Artificial Intelligence
Progenics Pharmaceuticals Announces Phase 3 CONDOR Trial of PyL™ in Prostate Cancer Achieved Primary Endpoint
– Met Primary Endpoint With a Correct Localization Rate of 84.8–87.0%, Highlighting Strong Diagnostic Performance
– Company Expects to Submit an NDA to the FDA in the Second Half of 2020
– Conference Call at 8:00 AM Eastern Time
NEW YORK, Dec. 23, 2019 (GLOBE NEWSWIRE) — Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company developing innovative targeted medicines and artificial intelligence to find, fight and follow cancer, today announced positive top line results from the Phase 3 CONDOR trial evaluating the diagnostic performance and clinical impact of PyL™ (18F-DCFPyL) in men with biochemical recurrence of prostate cancer. PyL is the Company’s PSMA-targeted small molecule positron emission tomography (PET) imaging agent designed to visualize prostate cancer.
“There is a need for improved diagnostics for prostate cancer to replace conventional imaging tests that have limited performance characteristics, especially in men with biochemical recurrence of their disease,” said Barry Siegel, MD, Professor of Radiology at Washington University School of Medicine in St. Louis. “The high positive predictive value demonstrated in this study reflects the clinical utility of PSMA-targeted PET imaging agents providing actionable information to physicians to guide treatment plans and improve disease management of one of the most prevalent cancers in the U.S.”
The Phase 3 CONDOR trial is a prospective, multi-center, open label pivotal trial in which 208 patients with biochemical recurrence of prostate cancer and uninformative baseline imaging based on conventional modalities (i.e. Axumin, Choline PET, CT/MR and/or bone scan) were dosed and imaged with PyL at 14 sites in the United States and Canada. The CONDOR trial achieved its primary endpoint, with a correct localization rate (CLR) of 84.8% to 87.0% among the three blinded independent readers (the lower bound of the 95% confidence intervals ranging from 77.8% to 80.4%). CLR is based on positive predictive value, defined as the percentage of patients with a one-to-one correspondence between localization of at least one lesion identified on 18F-DCFPyL PET/CT and a composite truth standard comprised of histopathology, conventional imaging and/or changes in PSA levels following radiation therapy.
Safety results showed PyL was well tolerated, consistent with the Phase 2 OSPREY trial results. There was one serious adverse event of hypersensitivity reported in one patient as related to the study drug. The most frequent adverse event reported was headache, which was reported in four patients (1.9% of the trial population).
“The positive results of our Phase 3 CONDOR trial reinforce our belief in the potential of PyL to enable better physician treatment decisions and, ultimately, improve patient outcomes. The rapid trial enrollment and physician support further underscore the excitement and positive reception of PyL as a new addition in the fight against prostate cancer and, together with the commercial performance of diagnostic agents in use today, reinforce our belief in the significant market opportunity for PyL,” said David Mims, Interim CEO. “Based on these positive results, we plan to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for PyL in the second half of 2020.”
Additional results from the CONDOR trial are expected to be presented at an upcoming medical meeting.
Investor Conference Call
Progenics will host a conference call today at 8:00 AM Eastern Time to discuss the results. The live and replayed webcast of the call will be available through the Company’s website at www.progenics.com. To participate in the live call by phone, dial (877) 250-8889 (USA) or (720) 545-0001 (international) and enter the passcode 9165086. The replay of the call will be available for 90 days.
About PyL™ for PET Imaging of Prostate Cancer
PyL (also known as 18F-DCFPyL) is a fluorinated PSMA-targeted positron emission tomography (“PET”) imaging agent that enables visualization of both bone and soft tissue metastases to determine the presence or absence of recurrent and/or metastatic prostate cancer.
About Prostate Cancer
Prostate cancer is the second most common form of cancer affecting men in the United States: an estimated one in nine men will be diagnosed with prostate cancer in his lifetime. The American Cancer Society estimates that each year approximately 174,650 new cases of prostate cancer will be diagnosed and about 31,620 men will die of the disease. Approximately 2.9 million men in the U.S. currently count themselves among prostate cancer survivors.
