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GP Strategies Reports Strong Third Quarter 2012 Financial Results
ELKRIDGE, Md., Nov. 1, 2012 /PRNewswire/ -- Global performance improvement solutions provider GP Strategies Corporation (NYSE: GPX) today reported financial results for the quarter ended September 30, 2012.
Overview of Third Quarter 2012 Results:
¦Revenue of $99.7 million for third quarter of 2012 compared to $88.9 million for third quarter of 2011
¦Gross profit of $17.9 million, or 18.0% of revenue, for third quarter of 2012 compared to $14.9 million, or 16.7% of revenue, for third quarter of 2011
¦Diluted earnings per share of $0.32 for third quarter of 2012 compared to $0.24 per share for third quarter of 2011
¦EBITDA of $10.4 million for third quarter of 2012 compared to $9.4 million for third quarter of 2011
The Company's revenue increased 12% or $10.7 million during the third quarter of 2012 compared to the third quarter of 2011. Revenue grew organically by 9% or $8.0 million during the third quarter, largely driven by growth in the Learning Solutions and Sandy segments due to increased training services for several new and existing customers. Gross profit increased 21% or $3.1 million during the third quarter of 2012 primarily due to organic revenue growth. The third quarter 2012 results include $0.5 million of acquisition-related transaction expenses compared to $0.1 million in the third quarter of 2011. In addition, the Company had a net loss on the change in fair value of contingent consideration of $0.8 million for the third quarter of 2012, for which no income tax benefit will be received, compared to a net gain of $0.3 million during the third quarter of 2011. Operating income increased 24% during the third quarter of 2012, excluding the net gain/loss on change in fair value of contingent consideration in the third quarters of both 2012 and 2011. Net income was $6.2 million, or $0.32 per diluted share, for the third quarter of 2012 compared to $4.6 million, or $0.24 per diluted share, for the third quarter of 2011. The third quarter 2012 results also include a $1.6 million non-recurring income tax benefit due to the reduction of a tax liability.
"GP Strategies continued to achieve strong organic growth in the quarter due to the strengthening and expansion of our platform," commented Scott N. Greenberg, Chief Executive Officer of GP Strategies. "We are seeing increased collaboration across the Company to provide integrated offerings that meet our clients' training and performance improvement needs. In addition, our recent acquisitions demonstrate our continued deployment of operating cash flow to further enhance our platform of services and products. We are very excited about our acquisition of BlessingWhite which strengthens our ability to deliver comprehensive leadership and professional development services to customers on a global basis."
Balance Sheet and Cash Flow Highlights
As of September 30, 2012, the Company had cash and cash equivalents of $12.6 million compared to $4.2 million as of December 31, 2011. The Company had no short-term borrowings or long-term debt outstanding and had $50 million of available borrowings under its line of credit as of September 30, 2012. Cash provided by operating activities was $17.0 million for the nine months ended September 30, 2012 compared to $10.6 million for the same period in 2011.
Investor Call
The Company has scheduled an investor conference call for 10:00 a.m. ET on November 1, 2012. In addition to prepared remarks from management, there will be a question and answer session on the call. The dial-in numbers for the live conference call are 800-749-1342 or 212-231-2919, using conference ID number 21609594. A telephone replay of the call will also be available beginning at 12:00 p.m. on November 1st, until 12:00 p.m. on November 15th. To listen to the replay, dial 800-633-8284 or 402-977-9140, using conference ID number 21609594.
Presentation of Non-GAAP Information
This press release contains non-GAAP financial measures, including EBITDA (earnings before interest, income taxes, depreciation and amortization). The Company believes this non-GAAP financial measure is useful to investors in evaluating the Company's results. This measure should be considered in addition to, and not as a replacement for, or superior to, either net income, as an indicator of the Company's operating performance, or cash flow, as a measure of the Company's liquidity. In addition, because EBITDA may not be calculated identically by all companies, the presentation here may not be comparable to other similarly titled measures of other companies. For a reconciliation of this non-GAAP financial measure to the most comparable GAAP equivalent, see the Non-GAAP Reconciliation – EBITDA, along with related footnotes, below.
About GP Strategies
GP Strategies Corporation (NYSE: GPX) is a global performance improvement solutions provider of sales and technical training, eLearning solutions, management consulting and engineering services. GP Strategies' solutions improve the effectiveness of organizations by delivering innovative and superior training, consulting and business improvement services, customized to meet the specific needs of its clients. Clients include Fortune 500 companies, manufacturing, process and energy industries, and other commercial and government customers. Additional information may be found at www.gpstrategies.com.
Forward-Looking Statements
We make statements in this press release that are considered forward-looking statements within the meaning of the Securities Exchange Act of 1934. These statements are not guarantees of our future performance and are subject to risks, uncertainties and other important factors that could cause our actual performance or achievements to be materially different from those we project. For a full discussion of these risks, uncertainties and factors, we encourage you to read our documents on file with the Securities and Exchange Commission, including those set forth in our periodic reports under the forward-looking statements and risk factors sections. Except as required by law, we do not intend to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Is This the Future of the Auto Industry?
Natural gas is one of the cleanest, safest, and most useful of all energy sources. Unlike oil and coal, natural gas is clean burning and emits lower levels of harmful byproducts into the air. Natural gas could have a strong outlook because of its environmentally friendly nature. Large quantities of shale gas, three-dimensional seismology, horizontal drilling and innumerable computer-related breakthroughs have aided the United States in increasing the percent of natural gas consumed that is domestically produced. According to the EIA, of the natural gas consumed in the United States in 2011, about 94% was produced domestically. This is a drastic improvement from ten years ago when only 84% of natural gas consumed was produced domestically. Here’s a list of three ETFs that can capitalize on this boost.
Although the transportation sector only accounts for 3% of natural gas used in the United States, a surplus of the resource has sparked conversation about converting the auto industry from oil to natural gas. Natural gas has been a recognized transportation fuel since the early twentieth century, but crude oil remains the dominant choice. Advances in natural gas extraction technologies are enabling the delivery of abundant, affordable natural gas and the prospect of a shift to greater use of natural gas as a transportation fuel.
