IMPORTANT Info on Kevetrin-OC trial per 10Q (curre
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Posted On: 02/07/2018 6:12:01 PM
IMPORTANT Info on Kevetrin-OC trial per 10Q (current trial discontinued until oral Kevetrin available which could be administered more often and in greater dosage):
Kevetrin
The Company has commenced a Phase 2a trial of Kevetrin in treating latestage
ovarian cancer. The main objective of the trial focuses on confirming the
modulation by Kevetrin of p53 pathways in tumors, as well as monitoring the response of tumors to the treatment. Highly encouraging preliminary positive data
from the first patients treated showed direct evidence of molecular pathways modulation in tumors. Modulation of the p53 protein was observed in response to
administration of Kevetrin; pathways analyses also pointed to concomitant cell cycle modulation at the level of gene expression. The Company believes that
further pathways detail and clinical tumor responses would best be observable with more frequent and potentially higher drug exposure. Thus, the Company
has decided to discontinue further enrollment into the current clinical trial and consider a similar trial when ongoing efforts result in the 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 halflife
of approximately two hours. Kevetrin’s short halflife
makes it a compelling candidate for an oral drug delivery treatment for the main
purpose of allowing simple daily, or multipletimes
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 began January 2017.
Kevetrin
The Company has commenced a Phase 2a trial of Kevetrin in treating latestage
ovarian cancer. The main objective of the trial focuses on confirming the
modulation by Kevetrin of p53 pathways in tumors, as well as monitoring the response of tumors to the treatment. Highly encouraging preliminary positive data
from the first patients treated showed direct evidence of molecular pathways modulation in tumors. Modulation of the p53 protein was observed in response to
administration of Kevetrin; pathways analyses also pointed to concomitant cell cycle modulation at the level of gene expression. The Company believes that
further pathways detail and clinical tumor responses would best be observable with more frequent and potentially higher drug exposure. Thus, the Company
has decided to discontinue further enrollment into the current clinical trial and consider a similar trial when ongoing efforts result in the 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 halflife
of approximately two hours. Kevetrin’s short halflife
makes it a compelling candidate for an oral drug delivery treatment for the main
purpose of allowing simple daily, or multipletimes
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 began January 2017.
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