|By Marketwired .||
|November 7, 2012 02:19 PM EST||
VANCOUVER, BRITISH COLUMBIA -- (Marketwire) -- 11/07/12 -- RepliCel Life Sciences Inc. (OTCBB:REPCF) (the "Company" or "RepliCel") is pleased to report on its pre-filing scientific meeting with the German Competent Authority responsible for cellular therapies - the Paul Ehrlich Institute (PEI).
During the latter part of 2012, the Company has been making enhancements to the RepliCel(TM) procedure to improve the quality, characterization, and shelf-life of its autologous hair cell product which has been named RCH-01. RepliCel's scientific team met with experts from the PEI on November 2, 2012 to discuss these important revisions and to receive guidance on its proposed current Good Manufacturing Practice (cGMP)-compliant manufacturing process and product specifications that will be used in the conduct of RepliCel's upcoming Phase II, dose-ranging clinical trial. The PEI experts agreed that the proposed manufacturing process for RCH-01 is acceptable for the conduct of a Phase II study and recommended some additional validation work on the manufacturing process be included in the investigational medicinal product dossier (IMPD) that forms part of the clinical trial application.
The results achieved at this meeting have laid the groundwork for the next pre-filing meeting with PEI experts during which time RepliCel's scientific team will discuss the design and methodology of its Phase II clinical trial to be implemented in Germany. This trial is designed to confirm the efficacy of injections of RCH-01 in over 100 male participants. In addition to augmenting the Company's information on the safety of injections of RCH-01, the trial will also provide insight into the optimal treatment regimen for hair growth. The meeting with the PEI, and subsequent confirmation of the design of the Phase II clinical trial, will be completed prior to the end of 2012.
RepliCel's scientific team anticipates the non-binding recommendations received at these meetings, in advance of submitting the formal clinical trial application, will help ensure that all regulatory requirements are met in order to facilitate a smooth review, approval, and implementation of future clinical research. The Company anticipates initiation of the Phase II study by mid-2013.
"We are pleased with the direction and counsel offered by the experts at the PEI," stated Darrell Panich, RepliCel's VP Clinical Affairs. "Our next step is to reappear before a different panel of experts at the PEI next month to obtain counsel that will assist us in finalizing the clinical design which will allow us to complete our application. We are delighted to be one step closer to the initiation of our Phase II trial."
About RepliCel Life Sciences
The Company has developed RepliCel(TM), a natural hair cell replication technology that has the potential to become the world's first, minimally invasive solution for androgenetic alopecia and general hair loss in men and women. RepliCel(TM) is based on autologous cell implantation technology that replicates a patient's hair cells from their own healthy hair follicles and, when reintroduced into areas of hair loss, the Company hopes to initiate natural hair regeneration. Patents for the technology have been issued by the European Union and Australia and are pending in other major international jurisdictions. The RepliCel(TM) procedure has been developed over the past ten years by the Company's recognized research scientists and medical experts - specialists in the fields of hair growth, hair biology and dermatology. Additional information on RepliCel is available at www.replicel.com.
Notice Regarding Forward Looking Statements
This press release contains projections and forward-looking statements, as that term is defined under applicable securities laws. Statements in this press release, which are not purely historical, are forward-looking statements and include that RepliCel(TM) has the potential to become the world's first, minimally invasive solution for androgenetic alopecia and general hair loss in men and women and that RepliCel will initiate the Phase II study by mid-2013. These statements are only predictions and involve known and unknown risks which may cause actual results and the Company's plans and objectives to differ materially from those expressed in the forward-looking information, including: negative results from the Company's clinical trials; the inability to meet the proposed timeline for clinical trials; the effects of government regulation on the Company's business; risks associated with the Company's ability to obtain and protect rights to its intellectual property; risks and uncertainties associated with the Company's ability to raise additional capital; and other factors beyond the Company's control. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, it cannot guarantee future results, levels of activity or performance. Further, any forward-looking statements speak only as of the date on which such statement is made, and, except as required by applicable law, the Company undertakes no obligation to update any forward-looking statement to reflect events or circumstances after the date on which such statement is made or to reflect the occurrence of unanticipated events. New factors emerge from time to time, and it is not possible for management to predict all of such factors and to assess in advance the impact of such factors on the Company's business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statement. Readers should consult all of the information set forth herein and should also refer to the risk factor disclosure outlined in the Company's annual report on Form 20-F for the fiscal year ended December 31, 2011 and other periodic reports filed from time-to-time with the Securities and Exchange Commission on Edgar at www.sec.gov and with the British Columbia Securities Commission on SEDAR at www.sedar.com.
