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StandoutStocks.com: "Stocks that Standout" picks for today are: CPHD, OGXI, PMTC, UNDT

Wed. June 24, 2009; Posted: 11:52 AM
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Jun 24, 2009 (M2 PRESSWIRE via COMTEX) -- UNDT | Quote | Chart | News | PowerRating -- StandoutStocks.com "Stocks that Standout" picks for today are: Cepheid (NASDAQ: CPHD), OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI), PTC (NASDAQ: PMTC), Universal Detection Technology (OTCBB: UNDT)

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Jun 24, 2009 -- Cepheid (NASDAQ: CPHD | Quote | Chart | News | PowerRating) today noted that a new article, Evaluation of Universal Antenatal Screening for Group B Streptococcus, published in the June 2009 issue of the New England Journal of Medicine concluded that rapid, PCR-based testing at the time of admission for delivery may improve the accuracy of Group B streptococcal (GBS) screening over the normal antepartum testing done at 35-37 weeks of gestation.

GBS disease is one of the most common infections in the first week following birth and is a leading cause of infant mortality and serious neonatal infections such as sepsis, pneumonia and meningitis. Transmission of GBS occurs from colonized women to their babies during childbirth.

The new article points out that current U.S. Centers for Disease Control (CDC) guidelines for preventing neonatal GBS disease, which call for culture-based screening of expectant mothers at 35-37 weeks of gestation, have helped to reduce incidence of early-onset GBS disease since their implementation in 2002. However, the study also finds that 61.4% of full-term infants born with GBS disease were born to women who had previously screened negative during their 35-37 week gestation.

"This revealing study shows clearly that screening for GBS at 35 to 37 weeks gestation leaves many newborns at significant risk of GBS infection, presumably due to either false negative culture results or due to a change in GBS status, from negative to positive, over time," said David Persing, MD, PhD, Cepheid's Executive Vice President, Chief Medical & Technology Officer. "As indicated by the study authors, a more accurate way to identify colonization status and target antimicrobial therapy may be to perform a rapid test at or around the time of delivery."

Cepheid's Xpert(R) GBS test is designed to run on a STAT basis, returning positive results in as little as 32 minutes. It is the only in vitro diagnostic test to fully meet current CDC criteria for rapid intrapartum GBS testing. Xpert GBS is also the only PCR-based antepartum and intrapartum GBS test to receive 'Moderate Complexity' CLIA categorization by the U.S. Food & Drug Administration (FDA), enabling healthcare professionals such as labor and delivery nurses to run the test near-patient -- 24 hours a day, 365 days a year.

Xpert GBS runs on Cepheid's GeneXpert(R) System, the world's leading on-demand molecular diagnostic platform.

About the GeneXpert System Molecular Diagnostic Platform

The GeneXpert System is a closed, self-contained, fully-integrated and automated platform that represents a paradigm shift in the automation of molecular analysis, producing accurate results in a timely manner with minimal risk of contamination. The GeneXpert System is the only system to combine on-board sample preparation with real-time PCR (polymerase chain reaction) amplification and detection functions for fully integrated and automated nucleic acid analysis. The system is designed to purify, concentrate, detect and identify targeted nucleic acid sequences thereby delivering answers directly from unprocessed samples. Modular in design, the GeneXpert System has a variety of configurations to meet the broad range of testing demands of any clinical environment.

About Cepheid

Based in Sunnyvale, Calif., Cepheid is an on-demand molecular diagnostics company that develops, manufactures, and markets fully-integrated systems and tests for genetic analysis in the clinical, industrial and biothreat markets. The company's systems enable rapid, sophisticated genetic testing for organisms and genetic-based diseases by automating otherwise complex manual laboratory procedures. The company's easy-to-use systems integrate a number of complicated and time-intensive steps, including sample preparation, DNA amplification and detection, which enable the analysis of complex biological samples in its proprietary test cartridges. Through its strong molecular biology capabilities, the company is focusing on those applications where rapid molecular testing is particularly important, such as identifying infectious disease and cancer in the clinical market; food, agricultural, and environmental testing in the industrial market; and identifying bio-terrorism agents in the biothreat market.

Jun 24, 2009 -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI | Quote | Chart | News | PowerRating) announced today that the company has reached an agreement with the U.S. Food and Drug Administration (FDA) via the special protocol assessment process (SPA) on an amendment to the design of a Phase 3 registration trial of OGX-011, its lead product candidate targeting castrate resistant prostate cancer (CRPC). The FDA has agreed on modifications to the study population of a previously reviewed Phase 3 trial featuring survival as the primary endpoint. The study population has been modified to evaluate patients receiving first-line chemotherapy, rather than those receiving second-line chemotherapy. FDA agreed that the amended protocol adequately addresses the objectives necessary to support a regulatory submission.

