KEVETRIN RESULTS for phase 2 as posted on the FDA
Post# of 72440
(Total Views: 467)
Posted On: 05/16/2019 8:26:13 AM
KEVETRIN RESULTS for phase 2 as posted on the FDA site . I remember some mentioning the results weren't posted. I remember some just making crap up and posting it as fact. Nahhh, that never happens.
https://clinicaltrials.gov/ct2/show/results/N...amp;rank=2
So it was Feb - Nov. I remembered it being months, not a year. Only 2 people, but impressive enough to move forward and make it into an oral and draw up a protocol for a full blown phase 2 trial. Take a look at their 10-Q as well. Note the CRO commitments.
To obtain maximum value of the Brilacidin-IBD asset, the Company plans to develop the drug candidate as an oral dose (pill or tablet). The Company has completed early testing evaluating the stability of Brilacidin in simulated gastric fluid—a synthetic form of the fluid found in the stomach. Results showed very minimal degradation of Brilacidin across 4 hours, suggesting a simple formulation of Brilacidin likely would not be subject to rapid breakdown once in the stomach. This finding should enable initial clinical testing with a simple formulation of the drug candidate delivered to the gut while a more elegant, tailored oral dosage form of Brilacidin is developed and refined, in parallel. Planned next steps in the development of Brilacidin for oral delivery include clinical testing of Brilacidin in healthy volunteers to assess safety and toleration, the pharmacokinetic profile and effects on the gut’s microbiome.
The Company has completed a Phase 2a trial of Kevetrin in treating late-stage Ovarian Cancer. The main objective of the trial focused on confirming the modulation by Kevetrin of p53 pathways in tumors, as well as monitoring the response of tumors to the treatment. The study was successful in demonstrating modulation of p53 directly in ovarian cancer tumor tissue in patients. We are currently focused on development of an oral formulation of Kevetrin for treating cancer. Pharmacokinetic data collected on Kevetrin during the initial Phase 1 clinical trial demonstrates that the compound has a short half-life of approximately two hours. Kevetrin’s short half-life makes it a compelling candidate for an oral drug delivery treatment for the main purpose of allowing simple daily, or multiple-times daily, administrations within or outside the hospital setting. Compared to injectable or intravenous treatments, oral therapy is the preferred drug delivery method of patients. Preliminary laboratory studies are encouraging and support the potential of developing an oral formulation, but there are no assurances made or implied that the Company will be successful in completing development of an oral formulation. Toxicology studies for the oral formulation of Kevetrin are approximately half completed, with the remainder of this work now prioritized as the Company secures additional financial resources. Next steps in the development of Kevetrin include: completing toxicology work for an oral formulation; developing the oral formulation (pill or tablet); requesting an FDA meeting to discuss trial results to date and the design of future trials; and performing a dosing safety study in healthy volunteers once the oral formulation has been developed. Once completed, these steps would likely lead directly to Phase 2 testing of oral Kevetrin in both solid tumors and leukemias, with ovarian cancer likely continuing to be the lead indication.
Innovation is evaluating Brilacidin, under Fast Track designation, in a Phase 2 clinical trial as an oral rinse to attenuate Oral Mucositis in patients with Head and Neck Cancer who have received chemoradiation. Topline study results indicate Brilacidin has a high potential for preventative treatment, as evidenced by a clear reduction of Severe OM (SOM) among patients on Brilacidin as compared to those on placebo. Additional secondary endpoint analysis, showing Brilacidin delayed the onset as well as reduced the duration of SOM, supports the drug candidate's therapeutic effect. The Company and the U.S. Food and Drug Administration (FDA) have completed an End-of-Phase 2 meeting. Both parties agreed to an acceptable Brilacidin Phase 3 development pathway.
https://www.ipharminc.com/brilacidin-1
Open link to see hyper links.
Innovation Pharmaceuticals Reports Positive Topline Results from Phase 2 Placebo-Controlled Trial of Brilacidin for the Prevention of Oral Mucositis in Head and Neck Cancer Patients
http://www.ipharminc.com/press-release/2017/1...r-patients
Innovation Pharmaceuticals Concludes Data Analysis of its Phase 2 Clinical Trial for Severe Oral Mucositis in Head and Neck Cancer; Positioning to Fill a Substantial Void in Supportive Cancer Care
http://www.ipharminc.com/press-release/2018/5...ancer-care
Launching the subsidiary will almost certainly come with a licensing deal.
The recent offering, when complete, or maybe interrupted by the licensing deal (since we haven't seen it close yet it is on the list of possibilities) will give IPIX what it needs to get things done until the deal goes through. Or at least I believe that's the plan.
