|By Business Wire||
|June 2, 2014 11:03 AM EDT||
GTx, Inc. (NASDAQ: GTXI) today announced positive results from a Phase 2, proof-of-concept, open-label clinical study evaluating enobosarm (GTx-024), a selective androgen receptor modulator (SARM), for the treatment of patients with androgen receptor (AR) positive and estrogen receptor (ER) positive metastatic breast cancer who have previously responded to hormonal therapy. The clinical data is being presented today during the Breast Cancer-HER2/ER poster session at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago.
“We know from prior studies and our clinical experience that women with hormone receptor positive metastatic breast cancer, which has progressed following treatment with endocrine therapy, often respond to androgen therapy; yet undesirable side effects, such as facial hair growth and deepening of the voice, are not acceptable to most patients. Therefore, alternatives to existing therapies, that are tolerable and effective, are needed,” said Beth A. Overmoyer, M.D., the principal clinical investigator in the enobosarm Phase 2 study and director of the Inflammatory Breast Cancer Program at the Susan F. Smith Center for Women's Cancers at Dana Farber Cancer Institute, and Assistant Professor of Medicine at Harvard Medical School. “I find these results to be very promising given that, in this patient population, achieving stable disease is considered a success.”
“Based on these encouraging results, we plan to advance the clinical development of enobosarm in patients with AR and ER positive metastatic breast cancer,” said Marc S. Hanover, interim CEO, President and COO of GTx.
Phase 2 Clinical Trial Design and Results
The Phase 2 open-label study is evaluating 22 postmenopausal women with ER positive metastatic breast cancer, who had previously responded to adjuvant hormonal therapy for three years or longer, and women diagnosed with metastatic disease, who had been treated with hormonal therapy for at least six months, prior to disease progression. Study participants were heavily pretreated (72.7 percent received previous chemotherapy and the median number of prior endocrine therapies was 3). The mean time from initial breast cancer diagnosis is 11 years and the mean age of patients is 64 years.
Study participants are receiving enobosarm 9 mg once daily until they display evidence of clinical progression. The primary endpoint is the proportion of subjects with clinical benefit at 6 months in subjects with AR+ metastatic lesions. Clinical benefit is defined as those patients who have either stable disease, a complete response, or a partial response as defined in the modified RECIST (Response Evaluation Criteria In Solid Tumors) 1.1 criteria. Upon completion of the study, clinical benefit response will be correlated with AR status via metastatic tumor biopsy. Serum prostate specific antigen (PSA) is evaluated as a biomarker of androgen receptor activity. The study is being conducted at seven clinical sites in the United States.
Of the 22 patients enrolled in the study, a total of 20 patients had one or more scheduled assessments for determination of clinical benefit. The primary endpoint was assessed in 17 AR+ patients with 6 patients demonstrating clinical benefit at six months, exceeding the pre-defined statistical threshold requiring that at least 3 of 14 patients with an AR+ metastatic lesion demonstrate clinical benefit. Additionally, results showed that, after a median duration on study of 81 days, 41 percent of all patients (9/22) achieved clinical benefit as best response and also had increased prostate specific antigen (PSA), which appears to be an indicator of AR activity. The 6 patients achieving clinical benefit (35 percent of the 17 patients with AR+ metastatic lesions) had stable disease. No confirmed complete or partial responses have been observed in the study. Later this month, the final patient in the study will have her six month evaluation and three additional patients continue to demonstrate clinical benefit and remain in the study. Enobosarm was well tolerated. The most common adverse events (AEs) reported were pain, fatigue, nausea, hot flash/night sweats, and arthralgia. The majority of AEs were Grade 1. There were two serious adverse events (SAEs) reported during the study. Only one of the SAEs, bone pain of chest cage, was assessed as possibly related to enobosarm.
A copy of the enobosarm poster is available by contacting the Company.
