20170303|CTIX|60624|0|161003|O 37.65% regsho.fi
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Posted On: 03/03/2017 5:40:55 PM
20170303|CTIX| 60624 |0| 161003 |O 37.65%
regsho.finra.org/FORFshvol20170303.txt
imo a report of + 30% reveals NON RETAILs' stress
data below does not include pre mkt or after hour's t trades
http://otcshortreport.com/?index=CTIX&action=view
last @
CELLCEUTIX CORPORATION
0.968Down -0.012 (-1.22 %)AS OF 3:59:29PM ET 03/03/2017
Last Trade 0.968
Trade Time 3:59:29pm ET
Change -0.012
% Change -1.22%
Open 0.98
Day High 0.9897
Day Low 0.94
Previous Close
03/03/2017 0.968
52-Week High
03/29/2016 1.92
52-Week Low
02/27/2017 0.86
Price Performance (Last 52 Weeks)
03/02/2017 -20.97%
Volume 161,003
Volume (10 day Average) 351,382
Volume (90 day Average) 236,360
CTIX Update today @ 3:50PM
Cellceutix Provides Update on Developing p53 Drug Candidate Kevetrin as an Oral Anti-Cancer Agent
BEVERLY, Mass., March 03, 2017 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (OTCQB:CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, is pleased to update shareholders on continuing efforts to develop the oral dosing of Kevetrin.
Based on positive results from Cellceutix’s Phase 1 trial of Kevetrin in solid tumors conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, the Company is moving forward with a Phase 2 trial of intravenously-administered Kevetrin in patients with late-stage, platinum-resistant ovarian cancer. Cellceutix has decided to pursue an oral formulation for Kevetrin to improve patient convenience and potentially increase therapeutic efficacy given the drug’s short half-life and other pharmacokinetics, as discussed below.
As background, pre-clinical work determined the bioavailability of Kevetrin was 79 percent when given orally in Sprague-Dawley rats. To further establish the efficacy of oral Kevetrin, in vivo mouse studies were carried out in an ascites ovarian tumor model using OVCAR-3 and OV-90 tumor models, both of which possess different mutant p53 genes. Importantly, these pre-clinical results showed that the overall efficacy of Kevetrin was similar across both oral and intraperitoneal routes of drug administration.
Cellceutix has initiated a series of GLP (Good Laboratory Practice) studies to assess the safety of Kevetrin given orally. Considering that Kevetrin is a non-cytotoxic drug, our intent, with FDA permission, is to next proceed with a Phase 1 clinical trial in healthy volunteers using the oral route. These studies are being conducted by approved vendors and include: photosafety testing, pharmacokinetics, in vivo metabolism, metabolic stability, protein binding, and genetic and physiological toxicology reports.
Preliminary data analyses in a pharmacokinetic study in rats revealed a half-life of approximately 1 hour and a clearance of 78ml/min/kg for both oral and intravenous (IV) dosing. Results of an initial photosafety study demonstrated a molar extinction coefficient value of less than 5 L/mol*cm over a range of wavelengths above 290 nm, well below the 1000 L/mol*cm limit stated in ICH guidelines—indicating Kevetrin has no phototoxicity. A preliminary toxicity study showed that at doses up to 500 mg/kg given orally daily for 7 days, Kevetrin was well-tolerated by the rats as indicated by an 11 percent increase in body weight and no abnormal clinical observations. Further, this dose was greater than the doses used in the preclinical efficacy study. Remaining safety studies will be completed in the second half of this year.
In related news: Last week, Cellceutix research partners in Italy shared results with the Company from their ongoing preclinical work evaluating Kevetrin in Acute Myeloid Leukemia (AML), Pancreatic Cancer and human Gliobastoma Multiforme (hGBM). The data will be presented (by them) at scientific conferences, and is consistent with, and further informs, our knowledge of Kevetrin. Also, efficacy data from the 2nd cohort in the Brilacidin-Ulcerative Colitis proof-of-concept study is in the last stage of being compiled by the CRO and, following a final review, will be released.