LOOKING FORWARD TO SEEING $IPIX BACK OVER THE $$$
$IPIX
Wanted to share this here as well.
https://clinicaltrials.gov/ct2/show/results/N...amp;rank=2
So it was Feb - Nov. I remembered it being months, not a year. Only 2 people, but impressive enough to move forward and make it into an oral and draw up a protocol for a full blown phase 2 trial. Take a look at their 10-Q as well. Note the CRO commitments.
To obtain maximum value of the Brilacidin-IBD asset, the Company plans to develop the drug candidate as an oral dose (pill or tablet). The Company has completed early testing evaluating the stability of Brilacidin in simulated gastric fluid—a synthetic form of the fluid found in the stomach. Results showed very minimal degradation of Brilacidin across 4 hours, suggesting a simple formulation of Brilacidin likely would not be subject to rapid breakdown once in the stomach. This finding should enable initial clinical testing with a simple formulation of the drug candidate delivered to the gut while a more elegant, tailored oral dosage form of Brilacidin is developed and refined, in parallel. Planned next steps in the development of Brilacidin for oral delivery include clinical testing of Brilacidin in healthy volunteers to assess safety and toleration, the pharmacokinetic profile and effects on the gut’s microbiome.
The Company has completed a Phase 2a trial of Kevetrin in treating late-stage Ovarian Cancer. The main objective of the trial focused on confirming the modulation by Kevetrin of p53 pathways in tumors, as well as monitoring the response of tumors to the treatment. The study was successful in demonstrating modulation of p53 directly in ovarian cancer tumor tissue in patients. We are currently focused on development of an oral formulation of Kevetrin for treating cancer. Pharmacokinetic data collected on Kevetrin during the initial Phase 1 clinical trial demonstrates that the compound has a short half-life of approximately two hours. Kevetrin’s short half-life makes it a compelling candidate for an oral drug delivery treatment for the main purpose of allowing simple daily, or multiple-times daily, administrations within or outside the hospital setting. Compared to injectable or intravenous treatments, oral therapy is the preferred drug delivery method of patients. Preliminary laboratory studies are encouraging and support the potential of developing an oral formulation, but there are no assurances made or implied that the Company will be successful in completing development of an oral formulation. Toxicology studies for the oral formulation of Kevetrin are approximately half completed, with the remainder of this work now prioritized as the Company secures additional financial resources. Next steps in the development of Kevetrin include: completing toxicology work for an oral formulation; developing the oral formulation (pill or tablet); requesting an FDA meeting to discuss trial results to date and the design of future trials; and performing a dosing safety study in healthy volunteers once the oral formulation has been developed. Once completed, these steps would likely lead directly to Phase 2 testing of oral Kevetrin in both solid tumors and leukemias, with ovarian cancer likely continuing to be the lead indication.
Innovation is evaluating Brilacidin, under Fast Track designation, in a Phase 2 clinical trial as an oral rinse to attenuate Oral Mucositis in patients with Head and Neck Cancer who have received chemoradiation. Topline study results indicate Brilacidin has a high potential for preventative treatment, as evidenced by a clear reduction of Severe OM (SOM) among patients on Brilacidin as compared to those on placebo. Additional secondary endpoint analysis, showing Brilacidin delayed the onset as well as reduced the duration of SOM, supports the drug candidate's therapeutic effect. The Company and the U.S. Food and Drug Administration (FDA) have completed an End-of-Phase 2 meeting. Both parties agreed to an acceptable Brilacidin Phase 3 development pathway.
https://www.ipharminc.com/brilacidin-1
Open link to see hyper links.
Innovation Pharmaceuticals Reports Positive Topline Results from Phase 2 Placebo-Controlled Trial of Brilacidin for the Prevention of Oral Mucositis in Head and Neck Cancer Patients
http://www.ipharminc.com/press-release/2017/1...r-patients
Innovation Pharmaceuticals Concludes Data Analysis of its Phase 2 Clinical Trial for Severe Oral Mucositis in Head and Neck Cancer; Positioning to Fill a Substantial Void in Supportive Cancer Care
http://www.ipharminc.com/press-release/2018/5...ancer-care
Launching the subsidiary will almost certainly come with a licensing deal.
The recent offering, when complete, or maybe interrupted by the licensing deal (since we haven't seen it close yet it is on the list of possibilities) will give IPIX what it needs to get things done until the deal goes through. Or at least I believe that's the plan.
LOOKING FORWARD TO SEEING $IPIX BACK OVER THE $$$
$IPIX
Wanted to share this here as well.
(3)
(0)Innovation Pharmaceuticals Inc (IPIX) Stock Research Links
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