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"Penny Stocks that Perform" picks are: ARRY, MANT, SNWL, UNDT
(M2 PressWIRE Via Acquire Media NewsEdge) "Penny Stocks that Perform" picks are: Array BioPharma Inc. (NASDAQ: ARRY), ManTech International Corporation (NASDAQ: MANT), SonicWALL, Inc. (NASDAQ: SNWL), Universal Detection Technology (OTCBB: UNDT)
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Jul 8, 2009 -- Array BioPharma Inc. (NASDAQ: ARRY) today announced top-line results from its Phase 1 seven-day dose escalation trial up to 1,200 mg daily of p38 inhibitor, ARRY-797, in healthy volunteers. In addition, the top-line results were announced in a second study, where ARRY-797 was evaluated in a 28-day Phase 1b trial in stable rheumatoid arthritis (RA) patients taking methotrexate. This study compared two doses of ARRY-797 to placebo.
A preliminary analysis of both trials indicates that ARRY-797 was well tolerated with a pharmacokinetic profile consistent with earlier studies. In the 28-day, three-arm RA study with a total of 28 patients, ARRY-797 showed inhibition of CRP levels (marker of inflammation) only during the first three weeks of dosing and a beneficial reduction in NTx levels (marker of bone remodeling) throughout the study. In addition, ARRY-797 showed a trend to improve the patients' assessment of pain (VAS score) over the course of the study.
"In the 28-day RA study, ARRY-797 demonstrated a transient inhibition of the inflammatory biomarker CRP and a trend towards analgesic efficacy in the pain endpoint," said Kevin Koch, Ph.D., President and Chief Scientific Officer. "Since these results are similar to other p38 inhibitors evaluated in rheumatoid arthritis, these findings have led us to discontinue testing of ARRY-797 in chronic inflammatory diseases. We continue to believe that a p38 inhibitor holds promise in treating patients with cancer and sub-chronic pain."
The Company continues to conduct a full analysis of safety, pharmacokinetics and efficacy data from both studies. Array anticipates that complete results from the studies will be presented at a medical conference in 2010. Based on these preliminary results, Array plans to cease the enrollment of new patients in its current clinical trial of ARRY-797 in ankylosing spondylitis patients.
Phase 1b Dose Escalation Trial in Healthy Volunteers: Clinical Study Design and Results
This Phase 1b dose escalation trial was a randomized, double-blind, placebo-controlled study in healthy volunteers and was designed to evaluate the safety and pharmacokinetics of ARRY-797 after single-day and multiple-day administration of ARRY-797. Single ascending-doses of 900 mg (once) and 1,200 mg/day (800 mg followed by 400 mg 12 hours later), and multiple-day, ascending-doses of 200, 300 and 400 mg/day TID (every eight hours) for eight consecutive days were explored.
Safety, Tolerability and Pharmacokinetics: Overall, ARRY-797 was well-tolerated after single-day and multiple-day administration of total daily doses of 600 mg, 900 mg, and 1,200 mg. In the multiple-day cohorts up to 400 mg TID, no adverse event (AE) was reported by more than one subject in any treatment group and all AEs were considered mild in intensity. In the single-day cohorts, mild dizziness was reported by two of the 6 subjects receiving a 900 mg dose of ARRY-797 and moderate dizziness by one of the 6 subjects receiving 800 mg followed by 400 mg ARRY-797. Approximately dose-proportional increases in mean total and peak exposures were observed with increasing dose following single- and multiple-dose administration. Mean plasma concentrations of ARRY-797 reached steady-state on day two after repeat-dose administration with modest accumulation.
Phase 1b 28-day Study in Patients with RA: Clinical Study Design and Results
This Phase 1b trial was a randomized, double-blind, placebo-controlled design that enrolled 29 patients with RA. Twenty eight patients completed four weeks of treatment. The trial was conducted at six sites in the United States. Patients received either 100 mg or 200 mg ARRY-797 twice daily, or placebo. In addition, all patients were on a background of methotrexate and could receive certain NSAIDs (including COX-2 inhibitors), corticosteroids (low-dose), opioids/analgesics, aspirin, or acetaminophen. Patients were evaluated every seven days for improvement in clinical signs and symptoms according three measures: CRP levels (marker of inflammation), patient's assessment of arthritis pain (VAS score), and NTx levels (marker of bone remodeling).