A report prepared for the Natural Gas Foundation states that while the price of natural gas per unit energy has historically been lower than liquid fossil fuels, this price differential must be large enough to overcome barriers to substantial market penetration by natural gas vehicles (NGV). These barriers include the capital expenses associated with infrastructure development for storage of natural gas in compressed or liquefied form, and the cost premium for lower-production vehicles with more expensive fuel tanks. Additional barriers have included the lagging optimization and availability of NGV. Although these latter two obstacles have been reduced in recent years, lingering negative perceptions persist as a result of early-adopters’ experience with less-developed engine and vehicle technologies.
Billionaire energy investor T. Boone Pickens, can attest to the fact that natural gas is currently much cheaper than gasoline (Click here to see Pickens’s latest prediction). Instead of fueling up for $4 a gallon, “Pickens fuel” costs about $1 a gallon. Unfortunately, it will not run a conventional car or truck engine, because Pickens’s Honda Civic GX runs on natural gas. Honda (NYSE: HMC) makes a few Civics with natural gas engines, and Chrysler and General Motors (NYSE: GM) plan to make some natural gas pick-up trucks. The graph below gives credence to this price differential.
As part of a new promotional effort, Honda is offering a $3,000 debit card good at Clean Energy natural gas filling stations with the purchase of a 2012 model year Civic Natural Gas vehicle. There are 40 Clean Energy filling stations in Southern California and about 160 nationwide. To fuel up, natural gas car owners pay roughly $2 a gallon, slightly more than Pickens’s home fueling station, but about half the price of gasoline. The natural gas version Civic starts at about $27,000, about $5,600 more than the gasoline Civic.
General Motors will offer a bi-fuel version of their 2013 Chevrolet Silverado and GMC Sierra pickup trucks that will run on either gasoline or natural gas. After speaking with Chevy Volt owners, GM realized that their customers worry about running out of fuel. By making bi-fuel engines, GM is relieving buyers of the need to stay within range of a local natural-gas fueling station. GM has not released the fuel economy or the prices of either of their 2013 bi-fuel trucks, but there’s a roadblock in the way of automakers producing large volumes of natural gas engines in the passenger car segment. Automakers know that until consumers are sure they can find a natural gas fueling station as readily available as a conventional one, the majority will stick to what they know best.
Companies are beginning to take on the risks associated with developing a natural gas transportation market with hopes of reaping in large returns. GP Strategies (NYSE: GPX), a global performance improvement provider, has branched out of their traditional business and started to build natural gas filling stations. Doug Sharp, president of GP Strategies, believes “the first customers who convert to natural gas vehicles will be the return-to-base operations, and the second will be the long-haul truckers.”
Return-to-base customers are like buses, which have designated daily routes and return to their base at designated times. Mike Mackey, vice president of GP’s Alternative Fuel’s Group, spoke on the long-haul trucker market stating “long-haulers typically travel 80,000 miles a year, burning 14,000 gallons of fuel, generally diesel fuel. At current fuel prices, a trucker would save $21,000 a year buying natural gas rather than diesel. Clean Energy Fuels (NASDAQ: CLNE) has natural gas fueling stations for vehicles in the United States and Canada, and is America’s largest provider of natural gas for transportation. Co-founded by T. Boone Pickens, the company operates about 150 liquefied natural gas (LNG) stations, and is building across the country. 70 stations are expected to be built in 2012, with each station costing roughly $1.5 million.
A good example of the return-to-base customers using natural gas can be seen looking at United Parcel Service (NYSE: UPS). The package delivery company has a strong commitment to the environment and operates roughly 1,100 natural gas trucks powered by compressed natural gas (CNG) and liquefied natural gas (LNG) with Cummins Inc. (CMI) and Westport Innovations Inc (WPRT) engines.
Mike Britt, director of vehicle engineering at UPS stated “Investment in a fuel-efficient technology that helps reduce our carbon footprint and reduce our dependence on petroleum remains a key component of UPS’s transport strategy.” Natural gas vehicles work great for return-to-base vehicle users like UPS. By having routes down to a science, UPS can confidently have delivery trucks fuel up at their base before running the daily routes, and then return upon completion and fuel up the next day. The premium paid for the NGV’s is quickly paid off by the savings on fuel, and an image boost doesn’t hurt.
For now, there are only about 1,000 natural gas filling stations in the U.S., compared with more than 160,000 gasoline and diesel stations. Stations are most prevalent in California, Oklahoma, New York, and Utah. A report for the Natural Gas Foundation titled Natural Gas as a Transportation Fuel stated:
“As NGVs become mainstream in the initially targeted markets, the costs of NGV adoption are expected to decrease allowing more favorable economics for additional sectors to enter the NGV market, ultimately including personal passenger cars and home refueling. The rate of NGV adoption, however, may be increased with programs designed to reduce the initial barriers to market entry: vehicle premium costs, refueling station availability, and consumer confidence in NGVs. Market acceleration is necessary in instances when supply infrastructure and fueling demand need to be simultaneously developed to mitigate the risk to ratepayers or shareholders of unused assets.”
While it remains to be seen exactly when this gap with start to converge, it appears that companies like Clean Energy Fuels and GP Strategies would be excellent ways to gain exposure to the potential of this industry, and automakers Honda, GM, and Chrysler can capitalize quite significantly with their natural gas-enabled vehicles. For a complete look at T. Boone Pickens’s 13F portfolio, continue reading here.
GP Strategies Corp: 3rd Straight Earnings Beat Enhances Long Case
http://seekingalpha.com/article/906171-gp-strategies-corp-3rd-straight-earnings-beat-enhances-long-case
Manufacturers' training challenges and how GP Strategies can help; $GPX
In the US today, manufacturers are facing a three-fold challenge: the need for ready pool workers, a poor outlook for future skilled workers, and an economy no longer based on manufacturing.
Company workforces are aging as baby boomers get older and begin to retire. However, manufacturers lack a ready pool of skilled workers to replace them. As a developed country, the US has experienced a socioeconomic shift: Parents don’t want their children to become skilled workers; they want their children to focus on vocations such as doctors, lawyers, and executives. What’s more, the economy itself has changed. We no longer have a manufacturing-oriented economy; instead, we have a service-oriented economy, meaning that we have shifted our skilled training offshore.
In a video entitled Bridging the Skills Gap in Today’s Economy, Eric Rodgers of GP Strategies discusses these challenges as well as how to address them. He explains that today’s workers need four types of knowledge, each one building on the one before it:
¦Core Competencies
¦Fundamentals
¦Applied Fundamentals
¦Equipment-Specific Training (this part has to be hands-on)
Rodgers then poses the question, “Where are companies going to find this kind of talent pool?” It’s a difficult question. Traditionally, manufacturers could rely on the military and community colleges to produce a ready pool of skilled workers, but the military pool is drying up and community colleges can no longer keep up with the complex processes that today’s workers need to perform to operate a modern piece of machinery.