"We are now ready to proceed with two Phase 3 trial designs from the FDA via the SPA process, one in first-line and one in second-line treatment of advanced prostate cancer," said Scott Cormack, President and CEO of OncoGenex Pharmaceuticals. "The trial for first-line treatment evaluates overall survival benefit for OGX-011 while the trial for second-line treatment evaluates for a durable pain palliation benefit. Based on the robustness of the OGX-011 survival benefit observed in the randomized Phase 2 trial for first-line docetaxel treatment, we felt evaluating both of these patient populations, as well as both endpoints, in our Phase 3 trials better positions the availability of OGX-011 treatment to a larger number of men with prostate cancer."

The Phase 3 trial has been designed in collaboration with internationally recognized experts in the treatment of patients with castrate resistant prostate cancer (CRPC) including Dr. Celestia Higano at the University of Washington and Dr. Kim Chi at the University of British Columbia. The revised trial will be a randomized, controlled, international study in 800 men with metastatic CRPC who are in need of first-line chemotherapy. Patients will be randomized to receive treatment with either OGX-011 and docetaxel/prednisone or docetaxel/prednisone alone. The primary endpoint of the study will be overall survival. It is expected that approximately 80 sites, primarily from United States and Canada, will participate in this study.

The planned initiation of this Phase 3 trial evaluating survival is supported by Phase 2 data from patients receiving OGX-011 plus docetaxel as first-line chemotherapy presented at the 2009 Annual Meeting of the American Society of Clinical Oncology (ASCO) and reported on May 30th of this year. Analyses indicated the median overall survival in patients with advanced metastatic prostate cancer who were treated with OGX-011 plus docetaxel in a randomized Phase 2 trial was 23.8 months compared to 16.9 months for patients treated with docetaxel alone -- a 6.9 month observed survival advantage for the OGX-011 arm. Furthermore, the unadjusted hazard ratio (HR), a measure used to compare the death rates between treatment groups, was 0.61, representing a 39% lower rate of death for patients treated with OGX-011.

About OGX-011

OGX-011 is designed to inhibit the production of clusterin, a protein that is associated with cancer treatment resistance, and has completed Phase 2 clinical trials in prostate, lung and breast cancer.

Based on clinical results to date, OncoGenex intends to conduct two Phase 3 registration trials with OGX-011 in metastatic castrate resistant prostate cancer, subject to the receipt of additional funding. The U.S. Food & Drug Administration (FDA) has now agreed on the design of both Phase 3 registration trials, via the Special Protocol Assessment (SPA) process, of OGX-011 in combination with chemotherapy. One trial design investigates overall survival as the primary endpoint in patients treated with first-line docetaxel chemotherapy; the other trial design investigates pain palliation as the primary endpoint in patients treated with second-line docetaxel chemotherapy.

OGX-011 has received Fast Track designation from the FDA for the treatment of progressive metastatic prostate cancer in combination with docetaxel.

About the Special Protocol Assessment and Agreement Process

Under a Special Protocol Assessment (SPA), a company and the FDA can reach an agreement on the design and size of a clinical trial to support a regulatory submission. This agreement can be in writing and cannot be changed after the clinical trial begins except: (i) with written agreement of the company and the FDA; or (ii) if the director of the FDA reviewing division determines that "a substantial scientific issue essential to determining the safety or effectiveness of the drug" was identified after testing began.

About OncoGenex

OncoGenex is a biopharmaceutical company committed to the development and commercialization of new therapies that address unmet needs in the treatment of cancer. OncoGenex has a deep oncology pipeline, with each product candidate having a distinct mechanism of action and representing a unique opportunity for cancer drug development. OGX-011, the lead candidate that has completed five Phase 2 clinical trials in prostate, lung and breast cancers, is designed to inhibit the production of a specific protein associated with treatment resistance; OGX-427 is in Phase 1 clinical development; SN2310 has completed the Phase 1 clinical trial; and CSP-9222 and OGX-225 are currently in pre-clinical development.

OGX-011, OGX-427 and OGX-225 utilize second-generation antisense technology, licensed from Isis Pharmaceuticals (NASDAQ: ISIS), to effectively target and inhibit production of specific proteins in tumor cells. OncoGenex and Isis partnered in the successful discovery of OGX-011, OGX-427 and OGX-225 and with respect to OGX-011, in its initial development. In 2008, OncoGenex and Isis amended their OGX-011 agreement to provide OncoGenex with sole rights to OGX-011 and sole responsibility for development and related costs and partnering decisions, subject to financial obligations to Isis. OncoGenex is also solely responsible for development and related costs and partnering decisions regarding OGX-427 and OGX-225. Key intellectual property related to OGX-011, OGX-427 and OGX-225 were discovered by the University of British Columbia and the Vancouver Prostate Centre, and were exclusively licensed to OncoGenex.