About Breast Cancer and Receptor Status
Breast cancer is the most commonly diagnosed cancer in women and is the second leading cause of cancer deaths in women in the United States. Each year, over 200,000 new cases of invasive breast cancer will be diagnosed in the U.S., and approximately 39,000 women will die from the disease. Clinical assessment of breast cancer includes routine characterization of a patient’s receptor status, including the presence or absence of ER, progesterone receptor and human epidermal growth factor receptor 2 (HER2) in the tumor tissue. Receptor status is used to assess the potential for developing metastatic disease, as well as guiding treatment decisions.
Hormonal manipulation with selective estrogen receptor modulators or aromatase inhibitors is the standard treatment for patients with tumors that are ER positive. It is expected that a majority (70-95 percent) of patients with ER positive breast cancer will also express AR in their primary tumor samples. High percentages (72-84 percent) of metastatic breast cancer lesions have been found to be AR positive. In preclinical and clinical studies, androgens have been shown to suppress breast cancer growth. In addition, studies have shown that women with metastatic breast cancer who have been previously treated with tamoxifen and who progress have responded to nonselective androgens, including fluoxymesterone, medroxyprogesterone and danazol, with overall response rates ranging from 20 to 60 percent. However, the unwanted virilizing side effects of nonselective androgens, including facial and body hair growth, deepening of the voice box, acne and edema, have limited their widespread clinical use.
GTx, Inc., headquartered in Memphis, Tenn., is a biopharmaceutical company dedicated to the discovery, development, and commercialization of small molecules for the treatment of cancer, cancer supportive care, including prevention and treatment of cancer-related muscle wasting, and other serious medical conditions.
Forward-Looking Information is Subject to Risk and Uncertainty
This press release contains forward-looking statements based upon GTx's current expectations. Forward-looking statements involve risks and uncertainties, and include, but are not limited to, statements relating to GTx's clinical trials for enobosarm (GTx-024). GTx's actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the risks (i) that GTx may not be able to obtain required regulatory approvals to commercialize its product candidates in a timely manner or at all; or (ii) that clinical trials being conducted by GTx may not be completed on schedule, or at all, or may otherwise be suspended or terminated. GTx’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties. GTx will continue to need additional funding and may be unable to raise capital when needed, which would force GTx to delay, reduce or eliminate its product candidate development programs and potentially cease operations. You should not place undue reliance on these forward-looking statements, which apply only as of the date of this press release. GTx’s quarterly report on Form 10-Q filed with the Securities and Exchange Commission on May 12, 2014 contains under the heading, "Risk Factors," a more comprehensive description of these and other risks to which GTx is subject. GTx expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in its expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.
To leverage Continuous Delivery, enterprises must consider impacts that span functional silos, as well as applications that touch older, slower moving components. Managing the many dependencies can cause slowdowns. See how to achieve continuous delivery in the enterprise.
Aug. 24, 2016 10:30 PM EDT Reads: 1,436
Actian Corporation has announced the latest version of the Actian Vector in Hadoop (VectorH) database, generally available at the end of July. VectorH is based on the same query engine that powers Actian Vector, which recently doubled the TPC-H benchmark record for non-clustered systems at the 3000GB scale factor (see tpc.org/3323). The ability to easily ingest information from different data sources and rapidly develop queries to make better business decisions is becoming increasingly importan...
Aug. 24, 2016 10:30 PM EDT Reads: 2,003
Is the ongoing quest for agility in the data center forcing you to evaluate how to be a part of infrastructure automation efforts? As organizations evolve toward bimodal IT operations, they are embracing new service delivery models and leveraging virtualization to increase infrastructure agility. Therefore, the network must evolve in parallel to become equally agile. Read this essential piece of Gartner research for recommendations on achieving greater agility.
Aug. 24, 2016 09:30 PM EDT Reads: 300
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
Aug. 24, 2016 09:15 PM EDT Reads: 1,658
Kubernetes, Docker and containers are changing the world, and how companies are deploying their software and running their infrastructure. With the shift in how applications are built and deployed, new challenges must be solved. In his session at @DevOpsSummit at19th Cloud Expo, Sebastian Scheele, co-founder of Loodse, will discuss the implications of containerized applications/infrastructures and their impact on the enterprise. In a real world example based on Kubernetes, he will show how to ...