The answer: They’re going to have to reach in-house, internalize their training programs, and build from within.
Fortunately, there are training experts available to help. GP Strategies has been focusing primarily on custom training since 1966. You simply won’t find another provider who does it better or with more consistent success than GP Strategies.
The company offers the flexibility of custom, tailored, and off-the-shelf technical training courses and courseware. They design, develop, deliver, and support every type of training modality, from instructor-led courses and hands-on labs to web-based training (WBT), simulation, on-the-job training, and blended solutions. They can even deliver instructor-led courses at your site or a mutually agreed upon alternative.
GP Strategies also provides training program support based on your site, your personnel, and your equipment. They can conduct training analysis, needs assessments, gap assessments, training center design and build-out, productivity simulation, and even a planning and scheduling game called Outage! And if you require technical documentation development services, their experienced professionals deliver a wide range, including operations, maintenance, compliance, and emergency management process and procedure requirements. Read more at GPStrategies.com.
GP Strategies (GPX): Proven Experience in the Financial Sector
In recent years, the financial services market has seen a dramatic reshaping, which has caused many challenges for financial organizations. Companies today are under constant pressure to satisfy stringent regulatory and compliance requirements while continuing to meet customer demands, even as those demands grow increasingly difficult to meet. Additionally, companies face increasing public and government scrutiny and bear a tremendous burden to perform in every aspect of the operation.
GP Strategies™ can help. With more than 40 years of experience, GP Strategies has provided training, consulting, and engineering services to companies in industries ranging from aerospace to government to automotive, life sciences, food and beverage, and others, including, more recently, the financial services sector. Financial clients have benefitted from a wide variety of service offerings, including eLearning, content development, training, and more.
GP Strategies has the experience needed to meet its clients’ critical training needs. In one case, the company was asked to create a custom program for a large, global banking and financial services client to help them become a center of excellence in complaint handling, while at the same time helping to demonstrate their ongoing commitment to treating customers fairly. The development of this program represented an important part of the bank’s overall strategy, enabling them to ensure that their existing customers remained satisfied with the services that the bank provided and would go on to hopefully purchase further services.
After a period of research across a number of the client’s departments and branches involving customers and staff, a program was developed to enhance individual and team understanding, knowledge, and skills in successfully handling customer complaints. It was created in two parts: first, an eLearning pre-course module that helped to position the issue of complaints, and second, a one-day interactive workshop that provided learners with the skills and techniques needed to handle customer complaints followed by an opportunity to use the new skills and techniques via a series of case studies. Customer complaint satisfaction increased by seven percent within the first six months. As a result of the improvement in customer satisfaction for this one program alone, two additional subsidiaries of the bank engaged GP Strategies to design and deliver similar complaint handling workshops for call center and branch employees.
In 2011, another major financial institution selected GP Strategies to support its centralized worldwide training center. The customer’s goal was to outsource its worldwide training development while reducing the number of vendors from several dozen to two, including GP Strategies. In the first year, GP Strategies completed over 300 training programs in a wide range of modalities, including web-based training (WBT), instructor-led training (ILT), virtual instructor-led training (VILT), interactive web sites, job aids, and mobile learning. Topic areas included consumer products, wealth investments, compliance, retail operations, systems, and new hire orientation. In addition, GP Strategies was selected to handle all course maintenance, copy/edit, and QA for courses produced internally and externally. Courses have been produced for this customer in the US, UK, and Asia.
In 2012, GP Strategies further increased its presence in the financial sector with contract wins to provide learning solutions to two new financial services clients. Revenue from the financial services industry represented approximately six percent of GP Strategies’ consolidated revenue for the six months ended June 30, 2012. Read more at GPStrategies.com.
You beat me to it! Very exciting, business rolling in the private sector. Working with a company like Martin is a nice feather in the cap.
GP Strategies to Report Second Quarter 2012 Results on August 2, 2012
ELKRIDGE, Md., July 27, 2012 /PRNewswire/ -- Global performance improvement solutions provider GP Strategies Corporation (NYSE: GPX) announced that it will release its financial results for the second quarter ended June 30, 2012 on Thursday, August 2, 2012.
The Company has scheduled an investor conference call for 10:00 a.m. ET on August 2, 2012. In addition to prepared remarks from management, there will be a question and answer session on the call. The dial-in number for the live conference call will be 800-931-6429 or 212-231-2937 using conference ID number 21600922. A telephone replay of the call will also be available beginning at 12:00 p.m. on August 2nd and will be available until 12:00 p.m. on August 16th. To listen to the replay, dial 800-633-8284 or 402-977-9140, using conference ID number 21600922. A replay will also be available on GP Strategies' website shortly after the conclusion of the call.
About GP Strategies
GP Strategies Corporation (NYSE: GPX) is a global performance improvement solutions provider of sales and technical training, eLearning solutions, management consulting and engineering services. GP Strategies' solutions improve the effectiveness of organizations by delivering innovative and superior training, consulting and business improvement services, customized to meet the specific needs of its clients. Clients include Fortune 500 companies, manufacturing, process and energy industries, and other commercial and government customers.
© 2012 GP Strategies Corporation. All rights reserved. GP Strategies and the GP Strategies logo design are trademarks of GP Strategies Corporation.
(Logo: http://photos.prnewswire.com/prnh/20120327/MM77734LOGO)
SOURCE GP Strategies Corporation
For further information: Scott N. Greenberg, Chief Executive Officer, +1-410-379-3640; Sharon Esposito-Mayer, Chief Financial Officer, +1-410-379-3636; Ann M. Blank, Investor Relations, +1-410-379-3725
Initial Images Show Positive Results for BFPET in Patients With Coronary Artery Disease
FluoroPharma Medical, Inc. (FPMI), a company specializing in the development of novel diagnostic imaging products that utilize positron emission tomography (PET) technology for the detection and assessment of disease before clinical manifestation, today announced that they have received high quality images in an investigator-sponsored clinical trial in China where patients with CAD were given BFPET, its imaging agent for measuring cardiovascular blood flow. This is most encouraging as the company is starting phase II trials.