Identity is in everything and customers are looking to their providers to ensure the security of their identities, transactions and data. With the increased reliance on cloud-based services, service providers must build security and trust into their offerings, adding value to customers and improving the user experience. Making identity, security and privacy easy for customers provides a unique advantage over the competition.
Aug. 29, 2016 08:30 PM EDT Reads: 2,435
Qosmos has announced new milestones in the detection of encrypted traffic and in protocol signature coverage. Qosmos latest software can accurately classify traffic encrypted with SSL/TLS (e.g., Google, Facebook, WhatsApp), P2P traffic (e.g., BitTorrent, MuTorrent, Vuze), and Skype, while preserving the privacy of communication content. These new classification techniques mean that traffic optimization, policy enforcement, and user experience are largely unaffected by encryption. In respect wit...
Aug. 29, 2016 08:15 PM EDT Reads: 1,865
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. 29, 2016 08:00 PM EDT Reads: 908
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. 29, 2016 07:45 PM EDT Reads: 1,657
SYS-CON Events announced today that 910Telecom 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. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...
Aug. 29, 2016 07:00 PM EDT Reads: 1,978
Traditional on-premises data centers have long been the domain of modern data platforms like Apache Hadoop, meaning companies who build their business on public cloud were challenged to run Big Data processing and analytics at scale. But recent advancements in Hadoop performance, security, and most importantly cloud-native integrations, are giving organizations the ability to truly gain value from all their data. In his session at 19th Cloud Expo, David Tishgart, Director of Product Marketing ...
Aug. 29, 2016 06:45 PM EDT Reads: 827
Almost two-thirds of companies either have or soon will have IoT as the backbone of their business in 2016. However, IoT is far more complex than most firms expected. How can you not get trapped in the pitfalls? In his session at @ThingsExpo, Tony Shan, a renowned visionary and thought leader, will introduce a holistic method of IoTification, which is the process of IoTifying the existing technology and business models to adopt and leverage IoT. He will drill down to the components in this fra...
Aug. 29, 2016 06:15 PM EDT Reads: 305
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. 29, 2016 06:15 PM EDT Reads: 789
Why do your mobile transformations need to happen today? Mobile is the strategy that enterprise transformation centers on to drive customer engagement. In his general session at @ThingsExpo, Roger Woods, Director, Mobile Product & Strategy – Adobe Marketing Cloud, covered key IoT and mobile trends that are forcing mobile transformation, key components of a solid mobile strategy and explored how brands are effectively driving mobile change throughout the enterprise.
Aug. 29, 2016 05:03 PM EDT Reads: 250
DevOps at Cloud Expo – being held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA – announces that its Call for Papers is open. Born out of proven success in agile development, cloud computing, and process automation, DevOps is a macro trend you cannot afford to miss. From showcase success stories from early adopters and web-scale businesses, DevOps is expanding to organizations of all sizes, including the world's largest enterprises – and delivering real results. Am...
Aug. 29, 2016 04:30 PM EDT Reads: 3,564
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. All major researchers estimate there will be tens of billions devices - comp...
Aug. 29, 2016 02:15 PM EDT Reads: 3,741
As the world moves toward more DevOps and Microservices, application deployment to the cloud ought to become a lot simpler. The Microservices architecture, which is the basis of many new age distributed systems such as OpenStack, NetFlix and so on, is at the heart of Cloud Foundry - a complete developer-oriented Platform as a Service (PaaS) that is IaaS agnostic and supports vCloud, OpenStack and AWS. Serverless computing is revolutionizing computing. In his session at 19th Cloud Expo, Raghav...
Aug. 29, 2016 02:00 PM EDT Reads: 992
DevOps at Cloud Expo, taking place Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long dev...
Aug. 29, 2016 02:00 PM EDT Reads: 2,482
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, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Aug. 29, 2016 12:45 PM EDT Reads: 2,026
There is growing need for data-driven applications and the need for digital platforms to build these apps. In his session at 19th Cloud Expo, Muddu Sudhakar, VP and GM of Security & IoT at Splunk, will cover different PaaS solutions and Big Data platforms that are available to build applications. In addition, AI and machine learning are creating new requirements that developers need in the building of next-gen apps. The next-generation digital platforms have some of the past platform needs a...
Aug. 29, 2016 12:15 PM EDT Reads: 832