HOUSTON, TX, USA and VANCOUVER, Canada I July 15, 2020 I ESSA Pharma Inc. (Nasdaq: EPIX) (TSXV: EPI), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced the first patient dosed in a Phase 1 clinical trial designed to demonstrate the safety and tolerability of EPI-7386 in metastatic castration-resistant prostate cancer (“mCRPC”) patients who failed standard of care treatments, including second generation anti-androgens. EPI-7386 is a small molecule inhibitor of the N-terminal domain of the androgen receptor (AR) which has shown preclinical activity in both anti-androgen sensitive and anti-androgen resistant prostate cancer models.
“The initiation of this study represents a significant milestone for ESSA as it brings us a step closer to offering a potentially meaningful new therapeutic option to prostate cancer patients,” said Dr. David Parkinson MD, Chief Executive Officer of ESSA. “The fact that EPI-7386 was first synthesized less than two years ago and yesterday began dosing in patients is a testament to the efficiency of our team and our collaborators”. Dr. Parkinson continued, “The results from this trial will guide our future development plans and confirm the potential contribution of N-terminal domain AR inhibition to the treatment of prostate cancer”.
The Phase 1 clinical trial (NCT04421222) expects to enroll approximately 18 mCRPC patients in the dose escalation part of the study at selected clinical sites in the United States and Canada, with an additional ten patients planned to be enrolled in a dose expansion cohort involving additional clinical sites. The study will evaluate the safety and tolerability of EPI-7386 while additionally characterizing the pharmacokinetic, biological and anti-tumor effects of therapy.
About ESSA Pharma Inc.
ESSA is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of castration-resistant prostate cancer in patients whose disease is progressing despite treatment with current therapies. ESSA’s proprietary “aniten” compounds bind to the N-terminal domain of the androgen receptor (“AR”), inhibiting AR driven transcription and the AR signaling pathway in a unique manner which bypasses the drug resistance mechanisms associated with current anti-androgens. The Company is currently conducting a phase 1 study of EPI-7386 in patients with mCRPC who are failing current standard-of-care therapies. For more information, please visit www.essapharma.com and follow us on Twitter under @ESSAPharma.
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, 2018). 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 six decades. Although tumors are often initially sensitive to medical or surgical therapies that decrease levels of testosterone, 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 five 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 who 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 animal 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: 199
HOUSTON, TX, USA and VANCOUVER, Canada I July 15, 2020 I ESSA Pharma Inc. (Nasdaq: EPIX) (TSXV: EPI), a clinical-stage pharmaceutical company focused on developing novel therapies for the treatment of prostate cancer, today announced the first patient dosed in a Phase 1 clinical trial designed to demonstrate the safety and tolerability of EPI-7386 in metastatic castration-resistant prostate cancer (“mCRPC”) patients who failed standard of care treatments, including second generation anti-androgens. EPI-7386 is a small molecule inhibitor of the N-terminal domain of the androgen receptor (AR) which has shown preclinical activity in both anti-androgen sensitive and anti-androgen resistant prostate cancer models.
“The initiation of this study represents a significant milestone for ESSA as it brings us a step closer to offering a potentially meaningful new therapeutic option to prostate cancer patients,” said Dr. David Parkinson MD, Chief Executive Officer of ESSA. “The fact that EPI-7386 was first synthesized less than two years ago and yesterday began dosing in patients is a testament to the efficiency of our team and our collaborators”. Dr. Parkinson continued, “The results from this trial will guide our future development plans and confirm the potential contribution of N-terminal domain AR inhibition to the treatment of prostate cancer”.
The Phase 1 clinical trial (NCT04421222) expects to enroll approximately 18 mCRPC patients in the dose escalation part of the study at selected clinical sites in the United States and Canada, with an additional ten patients planned to be enrolled in a dose expansion cohort involving additional clinical sites. The study will evaluate the safety and tolerability of EPI-7386 while additionally characterizing the pharmacokinetic, biological and anti-tumor effects of therapy.
About ESSA Pharma Inc.
ESSA is a clinical-stage pharmaceutical company focused on developing novel and proprietary therapies for the treatment of castration-resistant prostate cancer in patients whose disease is progressing despite treatment with current therapies. ESSA’s proprietary “aniten” compounds bind to the N-terminal domain of the androgen receptor (“AR”), inhibiting AR driven transcription and the AR signaling pathway in a unique manner which bypasses the drug resistance mechanisms associated with current anti-androgens. The Company is currently conducting a phase 1 study of EPI-7386 in patients with mCRPC who are failing current standard-of-care therapies. For more information, please visit www.essapharma.com and follow us on Twitter under @ESSAPharma.
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, 2018). 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 six decades. Although tumors are often initially sensitive to medical or surgical therapies that decrease levels of testosterone, 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 five 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 who 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 animal 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: 199