Patients are being imaged at the PLA 301 hospital in Beijing where the images give a direct comparison between stress perfusion imaging using sestamibi and BFPET. According to Dr. Alan Fischman, former head of nuclear medicine at Massachusetts General Hospital and the principal investigator of the BFPET phase I trial, "initial results are impressive. Image quality obtained using PET is superb. BFPET shows clear diagnostic qualities as well as increased resolution, inherent in PET. The initial images look spectacular and we are confident that when all the patients are imaged, the data will further support clinical development of the agent." Approximately 20 patients are expected to be imaged with this investigator-initiated study concluding by the beginning of the 4th quarter of 2012.
"These images mark a milestone for BFPET and this exciting technology; bringing it a step closer to the world's medical community. We firmly believe, however, that the true beneficiaries of imaging agents like BFPET will be patients as it offers the potential for non-invasive diagnostic images with higher specificity. This will provide early and more accurate information to enable more effective patient management decisions," commented Thijs Spoor, FluoroPharma's President and Chief Executive Officer. "Today's announcement supports our earlier findings and increases our confidence that the images we observed in Phase I will be reproduced in Phase II. It also validates the importance and value of FluoroPharma's technology in important growth markets where diagnostic imaging is playing an increasingly significant role in the early detection of disease," he added.
About BFPET: Myocardial Perfusion Imaging FluoroPharma's BFPET is a novel imaging agent for myocardial perfusion imaging with the potential for measuring cardiovascular blood flow. BFPET, a Flourine-18 labeled tracer, has been designed to enter the myocardial cells in direct proportion to blood flow and cell membrane potential. These are two of the most important physiological indicators upon which adequate blood supply to the heart depends. BFPET has been designed to differentiate among those cells of the myocardium that may be ischemic, infarcted and those that are healthy.
Ischemic and infarcted cells should take up less BFPET than healthy myocardial cells. The signal emitted by BFPET should be inversely proportional to the extent of myocardial injury. Therefore, FluoroPharma believes that ischemic heart tissue can be reliably detected by using BFPET
Late last year, FluoroPharma announced that it had been granted patent rights in China for BFPET and another imaging agent, AZPET which is still in the very early phase of discovery.
About Symptomatic coronary artery disease (CAD) Symptomatic coronary artery disease (CAD) affects millions of patients worldwide and, according to the World Health Organization, cardiovascular diseases are the leading causes of death and disability in the world. Cardiologists' demand for faster, more accurate diagnostic tools continuously drives the development of non-invasive techniques with increased sensitivity and accuracy for the detection and assessment of acute and chronic CAD
About FluoroPharma Medical FluoroPharma is a biopharmaceutical company engaged in the discovery and development of proprietary PET imaging products to evaluate cardiac disease at the cellular and molecular levels. The Company has licensed technology from the Massachusetts General Hospital in Boston.
The Company's goal is to enable personalized medicine through advanced imaging products that will help the medical community diagnose disease more accurately at the earliest stages, leading to more effective treatment, management and better patient outcomes.
The Company's initial focus is the development of breakthrough positron emission tomography (PET) imaging agents for the efficient detection and assessment of acute and chronic forms of coronary artery disease (CAD). FluoroPharma is advancing two products in clinical trials for assessment of acute and chronic forms of coronary disease. These first in class agents have been designed to rapidly target myocardial cells. Other products in development include agents for detection of inflamed atherosclerotic plaque in peripheral arteries, agents with the potential to image Alzheimer's disease and agents that could potentially be used for imaging specific cancers.
In addition to the United States, Europe and China, patents related to FluoroPharma's portfolio of imaging compounds have been issued in Japan, Canada, Australia, Finland, Portugal, Ireland and Mexico.
GP Strategies Awarded Blanket Purchase Agreement By the US Department of Health and Human Services
/PRNewswire/ -- Global performance improvement solutions provider GP Strategies Corporation (NYSE: GPX) announced today that it has been awarded a Blanket Purchase Agreement (BPA) by the US Department of Health and Human Services (HHS). The BPA will allow GP Strategies to continue to provide support for the HHS University (HHSU) Learning Management System (LMS), including hosting, Tier 2 helpdesk and technical support for over 120,000 users. GP Strategies estimates that the BPA has a value of approximately $3M if all currently ordered services are continued for the base period and three option years, with the potential for greater value if additional services are ordered.
GP Strategies was contracted to implement the HHS LMS in 2007 and has been providing application, hosting and helpdesk support since the system went live. During that time, GP Strategies also provided customer interfaces and reporting solutions, upgrade services and Talent Management best practices to ensure HHSU meets the training needs of its constituents.
Billy Biggs, GP Strategies' Public Sector Director, said, "The recent award of the HHS Blanket Purchase Agreement reinforces GP Strategies' reputation as an organization that values long-term customer relationships. We were fortunate to win the original HHS Learning Management System implementation contract in 2007 after a very competitive evaluation process. After five years of supporting their LMS, we are excited to have the opportunity to extend our relationship with the HHSU team and look forward to supporting their current and future learning technology needs."
For more information about GP Strategies' learning solutions, visit http://learningsolutions.gpstrategies.com/.
About GP Strategies
GP Strategies Corporation (NYSE: GPX) is a global performance improvement solutions provider of sales and technical training, eLearning solutions, management consulting and engineering services. GP Strategies' solutions improve the effectiveness of organizations by delivering innovative and superior training, consulting and business improvement services, customized to meet the specific needs of its clients. Clients include Fortune 500 companies, manufacturing, process and energy industries, and other commercial and government customers. GP Strategies Corporation is the new name of General Physics Corporation, which merged with its parent company (also called GP Strategies) on December 31, 2011 and changed its name. Additional information may be found at www.gpstrategies.com.
© 2012 GP Strategies Corporation. All rights reserved. GP Strategies and the GP Strategies logo design are trademarks of GP Strategies Corporation.
(Logo: http://photos.prnewswire.com/prnh/20120327/MM77734LOGO )
SOURCE GP Strategies Corporation
For further information: Scott N. Greenberg, Chief Executive Officer, 410-379-3640, or Sharon Esposito-Mayer, Chief Financial Officer, 410-379-3636, or Jamie Coffey, Director, Communications, 443-255-3400
Coronado Biosciences Nominates Harlan Weisman, M.D. to Slate of Directors
In an SEC filing today, Coronado Biosciences (Nasdaq: CNDO) nominated Harlan F. Weisman, M.D. as a director nominee. Dr. Weisman is the founder and Managing Director of And-One Consulting, LLC, a consulting firm which was formed in March 2012 and focuses on assisting companies formulate and lead successful global strategies for accelerating medical product development, regulatory approval and market acceptance.