About PROGENICS
Progenics is an oncology company focused on the development and commercialization of innovative targeted medicines and artificial intelligence to find, fight and follow cancer, including: therapeutic agents designed to treat cancer (AZEDRA®, 1095, and PSMA TTC); prostate-specific membrane antigen (“PSMA”) targeted imaging agents for prostate cancer (PyL™ and 1404); and imaging analysis technology (aBSI and PSMA AI). Progenics has three commercial products, AZEDRA, for the treatment of patients with unresectable, locally advanced or metastatic pheochromocytoma or paraganglioma (rare neuroendocrine tumors of neural crest origin) who require systemic anticancer therapy; and oral and subcutaneous formulations of RELISTOR® (methylnaltrexone bromide) for the treatment of opioid-induced constipation, which are partnered with Bausch Health Companies Inc.
Forward Looking Statements
This press release contains projections and other “forward-looking statements” regarding future events. Statements contained in this communication that refer to Progenics’ estimated or anticipated future results or other non-historical facts are forward-looking statements that reflect Progenics’ current perspective of existing trends and information as of the date of this communication and include statements regarding Progenics’ strategic and operational plans and delivering value for shareholders. Forward looking statements generally will be accompanied by words such as “anticipate,” “believe,” “plan,” “could,” “should,” “estimate,” “expect,” “forecast,” “outlook,” “guidance,” “intend,” “may,” “might,” “will,” “possible,” “potential,” “predict,” “project,” or other similar words, phrases or expressions. Such statements are predictions only and are subject to risks and uncertainties that could cause actual events or results to differ materially. These risks and uncertainties include, among others: risks associated with the proposed merger transaction with Lantheus Holdings, Inc.; market acceptance for approved products; the risk that the commercial launch of AZEDRA may not meet revenue and income expectations; the cost, timing and unpredictability of results of clinical trials and other development activities and collaborations; the unpredictability of the duration and results of regulatory review of New Drug Applications (NDA) and Investigational NDAs; the inherent uncertainty of outcomes in the intellectual property disputes such as the dispute with the University of Heidelberg regarding PSMA-617; our ability to successfully develop and commercialize products that incorporate licensed intellectual property; the effectiveness of the efforts of our partners to market and sell products on which we collaborate and the royalty revenue generated thereby; generic and other competition; the possible impairment of, inability to obtain and costs of obtaining intellectual property rights; possible product safety or efficacy concerns, general business, financial, regulatory and accounting matters, litigation and other risks; and risks related to changes in the composition of our Board of Directors following the delivery of shareholder consents in response to the recent consent solicitation conducted by one of our shareholders. More information concerning Progenics and such risks and uncertainties is available on its website, and in its press releases and reports it files with the Securities and Exchange Commission (the “SEC”), including those risk factors included in its Annual Report on Form 10-K for the year ended December 31, 2018, as updated in its subsequent Quarterly Reports on Form 10-Q. Progenics is providing the information in this press release as of its date and, except as expressly required by law, Progenics disclaims any intent or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or circumstances or otherwise.
Additional information concerning Progenics and its business may be available in press releases or other public announcements and public filings made after this press release. For more information, please visit www.progenics.com. Information on or accessed through our website or social media sites is not included in the company’s SEC filings.
(PGNX-F)
Contact
Melissa Downs
Investor Relations
(646) 975-2533
[email protected]
Artificial Intelligence
Oncolytics Biotech® Announces Upcoming Presentations at the American Society of Clinical Oncology Annual Meeting
SAN DIEGO and CALGARY, AB, April 25, 2024 /PRNewswire/ — Oncolytics Biotech® Inc. (NASDAQ: ONCY) (TSX: ONC), a leading clinical-stage company specializing in immunotherapy for oncology, today announced the acceptance of two abstracts at the 2024 American Society of Clinical Oncology (ASCO) Annual Meeting, which is taking place from May 31 – June 4, 2024, in Chicago, Illinois. Details on the abstracts and poster presentation are shown below.
Title: Phase 1/2 randomized, open-label, multicenter, Simon two-stage study of pelareorep combined with modified FOLFIRINOX +/- atezolizumab in patients with metastatic pancreatic ductal adenocarcinoma.
Presentation Type: PosterAbstract Number: TPS4203Session Title: Gastrointestinal Cancer – Gastroesophageal, Pancreatic, and HepatobiliarySession Date and Time: June 1, 2024, 1:30 – 4:30 p.m. CTTitle: Pelareorep driven blood TIL expansion in patients with pancreatic, breast and colon cancer.Presentation Type: Online abstractAbstract Number: e14625
Abstracts will be published on the ASCO Annual Meeting website at 5:00 p.m. ET on May 23, 2024.