Effects on Signs and Symptoms of Rheumatoid Arthritis: The CRP levels at the 200 mg BID dose of ARRY-797 showed a statistically significant decrease during the first three weeks of the study but returned to baseline on week four. Also, the patient's assessment of pain (VAS score) showed trends to decrease in the 200 mg BID arm. The NTx levels for both active arms separated from placebo by as much as 30 percent in the 100 mg arm and 50 percent in the 200 mg arm.
Safety, Tolerability and Pharmacokinetics: ARRY-797 was well-tolerated through 29 days of dosing. There were no premature discontinuations for serious AEs in any of the study arms. The most common AEs were generally mild or moderate and were not significantly different than placebo. Based upon a preliminary assessment, the exposure of ARRY-797 was consistent with previous studies in healthy volunteers, there were no apparent drug-drug interactions between methotrexate and ARRY-797, and no apparent food effect was observed.
ARRY-797 in Acute Pain
The efficacy of ARRY-797 previously was evaluated in two acute inflammatory pain trials in patients with post-surgical dental pain. ARRY-797 achieved its primary and secondary endpoints for analgesic efficacy and was well-tolerated in both trials.
In the first trial, the analgesic effect of 400 mg of ARRY-797, compared to placebo, was statistically significant based upon the primary endpoint of total pain relief over six hours post dose (p<0.0001). The analgesic effect was also statistically significant for total pain relief over three, eight, 12, and 24 hours post dose. Other analgesic endpoints, including total pain intensity, time to meaningful pain relief, and time to analgesia were also significantly improved versus placebo. Peri-operative dosing with 200 mg before and 200 mg after surgery also resulted in a substantial reduction in total pain intensity. Array believes the efficacy observed in this study is due to the simultaneous inhibition of the pain mediator PGE2 and the inflammatory mediators TNF, IL-1, and IL-6. No serious AEs were reported and non-serious adverse events were evenly balanced across the three groups.
In the second trial, three doses of ARRY-797 (200 mg, 400 mg, and 600 mg) were compared to placebo and celecoxib (400 mg). In the primary efficacy measure of total pain relief over six hours post dose (p<0.001), ARRY-797 produced a dose-dependent analgesic response, compared to placebo. ARRY-797 (400 and 600 mg) and celecoxib (400 mg) demonstrated significant analgesic benefit, a rapid onset of action (within 1 hour), and good duration of analgesia.
About ARRY-797 / Pan-cytokine Inhibitor
ARRY-797 is a potent and highly selective p38a inhibitor that decreases production of PGE2 as well as cytokines such as TNF and IL-1. The anti-inflammatory and analgesic efficacy of ARRY-797 have been demonstrated in two previously reported clinical studies using an acute dental pain model (ACR 2008 Poster #357). In those studies, ARRY-797, administered orally at the onset of moderate to severe pain, provided a dose-related analgesic benefit as measured by total pain relief over six hours following dosing, as well as a profound reduction in post surgical CRP elevation. The time to onset, magnitude, and duration of analgesia were similar for ARRY-797 at the two highest doses evaluated (400 mg and 600 mg) and celecoxib 400 mg.
About Pan-cytokine Inhibition for Inflammation and Pain
p38 is a kinase target that regulates the production TNF, IL-1, and IL-6 as well as PGE2. PGE2 is an important mediator of inflammatory pain and its production is the target of NSAIDs. Many forms of acute and chronic pain have inflammatory origins, and pan-cytokine suppression may treat both the inflammation and the resulting pain. Array believes modulation of all three cytokines plus PGE2 may be more effective than inhibition of any one in isolation for controlling both the underlying inflammation and the resulting symptoms such as pain.
About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development, and commercialization of targeted small molecule drugs to treat patients afflicted with cancer, inflammatory, and metabolic diseases. Our proprietary drug development pipeline includes clinical candidates that are designed to regulate therapeutically important target proteins and are aimed at significant unmet medical needs. In addition, leading pharmaceutical and biotechnology companies collaborate with Array to discover and develop drug candidates across a broad range of therapeutic areas.
