Welcome!

News Feed Item

GTx Reports Positive Clinical Data from Open Label Phase 2 Study of Enobosarm in Patients with Androgen and Estrogen Receptor Positive Metastatic Breast Cancer

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.

About GTx

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.

More Stories By Business Wire

Copyright © 2009 Business Wire. All rights reserved. Republication or redistribution of Business Wire content is expressly prohibited without the prior written consent of Business Wire. Business Wire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
We all know the latest numbers: Gartner, Inc. forecasts that 6.4 billion connected things will be in use worldwide in 2016, up 30 percent from last year, and will reach 20.8 billion by 2020. We're rapidly approaching a data production of 40 zettabytes a day – more than we can every physically store, and exabytes and yottabytes are just around the corner. For many that’s a good sign, as data has been proven to equal money – IF it’s ingested, integrated, and analyzed fast enough. Without real-ti...
"We view the cloud not really as a specific technology but as a way of doing business and that way of doing business is transforming the way software, infrastructure and services are being delivered to business," explained Matthew Rosen, CEO and Director at Fusion, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
"Software-defined storage is a big problem in this industry because so many people have different definitions as they see fit to use it," stated Peter McCallum, VP of Datacenter Solutions at FalconStor Software, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
I wanted to gather all of my Internet of Things (IOT) blogs into a single blog (that I could later use with my University of San Francisco (USF) Big Data “MBA” course). However as I started to pull these blogs together, I realized that my IOT discussion lacked a vision; it lacked an end point towards which an organization could drive their IOT envisioning, proof of value, app dev, data engineering and data science efforts. And I think that the IOT end point is really quite simple…
With 15% of enterprises adopting a hybrid IT strategy, you need to set a plan to integrate hybrid cloud throughout your infrastructure. In his session at 18th Cloud Expo, Steven Dreher, Director of Solutions Architecture at Green House Data, discussed how to plan for shifting resource requirements, overcome challenges, and implement hybrid IT alongside your existing data center assets. Highlights included anticipating workload, cost and resource calculations, integrating services on both sides...
In his session at @DevOpsSummit at 19th Cloud Expo, Yoseph Reuveni, Director of Software Engineering at Jet.com, will discuss Jet.com's journey into containerizing Microsoft-based technologies like C# and F# into Docker. He will talk about lessons learned and challenges faced, the Mono framework tryout and how they deployed everything into Azure cloud. Yoseph Reuveni is a technology leader with unique experience developing and running high throughput (over 1M tps) distributed systems with extre...
"We are a well-established player in the application life cycle management market and we also have a very strong version control product," stated Flint Brenton, CEO of CollabNet,, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
"We provide DevOps solutions. We also partner with some key players in the DevOps space and we use the technology that we partner with to engineer custom solutions for different organizations," stated Himanshu Chhetri, CTO of Addteq, in this SYS-CON.tv interview at DevOps at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
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...
"Operations is sort of the maturation of cloud utilization and the move to the cloud," explained Steve Anderson, Product Manager for BMC’s Cloud Lifecycle Management, in this SYS-CON.tv interview at 18th Cloud Expo, held June 7-9, 2016, at the Javits Center in New York City, NY.
The IoT has the potential to create a renaissance of manufacturing in the US and elsewhere. In his session at 18th Cloud Expo, Florent Solt, CTO and chief architect of Netvibes, discussed how the expected exponential increase in the amount of data that will be processed, transported, stored, and accessed means there will be a huge demand for smart technologies to deliver it. Florent Solt is the CTO and chief architect of Netvibes. Prior to joining Netvibes in 2007, he co-founded Rift Technologi...
Enterprise networks are complex. Moreover, they were designed and deployed to meet a specific set of business requirements at a specific point in time. But, the adoption of cloud services, new business applications and intensifying security policies, among other factors, require IT organizations to continuously deploy configuration changes. Therefore, enterprises are looking for better ways to automate the management of their networks while still leveraging existing capabilities, optimizing perf...
Security, data privacy, reliability and regulatory compliance are critical factors when evaluating whether to move business applications from in-house client hosted environments to a cloud platform. In her session at 18th Cloud Expo, Vandana Viswanathan, Associate Director at Cognizant, In this session, will provide an orientation to the five stages required to implement a cloud hosted solution validation strategy.
Unless your company can spend a lot of money on new technology, re-engineering your environment and hiring a comprehensive cybersecurity team, you will most likely move to the cloud or seek external service partnerships. In his session at 18th Cloud Expo, Darren Guccione, CEO of Keeper Security, revealed what you need to know when it comes to encryption in the cloud.
The cloud competition for database hosts is fierce. How do you evaluate a cloud provider for your database platform? In his session at 18th Cloud Expo, Chris Presley, a Solutions Architect at Pythian, gave users a checklist of considerations when choosing a provider. Chris Presley is a Solutions Architect at Pythian. He loves order – making him a premier Microsoft SQL Server expert. Not only has he programmed and administered SQL Server, but he has also shared his expertise and passion with b...