About Oncolytics Biotech Inc.
Oncolytics is a clinical-stage biotechnology company developing pelareorep, an intravenously delivered immunotherapeutic agent. Pelareorep has demonstrated promising results in two randomized Phase 2 studies in metastatic breast cancer and Phase 1 and 2 studies in pancreatic cancer. It acts by inducing anti-cancer immune responses and promotes an inflamed tumor phenotype — turning “cold” tumors “hot” — through innate and adaptive immune responses to treat a variety of cancers.
Pelareorep has demonstrated synergies with multiple approved oncology treatments. Oncolytics is currently conducting and planning combination clinical trials with pelareorep in solid and hematological malignancies as it advances towards registrational studies in metastatic breast cancer and pancreatic cancer, both of which have received Fast Track designation from the FDA. For further information, please visit: www.oncolyticsbiotech.com or follow the company on social media on LinkedIn and on X @oncolytics.
Company Contact
Jon Patton
Director of IR & Communication
[email protected]
Investor Relations for Oncolytics
Timothy McCarthy
LifeSci Advisors
+1-917-679-9282
[email protected]
View original content:https://www.prnewswire.co.uk/news-releases/oncolytics-biotech-announces-upcoming-presentations-at-the-american-society-of-clinical-oncology-annual-meeting-302127245.html
Artificial Intelligence
Internet of Things (IoT) Market to Expand at a Stellar 19.4% CAGR through 2031 | SkyQuest Technology
WESTFORD, Mass., April 25, 2024 /PRNewswire/ — SkyQuest projects that the Internet of Things (IoT) Market will attain a value of USD 1572.37 billion by 2031, with a CAGR of 19.4% over the forecast period (2024-2031). Internet of Things (IoT) refers to the network of connected devices over the internet that are embedded with sensors and software. Growing adoption of automation around the world and advancements in connected device technologies are forecasted to be key factors driving the Internet of Things (IoT) market growth in the future.
Download a detailed overview:
https://www.skyquestt.com/report/internet-of-things-market
Browse in-depth TOC on “Internet of Things (IoT) Market”
Pages – 197Tables – 69Figures – 75Internet of Things (IoT) Market Overview:
Report Coverage
Details
Market Revenue in 2023
$ 380.6 billion
Estimated Value by 2031
$1572.37 billion
Growth Rate
Poised to grow at a CAGR of 19.4%
Forecast Period
2024–2031
Forecast Units
Value (USD Billion)
Report Coverage
Revenue Forecast, Competitive Landscape, Growth Factors, and Trends
Segments Covered
Component Type, Application, and Region
Geographies Covered
North America, Europe, Asia Pacific, and the Rest of the world
Report Highlights
Updated financial information / product portfolio of players
Key Market Opportunities
Rising demand for connected healthcare and growing use of industrial automation solutions
Key Market Drivers
Advancements in connectivity and connected device technologies
Hardware is Estimated to Dominate the Global Market Share Owing to High Use of Hardware Components in IoT
Hardware components such as sensors and actuators are highly vital to the proper functioning of any kind of Internet of Things (IoT) device. Growing adoption of IoT devices in different industry verticals for various applications is promoting market growth via this segment. The development of new hardware solutions also helps this segment maintain its dominance.
Smart Agriculture is the Fastest-growing Segment Owing to Rising Adoption of Precision Agriculture Practice
Rising emphasis on improving agricultural yield and sustainability has resulted in the growing adoption of smart agriculture and precision agriculture practices. IoT devices play a crucial role in monitoring and controlling different elements of a smart agriculture setup that is mostly automated using different smart devices thereby contributing to the IoT market growth as well.
Growing Adoption of 5G Technology Allowing North America to Dominate the Global Internet of Things (IoT) Market
Rapid adoption of 5G technology and high use of cloud-based platforms are key factors allowing North America to lead the demand for Internet of Things (IoT) around the world. Surging investments in the research and development of advanced technologies and the presence of key tech giants such as Amazon, Google, IBM, and Microsoft also helps the dominance of this region. Canada and the United States remain the most lucrative markets for Internet of Things (IoT) companies in North America through 2031.
