|By PR Newswire||
|June 5, 2013 09:30 AM EDT||
WORCESTER, Mass. and TORONTO, June 5, 2013 /PRNewswire/ -- Generex Biotechnology Corporation (www.generex.com) (OTCBB: GNBT) today announced two presentations showing the strengths of AE37 as a viable and promising treatment option for patients who have had breast cancer. The compound is being developed by its wholly-owned subsidiary, Antigen Express, Inc. (www.antigenexpress.com). The two presentations were made at the 2013 Annual Meeting of the American Society of Clinical Oncology (ASCO) held in Chicago from May 31 to June 4.
The two presentations focused on the safety and long-term immunity that can be achieved with AE37 treatment. The first presentation, "Risk factors for development of delayed urticarial reactions in the phase II trial of HER2 peptide vaccines plus GM-CSF versus GM-CSF alone in high-risk breast cancer patients to prevent recurrence", by Alfred Trappey et al, reports on cumulative safety data from the ongoing Phase II efficacy study. The maximum toxicities observed (allergic reactions) occur very infrequently, are easily managed, and have no long-term consequences. In addition, they were observed both in the control arm of the study as well as in the peptide arm, indicating that they were associated with the GM-CSF adjuvant rather than the peptide. The demonstrated safety of AE37 in this larger Phase II patient population confirms prior observations from earlier previous Phase I studies.
"I am very pleased with the progress Antigen Express has made over the years, particularly with the AE37 vaccine program," stated Richard Purcell, Chief Operating Officer of Antigen Express. "The AE37 data continues to track positively, as shown by the immunological and safety results presented in Chicago this week. Given the buzz, excitement, and significant focus on immunotherapy at ASCO this year, a big pharma partnership is a realistic expectation for the Company in the near future."
The second presentation extended results from a published 2013 ASCO abstract, ("Effect of immunization with Ii-Key modified HER2 (776-790) peptide vaccine (AE37) on immunologic responses in prostate cancer patients", by Sonia Perez et al) showing that AE37 induced immunological responses for longer time periods than have been observed with any other peptide vaccines used for breast cancer. In particular, the recent presentation "Booster inoculations of the AE37 peptide vaccine enhance immunological responses in a phase II study", by Eleftheria Anastasopoulou et al, showed that administration of AE37 as a booster for up to two years after the initial therapy further increased the level of specific anti-tumor immunity that could be observed in patients. Not only can the specific immune response be maintained but is even augmented by subsequent dosing.
The strong safety profile and superior immunogenicity set AE37 apart, both from other types of immunotherapy as well as other peptide immunotherapies targeting breast cancer. Combined with highly encouraging interim results, showing a reduction of relapse in patients treated with AE37 in a controlled, randomized Phase II efficacy trial, these latest studies support ongoing plans the Company has for a pivotal Phase III registration trial.
"Several distinct products are being developed with the Antigen Express Ii-Key technology and are at various stages of development," said Joe Moscato of Company consultant Seahawk Capital Partners, Inc. "Our attendance at ASCO 2013 gave Antigen Express the opportunity to initiate and continue discussions with multiple interested prospective big pharma partners and collaborators. The different products have applicability in diseases such as breast cancer, prostate cancer, ovarian cancer, influenza, and HIV. Interim data from October of 2011 suggested efficacy in our AE37 breast cancer vaccine, enhanced with our proprietary Ii-Key/HER2 antigen hybrid, has helped to validate Antigen Express' Ii-Key technology overall." Mr. Moscato went on to say: "The Ii-Key hybrid technology allows tumor-associated or foreign antigens, like viral antigens, to potently enhance the immune system's ability to recognize and destroy cancerous or virus-infected cells bearing any of the targeted antigens, as well as generate immunological memory. We are committed to finding alliances and partners to work together on the best clinical trial programs for each distinct product and, as the end of this year approaches, and new data is unveiled in our late-stage Phase IIb breast cancer trial, we are looking to have sufficient positive data to attract and finalize key partnerships and collaborations."
