|By PR Newswire||
|October 7, 2013 05:07 PM EDT||
LYNBROOK, N.Y., Oct. 7, 2013 /PRNewswire/ -- BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX® in the U.S. and XIAPEX® in the EU, announced today that data from multiple trials evaluating the use of XIAFLEX ("collagenase clostridium histolyticum" or "CCH") in adult patients with Dupuytren's contracture with a palpable cord were presented by BioSpecifics' partner Auxilium Pharmaceuticals, Inc. (Auxilium) at the 68th Annual Meeting of the American Society for Surgery of the Hand ("ASSH") that took place in San Francisco, California, on October 3 – 5, 2013.
"We believe the data presented at ASSH on XIAFLEX further validates that XIAFLEX is a safe and efficacious treatment for adult patients with Dupuytren's contracture and it remains the only non-surgical option available today," commented Thomas L. Wegman, President of BioSpecifics. "We continue to support Auxilium in their commercialization efforts for this product and look forward to potentially adding a second FDA-approved indication by the end of the year for Peyronie's disease."
Auxilium presented results at ASSH from Year 4 of the Collagenase Optimal Reduction of Dupuytren's - Long-term Evaluation of Success Study ("CORDLESS"). CORDLESS is a five-year observational study designed to assess the rates of recurrence following treatment with XIAFLEX, as well as long-term safety and progression of disease in patients from earlier Auxilium studies. These data indicated that 57.9 percent of patients previously successfully treated with XIAFLEX did not experience disease recurrence based on the study's definition of recurrence, which is a 20 degree change of contracture with a palpable cord, or the joint undergoing medical or surgical intervention. Of the 623 joints assessed, only 12.8 percent of those joints received medical or surgical intervention through Year 4 and of these patients, most were retreated with XIAFLEX. The data also reveal no new long-term adverse events. Of the 86 serious AEs reported through four years of follow-up, only one was considered related to XIAFLEX (decrease in ring finger circumference due to Dupuytren's contracture resolution).
Additional data highlights from the CORDLESS study can be found in Auxilium's press release issued today.
CORDLESS study authors also presented an update on XIAFLEX safety data following three years of post-approval use and determined that after an estimated 49,078 XIAFLEX injections were administered to approximately 36,500 adult patients in the U.S. for the treatment of Dupuytren's contracture with a palpable cord, there was no clinically meaningful change in the nature of events reported relative to the one year post-marketing safety profile. Adverse events were most commonly localized, non-serious reactions to XIAFLEX injections, including skin tears, contusion (bruising), peripheral edema (swelling), extremity pain and injection site reactions.
Based on data from a previous Phase 3b trial, Stephen Coleman and his colleagues at the Brisbane Hand and Upper Limb Clinic provided an analysis on the use of local anesthesia (LA) prior to Dupuytren's contracture correction procedures. Sixty adult patients with Dupuytren's contracture with a palpable cord were enrolled and treated, with 120 treated joints (75 metacarpophalangeal (MP), 45 proximal interphalangeal (PIP). Overall 27/60 patients received LA prior to finger extension; the remaining patients had finger extension procedures without LA. As presented in the poster , it was determined that the use of LA prior to a finger extension procedure following XIAFLEX injection led to greater improvement in the correction of contracture (82.6% vs. 69.8%), despite the patients having more severe contracture (total fixed flexion contracture (FFC) 90.3˚ vs 84.2˚). It was also demonstrated that PIP joints tended to show a better response than MP joints. Percent changes from baseline including FFC for PIP joints were 74.7% with LA and 59.7% without while MP joints were 77.8% and 74.4%, respectively. LA was not utilized in earlier Phase 3 trials but may allow physicians to use more force during the finger extension procedure without significant added pain to the patient.
 Peimer CA et al. Nonsurgical treatment of Dupuytren's contracture: 1-year US post-marketing safety data for collagenase clostridium histolyticum. Hand. 2012;7:143-146.
 Coleman S et al. Use of Local Anesthesia Prior to Finger Extension Following Injection of Collagenase Clostridium Histolyticum for Dupuytren's Contracture. Poster presented at ASSH 2013, the 68th Annual Meeting of the American Society for Surgery of the Hand. 2013 Oct 3-5; San Francisco CA.
About BioSpecifics Technologies Corp.
BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed injectable collagenase for twelve clinical indications to date. Injectable collagenase is currently marketed as XIAFLEX® (collagenase clostridium histolyticum (CCH)) in the U.S. for the treatment of adult Dupuytren's contracture patients with a palpable cord in the palm by BioSpecifics' partner, Auxilium Pharmaceuticals, Inc. (Auxilium) and marketed in Europe and approved in Canada. Swedish Orphan Biovitrum AB has marketing rights for XIAPEX® (the EU tradename for CCH) for the treatment of Dupuytren's contracture and Peyronie's disease in 71 Eurasian and African countries. Asahi Kasei Pharma Corporation has development and commercialization rights for XIAFLEX for the treatment of Dupuytren's contracture and Peyronie's disease in Japan and Actelion Pharmaceuticals Ltd. has development and commercialization rights for XIAFLEX for these two indications in Canada, Mexico, Brazil and Australia. CCH is in clinical development for the treatment of several additional promising indications. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set an action date for XIAFLEX for Peyronie's disease of December 6, 2013. Auxilium is testing CCH for frozen shoulder syndrome and cellulite and expects to initiate a Phase II trial of CCH for cellulite and next stage trials of CCH for frozen shoulder syndrome in the fourth quarter of 2013. BioSpecifics is currently managing the development of CCH for the treatment of human and canine lipomas, both of which are in Phase II trials, and expects to report top-line data from these trials by the end of 2013. For more information, please visit www.biospecifics.com.
This release includes "forward-looking statements" within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are "forward-looking statements". The forward-looking statements include statements concerning, among other things, the timing of the review and potential approval by the FDA of XIAFLEX as a treatment for Peyronie's disease; the extent to which additional indications are promising; the timing for Auxilium to initiate a phase II trial of CCH as a treatment for cellulite and next stage trials of CCH as a treatment for frozen shoulder; and the timing of reporting top-line data from BioSpecifics' trials of CCH for the treatment of human lipoma and canine lipoma. In some cases, you can identify these statements by forward-looking words such as "believe," "expect," "anticipate," "plan," "estimate," "likely," "may," "will," "could," "continue," "project," "predict," "goal," the negative or plural of these words, and other similar expressions. These forward-looking statements are our predictions based on our current expectations and our projections about future events. There are a number of important factors that could cause our actual results to differ materially from those indicated by such forward-looking statements, including the ability of Auxilium and its partners to achieve their respective objectives for XIAFLEX in their applicable territories; the uncertainties inherent in the initiation of future clinical trials; Auxilium or any of its partners modifying their respective objectives and/or allocating resources other than to XIAFLEX; the potential market for XIAFLEX in a given indication being smaller than anticipated; the potential of XIAFLEX to be used in additional indications and the initiation, timing and outcome of clinical trials of XIAFLEX for additional indications; the timing of regulatory filings and action; the receipt of any applicable milestone payments from Auxilium; and other risk factors identified in our Annual Report on Form 10-K for the year ended December 31, 2012, our Quarterly Reports on Form 10-Q for the quarters ended March 31, 2013 and June 30, 2013, and our Current Reports on Form 8-K filed with the SEC. All forward-looking statements included in this release are made as of the date hereof, and we assume no obligation to update these forward-looking statements.
SOURCE BioSpecifics Technologies Corp.
Internet of @ThingsExpo has announced today that Chris Matthieu has been named tech chair of Internet of @ThingsExpo 2017 New York The 7th Internet of @ThingsExpo will take place on June 6-8, 2017, at the Javits Center in New York City, New York. Chris Matthieu is the co-founder and CTO of Octoblu, a revolutionary real-time IoT platform recently acquired by Citrix. Octoblu connects things, systems, people and clouds to a global mesh network allowing users to automate and control design flo...
Dec. 8, 2016 04:30 AM EST Reads: 722
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.
Dec. 8, 2016 04:00 AM EST Reads: 4,811
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...
Dec. 8, 2016 04:00 AM EST Reads: 3,789
"We're a cybersecurity firm that specializes in engineering security solutions both at the software and hardware level. Security cannot be an after-the-fact afterthought, which is what it's become," stated Richard Blech, Chief Executive Officer at Secure Channels, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 8, 2016 04:00 AM EST Reads: 1,025
According to Forrester Research, every business will become either a digital predator or digital prey by 2020. To avoid demise, organizations must rapidly create new sources of value in their end-to-end customer experiences. True digital predators also must break down information and process silos and extend digital transformation initiatives to empower employees with the digital resources needed to win, serve, and retain customers.
Dec. 8, 2016 02:45 AM EST Reads: 1,295
The WebRTC Summit New York, to be held June 6-8, 2017, at the Javits Center in New York City, NY, announces that its Call for Papers is now open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 20th International Cloud Expo and @ThingsExpo. WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web co...
Dec. 8, 2016 01:45 AM EST Reads: 1,406
In his general session at 19th Cloud Expo, Manish Dixit, VP of Product and Engineering at Dice, discussed how Dice leverages data insights and tools to help both tech professionals and recruiters better understand how skills relate to each other and which skills are in high demand using interactive visualizations and salary indicator tools to maximize earning potential. Manish Dixit is VP of Product and Engineering at Dice. As the leader of the Product, Engineering and Data Sciences team at D...
