|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.
Companies can harness IoT and predictive analytics to sustain business continuity; predict and manage site performance during emergencies; minimize expensive reactive maintenance; and forecast equipment and maintenance budgets and expenditures. Providing cost-effective, uninterrupted service is challenging, particularly for organizations with geographically dispersed operations.
May. 26, 2016 08:45 AM EDT Reads: 1,704
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
May. 26, 2016 08:45 AM EDT Reads: 2,833
SYS-CON Events announced today that AppNeta, the leader in performance insight for business-critical web applications, will exhibit and present at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. AppNeta is the only application performance monitoring (APM) company to provide solutions for all applications – applications you develop internally, business-critical SaaS applications you use and the networks that deli...
May. 26, 2016 08:30 AM EDT Reads: 2,188
Join us at Cloud Expo | @ThingsExpo 2016 – June 7-9 at the Javits Center in New York City and November 1-3 at the Santa Clara Convention Center in Santa Clara, CA – and deliver your unique message in a way that is striking and unforgettable by taking advantage of SYS-CON's unmatched high-impact, result-driven event / media packages.
May. 26, 2016 08:15 AM EDT Reads: 2,085
With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo 2016 in New York and Silicon Valley. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be! Internet of @ThingsExpo, taking place Nov 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 17th Cloud Expo and will feature technical sessions from a rock star conference faculty ...
May. 26, 2016 08:15 AM EDT Reads: 2,395
In the rush to compete in the digital age, a successful digital transformation is essential, but many organizations are setting themselves up for failure. There’s a common misconception that the process is just about technology, but it’s not. It’s about your business. It shouldn’t be treated as an isolated IT project; it should be driven by business needs with the committed involvement of a range of stakeholders.
May. 26, 2016 08:00 AM EDT Reads: 2,172
SYS-CON Events announced today that BMC Software has been named "Siver Sponsor" of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. BMC is a global leader in innovative software solutions that help businesses transform into digital enterprises for the ultimate competitive advantage. BMC Digital Enterprise Management is a set of innovative IT solutions designed to make digital business fast, seamless, and optimized from mainframe to mo...
May. 26, 2016 08:00 AM EDT Reads: 1,927
SoftLayer operates a global cloud infrastructure platform built for Internet scale. With a global footprint of data centers and network points of presence, SoftLayer provides infrastructure as a service to leading-edge customers ranging from Web startups to global enterprises. SoftLayer's modular architecture, full-featured API, and sophisticated automation provide unparalleled performance and control. Its flexible unified platform seamlessly spans physical and virtual devices linked via a world...
May. 26, 2016 07:45 AM EDT Reads: 1,855
The IoTs will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, will demonstrate how to move beyond today's coding paradigm and share the must-have mindsets for removing complexity from the development proc...
May. 26, 2016 07:45 AM EDT Reads: 1,835
18th Cloud Expo, taking place June 7-9, 2016, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterprises are using some...
May. 26, 2016 07:45 AM EDT Reads: 2,909
SYS-CON Events announced today that Isomorphic Software will exhibit at SYS-CON's [email protected] at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Isomorphic Software provides the SmartClient HTML5/AJAX platform, the most advanced technology for building rich, high-productivity enterprise web applications for any device. SmartClient couples the industry’s broadest, deepest UI component set with a java server framework to deliver an end-...
May. 26, 2016 07:30 AM EDT Reads: 1,952
In his keynote at 18th Cloud Expo, Andrew Keys, Co-Founder of ConsenSys Enterprise, will provide an overview of the evolution of the Internet and the Database and the future of their combination – the Blockchain. Andrew Keys is Co-Founder of ConsenSys Enterprise. He comes to ConsenSys Enterprise with capital markets, technology and entrepreneurial experience. Previously, he worked for UBS investment bank in equities analysis. Later, he was responsible for the creation and distribution of life ...
May. 26, 2016 07:30 AM EDT Reads: 1,817
SYS-CON Events announced today that Tintri Inc., a leading producer of VM-aware storage (VAS) for virtualization and cloud environments, will exhibit at the 18th International CloudExpo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, New York, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
May. 26, 2016 07:15 AM EDT Reads: 2,150
Designing IoT applications is complex, but deploying them in a scalable fashion is even more complex. A scalable, API first IaaS cloud is a good start, but in order to understand the various components specific to deploying IoT applications, one needs to understand the architecture of these applications and figure out how to scale these components independently. In his session at @ThingsExpo, Nara Rajagopalan is CEO of Accelerite, will discuss the fundamental architecture of IoT applications, ...
May. 26, 2016 06:45 AM EDT Reads: 1,023
The IoT is changing the way enterprises conduct business. In his session at @ThingsExpo, Eric Hoffman, Vice President at EastBanc Technologies, discuss how businesses can gain an edge over competitors by empowering consumers to take control through IoT. We'll cite examples such as a Washington, D.C.-based sports club that leveraged IoT and the cloud to develop a comprehensive booking system. He'll also highlight how IoT can revitalize and restore outdated business models, making them profitable...
May. 26, 2016 06:30 AM EDT Reads: 2,658