Transcripción de la conferencia de ayer de CTIX, hablando sobre Kevetrin y Prurisol, y sobre la reciente adquisición de la quebrada Polymedix, con algunos compuestos en Fase II...
http://www.earningsimpact.com/Transcript/83510/CTIX/Cellceutix-Corp---15th-Annual-Rodman-and-Renshaw-Global-Investment-Conference/Page/2#sthash.jmuo3vLx.dpbs
Algunos extractos:
PolyMedix was a clinical stage biotechnology company with a full pipeline of drug candidates for infectious diseases, cancer supportive care and antimicrobial applications. The company had two drugs in human clinical trials with it's flagship being a first-in-class small molecule antibiotic named Brilacidin for acute bacterial skin and skin structure infections or ABSSSI.
A 200 patient Phase 2 trial of Brilacidin showed the drug to be as efficacious, safe and generally well tolerated in patients.
Brilacidin hit it's primary endpoints with high and low doses outperforming Cubist Pharmaceuticals' Cubicin in the control arm of the study. We have been thoroughly evaluating the PolyMedix assets including their robust pipeline and substantial equipment assets and shortly after the company went into bankruptcy in April. - See more at: http://www.earningsimpact.com/Transcript/83510/CTIX/Cellceutix-Corp---15th-Annual-Rodman-and-Renshaw-Global-Investment-Conference/Page/2#sthash.jmuo3vLx.dpuf
It is notable that Pfizer's Zyvox which is approved for treatment of bacterial infections generated $1.35 billion of sales in 2012. It is our current contention that Brilacidin could potentially be a better drug and we are eager to move forward into a Phase 2b trial. - See more at: http://www.earningsimpact.com/Transcript/83510/CTIX/Cellceutix-Corp---15th-Annual-Rodman-and-Renshaw-Global-Investment-Conference/Page/3#sthash.Gyu52Xgj.dpuf
he trials are evaluating Kevetrin under the most challenging of situations treating late stage advance solid tumor cancer patients that have exhausted other treatment options without success.
In our dose escalation study patients are being administered Kevetrin once per week for three weeks followed by one week free of treatment. Repeat doses are administered at the discretion of the principal investigator. The primary end point in any early trial of safety but we're also determining the maximum tolerated dose Kevetrin's effect on tumor size, serum tumor markers and p21 expression on lymphocytes as a biomarker.
To-date four cohorts have completed treatment with encouraging results including one patient completing seven cycles. We are encouraged by what has been seen so far regarding tolerability serum tumor markers and disease progression. No dose limiting toxicity has been demonstrated to-date.
While we are still at low dosing levels, the researchers have observed stabilization of tumors by restaging in multiple types of cancer in six patients although disease progression occurred following stabilization. Again it's important to remember that we are dealing with critically yield drug-resistant cancer patients whose prognosis is generally measured in months. We interpret signs of stabilization at low doses that is helpful for future cohorts as dosing levels increase. - See more at: http://www.earningsimpact.com/Transcript/83510/CTIX/Cellceutix-Corp---15th-Annual-Rodman-and-Renshaw-Global-Investment-Conference/Page/4#sthash.dTikPZoG.dpuf
Beth Israel Deaconess has informed us of their intention to conduct a SPORE grant funded Phase 2 trial to research Kevetrin in conjunction with the Pfizer multikinase inhibitor as a potential new therapy for renal cell carcinoma the most common form of adult kidney cancer. A pre-clinical research study at Beth Israel combine Kevetrin with sunitinib on a drug-resistant cancer cell line and showed very promising results. - See more at: http://www.earningsimpact.com/Transcript/83510/CTIX/Cellceutix-Corp---15th-Annual-Rodman-and-Renshaw-Global-Investment-Conference/Page/6#sthash.5vWENqj8.dpuf
We are also actively developing Prurisol, an oral anti-psoriasis drug under guidance from the Food and Drug Administration that a 505(b)(2) approach is acceptable as the active moiety of Prurisol as an approved drug allowing us to skip right to mid-stage trials. Prurisol was planned to enter the clinic in a matter of weeks with the commencement of Phase II Proof of Concept trial in Europe. - See more at: http://www.earningsimpact.com/Transcript/83510/CTIX/Cellceutix-Corp---15th-Annual-Rodman-and-Renshaw-Global-Investment-Conference/Page/6#sthash.5vWENqj8.dpuf
We have recently spoken about our intention to off-list to a senior exchange. We are presently interviewing for our independent directors. Depending on which exchange we intent to apply the share price can be an issue but we feel that the PolyMedix acquisition has now added immense value to our company and shareholders.
We are not considering a reserve split to meet share price requirements.
- See more at: http://www.earningsimpact.com/Transcript/83510/CTIX/Cellceutix-Corp---15th-Annual-Rodman-and-Renshaw-Global-Investment-Conference/Page/8#sthash.pHUcqLfu.dpuf