Jul 8, 2009 -- ManTech International Corporation (NASDAQ: MANT) announced today that it has established ManTech Cyber Solutions International, Inc., a wholly-owned subsidiary formed to develop and market new cyber products and solutions to U.S. local, state and federal government customers, as well as enterprise commercial markets. ManTech CSI, Inc. is a high-end cyber company that uses R&D to build new tools and develop tactics that meet customer needs in the cyber field.
Alex Nieves, Cyber Sector Senior Vice President, ManTech Security and Mission Assurance, has been named President of ManTech CSI, Inc. and Tiffanny Gates has been named Vice President. Ms. Gates was CEO of ETG, when it was acquired by ManTech in August 2008.
"ManTech CSI, Inc. will develop products and solutions based on our more than 17 years experience providing cyber operations support to the U.S. government and private industry," said Mr. Nieves. "We will leverage the experience of our cyber personnel who are experts in the field and have authored books and articles on cyber defense, service oriented architecture security and network security monitoring."
Larry Prior, President and Chief Operating Officer of ManTech International Corporation said, "There is a large demand for cyber solutions in the marketplace and defending against cyber threats is critical to our national interest. We launched ManTech CSI, Inc. to focus our development on products and tools that will help our customers in government and industry to meet this rising challenge. Providing cyber services continues to be a core capability for parent company ManTech where we are centered on delivering services and training across the spectrum of computer network operations."
What's next for ManTech CSI, Inc.?
ManTech CSI, Inc. plans to launch its most recent product CROWBAR(TM) this week and will use various tools such as Twitter and blogs to interact with cyber professionals, potential cyber talent and its customer base. While the majority of products are developed specifically for official U.S. federal, state and local entities and related commercial enterprises, the company will also provide free tools to the general public found on the new website http://CyberSolutions.ManTech.com.
ManTech CSI, Inc. has a new look with a new logo that includes hexadecimal code. The company will change the code on a bi-weekly basis to challenge cyber professionals and post on their website and on Twitter. Join Twitter today and follow ManTech CSI, Inc. for more announcements and information on events, programs, new tools and products, free tools and challenges to cyber professionals.
About ManTech Cyber Solutions International, Inc.
ManTech Cyber Solutions International, Inc., headquartered in Vienna, VA, is a wholly-owned subsidiary of ManTech International Corporation. ManTech CSI, Inc. specializes in the development of cyber products and security solutions for federal, state and local governments as well as commercial enterprises. ManTech CSI, Inc. leverages the advanced capabilities of ManTech's numerous research and development laboratories to produce new products that solve the hardest problems in the cyber field.
About ManTech International Corporation:
Headquartered in Fairfax, Virginia with approximately 8,000 professionals, ManTech International Corporation is a leading provider of innovative technologies and solutions for mission-critical national security programs for the Intelligence Community; the departments of Defense, State, Homeland Security and Justice; the Space Community, National Oceanic and Atmospheric Administration, and other U.S. federal government customers. ManTech's expertise includes systems engineering, systems integration, software development services, enterprise architecture, cyber security, information assurance, intelligence operations and analysis support, network and critical infrastructure protection, information operations and information warfare support, information technology, communications integration, global logistics and supply chain management, and service oriented architectures. The company supports the advanced telecommunications systems that are used in Operation Iraqi Freedom and in other parts of the world; has developed a secure, collaborative communications system for the U.S. Department of Homeland Security; and builds and maintains secure databases that track terrorists. The company operates in the United States and 40 countries. In 2008, BusinessWeek magazine chose ManTech for its 'InfoTech 100' listing representing the best performing tech companies in the world; Forbes.com named ManTech as one of the 400 Best Big Companies in the nation; and A-Space, a Web 2.0 enhanced collaboration tool that ManTech developed for the Intelligence Community was named one of the Top 50 Inventions of the Year by Time magazine. Also in 2008, GI Jobs magazine named ManTech a Top Ten Military Friendly Employer for the third year in a row.