Alerts
Sign-up for Cellceutix email alerts at:
http://www.cellceutix.com/email-alerts
About Kevetrin
Kevetrin is a small molecule that has demonstrated the potential of becoming a breakthrough cancer treatment by inducing activation of p53, a protein frequently referred to as the “Guardian of the Genome” due to its critical role in controlling cell mutations. In the majority of cancers, and regardless of origin, type, and location, the p53 pathway is mutated, preventing the body from performing its natural anti-tumor functions. Conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, a Phase 1 clinical trial evaluating Kevetrin in treating advanced solid tumors has been successfully completed, with patients showing good toleration and encouraging signs of potential therapeutic response. Cellceutix has initiated a Phase 2a trial of Kevetrin in platinum-resistant/refractory ovarian cancer. Patients will receive more frequent dosing (3 times per week) at higher levels and then receive standard of care treatment. Efforts also are underway to develop Kevetrin as an oral anti-cancer agent that can be administered daily, potentially even multiple times per day. The FDA has awarded Kevetrin Orphan Drug status for ovarian cancer, pancreatic cancer, and retinoblastoma, qualifying it for developmental incentives and a potential extra 7 years of market exclusivity upon drug approval. The FDA also has granted Kevetrin Rare Pediatric Disease designation for childhood retinoblastoma.
Learn more here:
http://www.cellceutix.com/kevetrin-1/
About Ovarian Cancer
Ovarian cancer is a common type of cancer that commonly begins in women’s ovaries. Malignant ovarian tumor cells metastasize either directly through the organs of the pelvis region, or through the bloodstream, or the lymphatic system. The causes of ovarian cancer are still not known, though women over the age of 63 represent more than 50 percent of newly diagnosed cases, with the cancer more frequently found in white women than other ethnicities. Ovarian cancer ranks fifth in cancer deaths among women worldwide. It is estimated that in 2016, in the United States, over 22,000 women will be diagnosed with ovarian cancer, with approximately 14,000 women dying from the disease. A $1.6 billion market, current treatment is often limited to surgery and chemotherapy and there is no cure.
More information can be found at:
https://seer.cancer.gov/statfacts/html/ovary.html
About Cellceutix Phase 2a Ovarian Cancer Trial Design
CTIX-KEV-201 is an open-label, Phase 2a study evaluating the safety, tolerability, and pharmacokinetics of Kevetrin as well as changes in select biomarkers and objective tumor response when administered to patients with platinum-resistant/refractory ovarian cancer. The clinical trial comprises two different short-term treatment regimens and will enroll an estimated 10 patients. Primary outcome measures include the incidence of Treatment-Emergent Adverse Events (TEAEs) and changes in pre-specified biomarkers (via tumor biopsy, examination of ascites fluid and peripheral blood), pre-treatment and post-treatment, at 3 weeks. Secondary outcome measures include objective tumor response, per Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) and plasma concentrations of Kevetrin.