Request Free Customization of this report:
https://www.skyquestt.com/speak-with-analyst/internet-of-things-market
Internet of Things (IoT) Market Insights:
Drivers
Advancements in connectivity and connected device technologies.Growing demand for Industrial IoT (IIoT) solutions.Increasing number of smart cities and development of smart infrastructure.Restraints
Lack of standardization of IoT devices and technologies.Privacy and data security issues.Interoperability challenges and complex integration scenarios.Prominent Players in Internet of Things (IoT) Market
MicrosoftCisco SystemsIntelSiemens (Germany)AWS (US)Oracle (US)Qualcomm (UK)SAP (Germany)IBM (US)Google (US)View report summary and Table of Contents (TOC):
https://www.skyquestt.com/report/internet-of-things-market
Key Questions Answered in Internet of Things (IoT) Market Report
What are the top drivers for Internet of Things (IoT) market going forward?Who are the leading Internet of Things (IoT) market players?Where will demand for Internet of Things (IoT) be high?Which component accounts for a dominant revenue share of the global Internet of Things (IoT) market?This report provides the following insights:
Analysis of key drivers (advancements in connectivity and connected device technologies, growing demand for industrial IoT (IIoT), development of smart infrastructure for smart cities, growing use of smart devices ), restraints (lack of standardization, complexities in integration, concerns regarding security and privacy of data), and opportunities (rising popularity of connected healthcare, increasing adoption of Industry 4.0, rising use of industrial automation), influencing the growth of Internet of Things (IoT) market.Market Penetration: All-inclusive analysis of product portfolio of different market players and status of new product launches.Product Development/Innovation: Elaborate assessment of R&D activities, new product development, and upcoming trends of the Internet of Things (IoT) market.Market Development: Detailed analysis of potential regions where the market has potential to grow.Market Diversification: Comprehensive assessment of new product launches, recent developments, and emerging regional markets.Competitive Landscape: Detailed analysis of growth strategies, revenue analysis, and product innovation by new and established market players.Related Reports:
Global Internet of Things in Retail Market
Global Internet of Things (IoT) in Agriculture Market
Global Internet of Things (IoT) Microcontroller Market
Global IOT In Healthcare Market
Global IOT in Manufacturing Market
About Us:
SkyQuest is an IP focused Research and Investment Bank and Accelerator of Technology and assets. We provide access to technologies, markets and finance across sectors viz. Life Sciences, CleanTech, AgriTech, NanoTech and Information & Communication Technology.
We work closely with innovators, inventors, innovation seekers, entrepreneurs, companies and investors alike in leveraging external sources of R&D. Moreover, we help them in optimizing the economic potential of their intellectual assets. Our experiences with innovation management and commercialization has expanded our reach across North America, Europe, ASEAN and Asia Pacific.
Contact:
Mr. Jagraj Singh Skyquest Technology1 Apache Way,Westford,Massachusetts 01886USA (+1) 351-333-4748Email: [email protected] Our Website: https://www.skyquestt.com/
View original content:https://www.prnewswire.co.uk/news-releases/internet-of-things-iot-market-to-expand-at-a-stellar-19-4-cagr-through-2031–skyquest-technology-302127239.html
Artificial Intelligence
Sapiens Unveils Enhanced Reinsurance and Analytics Solution Catering to Evolving Market Demands
Latest version enhances operational efficiency, regulatory reporting, and strategic decision-making with robust business insights
ROCHELLE PARK, N.J., April 25, 2024 /PRNewswire/ — Sapiens International Corporation, (NASDAQ: SPNS) (TASE: SPNS), a leading global provider of software solutions for the insurance industry, today announced the launch of its latest version of Sapiens ReinsuranceMaster.
The new release of Version 9 brings a multitude of enhancements and technology stack updates, designed to empower insurers and reinsurers with robust, enriched functionality to support business requirements. This includes automating global inter-company retrocession, facilitating U.S. NAIC statutory reporting (Schedule F), and real-time reinsurance allocation support (‘reinsurance as a service’).
The latest release offers a multitude of enhancements, with one of the standout features being the seamless integration of Sapiens Intelligence with Sapiens ReinsuranceMaster. This integration empowers users with advanced data capabilities and actionable insights through out-of-the-box reinsurance reports and analytics of the reinsurance portfolio’s performance.
In addition, the new release brings significant improvements to the user experience, with a revamped user interface, enhancements in processing performance through improvements and parallel processing mechanisms, improved scalability and operability.