About Generex Biotechnology Corporation
Generex is engaged in the research, development, and commercialization of drug delivery systems and technologies. Generex has developed a proprietary platform technology for the delivery of drugs into the human body through the oral cavity (with no deposit in the lungs). The Company's proprietary liquid formulations allow drugs typically administered by injection to be absorbed into the body by the lining of the inner mouth using the Company's proprietary RapidMist™ device. Antigen Express, Inc. is a wholly owned subsidiary of Generex. The core platform technologies of Antigen Express comprise immunotherapeutic vaccines for the treatment of malignant, infectious, allergic, and autoimmune diseases. Antigen Express has pioneered the use of specific CD4+ T-helper stimulation technologies in immunotherapy. One focuses on modification of peptides with Ii-Key to increase potency, while a second relies on inhibition of expression of the Ii protein. Antigen Express scientists, and others, have shown clearly that suppression of expression of the Ii protein in cancer cells allows for potent stimulation of T-helper cells and prevents the further growth of cancer cells. For more information, visit the Generex website at www.generex.com or the Antigen Express website at www.antigenexpress.com.
Cautionary Note Regarding Forward-Looking Statements
This release and oral statements made from time to time by Generex representatives in respect of the same subject matter may contain "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by introductory words such as "expects," "plan," "believes," "will," "achieve," "anticipate," "would," "should," "subject to" or words of similar meaning, and by the fact that they do not relate strictly to historical or current facts. Forward-looking statements frequently are used in discussing potential product applications, potential collaborations, product development activities, clinical studies, regulatory submissions and approvals, and similar operating matters. Many factors may cause actual results to differ from forward-looking statements, including inaccurate assumptions and a broad variety of risks and uncertainties, some of which are known and others of which are not. Known risks and uncertainties include those identified from time to time in the reports filed by Generex with the Securities and Exchange Commission, which should be considered together with any forward-looking statement. No forward-looking statement is a guarantee of future results or events, and one should avoid placing undue reliance on such statements. Generex undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Generex cannot be sure when or if it will be permitted by regulatory agencies to undertake additional clinical trials or to commence any particular phase of clinical trials. Because of this, statements regarding the expected timing of clinical trials or ultimate regulatory approval cannot be regarded as actual predictions of when Generex will obtain regulatory approval for any "phase" of clinical trials or when it will obtain ultimate regulatory approval by a particular regulatory agency. Generex claims the protection of the safe harbor for forward-looking statements that is contained in the Private Securities Litigation Reform Act.
SOURCE Generex Biotechnology Corporation
In his session at @ThingsExpo, Chris Klein, CEO and Co-founder of Rachio, will discuss next generation communities that are using IoT to create more sustainable, intelligent communities. One example is Sterling Ranch, a 10,000 home development that – with the help of Siemens – will integrate IoT technology into the community to provide residents with energy and water savings as well as intelligent security. Everything from stop lights to sprinkler systems to building infrastructures will run ef...
May. 5, 2016 02:00 AM EDT Reads: 1,281
Redis is not only the fastest database, but it has become the most popular among the new wave of applications running in containers. Redis speeds up just about every data interaction between your users or operational systems. In his session at 18th Cloud Expo, Dave Nielsen, Developer Relations at Redis Labs, will shares the functions and data structures used to solve everyday use cases that are driving Redis' popularity.
May. 5, 2016 01:45 AM EDT Reads: 1,215
Many private cloud projects were built to deliver self-service access to development and test resources. While those clouds delivered faster access to resources, they lacked visibility, control and security needed for production deployments. In their session at 18th Cloud Expo, Steve Anderson, Product Manager at BMC Software, and Rick Lefort, Principal Technical Marketing Consultant at BMC Software, will discuss how a cloud designed for production operations not only helps accelerate developer...
May. 5, 2016 01:00 AM EDT Reads: 1,305
Manufacturers are embracing the Industrial Internet the same way consumers are leveraging Fitbits – to improve overall health and wellness. Both can provide consistent measurement, visibility, and suggest performance improvements customized to help reach goals. Fitbit users can view real-time data and make adjustments to increase their activity. In his session at @ThingsExpo, Mark Bernardo Professional Services Leader, Americas, at GE Digital, will discuss how leveraging the Industrial Interne...