From October 2005 to March 2012, Dr. Weisman was Chief Science and Technology Officer of Johnson and Johnson’s (NYSE: JNJ) Medical Device and Diagnostics business. Dr. Weisman is a graduate of the University of Maryland and the University of Maryland School of Medicine. Dr. Weisman served his residency at Mount Sinai Hospital in New York and was a fellow in cardiovascular disease at Johns Hopkins Hospital.
VIDEO: GP Strategies’ CFO, Sharon Esposito-Mayer, Discusses International Growth
Very cool video's produced by the company
http://blog.gpstrategies.com/general/gp-strategies-cfo-sharon-espositomayer-discusses-international-growth/
AtheroNova Receives Notice of Allowance for Its US Patent Application - $AHRO
AtheroNova Inc. (AHRO), a biotech company focused on the research and development of ahrocompounds to regress atherosclerotic plaque, announced that it has received a Notice of Allowance for its patent application for Dissolution of Arterial Plaque. The patent will issue within the next few months when the US Patent Office completes its registration process. This announcement culminates over five years of effort in pursuit of a patent covering the use of hyodeoxycholic acid for atherosclerotic plaque lesions.
"We have worked diligently with our patent counsel, McDermott Will & Emery LLP, to achieve this major milestone and we want to thank them for their efforts," said AtheroNova CEO Thomas W. Gardner. "We are very confident that this patent will support our development project for AHRO-001 and will enhance our ability to fully capitalize on the intellectual property potential that this patent represents. We can now move forward with several additional compounds in the AHRO family described in our patent applications. AtheroNova is continuing to build significant momentum as we prepare for initiation of our Phase I clinical trials later this year."
"We are pleased that the U.S. Patent Office has found AtheroNova's claims for treating atherosclerosis using a bile acid to be patentable," stated James W. Hill, MD, AtheroNova's patent counsel with McDermott Will & Emery. "The method involves administering the naturally occurring bile acid hyodeoxycholic acid, or HDCA, to a patient such that its concentration in the patient's blood is maintained above a certain level for a period of time. In mice studies at UCLA, HDCA was effective in inhibiting progression of arterial plaque in a way that may bode well for treatment of human atherosclerosis."
About AHRO-001
AHRO-001 is AtheroNova's first novel application for the treatment and prevention of atherosclerosis. Atherosclerotic plaque is the primary underlying cause of heart disease and stroke in industrialized countries. AHRO-001 uses certain pharmacological compounds to regress atherosclerotic plaque deposits through a process known as delipidization. Delipidization dissolves plaques in artery walls, which are then removed by natural body processes. AtheroNova plans to develop multiple applications for its patents-pending compounds that can be used in pharmaceutical-grade products for the treatment of atherosclerosis. Atherosclerosis and related pharmaceutical costs run more than $41 billion annually in the United States alone. Market sectors potentially served by AHRO-001 include: Cardiovascular Disease, Stroke, Peripheral Artery Disease, Dementia and Alzheimer's and Erectile Dysfunction, all of which have been linked to atherosclerosis.
About AtheroNova
AtheroNova Inc., through its wholly-owned subsidiary, AtheroNova Operations, Inc., is an early stage biotech company focused on discovery, research, development and licensing of novel compounds to reduce or regress atherosclerotic plaque deposits. The Company's focus on compounds to reduce atherosclerotic plaque deposits addresses the most lucrative segments of the multi-billion dollar prescription drug market: cardiovascular disease and stroke prevention. www.AtheroNova.com.
Forward-Looking Statements
Except for historical information contained herein, the statements in this release are forward-looking and made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently unreliable and actual results may differ materially. Examples of forward-looking statements in this news release include statements regarding the suitability of the compound for its intended use, mechanisms of action, intellectual property as well as the development of applications for AtheroNova's technology. Factors which could cause actual results to differ materially from these forward-looking statements include such factors as significant fluctuations in expenses associated with clinical trials, failure to secure additional financing, the inability to complete regulatory filings with the Food and Drug Administration, the introduction of competing products, or management's ability to attract and maintain qualified personnel necessary for the development and commercialization of its planned products, and other information that may be detailed from time to time in AtheroNova's filings with the United States Securities and Exchange Commission. AtheroNova undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Pegasi Announces Initial Production Results of Its First Horizontal Well
Pegasi Energy Resources Corp. /quotes/zigman/500090/quotes/nls/pgsi PGSI +2.74% (the "Company") is pleased to announce the initial production results of its first horizontal well in Cass County, Texas. The completion of the Morse Unit # 1-H involved hydraulic fracturing of the well's 2,000 ft horizontal borehole in five stages. Baker Hughes field services performed the hydraulic fracturing operations in late June using their proprietary Frac-Point(TM) fracture completion system. The Company holds a 56% working interest in the well.
In its first five days of continuous production, the well produced a total of 1,404 Bbls of oil giving an average initial production rate of 281 Bbls of oil per day. The well has produced high quality, light, sweet oil with an API gravity greater than 40 degrees. There is associated gas production which has not been measured at this time.
CEO Michael Neufeld commented: "We are very satisfied with the results of our first horizontal well. The results of the Morse prove that horizontal wells can produce high quality oil from the Bossier shale in the mature Rodessa oil field of East Texas. The results of the 5-stage fracture completion of the Morse give us great confidence in our proposed strategy for the further development of the Cornerstone Project which will involve drilling horizontal wells of 3,000 to 5,000 ft in length. On the basis of the Morse's initial production results, we would expect these longer wells, which will be fractured in 15 to 25 stages, to achieve initial production rates of 840 to 1,400 Bbls of oil per day."
About Pegasi Energy Resources Corporation
Pegasi Energy Resources Corporation is an organic growth-oriented independent oil and gas exploration and production company, headquartered in Tyler, Texas. Pegasi is focused on a repeatable, low geological risk, high potential project in the active East Texas oil and gas region. The company's strategy is focused on establishing a portfolio of drilling opportunities to exploit undeveloped reserves to grow production, as well as undertaking exploration to grow future reserves. Additional information concerning Pegasi Energy is available at www.pegasienergy.com .
