HOUSTON, TX, USA and VANCOUVER, Canada I May 4, 2015 I ESSA Pharma Inc. (“ESSA” or the “Company”) (TSX-V: EPI) announced today that it has received notification from the Food and Drug Administration (“FDA” or the “Agency”) in the US that the Company’s IND application, filed March 31, 2015, has been placed on clinical hold pending receipt by the FDA of additional chemistry and pharmaceutical data related to the stability of the drug substance and drug product and a Certificate of Analysis on drug product.
The Company had sought approval of their IND application for the treatment of patients with metastatic castration-resistant prostate cancer who failed abiraterone and/or enzalutamide. The IND application is a complete description of the chemistry, non-clinical pharmacodynamics and pharmacokinetics, animal toxicology, manufacturing, and other relevant information related to EPI-506.
“We fully appreciate the Agency’s perspective.” stated Bob Rieder, ESSA’s CEO. “We will submit the required data as soon as they are available for the Agency’s review. The delay caused by this circumstance is not expected to be significant, since the availability of those data had already been built in to the timelines prior to the IND submission. We have targeted Q3/2015 for first-patient-in, and that guidance remains valid”.
EPI-506 was designed to block a novel target on the androgen receptor, the N-terminal domain. Inhibition of the N-terminal domain of androgen receptor has the potential to block tumor growth after current hormone-therapy drugs have failed. That potential has been demonstrated in several well-accepted in vitro and in vivo studies showing that EPI-506 inhibits tumor growth in those prostate cancer models. The target patient population for EPI-506 – metastatic castration resistant prostate cancer (“mCRPC”) patients who have failed current hormone therapies – represents the greatest unmet medical need in this therapeutic area.
In its upcoming Phase 1/2 clinical trial, ESSA intends to demonstrate the safety, tolerability, maximum tolerated-dose, pharmacokinetics, and efficacy of EPI-506 in metastatic CRPC patients who have failed abiraterone or enzalutamide or both.
About Prostate Cancer
Prostate cancer is the second most commonly diagnosed cancer among men and the fifth most common cause of male cancer death worldwide (Globocan, 2012). Adenocarcinoma of the prostate is dependent on androgen for tumor progression and depleting or blocking androgen action has been a mainstay of hormonal treatment for over 6 decades. Although tumors are often initially sensitive to medical or surgical therapies that decrease levels of testosterone (i.e., ADT), disease progression despite castrate levels of testosterone generally represents a transition to the lethal variant of the disease (mCRPC) and most patients ultimately succumb to the illness. The treatment of mCRPC patients has evolved rapidly over the past 5 years; despite these advances, additional treatment options are needed to improve clinical outcomes in patients, particularly those who fail existing treatments including Abiraterone or Enzalutamide or those that have contraindications to receive those drugs. Over time, patients with mCRPC generally experience continued disease progression, worsening pain, leading to substantial morbidity and limited survival rates. In both in-vitro and in-vivo studies, ESSA’s novel approach to blocking the androgen pathway has been shown to be effective in blocking tumor growth when current therapies are no longer effective.
SOURCE: ESSA Pharma
Post Views: 137
HOUSTON, TX, USA and VANCOUVER, Canada I May 4, 2015 I ESSA Pharma Inc. (“ESSA” or the “Company”) (TSX-V: EPI) announced today that it has received notification from the Food and Drug Administration (“FDA” or the “Agency”) in the US that the Company’s IND application, filed March 31, 2015, has been placed on clinical hold pending receipt by the FDA of additional chemistry and pharmaceutical data related to the stability of the drug substance and drug product and a Certificate of Analysis on drug product.
The Company had sought approval of their IND application for the treatment of patients with metastatic castration-resistant prostate cancer who failed abiraterone and/or enzalutamide. The IND application is a complete description of the chemistry, non-clinical pharmacodynamics and pharmacokinetics, animal toxicology, manufacturing, and other relevant information related to EPI-506.
“We fully appreciate the Agency’s perspective.” stated Bob Rieder, ESSA’s CEO. “We will submit the required data as soon as they are available for the Agency’s review. The delay caused by this circumstance is not expected to be significant, since the availability of those data had already been built in to the timelines prior to the IND submission. We have targeted Q3/2015 for first-patient-in, and that guidance remains valid”.
EPI-506 was designed to block a novel target on the androgen receptor, the N-terminal domain. Inhibition of the N-terminal domain of androgen receptor has the potential to block tumor growth after current hormone-therapy drugs have failed. That potential has been demonstrated in several well-accepted in vitro and in vivo studies showing that EPI-506 inhibits tumor growth in those prostate cancer models. The target patient population for EPI-506 – metastatic castration resistant prostate cancer (“mCRPC”) patients who have failed current hormone therapies – represents the greatest unmet medical need in this therapeutic area.
In its upcoming Phase 1/2 clinical trial, ESSA intends to demonstrate the safety, tolerability, maximum tolerated-dose, pharmacokinetics, and efficacy of EPI-506 in metastatic CRPC patients who have failed abiraterone or enzalutamide or both.
About Prostate Cancer
Prostate cancer is the second most commonly diagnosed cancer among men and the fifth most common cause of male cancer death worldwide (Globocan, 2012). Adenocarcinoma of the prostate is dependent on androgen for tumor progression and depleting or blocking androgen action has been a mainstay of hormonal treatment for over 6 decades. Although tumors are often initially sensitive to medical or surgical therapies that decrease levels of testosterone (i.e., ADT), disease progression despite castrate levels of testosterone generally represents a transition to the lethal variant of the disease (mCRPC) and most patients ultimately succumb to the illness. The treatment of mCRPC patients has evolved rapidly over the past 5 years; despite these advances, additional treatment options are needed to improve clinical outcomes in patients, particularly those who fail existing treatments including Abiraterone or Enzalutamide or those that have contraindications to receive those drugs. Over time, patients with mCRPC generally experience continued disease progression, worsening pain, leading to substantial morbidity and limited survival rates. In both in-vitro and in-vivo studies, ESSA’s novel approach to blocking the androgen pathway has been shown to be effective in blocking tumor growth when current therapies are no longer effective.
SOURCE: ESSA Pharma
Post Views: 137