For more information on the CTIX-KEV-201 Phase 2a study, please visit:
https://clinicaltrials.gov/ct2/show/NCT03042702
===
a good weekend all
4kids
regsho.finra.org/FORFshvol20170303.txt
imo a report of + 30% reveals NON RETAILs' stress
data below does not include pre mkt or after hour's t trades
Mar 03 NA NA NA 161,003 60,624 37.65%
Mar 02 0.98 1.00 0.96 177,516 70,655 39.80%
Mar 01 0.98 1.00 0.94 149,277 26,717 17.90%
Feb 28 1.00 1.03 0.97 216,272 99,287 45.91%
Feb 27 0.98 0.98 0.86 217,040 81,321 37.47%
Feb 24 0.91 0.96 0.89 553,686 166,571 30.08%
Feb 23 0.95 0.98 0.92 324,468 123,341 38.01%
Feb 22 0.97 1.05 0.90 524,361 135,023 25.75%
Feb 21 0.93 0.98 0.92 378,321 122,588 32.40%
Feb 17 0.97 1.00 0.93 427,165 120,971 28.32%
Feb 16 0.98 1.00 0.95 523,711 181,044 34.57%
Feb 15 1.00 1.01 0.96 245,204 84,376 34.41%
Feb 14 1.00 1.06 0.97 325,012 81,098 24.95%
Feb 13 1.06 1.11 1.01 108,059 23,255 21.52%
Feb 10 1.08 1.14 1.07 123,250 44,549 36.15%
Feb 09 1.09 1.09 1.03 89,667 23,149 25.82%
Feb 08 1.07 1.13 1.02 224,765 42,156 18.76%
Feb 07 1.13 1.15 1.11 101,159 18,513 18.30%
Feb 06 1.15 1.16 1.10 163,290 68,667 42.05%
Feb 03 1.11 1.12 1.04 256,342 109,235 42.61%
Feb 02 1.05 1.05 1.00 212,053 37,611 17.74%
Feb 01 1.03 1.03 0.97 209,923 96,738 46.08%
http://otcshortreport.com/?index=CTIX&action=view
last @
CELLCEUTIX CORPORATION
0.968Down -0.012 (-1.22 %)AS OF 3:59:29PM ET 03/03/2017
Last Trade 0.968
Trade Time 3:59:29pm ET
Change -0.012
% Change -1.22%
Open 0.98
Day High 0.9897
Day Low 0.94
Previous Close
03/03/2017 0.968
52-Week High
03/29/2016 1.92
52-Week Low
02/27/2017 0.86
Price Performance (Last 52 Weeks)
03/02/2017 -20.97%
Volume 161,003
Volume (10 day Average) 351,382
Volume (90 day Average) 236,360
CTIX Update today @ 3:50PM
Cellceutix Provides Update on Developing p53 Drug Candidate Kevetrin as an Oral Anti-Cancer Agent
BEVERLY, Mass., March 03, 2017 (GLOBE NEWSWIRE) -- Cellceutix Corporation, (OTCQB:CTIX) (“the Company”), a clinical stage biopharmaceutical company developing innovative therapies with dermatology, oncology, anti-inflammatory, and antibiotic applications, is pleased to update shareholders on continuing efforts to develop the oral dosing of Kevetrin.
Based on positive results from Cellceutix’s Phase 1 trial of Kevetrin in solid tumors conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, the Company is moving forward with a Phase 2 trial of intravenously-administered Kevetrin in patients with late-stage, platinum-resistant ovarian cancer. Cellceutix has decided to pursue an oral formulation for Kevetrin to improve patient convenience and potentially increase therapeutic efficacy given the drug’s short half-life and other pharmacokinetics, as discussed below.
As background, pre-clinical work determined the bioavailability of Kevetrin was 79 percent when given orally in Sprague-Dawley rats. To further establish the efficacy of oral Kevetrin, in vivo mouse studies were carried out in an ascites ovarian tumor model using OVCAR-3 and OV-90 tumor models, both of which possess different mutant p53 genes. Importantly, these pre-clinical results showed that the overall efficacy of Kevetrin was similar across both oral and intraperitoneal routes of drug administration.
Cellceutix has initiated a series of GLP (Good Laboratory Practice) studies to assess the safety of Kevetrin given orally. Considering that Kevetrin is a non-cytotoxic drug, our intent, with FDA permission, is to next proceed with a Phase 1 clinical trial in healthy volunteers using the oral route. These studies are being conducted by approved vendors and include: photosafety testing, pharmacokinetics, in vivo metabolism, metabolic stability, protein binding, and genetic and physiological toxicology reports.
Preliminary data analyses in a pharmacokinetic study in rats revealed a half-life of approximately 1 hour and a clearance of 78ml/min/kg for both oral and intravenous (IV) dosing. Results of an initial photosafety study demonstrated a molar extinction coefficient value of less than 5 L/mol*cm over a range of wavelengths above 290 nm, well below the 1000 L/mol*cm limit stated in ICH guidelines—indicating Kevetrin has no phototoxicity. A preliminary toxicity study showed that at doses up to 500 mg/kg given orally daily for 7 days, Kevetrin was well-tolerated by the rats as indicated by an 11 percent increase in body weight and no abnormal clinical observations. Further, this dose was greater than the doses used in the preclinical efficacy study. Remaining safety studies will be completed in the second half of this year.