The Pegasi Energy Resources Corporation logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=4682
Forward-Looking Statements Disclosure
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of forward-looking words such as "anticipate," "believe," "forecast," "estimated" and "intend," among others. These forward-looking statements are based on the Company's current expectations and actual results could differ materially. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, history of losses; speculative nature of oil and natural gas exploration, particularly in the Rodessa Oil Field in East Texas on which the Company is focused; substantial capital requirements and ability to access additional capital; ability to meet the drilling schedule; changes in tax regulations applicable to the oil and natural gas industry; relationships with partners and service providers; ability to acquire additional leasehold interests or other oil and natural gas properties; defects in title to the Company's oil and natural gas interests; ability to manage growth in the Company's businesses; ability to control properties that the Company does not operate; lack of diversification; competition in the oil and natural gas industry; global financial conditions; oil and natural gas realized prices; ability to market and distribute oil and natural gas produced; seasonal weather conditions; and government regulation of the oil and natural gas industry, including potential regulations affecting hydraulic fracturing and environmental regulations such as climate change regulations. The Company does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set forth in the Annual Report on Form 10-K filed with the SEC on March 28, 2012 and future periodic reports filed with the Securities and Exchange Commission. All of the Company's forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date hereof.
This news release was distributed by GlobeNewswire, www.globenewswire.com
SOURCE: Pegasi Energy Resources Corporation
What The Shire Announcement Means For Intellipharmaceutics International (NASDAQ: IPCI; TSX: I)
Intellipharmaceutics International (NASDAQ: IPCI; TSX: I) is engaged in the research, development, and commercialization of controlled-release and targeted-release pharmaceutical products. Controlled-release means releasing a drug into the bloodstream or at a target site in the body, over an extended period of time or at predetermined times. In some circumstances, controlled-release drug delivery can enhance efficacy and patient compliance as compared to immediate release formats for the same drug.
With the FDA informing Shire on June 22, 2012 that it has approved the ANDA for generic Adderall XR filed by Actavis this certainly bodes well for Intellipharmaceutics’ generic Focalin XR for ADHD. IPCI has a strategic alliance with Par Pharmaceutical (NYSE: PRX) for generic Focalin XR who has publicly stated that they have a date certain launch of October 2012, assuming FDA approval on or before this date. IPCI has publicly stated that obtaining Focalin XR approval is a 2012 goal.
According to the Shire press release:
"The FDA’s response requires that all abbreviated new drug applications ( ANDAs) have to establish bioequivalence using partial area under the curve measurements at 5 hours and beyond 5 hours, for both d- and l- amphetamine. The FDA response is consistent with its recent decisions on other long acting ADHD products."
Read the full Shire press release.
FluoroPharma Medical, Inc. Offers Major Market Advantages @ Seeking Alpha
FluoroPharma Medical, Inc. (OTCQB: FPMI) engages in the discovery, development and commercialization of proprietary medical diagnostic imaging products. The company’s initial focus is the development of breakthrough positron emission tomography (PET) imaging agents for the efficient detection and assessment of acute and chronic forms of coronary artery disease (CAD). Other products in development include agents for detection of inflamed atherosclerotic plaque in peripheral arteries, amyloid plaque in Alzheimer’s disease and agents for detection of certain types of cancer.
At Seeking Alpha, contributor MissionIR writes that for a developing business to be considered valuable, it needs to "present products that have unique benefits not found elsewhere, providing a decided advantage in the marketplace." He argues that FluoroPharma is such a company, writing that "the products that FluoroPharma is developing have distinct advantages in their ability to highlight critical processes that point to developing cardiovascular disease, sometimes called coronary artery disease (CAD), the country's number one killer, at its earliest stages."
He goes on to elaborate on the company's 3 main products - CardioPET for the assessment of myocardial metabolism, BFPET for the assessment of blood flow for CAD, and VasoPET for the detection of vulnerable plaque in CAD (currently in preclinical development) - as well as their unique advantages.
Read the full article at Seeking Alpha.
Debbie Ung, Senior Vice President of GP Strategies Corporation’s Performance Readiness Group, talks about the group’s service offerings.
http://blog.gpstrategies.com/general/performance-readiness-applying-operational-lens-customer-workforce-strategy/
Recent Abundance of Natural Gas, GP Strategies Helps Navigate New Industry Terrain
The rising cost of energy is on everyone’s minds these days, from individual consumers to large companies. To bring down prices and work towards US energy independence, alternative energy sources are being researched and a variety of initiatives are in the works. However, in the ongoing quest for US energy independence, one development stands out above all others: shale gale, or technology’s advancing ability to release trillions of cubic feet of natural gas trapped in underground US shale formations. With this discovery, many experts believe that we’re set for fuel for the next 100 years. While this is obviously a phenomenal advancement, there is still a lot of work to be done to modify the economic and social infrastructure of existing industries so that they can run on natural gas.
Liquefied natural gas, or LNG, represents one important step along the way. LNG is natural gas that has been condensed to liquid form so that it can be more easily stored and transported. It requires the construction of storage facilities, pipelines and filling stations to get it from the ground to consumers. However, given the newness of natural gas in this abundance, a sizable gap remains between the sheer amount of the resource and consumer demand for it.
A recent article in Fortune Magazine gives some insight into this issue and discusses how the shale gas energy windfall is expected to impact several key economic sectors, including transportation.
When it comes to the US transportation industry, the most obvious use for LNG is as fuel for heavy-duty trucks. But conventional engines can’t run on LNG, and truck manufacturers are understandably hesitant to churn out LNG-powered engines on a massive scale until they know for sure that it will be profitable. So, how will the vehicle industry evolve with regard to natural gas?
GP Strategies Corporation, a global performance improvement company with decades of experience in the design and installation of cryogenic liquid and high-pressure gaseous storage and distribution systems, has a few ideas.
First quoted is the president of GP Strategies, Doug Sharp, who predicts that “the first customers who convert to natural gas vehicles will be the return-to-base operators, and the second will be the long-haul truckers.” Return-to-base operators are those users, like bus companies and delivery services, who fuel up at their own terminals in the morning, make their daily runs and return to base at the end of the day.
Mike Mackey, vice president of GP Strategies’ Alternative Fuels Group, lays out the math to support Sharp’s prediction and calculates that “at current fuel prices, a trucker would save $21,000 a year buying natural gas rather than diesel.”
