceutix for assistance in evaluating a drug program. The pharmaceutical company recognized the skill set of Cellceutix to efficiently and effectively analyze the mechanism of action of a compound.
Currently, the teams are reviewing and finalizing regulatory filings to proceed with clinical studies. Simultaneously, the newly acquired compounds are being studied to identify the best uses and targets for additional clinical trials. Cellceutix’s biologists believe that there could be a ‘treasure chest’ of drugs waiting to be developed for several disease indications that may never have been thought of by PolyMedix.
“Cellceutix has evolved into a formidable biotechnology company with a first-class team that is laser-focused on developing drugs that can benefit from expedited programs by the U.S. Food and Drug Administration such as Fast Track and the GAINS Act, and do so on a tight budget,” commented Leo Ehrlich, Chief Executive Officer at Cellceutix. “We have already paid for the manufacturing of Prurisol and the acquisition of PolyMedix, and still have approximately $5 million in cash on hand with another $1 million available from the Aspire financing that occurred last December. We are evaluating several financing proposals ranging from $10 million to $20 million that would solidify our financial strength as we move into additional clinical trials.
http://cellceutix.com/cellceutix-structures-f...ming-year/
Also pete - I am understanding it the same way that you are, that each team will be responsible for doing the day to day tactical planning and preparatory work required to commence a trial, but the trial will still be run by others outside of CTIX's actual scope. I am a bit fuzzy myself on exactly where the 5M savings comes in to play, but I'd assume something like that wouldn't be announced unless there was great confidence behind the statement.
Would also love to hear Seel's thoughts on this!
Calling Seel, Seel please report to IH headquarters
