Welcome!

News Feed Item

Versartis Presents Latest Positive Results From Its Pediatric Study of Long-Acting Growth Hormone Treatment at International Endocrinology Conference

MILAN, ITALY -- (Marketwired) -- 09/22/13 -- Versartis, Inc. today released the latest positive results from the company's ongoing VERTICAL clinical trial of VRS-317, its proprietary long-acting form of recombinant human growth hormone (rhGH), at the 9th Joint Meeting of Paediatric Endocrinology in Milan. The most recent data from this trial in pediatric patients were presented by George M. Bright, MD, Versartis Vice President of Medical Affairs, in an oral discussion titled "A Phase 1b/2a Study of a New Long-acting Growth Hormone (VRS-317) in Pre-pubertal Children with Growth Hormone Deficiency (GHD)." All currently approved growth hormone drugs require daily injections and consequently pose considerable challenges to patients with GHD. In contrast, VRS-317 is being developed to provide up to once-monthly dosing and promises to improve patients' ability to adhere to their therapy regimen and to improve their overall treatment outcomes.

The VERTICAL trial of VRS-317 consists of two stages: a single ascending dose stage (Phase 1b) to determine the safety, PK and PD of VRS-317 doses and to enable selection of dose regimens used in the repeat dose stage (Phase 2a) to obtain 6-month height velocity results. Results from the recently completed Phase 1b dose-escalating stage of the study were reported by Dr. Bright.

Dr. Bright commented, "The latest data from the Phase 1b demonstrated that a single dose of VRS-317 was very well tolerated in children with GHD and that we were able to safely raise IGF-I to the levels associated with good catch-up growth while using a reduced dosing frequency. Therefore, the data presented today provide strong support for the continued study of up to once-monthly dosing in the next stage of our trial, which was initiated earlier this month. This study will further determine the 3-month and 6-month height velocities in these GHD patients."

The VRS-317 VERTICAL Trial
The Versartis Trial In Children to Assess Long-Acting Growth Hormone (VERTICAL) study is being conducted in approximately 30 U.S. pediatric endocrinology centers and will enroll up to 72 naïve-to-treatment, pre-pubertal children with GHD that was documented by auxologic criteria and two GH stimulation tests.

In Phase 1b, the PK and PD (IGF-I) responses over a 30 day period were determined following a single, subcutaneous dose of VRS-317 at 6 ascending dose levels. Safety Review Committee meetings were held before each dose escalation to review collected data against protocol-specified stopping criteria. VRS-317 dosing began at 0.80 mg/kg, a dose shown to be safe and well tolerated in GHD adults in the previously completed trial, with dose increases to 1.20 mg/kg, 1.80 mg/kg, 2.70 mg/kg, 4.00 mg/kg and 6.00 mg/kg (equivalent to 4.8, 7.4, 11.1, 16.7, 24.7 and 37.0 mcg rhGH per kg per day taken for 30 days). In the United States, the typical dose of daily rhGH in children with GHD is approximately 40 mcg/kg/day. Thus, the VRS-317 doses studied in this trial are all below the amount of daily rhGH typically prescribed for these patients. VRS-317 dose selection for Phase 2a was based on safety and IGF-I responses from Phase 1b. Following Phase 2a dose selection, subjects are now being dosed in each of three dose cohorts for the determination of 3-month and 6-month height velocities.

Top Line Results
In the Phase 1b portion of the trial, 48 subjects (27M, 21F) with mean (SD) age 7.2 (2.2) yrs were studied in 6 dose cohorts (8 per cohort). At screening, mean (SD) HT-SDS was -2.7 (0.6), weight was 18.0 (4.6) kg and IGF-I SDS was -1.8 (0.7). VRS-317 plasma concentrations reach a maximum at a mean time of 3 days post-dose, are proportional to dose and remain detectable for up to 30 days from a single dose in all subjects tested. Maximal changes in IGF-I SDS occur between 2 to 14 days after a single dose on Day 1. The amplitude and duration of IGF-I responses increase with increasing VRS-317 dose. The increase in average IGF-1 SDS over 30 days was also proportional to dose and sufficient to support up to once-monthly dosing of VRS-317. Importantly, the prolonged IGF-I responses do not come at the expense of over-exposure to high IGF-I levels, where only a single value of IGF-I SDS in each of two patients has exceeded +2. All related adverse events that have been reported were mild and transient, with no serious or unexpected adverse events reported.

Conclusions
Single doses of VRS-317 from 0.8 to 6.0 mg/kg were safe and well tolerated when administered to 48 pre-pubertal children with GHD. In addition, dose proportional increases in VRS-317 levels and IGF-I responses were observed, indicating the flexibility for selecting doses and dose regimens of up to once-per-month dosing. Consequently, VRS-317 is a long-acting rhGH with the potential for up to monthly-dosing intervals in children with GHD.

About Versartis
Versartis, Inc. is a biotechnology company developing therapeutics for the treatment of endocrine disorders. The company's lead product candidate is VRS-317, a novel long-acting form of human growth hormone. VRS-317 is currently being investigated for safety and efficacy in pediatric GHD patients for up to once-monthly dosing. Versartis is pursuing the development of new therapeutic proteins utilizing the proprietary Amunix half-life extension technology (XTEN). XTEN is a novel hydrophilic sequence of natural amino acids and is expressed as a fusion protein with a therapeutically active peptide or protein. New compounds developed by Versartis using the XTEN technology are expected to provide improved therapeutic outcomes such as enhanced efficacy/compliance, fewer side effects, prolonged half-life (up to monthly dosing), as well as low-cost production and enhanced stability. Further information on Versartis can be found at www.versartis.com.