In a video on the GP Strategies blog, Sharp elaborates on the impact that natural gas can have on transportation, specifically emphasizing the need to “build out the infrastructure” of the long-haul trucking industry. He explains, “If we replace 25% of the transportation fuel that’s used today with natural gas, we’ll save something like $680 million a day in foreign oil purchases.”
Even with all these savings, why are a few special interest groups important to the transportation industry as a whole? The Fortune article explains:
“In coming years, additional natural gas filling stations will be built to take care of fleets like those of Kwik Trip, municipal bus liners or others, such as long haul trucks.”
Read the full Fortune article here
Law Targeting Counterfeit Electronics Will Have Global Implications, Study Finds
A recent company blog post discusses Section 818 of the U.S. National Defense Authorization Act for Fiscal Year 2012, a new Federal anti-counterfeiting law that is expected to have "broad international implications for hundreds of overseas companies that have supplied billions of dollars’ worth of items to the U.S. government."
An assessment by research and data supplier IHS iSupply reveals that Europe is "the largest supplier of electronics to the U.S., placing the region squarely in the sights of the new law. Europe accounts for 51% of all foreign electronics sales to the U.S. military; 47% comes from the Middle East and 2% comes from Asia."
Chairman, President, and CEO of Applied DNA Dr. James A. Hayward explains,
"Not only will the impact of Section 818 be felt worldwide, but also it is bound to cross from the public to the private sector. This is because many of the same facilities that supply the U.S. military also produce global electronic components for commercial applications. As a result, it is vital that the suppliers have new technological tools to identify components at risk of counterfeits."
Dr. Hayward's company is developing one potential way to help meet these challenges: DNA marking, a process in which botanical DNA is isolated, segmented, shuffled and reassembled to form an encrypted, unique and secure DNA marker which can be applied anywhere on a product to guarantee its authenticity.
DNA marking can be integrated into existing processes and procedures with minimal, if any, change in process. DNA is the "gold standard" of forensic evidence and is trusted and depended upon by law enforcement around the world. It is used by the FBI, Interpol and forensic labs worldwide; it is an accepted form of legal, forensic evidence that is accepted by courts globally.
Read more at adnas.com.
Zacks on Access Pharmaceuticals: MuGard sales continued to grow in 1Q12 and will keep current momentum; Outpeform (ACCP)
Access Pharmaceuticals (ACCP) is an emerging biopharmaceutical company specializing in products for cancer and supportive care. Access currently has one FDA-approved product, two products in Phase II clinical development, three products in preclinical development. Several of the company's products are based on Access' proprietary nanopolymer technologies which provide enhanced drug delivery options for both new and approved pharmaceutical active ingredients.
Zacks.com has released a report on Access Pharmaceuticals entitled "MuGard sales continued to grow in 1Q12 and will keep current momentum." Zacks maintains an "Outperform" rating on ACCP but lowers the price target.
Purchase the report online at AlacraStore.com.
Applied DNA Sciences smartDNA(R) System to Protect Against Copper Theft in Sweden
According to a recent press release, the Company's smartDNA anti-theft system will be used by police in Sweden to help prevent theft of copper wire and other copper electrical components in the Sweden national rail system. Copper theft in Sweden is a widespread problem, posing enormous security and economic problems. In one instance, "rail traffic connecting Stockholm, Malmö, and Copenhagen was brought to a standstill after thieves severed the high-voltage overhead lines in order to steal the valuable copper wire inside. Passengers on ten trains that travel on a stretch of track on the Southern Main Line (Södra stambanan) in south central Sweden were forced to disembark."
APDN's smartDNA will help solve this problem by directly linking copper thieves with the crime. When applied to the metal, "a unique, permanent smartDNA mark will forever associate the specific copper directly to a specific crime. The plant-derived DNA is extremely robust, and has proven highly resistant to harsh weather and to criminals' attempts to clean it from stolen product. Used widely in Sweden and the United Kingdom, smartDNA has proved a powerful deterrent."
Sweden Transport Administration maintenance officer Harly Nilsen explained that "thieves get DNA on them and at the same time, we can link what they have stolen to a specific location. Then we can prosecute them for more serious crime than we do now."
Anders Burén, Detective Superintendent and head of the surveillance unit at the regional Criminal Investigation Department in Stockholm, added,
"The police are often successful in finding copper theft suspects, along with their haul of copper. But, legally, if we cannot link them to a specific crime we have to let them go, along with the copper itself. smartDNA may help greatly in this problem."
The smartDNA security system will be used on a stretch of rail track, in a test beginning shortly. Depending on results, the product could be used nationally on the extensive Sweden rail system. Read more at Yahoo Finance.
Pharmacyclics, Inc. Rated "Buy," Good news for AtheroNova; $AHRO
AtheroNova (OTC:AHRO) is an early stage biotech company focused on the discovery, research, development and licensing of novel compounds designed to reduce or eliminate atherosclerotic plaque deposits. AtheroNova has developed intellectual property for a class of compounds that have the potential to significantly reduce the incidence and severity of atherosclerosis.
Another company developing products to improve upon therapeutics approaches to atherosclerosis, Pharmacyclics, Inc. (NASDAQ: PCYC), was recently reiterated as a “Buy” rating by Needham & Company, LLC, a firm focused on emerging growth companies in technology, biotechnology and life sciences. Needham assigned Pharmacyclics a price target of $32, an upgrade from a previous price target of $23. Read more at GainersToday.com.
As both companies are conducting similar work, this news bodes well for AtheroNova. AtheroNova recently announced that "it has signed an agreement with Frontage Laboratories, Inc. to commence work on the formulation, compounding and tabletization of the Company's AHRO-001 product in advance of the upcoming Phase I human clinical studies. [Frontage] will immediately commence work on the analysis, formulation and validation of the various processes and procedures for manufacturing AHRO-001 tablets." Read more about the agreement at PharmaLive.com.
