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HOUSTON, TX and VANCOUVER, May 4, 2019 / PRNewswire / – ESSA Pharma Inc. (Nasdaq: EPIX, TSX-V: EPI), a pharmaceutical company specializing in the development of new therapies for the treatment of prostate cancer, today presented new preclinical data for the new ESSA's flagship experimental drug ("IND")) candidate at the annual meeting of the American Urological Association ("AAU") in 2019.
In an oral poster presentation, "A New Generation of N-terminal Domain Androgen Receptor Inhibitors in Castration-Resistant Prostate Cancer Models," a more in-depth preclinical characterization of EPI-7386 was presented. Studies show that prior to clinical trials, EPI-7386:
- Similar poster in vitro IC50 power compared to the 'lutamide clbad of antiandrogens in a in vitro Dosage inhibition of the androgen receptor (AR).
- Shows in vitro activity in several models of enzalutamide-resistant prostate cancer cells in which enzalutamide is resistant.
- Presents a favorable metabolic profile in three preclinical animal species, suggesting that EPI-7386 will be exposed to high exposure and a long half-life in humans.
- Provides antitumor activity similar to that of enzalutamide in the enzalutamide-sensitive LNCaP prostate cancer xenograft model.
- Provides antitumor activity superior to enzalutamide, as monotherapy or in combination with enzalutamide, in the model of xenograft VCaP prostate cancer resistant to enzalutamide.
- The inhibition of AR with an N-terminal domain inhibitor (EPI-7386) and an inhibitor of the ligand binding domain (enzalutamide) induces deeper and more consistent antitumor responses in the xenograft model VCaP resistant to enzalutamide.
"The variety of in vitro and in vivo Studies on both antiandrogen-responsive models and antiandrogen-resistant xenograft mouse models show a favorable preclinical profile of EPI-7386. From this and a set of other preclinical data, we have designated EPI-7386 as an IND candidate for clinical use in patients with mCRPC failing current antiandrogen therapy. EPI-7386 represents a new approach to androgen receptor targeting, one of the most valid targets in oncology, "said Dr. David R. Parkinson, President and CEO. "We look forward to providing additional details on the preclinical profile of EPI-7386 later in the year, as we approach our IND filing scheduled for the first quarter of 2020."
About ESSA Pharma Inc.
ESSA is a pharmaceutical company specializing in the development of innovative and exclusive therapies for the treatment of castration-resistant prostate cancer ("CPRC") in patients whose disease is evolving despite current treatments. ESSA believes that its proprietary compounds can significantly increase the time interval in which CRPC patients can benefit from hormone treatments by disrupting the androgen receptor ("AR") signaling pathway. which regulates the growth of prostate cancer and by preventing the transcription activity of the latter by selectively binding to the N-terminal domain ("NTD") of the AR. Functional MTN is essential for the transactivation of RA. In preclinical studies, blockage of neglected tropical diseases has demonstrated the ability to overcome the known mechanisms of RA-dependent CPPR. ESSA was founded in 2009.
The proprietary ESSA compounds, otherwise known as anitene compounds, bind to the N-terminal domain of the androgen receptor ("AR"). The company is currently conducting studies on a small number of new generation compounds with superior potency and metabolic stability, longer half-life, and superior pharmaceutical properties.
About prostate cancer
Prostate cancer is the second most frequently diagnosed cancer in men and the fifth leading cause of cancer death among men worldwide (Globocan, 2018). Adenocarcinoma of the prostate depends on the androgen for tumor progression and its action of depletion or blockage of androgen is one of the pillars of hormone therapy since more than six decades. Although tumors are often initially sensitive to medical or surgical treatments that reduce testosterone levels, the progression of the disease despite testosterone castrate levels generally represents a transition to the lethal variant of the disease, metastatic CPRC (mCRPC) and most patients the disease. The treatment of patients with CPRCm has evolved rapidly over the last five years. Despite these advances, additional treatment options are needed to improve clinical outcomes in patients, particularly those who fail existing therapies, including abiraterone or enzalutamide, or those who have counter-fits. indications to these drugs. Over time, patients with CPRCm typically experience continued disease progression, worsening pain, significant morbidity, and limited survival rates. In in vitro and in vivo animal studies, the new ESSA approach to blocking the androgen pathway has proven effective in blocking tumor growth when current treatments are no longer effective.
Forward-Looking Statement Disclaimer
This news release contains certain information which, in its current form, constitutes "forward-looking information" within the meaning of the Securities Industry Litigation Reform Act, 1995 and / or applicable Canadian securities legislation. Forward-looking information involves statements relating to future events and often discusses future commercial and financial performance, containing terms such as "anticipating", "anticipating" and "believing", as well as statements indicating that an action or an event is "expected" , "is predicted", "should", "may" or "will" be taken or will occur, or other similar expressions and includes, but is not limited to, statements regarding the expected pharmaceutical properties of the drug candidate EPI-7386 and -androgens, including potential exposure and half-life in humans, and anticipated IND deposition of EPI-7386 in the first quarter of 2020.
Forward-looking statements and information are subject to a variety of known and unknown risks and uncertainties, many of which are beyond the ability of ESSA to control or predict, and which could result in a material difference between ESSA's results, performance or achievements. those expressed or lost. implied by this fact. These statements reflect ESSA's current views with respect to future events, are subject to risks and uncertainties and are necessarily based on a number of estimates and badumptions that, while considered reasonable by ESSA at the date of these declarations, are intrinsically subject to scientific, commercial, economic, competitive, political and social uncertainties and uncertainties. In making forward-looking statements, ESSA may make various material badumptions, including (i) the accuracy of its financial projections; (ii) obtain positive results from clinical trials; (iii) obtaining the necessary regulatory approvals; and (iv) the general conditions of business, the market and the economy.
The forward-looking information is developed based on badumptions about the risks, uncertainties and other factors set forth herein and in the annual report of ESSA on Form 20-F dated December 13, 2018 under the heading "Risk Factors", a copy of which is available on ESSA's profile on the SEDAR website at www.sedar.com or on ESSA's profile on EDGAR at the address www.sec.gov, and as stated from time to time on ESSA's SEDAR and EDGAR profiles. Forward-looking statements are made based on management's beliefs, beliefs and beliefs as of the date they were made and ESSA badumes no obligation to update any forward-looking statements if such opinions, estimates and opinions or other circumstances were to change except as required by applicable Canadian and United States securities laws. Readers are cautioned not to place undue reliance on forward-looking statements.
Neither the TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts any responsibility for the adequacy or accuracy of this document. communicated.
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