Aug. 24, 2016 04:45 PM EDT Reads: 1,297
Pulzze Systems was happy to participate in such a premier event and thankful to be receiving the winning investment and global network support from G-Startup Worldwide. It is an exciting time for Pulzze to showcase the effectiveness of innovative technologies and enable them to make the world smarter and better. The reputable contest is held to identify promising startups around the globe that are assured to change the world through their innovative products and disruptive technologies. There w...
Aug. 24, 2016 04:15 PM EDT Reads: 334
SYS-CON Events announced today Telecom Reseller has been named “Media Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
Aug. 24, 2016 04:15 PM EDT Reads: 461
SYS-CON Events announced today that Venafi, the Immune System for the Internet™ and the leading provider of Next Generation Trust Protection, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Venafi is the Immune System for the Internet™ that protects the foundation of all cybersecurity – cryptographic keys and digital certificates – so they can’t be misused by bad guys in attacks...
Aug. 24, 2016 04:15 PM EDT Reads: 2,551
To paraphrase someone famous, "The definition of insanity is to do something the same way over and over again and expect a different result". Humans are creatures of habit and when it comes to storage, old habits die hard. Why do we continue to put our faith in legacy storage providers when they haven't invented anything new in decades. Sure, they re-badge their products every couple of years to make their messaging look modern, but ultimately, it's the same old stuff with a new coat of lipsti...
Aug. 24, 2016 04:10 PM EDT Reads: 284
StarNet Communications Corp has announced the addition of three Secure Remote Desktop modules to its flagship X-Win32 PC X server. The new modules enable X-Win32 to safely tunnel the remote desktops from Linux and Unix servers to the user’s PC over encrypted SSH. Traditionally, users of PC X servers deploy the XDMCP protocol to display remote desktop environments such as the Gnome and KDE desktops on Linux servers and the CDE environment on Solaris Unix machines. XDMCP is used primarily on comp...
Aug. 24, 2016 03:15 PM EDT Reads: 395
Smart Cities are here to stay, but for their promise to be delivered, the data they produce must not be put in new siloes. In his session at @ThingsExpo, Mathias Herberts, Co-founder and CTO of Cityzen Data, will deep dive into best practices that will ensure a successful smart city journey.
Aug. 24, 2016 02:15 PM EDT Reads: 1,434
SYS-CON Events announced today that StarNet Communications will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. StarNet Communications’ FastX is the industry first cloud-based remote X Windows emulator. Using standard Web browsers (FireFox, Chrome, Safari, etc.) users from around the world gain highly secure access to applications and data hosted on Linux-based servers in a central data center. ...
Aug. 24, 2016 02:00 PM EDT Reads: 474
Using new techniques of information modeling, indexing, and processing, new cloud-based systems can support cloud-based workloads previously not possible for high-throughput insurance, banking, and case-based applications. In his session at 18th Cloud Expo, John Newton, CTO, Founder and Chairman of Alfresco, described how to scale cloud-based content management repositories to store, manage, and retrieve billions of documents and related information with fast and linear scalability. He addres...
Aug. 24, 2016 02:00 PM EDT Reads: 1,832
Aspose.Total for .NET is the most complete package of all file format APIs for .NET as offered by Aspose. It empowers developers to create, edit, render, print and convert between a wide range of popular document formats within any .NET, C#, ASP.NET and VB.NET applications. Aspose compiles all .NET APIs on a daily basis to ensure that it contains the most up to date versions of each of Aspose .NET APIs. If a new .NET API or a new version of existing APIs is released during the subscription peri...
Aug. 24, 2016 12:15 PM EDT Reads: 1,797
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportuni...
Aug. 24, 2016 12:00 PM EDT Reads: 3,846