Jun 24, 2009 -- PTC (NASDAQ: PMTC), The Product Development Company(R), today announced that it has been ranked top performer within the PLM industry in the recent "Product Lifecycle Management (PLM ) Solutions AXIS for Hardgoods Manufacturers, Q2, 2009 " report by leading technology research and consulting firm, the Aberdeen Group.

The Aberdeen AXIS is an objective, fact-based vendor assessment methodology based on vendor performance in KPI benchmarks from Aberdeen's domain-specific research, and the Market Readiness of the organization determined by over 250 evaluation criteria. The report measures PLM solution providers' capabilities in "Market Readiness" and "Value Delivered" and offers enterprise end-users a platform to understand and select PLM solutions.

According to the report, PTC achieved the highest overall score on Market Readiness and Value Delivered to customers. The report cites PTC's "ability to partner globally and its focus on enabling customer processes" as a key differentiator in the Market Readiness category. PTC's development of a second global headquarters facility in Shanghai, China is highlighted as a demonstration of its commitment to serving Asia and the Pacific Rim. The report also recognized PTC's focus on its customers' business processes and how its Windchill(R) solutions support those processes when planning enhancements and new product capabilities. Aberdeen concludes that "Customers can engage PTC in a discussion with confidence that the out-of-the-box solution can support their processes."

In assessing Value Delivered to customers, the report cites PTC's architectural and development strategy, the overall capabilities of Windchill, and its synergy and integration with other applications within the PTC Product Development System (PDS). Aberdeen states that "PTC's Windchill should be considered by any size manufacturer that is considering a PLM solution to support its efforts."

"We believe that Windchill is the best-in-class PLM solution in the industry, offering enterprises of all sizes the broad capabilities needed to achieve their product development initiatives," said Rob Gremley, executive vice president, marketing, PTC. "It's rewarding to be recognized for our commitment to deliver maximum value to our customers through superior technology."

Please see the "Product Lifecycle Management (PLM ) Solutions AXIS for Hardgoods Manufacturers" for additional detail.

About PTC

PTC provides discrete manufacturers with software and services to meet the globalization, time-to-market and operational efficiency objectives of product development. Using the company's CAD and content and process management solutions, organizations in the Industrial, High-Tech, Aerospace and Defense, Automotive, Consumer and Medical industries are able to support key business objectives and create innovative products that meet customer needs and comply with industry regulations.

Jun 24, 2009 -- Universal Detection Technology (OTCBB: UNDT), a developer of early-warning monitoring technologies to protect people from bioterrorism and other infectious health threats and provider of counter-terrorism consulting and training services, reported today that it has been awarded a North Atlantic Treaty Organization (NATO) CAGE Number for its biological weapon detection systems. The CAGE code allows for marketing of the instruments to NATO affiliated countries.

The NATO Commercial and Government Entity, or NCAGE, code is a five-character ID number that identifies government contractors. NCAGE codes are an important part for companies winning contracts with NATO affiliated countries. The UDT CAGE/NCAGE code is: 1WLU0. UNDT is now listed along with all U.S. and NATO companies with a CAGE/NCAGE Code. The code lists UNDT in a primary vendor database for the U.S. Federal Government and is used as a government tool for the Department of Homeland Security, Department of Defense, NATO and NASA Agencies. Having this information immediately available allows the U.S. Government and NATO countries to rapidly find the companies with the right capabilities to offer services for required government initiatives, including research & development projects, particular supply needs, up to a pandemic alert requirement or other emergency requirements.

"The awarding of our NCAGE code is a significant step for us to market our equipment to a rapidly expanding NATO alliance that has significant biological weapon detection needs," said Mr. Jacques Tizabi, UNDT's Chief Executive Officer.

About Universal Detection Technology

Universal Detection Technology is a developer of monitoring technologies, including bioterrorism detection devices. The Company on its own and with development partners is positioned to capitalize on opportunities related to Homeland Security. For example, the Company, in cooperation with NASA, has developed a bacterial spore detector that detects certain biohazard substances. The Company is also a reseller of handheld assays used for detection of five bioterrorism agents, radiation detection systems, and antimicrobial products.

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For full details on Cepheid (CPHD) click here. Cepheid (CPHD) has Short Term PowerRatings of 5. Details on Cepheid (CPHD) Short Term PowerRatings is available at This Link.

    


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