May. 5, 2016 12:45 AM EDT Reads: 1,377
The increasing popularity of the Internet of Things necessitates that our physical and cognitive relationship with wearable technology will change rapidly in the near future. This advent means logging has become a thing of the past. Before, it was on us to track our own data, but now that data is automatically available. What does this mean for mHealth and the "connected" body? In her session at @ThingsExpo, Lisa Calkins, CEO and co-founder of Amadeus Consulting, will discuss the impact of wea...
May. 5, 2016 12:00 AM EDT Reads: 1,189
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
May. 4, 2016 11:45 PM EDT Reads: 1,255
Increasing IoT connectivity is forcing enterprises to find elegant solutions to organize and visualize all incoming data from these connected devices with re-configurable dashboard widgets to effectively allow rapid decision-making for everything from immediate actions in tactical situations to strategic analysis and reporting. In his session at 18th Cloud Expo, Shikhir Singh, Senior Developer Relations Manager at Sencha, will discuss how to create HTML5 dashboards that interact with IoT devic...
May. 4, 2016 09:00 PM EDT Reads: 1,420
Up until last year, enterprises that were looking into cloud services usually undertook a long-term pilot with one of the large cloud providers, running test and dev workloads in the cloud. With cloud’s transition to mainstream adoption in 2015, and with enterprises migrating more and more workloads into the cloud and in between public and private environments, the single-provider approach must be revisited. In his session at 18th Cloud Expo, Yoav Mor, multi-cloud solution evangelist at Cloudy...
May. 4, 2016 07:30 PM EDT Reads: 1,702
In his session at 18th Cloud Expo, Sagi Brody, Chief Technology Officer at Webair Internet Development Inc., will focus on real world deployments of DDoS mitigation strategies in every layer of the network. He will give an overview of methods to prevent these attacks and best practices on how to provide protection in complex cloud platforms. He will also outline what we have found in our experience managing and running thousands of Linux and Unix managed service platforms and what specifically c...
May. 4, 2016 07:00 PM EDT Reads: 1,312
Artificial Intelligence has the potential to massively disrupt IoT. In his session at 18th Cloud Expo, AJ Abdallat, CEO of Beyond AI, will discuss what the five main drivers are in Artificial Intelligence that could shape the future of the Internet of Things. AJ Abdallat is CEO of Beyond AI. He has over 20 years of management experience in the fields of artificial intelligence, sensors, instruments, devices and software for telecommunications, life sciences, environmental monitoring, process...
May. 4, 2016 05:30 PM EDT Reads: 1,400
The demand for organizations to expand their infrastructure to multiple IT environments like the cloud, on-premise, mobile, bring your own device (BYOD) and the Internet of Things (IoT) continues to grow. As this hybrid infrastructure increases, the challenge to monitor the security of these systems increases in volume and complexity. In his session at 18th Cloud Expo, Stephen Coty, Chief Security Evangelist at Alert Logic, will show how properly configured and managed security architecture can...
May. 4, 2016 05:15 PM EDT Reads: 434
We’ve worked with dozens of early adopters across numerous industries and will debunk common misperceptions, which starts with understanding that many of the connected products we’ll use over the next 5 years are already products, they’re just not yet connected. With an IoT product, time-in-market provides much more essential feedback than ever before. Innovation comes from what you do with the data that the connected product provides in order to enhance the customer experience and optimize busi...
May. 4, 2016 05:00 PM EDT Reads: 1,330
Unless you don’t use the internet, don’t live in California, or haven’t been paying attention to the recent news… you should be aware that self-driving cars are on their way to becoming a reality. I have seen them – they are real. If you believe in the future reality of self-driving cars, then continue reading on. If you don’t believe in the future possibilities, then I am not sure what to do to convince you other than discuss the very real changes that will roll out with the consumer producti...
May. 4, 2016 04:30 PM EDT Reads: 829
A critical component of any IoT project is the back-end systems that capture data from remote IoT devices and structure it in a way to answer useful questions. Traditional data warehouse and analytical systems are mature technologies that can be used to handle large data sets, but they are not well suited to many IoT-scale products and the need for real-time insights. At Fuze, we have developed a backend platform as part of our mobility-oriented cloud service that uses Big Data-based approache...
May. 4, 2016 03:30 PM EDT Reads: 659