Contacts:
Corporate
Paul Westberg
SVP Business Development
Ph: 650 963-8585
Email: Email Contact

Media
Debra Bannister
Corporate Communications
Ph: 530 676-7373
Email: Email Contact

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
DX World EXPO, LLC, a Lighthouse Point, Florida-based startup trade show producer and the creator of "DXWorldEXPO® - Digital Transformation Conference & Expo" has announced its executive management team. The team is headed by Levent Selamoglu, who has been named CEO. "Now is the time for a truly global DX event, to bring together the leading minds from the technology world in a conversation about Digital Transformation," he said in making the announcement.
"Space Monkey by Vivent Smart Home is a product that is a distributed cloud-based edge storage network. Vivent Smart Home, our parent company, is a smart home provider that places a lot of hard drives across homes in North America," explained JT Olds, Director of Engineering, and Brandon Crowfeather, Product Manager, at Vivint Smart Home, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
SYS-CON Events announced today that Conference Guru has been named “Media Sponsor” of the 22nd International Cloud Expo, which will take place on June 5-7, 2018, at the Javits Center in New York, NY. A valuable conference experience generates new contacts, sales leads, potential strategic partners and potential investors; helps gather competitive intelligence and even provides inspiration for new products and services. Conference Guru works with conference organizers to pass great deals to gre...
DevOps is under attack because developers don’t want to mess with infrastructure. They will happily own their code into production, but want to use platforms instead of raw automation. That’s changing the landscape that we understand as DevOps with both architecture concepts (CloudNative) and process redefinition (SRE). Rob Hirschfeld’s recent work in Kubernetes operations has led to the conclusion that containers and related platforms have changed the way we should be thinking about DevOps and...
The Internet of Things 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, demonstrated how to move beyond today's coding paradigm and shared the must-have mindsets for removing complexity from the develop...
In his Opening Keynote at 21st Cloud Expo, John Considine, General Manager of IBM Cloud Infrastructure, led attendees through the exciting evolution of the cloud. He looked at this major disruption from the perspective of technology, business models, and what this means for enterprises of all sizes. John Considine is General Manager of Cloud Infrastructure Services at IBM. In that role he is responsible for leading IBM’s public cloud infrastructure including strategy, development, and offering m...
Companies are harnessing data in ways we once associated with science fiction. Analysts have access to a plethora of visualization and reporting tools, but considering the vast amount of data businesses collect and limitations of CPUs, end users are forced to design their structures and systems with limitations. Until now. As the cloud toolkit to analyze data has evolved, GPUs have stepped in to massively parallel SQL, visualization and machine learning.
The next XaaS is CICDaaS. Why? Because CICD saves developers a huge amount of time. CD is an especially great option for projects that require multiple and frequent contributions to be integrated. But… securing CICD best practices is an emerging, essential, yet little understood practice for DevOps teams and their Cloud Service Providers. The only way to get CICD to work in a highly secure environment takes collaboration, patience and persistence. Building CICD in the cloud requires rigorous ar...
"Evatronix provides design services to companies that need to integrate the IoT technology in their products but they don't necessarily have the expertise, knowledge and design team to do so," explained Adam Morawiec, VP of Business Development at Evatronix, in this SYS-CON.tv interview at @ThingsExpo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
To get the most out of their data, successful companies are not focusing on queries and data lakes, they are actively integrating analytics into their operations with a data-first application development approach. Real-time adjustments to improve revenues, reduce costs, or mitigate risk rely on applications that minimize latency on a variety of data sources. In his session at @BigDataExpo, Jack Norris, Senior Vice President, Data and Applications at MapR Technologies, reviewed best practices to ...
Widespread fragmentation is stalling the growth of the IIoT and making it difficult for partners to work together. The number of software platforms, apps, hardware and connectivity standards is creating paralysis among businesses that are afraid of being locked into a solution. EdgeX Foundry is unifying the community around a common IoT edge framework and an ecosystem of interoperable components.
"ZeroStack is a startup in Silicon Valley. We're solving a very interesting problem around bringing public cloud convenience with private cloud control for enterprises and mid-size companies," explained Kamesh Pemmaraju, VP of Product Management at ZeroStack, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Large industrial manufacturing organizations are adopting the agile principles of cloud software companies. The industrial manufacturing development process has not scaled over time. Now that design CAD teams are geographically distributed, centralizing their work is key. With large multi-gigabyte projects, outdated tools have stifled industrial team agility, time-to-market milestones, and impacted P&L stakeholders.
"Akvelon is a software development company and we also provide consultancy services to folks who are looking to scale or accelerate their engineering roadmaps," explained Jeremiah Mothersell, Marketing Manager at Akvelon, in this SYS-CON.tv interview at 21st Cloud Expo, held Oct 31 – Nov 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
Enterprises are adopting Kubernetes to accelerate the development and the delivery of cloud-native applications. However, sharing a Kubernetes cluster between members of the same team can be challenging. And, sharing clusters across multiple teams is even harder. Kubernetes offers several constructs to help implement segmentation and isolation. However, these primitives can be complex to understand and apply. As a result, it’s becoming common for enterprises to end up with several clusters. Thi...