In related news: Last week, Cellceutix research partners in Italy shared results with the Company from their ongoing preclinical work evaluating Kevetrin in Acute Myeloid Leukemia (AML), Pancreatic Cancer and human Gliobastoma Multiforme (hGBM). The data will be presented (by them) at scientific conferences, and is consistent with, and further informs, our knowledge of Kevetrin. Also, efficacy data from the 2nd cohort in the Brilacidin-Ulcerative Colitis proof-of-concept study is in the last stage of being compiled by the CRO and, following a final review, will be released.
Alerts
Sign-up for Cellceutix email alerts at:
http://www.cellceutix.com/email-alerts
About Kevetrin
Kevetrin is a small molecule that has demonstrated the potential of becoming a breakthrough cancer treatment by inducing activation of p53, a protein frequently referred to as the “Guardian of the Genome” due to its critical role in controlling cell mutations. In the majority of cancers, and regardless of origin, type, and location, the p53 pathway is mutated, preventing the body from performing its natural anti-tumor functions. Conducted at Dana-Farber Cancer Institute and Beth Israel Deaconess Medical Center, a Phase 1 clinical trial evaluating Kevetrin in treating advanced solid tumors has been successfully completed, with patients showing good toleration and encouraging signs of potential therapeutic response. Cellceutix has initiated a Phase 2a trial of Kevetrin in platinum-resistant/refractory ovarian cancer. Patients will receive more frequent dosing (3 times per week) at higher levels and then receive standard of care treatment. Efforts also are underway to develop Kevetrin as an oral anti-cancer agent that can be administered daily, potentially even multiple times per day. The FDA has awarded Kevetrin Orphan Drug status for ovarian cancer, pancreatic cancer, and retinoblastoma, qualifying it for developmental incentives and a potential extra 7 years of market exclusivity upon drug approval. The FDA also has granted Kevetrin Rare Pediatric Disease designation for childhood retinoblastoma.
Learn more here:
http://www.cellceutix.com/kevetrin-1/
About Ovarian Cancer
Ovarian cancer is a common type of cancer that commonly begins in women’s ovaries. Malignant ovarian tumor cells metastasize either directly through the organs of the pelvis region, or through the bloodstream, or the lymphatic system. The causes of ovarian cancer are still not known, though women over the age of 63 represent more than 50 percent of newly diagnosed cases, with the cancer more frequently found in white women than other ethnicities. Ovarian cancer ranks fifth in cancer deaths among women worldwide. It is estimated that in 2016, in the United States, over 22,000 women will be diagnosed with ovarian cancer, with approximately 14,000 women dying from the disease. A $1.6 billion market, current treatment is often limited to surgery and chemotherapy and there is no cure.
More information can be found at:
https://seer.cancer.gov/statfacts/html/ovary.html
About Cellceutix Phase 2a Ovarian Cancer Trial Design
CTIX-KEV-201 is an open-label, Phase 2a study evaluating the safety, tolerability, and pharmacokinetics of Kevetrin as well as changes in select biomarkers and objective tumor response when administered to patients with platinum-resistant/refractory ovarian cancer. The clinical trial comprises two different short-term treatment regimens and will enroll an estimated 10 patients. Primary outcome measures include the incidence of Treatment-Emergent Adverse Events (TEAEs) and changes in pre-specified biomarkers (via tumor biopsy, examination of ascites fluid and peripheral blood), pre-treatment and post-treatment, at 3 weeks. Secondary outcome measures include objective tumor response, per Response Evaluation Criteria in Solid Tumors (RECIST) (version 1.1) and plasma concentrations of Kevetrin.
For more information on the CTIX-KEV-201 Phase 2a study, please visit:
https://clinicaltrials.gov/ct2/show/NCT03042702
===
a good weekend all
4kids
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