Jul 8, 2009 -- SonicWALL, Inc. (NASDAQ: SNWL), a leading secure network infrastructure company, confirmed today that users of its Gateway AV/IPS technology are automatically protected against the recently discovered vulnerability within Microsoft's Internet Explorer (IE) browser. SonicWALL's vulnerability and malware research team yesterday deployed Intrusion Prevention (IPS) signatures that address the flaws in Window's IE, without the customer needing to manually update the service. As a result, customers with a current subscription to SonicWALL's gateway threat prevention services are automatically protected against the Microsoft Windows Internet Explorer vulnerability.
"While Microsoft is working to develop a patch update for this, there is a significant window of opportunity for hackers to exploit the vulnerability and infect PC's without the user's knowledge," commented Boris Yanovsky, Vice President of SonicWALL's vulnerability research team. "We expect to see social networking sites such as Facebook, Flickr and Twitter being leveraged to infect large numbers of computers worldwide. It's critical to protect our customers, so our gateway threat prevention services automatically defend against exploits of the Internet Explorer vulnerability."
Anyone who visits a site that's been hacked due to the IE vulnerability could be at risk. By exploiting the IE vulnerability, hackers can remotely take control of a user's computer as soon as the user visits a site that contains malicious code. Exploiting a component of Microsoft DirectShow, hackers are able to create HTML pages with malicious JavaScript parsed in an IE browser to infect users' computers' without their knowledge. The URL JavaScript is used to instantiate an instance of the vulnerable control and feed it a malformed image, likely to be logo.gif, causing it to crash and execute the malcode. Once initiated the hacker is able to launch a wide range of attacks on the computer that could include opening random files on the target machine, thus causing potential denial of service attacks.
The IPS signature names and their respective IDs, below, were deployed to production on Monday, July 6.
3015 MS DirectShow (msvidctl.dll) ActiveX Control Instantiation 1 3016 MS DirectShow (msvidctl.dll) ActiveX Control Instantiation 2 GAV: DirectShow_Msvidctl (Exploit)
SonicWALL has developed unique technologies to deliver zero day gateway anti-virus, anti-spyware and intrusion prevention signatures to its subscribers on a continual basis, allowing them to defend against new and existing Internet attacks and exploits such as phishing, viruses, DHA or DoS attacks and more. These technologies ensure that SonicWALL gateway threat prevention services customers are not affected by the Internet Explorer vulnerability.
About SonicWALL, Inc.
SonicWALL is committed to improving the performance and productivity of businesses of all sizes by engineering the cost and complexity out of running a secure network. Over one million SonicWALL appliances have been shipped through its global network of ten thousand channel partners to keep tens of millions of worldwide business computer users safe and in control of their data. SonicWALL's award-winning solutions include network security, secure remote access, content security, backup and recovery, and policy and management technology.
Jul 8, 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 submitted a proposal to a Request For Information (RFI) from the Department of Homeland Security (DHS). The RFI is for the Time Recorded Ubiquitous Sensor Technologies (TRUST) project initiated by the DHS.
The TRUST project was initiated by the DHS Science & Technology (S&T) Directorate to solicit innovative solutions to detect and provide alert to the presence of dangerous cargo in maritime shipping containers during their transit to U.S. ports.
The TRUST project is seeking game-changing technologies that offer break-through potential and that may be disruptive to the traditional manner in which technology development occurs. Accordingly, DHS S&T is willing to accept moderate to high technology development risk if a research effort promises a high payoff.
The TRUST project is distinct from the Safe Container (SAFECON) project initiated by the Department of Homeland Security's DHS S&T Directorate with the issuance of Broad Agency Announcement (BAA) and a subsequent RFI. Although both projects seek to detect dangerous cargo, the technical breakthrough sought through the SAFECON project focuses on the short dwell-time goal whereas TRUST project goals are to detect the presence of dangerous cargo while the container transits from the port of origin to its U.S. port of destination, assumed to be a minimum of 5 days. TRUST also allows system components to be mounted on or internal to the container.
"We responded to the RFI from the DHS as we believe our bio-weapon detection technologies meet the criteria requested by the project," 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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