“With the growing significance of reinsurance in today’s volatile environment, our latest version of Sapiens ReinsuranceMaster with Sapiens Intelligence offers even greater value to insurers and reinsurers, catering to the ever-changing demands of this dynamic market,” said Roni Al-Dor, Sapiens President & CEO. “Leveraging the shared experience from our other products as well as requirements from our global client base, the solution is now very well-positioned to support global automation of complex reinsurance programs and provide management with insights into reinsurance performance as well as statutory reporting.”
Sapiens ReinsuranceMaster is a comprehensive, single platform for large and multi-national reinsurance programs, providing full financial control and flexibility across all lines of business. The solution supports the entire range of reinsurance contracts, providing full support for all auditing requirements and a consolidated view of liabilities and risks, as well as helping prevent financial leakage.
Sapiens Intelligence, now a fully integrated component of Sapiens ReinsuranceMaster v.9, produces actionable insights to maximize the value of data and KPIs for smarter decision making, improving reinsurance business management.
About Sapiens
Sapiens International Corporation (NASDAQ and TASE: SPNS) empowers the financial sector, with a focus on insurance, to transform and become digital, innovative, and agile. With more than 40 years of industry expertise, Sapiens’ cloud-based SaaS insurance platform offers pre-integrated, low-code capabilities across core, data, and digital domains to accelerate our customers’ digital transformation. Serving over 600 customers in more than 30 countries, Sapiens offers insurers across property and casualty, workers’ compensation, and life insurance markets the most comprehensive set of solutions, from core to complementary, including Reinsurance, Financial & Compliance, Data & Analytics, Digital, and Decision Management. For more information visit https://sapiens.com or follow us on LinkedIn
Investor and Media Contact : Yaffa Cohen-Ifrah Sapiens Chief Marketing Officer and Head of Investor Relations Email: [email protected]
Forward Looking Statements
Certain matters discussed in this press release that are incorporated herein and therein by reference are forward-looking statements within the meaning of Section 27A of the Securities Act, Section 21E of the Exchange Act and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, that are based on our beliefs, assumptions and expectations, as well as information currently available to us. Such forward-looking statements may be identified by the use of the words “anticipate,” “believe,” “estimate,” “expect,” “may,” “will,” “plan” and similar expressions. Such statements reflect our current views with respect to future events and are subject to certain risks and uncertainties. There are important factors that could cause our actual results, levels of activity, performance or achievements to differ materially from the results, levels of activity, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to: the degree of our success in our plans to leverage our global footprint to grow our sales; the degree of our success in integrating the companies that we have acquired through the implementation of our M&A growth strategy; the lengthy development cycles for our solutions, which may frustrate our ability to realize revenues and/or profits from our potential new solutions; our lengthy and complex sales cycles, which do not always result in the realization of revenues; the degree of our success in retaining our existing customers or competing effectively for greater market share; the global macroeconomic environment, including headwinds caused by inflation, relatively high interest rates, potentially unfavorable currency exchange rate movements, and uncertain economic conditions, and their impact on our revenues, profitability and cash flows; difficulties in successfully planning and managing changes in the size of our operations; the frequency of the long-term, large, complex projects that we perform that involve complex estimates of project costs and profit margins, which sometimes change mid-stream; the challenges and potential liability that heightened privacy laws and regulations pose to our business; occasional disputes with clients, which may adversely impact our results of operations and our reputation; various intellectual property issues related to our business; potential unanticipated product vulnerabilities or cybersecurity breaches of our or our customers’ systems; risks related to the insurance industry in which our clients operate; risks associated with our global sales and operations, such as changes in regulatory requirements, wide-spread viruses and epidemics like the coronavirus epidemic, and fluctuations in currency exchange rates; and risks related to our principal location in Israel and our status as a Cayman Islands company.
While we believe such forward-looking statements are based on reasonable assumptions, should one or more of the underlying assumptions prove incorrect, or these risks or uncertainties materialize, our actual results may differ materially from those expressed or implied by the forward-looking statements. Please read the risks discussed under the heading “Risk Factors” in our Annual Report on Form 20-F for the year ended December 31, 2023, to be filed in the near future, in order to review conditions that we believe could cause actual results to differ materially from those contemplated by the forward-looking statements. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur. Except as required by law, we undertake no obligation to update publicly any forward-looking statements for any reason, to conform these statements to actual results or to changes in our expectations.
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View original content:https://www.prnewswire.co.uk/news-releases/sapiens-unveils-enhanced-reinsurance-and-analytics-solution-catering-to-evolving-market-demands-302127409.html
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