Dec. 8, 2016 12:30 AM EST Reads: 1,122
The Internet of Things (IoT) promises to simplify and streamline our lives by automating routine tasks that distract us from our goals. This promise is based on the ubiquitous deployment of smart, connected devices that link everything from industrial control systems to automobiles to refrigerators. Unfortunately, comparatively few of the devices currently deployed have been developed with an eye toward security, and as the DDoS attacks of late October 2016 have demonstrated, this oversight can ...
Dec. 8, 2016 12:15 AM EST Reads: 1,347
What happens when the different parts of a vehicle become smarter than the vehicle itself? As we move toward the era of smart everything, hundreds of entities in a vehicle that communicate with each other, the vehicle and external systems create a need for identity orchestration so that all entities work as a conglomerate. Much like an orchestra without a conductor, without the ability to secure, control, and connect the link between a vehicle’s head unit, devices, and systems and to manage the ...
Dec. 7, 2016 10:30 PM EST Reads: 874
"Once customers get a year into their IoT deployments, they start to realize that they may have been shortsighted in the ways they built out their deployment and the key thing I see a lot of people looking at is - how can I take equipment data, pull it back in an IoT solution and show it in a dashboard," stated Dave McCarthy, Director of Products at Bsquare Corporation, in this SYS-CON.tv interview at @ThingsExpo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 7, 2016 10:00 PM EST Reads: 1,196
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, discussed the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Dec. 7, 2016 08:15 PM EST Reads: 2,226
Businesses and business units of all sizes can benefit from cloud computing, but many don't want the cost, performance and security concerns of public cloud nor the complexity of building their own private clouds. Today, some cloud vendors are using artificial intelligence (AI) to simplify cloud deployment and management. In his session at 20th Cloud Expo, Ajay Gulati, Co-founder and CEO of ZeroStack, will discuss how AI can simplify cloud operations. He will cover the following topics: why clou...
Dec. 7, 2016 05:15 PM EST Reads: 938
As data explodes in quantity, importance and from new sources, the need for managing and protecting data residing across physical, virtual, and cloud environments grow with it. Managing data includes protecting it, indexing and classifying it for true, long-term management, compliance and E-Discovery. Commvault can ensure this with a single pane of glass solution – whether in a private cloud, a Service Provider delivered public cloud or a hybrid cloud environment – across the heterogeneous enter...
Dec. 7, 2016 05:15 PM EST Reads: 1,765
Everyone knows that truly innovative companies learn as they go along, pushing boundaries in response to market changes and demands. What's more of a mystery is how to balance innovation on a fresh platform built from scratch with the legacy tech stack, product suite and customers that continue to serve as the business' foundation. In his General Session at 19th Cloud Expo, Michael Chambliss, Head of Engineering at ReadyTalk, discussed why and how ReadyTalk diverted from healthy revenue and mor...
Dec. 7, 2016 04:30 PM EST Reads: 1,684
The many IoT deployments around the world are busy integrating smart devices and sensors into their enterprise IT infrastructures. Yet all of this technology – and there are an amazing number of choices – is of no use without the software to gather, communicate, and analyze the new data flows. Without software, there is no IT. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, Dave McCarthy, Director of Products at Bsquare Corporation; Alan Williamson, Principal...
Dec. 7, 2016 04:15 PM EST Reads: 427
The 20th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held June 6-8, 2017, at the Javits Center in New York City, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Containers, 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 opportunity. Submit your speaking proposal ...
Dec. 7, 2016 03:45 PM EST Reads: 2,274
You have great SaaS business app ideas. You want to turn your idea quickly into a functional and engaging proof of concept. You need to be able to modify it to meet customers' needs, and you need to deliver a complete and secure SaaS application. How could you achieve all the above and yet avoid unforeseen IT requirements that add unnecessary cost and complexity? You also want your app to be responsive in any device at any time. In his session at 19th Cloud Expo, Mark Allen, General Manager of...
Dec. 7, 2016 03:30 PM EST Reads: 1,793
Successful digital transformation requires new organizational competencies and capabilities. Research tells us that the biggest impediment to successful transformation is human; consequently, the biggest enabler is a properly skilled and empowered workforce. In the digital age, new individual and collective competencies are required. In his session at 19th Cloud Expo, Bob Newhouse, CEO and founder of Agilitiv, drew together recent research and lessons learned from emerging and established compa...
Dec. 7, 2016 02:30 PM EST Reads: 950
"IoT is going to be a huge industry with a lot of value for end users, for industries, for consumers, for manufacturers. How can we use cloud to effectively manage IoT applications," stated Ian Khan, Innovation & Marketing Manager at Solgeniakhela, in this SYS-CON.tv interview at @ThingsExpo, held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
Dec. 7, 2016 02:30 PM EST Reads: 4,328
Financial Technology has become a topic of intense interest throughout the cloud developer and enterprise IT communities. Accordingly, attendees at the upcoming 20th Cloud Expo at the Javits Center in New York, June 6-8, 2017, will find fresh new content in a new track called FinTech.
Dec. 7, 2016 02:15 PM EST Reads: 2,205