Training Outsourcing at GP Strategies
There has been an increasing trend in the number of companies choosing to outsource their training functions in an effort to reduce and control operating costs, increase speed to market for learning, gain access to training expertise, free up internal resources for more strategic purposes and supplement internal resources. GP Strategies™ offers training outsourcing services ranging from the administration of specific training needs to a comprehensive outsourcing of an organization’s training function and can include the following:
¦Strategic assessment & planning
¦Training content design/development
¦Training delivery
¦Administration/logistical functions
¦Student enrollment
¦Call center/help desk
¦Training logistics
¦Vendor and program management
¦Tuition reimbursement administration management
¦Technology integration
¦Learning Management System (LMS) administration/help desk
¦LMS hosting
GP Strategies provides training outsourcing solutions to a wide variety of market sectors, including:
¦Financial & Insurance
¦Information Technology
¦Electronics & Semiconductor
¦Life Sciences
¦Manufacturing
¦Government
GP Strategies (NYSE: GPX), which has been providing training services since 1966, has been successful in growing its training outsourcing business through winning large, multi-year contracts with Fortune 500 companies. In 2011, it won a major contract with a financial institution to support the centralization of its global training development across multiple lines of its business through various training delivery methods, including web-based, instructor-led, virtual instructor-led, interactive websites and mobile learning. In 2012, GP Strategies won another large contract with a financial institution to provide outsourced learning solutions.
GP Strategies’ typical training outsourcing contract has a three-to-five-year term, providing for long-term customer relationships. GP Strategies has a strong recurring customer base, with over 90% of its annual revenue generated by existing prior-year clients.
Insider Buying @ GP Strategies Corporation
Since May 10, 2012, Sagard Capital Partners, L.P. (“Sagard”) has purchased 74,438 shares of GP Strategies Corporation (GPX) stock, or $1.1 million worth, in the open market at share prices ranging from $14.99 to $15.83, based on SEC filings through May 30, 2012. Over the past twelve months, Sagard has purchased 557,775 shares of GPX stock, or $7.2 million worth, at share prices ranging from $12.22 to $15.83. Over the same twelve-month time period, Sagard has sold no shares of GPX stock.
Daniel M. Friedberg serves on the Board of Directors of GPX. Mr. Friedberg has been President and CEO of Sagard Capital Partners Management Corporation, the investment manager of Sagard, since its founding in 2005. Prior to Sagard, Dan was a partner at Bain and Company, where he led the firm’s New York and Canadian Private Equity Businesses. Dan joined Bain in 1987 in the London office, and was a founder of the Toronto office in 1989 and the New York office in 2000. Over the past 12 months, Friedberg Dan has sold no shares of GPX.
Intellipharmaceutics CEO Isa Odidi buys company shares on the open market; $IPCI
Intellipharmaceutics International (NASDAQ: IPCI; TSX: I) is engaged in the research, development, and commercialization of controlled-release and targeted-release pharmaceutical products. Controlled-release means releasing a drug into the bloodstream or at a target site in the body, over an extended period of time or at predetermined times. In some circumstances, controlled-release drug delivery can enhance efficacy and patient compliance as compared to immediate release formats for the same drug.
According to a recent Insider Transaction Detail, Intellipharmaceutics CEO Isa Odidi has been buying company shares on the open market. Read more.
About Dr. Isa Odidi
In 1998, Dr. Isa Odidi co-founded Intellipharmaceutics Inc., the predecessor of publicly-traded Intellipharmaceutics International Inc. From 1995 to 1998, Dr. Odidi held positions, first as Director, then as Vice President of Research of Drug Development and New Technologies, at Biovail Corporation International (now Biovail Corporation), a drug delivery company. Prior to 1995, Dr. Isa Odidi held senior positions in academia and in the pharmaceutical and health care industries. His work has been cited in textbooks and he has published over a hundred scientific and medical papers, articles, and textbooks. He currently holds a Chair as Professor of Pharmaceutical Technology at the Toronto Institute of Pharmaceutical Technology in Canada, and is an Adjunct Professor at the Institute for Molecular Medicine in California. Dr. Odidi received his B.Sc. degree in Pharmacy, and his M.Sc. in Pharmaceutical Technology and his Ph.D. in Pharmaceutics from the University of London. Dr. Odidi is also a graduate of the Western Executive Management Program and obtained his MBA from the Rotman School of Business at the University of Toronto. Read more at intellipharmaceutics.com.
This is good news... waiting for this one.
Access Pharmaceuticals To Host Investor Call On Wednesday, May 23, 2012 - $ACCP
Company Schedules Conference Call Wednesday, May 23rd at 11:00AM ET to Update Investors on MuGard Commercial Activities
ACCESS PHARMACEUTICALS, INC. (ACCP.OB), a biopharmaceutical company leveraging its access pharmaceuticalsproprietary drug-delivery platforms to develop treatments in areas of oncology, diabetes, and RNAi, will host an investor call to update investors on MuGardcommercialization activities, including progress with pharmacy benefit managers, payers and pharmacy formularies, and other new developments within the program.
The investor conference call is scheduled to be held on Wednesday, May 23, 2012 at 11:00 am ET. Interested parties may participate by dialing 877-407-4019 (US) or 201-689-8337 (International) approximately five to ten minutes before the call start time.
A replay of the call will be available starting on May 23, 2012 at 1:00 pm ET, through June 6, 2012 until 11:59 pm ET. Interested parties may access the replay by dialing 877-660-6853 (US) or 201-612-7415 (International) and entering account number 383 and conference ID number 377785.
About MuGard:
MuGard is a novel; ready-to-use mucoadhesive oral wound rinse and coating for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops. The market for the treatment of oral mucositis is estimated to be in excess of $1 billion world-wide. For more information, please visit www.MuGard.com.
About Access Pharmaceuticals:
Access Pharmaceuticals, Inc. is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access' products include MuGard™ (www.MuGard.com), which has received FDA marketing clearance for the management of patients with mucositis, ProLindac™, a second generation DACH Platinum in Phase 2 clinical testing of patients with ovarian cancer, and Thiarabine™, a novel nucleoside analog that has demonstrated both pre-clinical and clinical activity in certain cancers; currently in a Phase 1/2a trial in hematological malignancies at M.D. Anderson Cancer Center in Houston, Texas.
The company also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism. For additional information on Access Pharmaceuticals, please visit our website at www.accesspharma.com.
Agreed the technology is very advanced it has to fly eventually. Waiting on this one. Some attention from the right publications will put them on the map.
Pegasi Successfully Drills Its First Horizontal Well; Stock Sees Move Up; $PGSI
Pegasi Energy Resources Corp. (OTCBB:PGSI), a Nevada corporation (“PERC” or “Pegasi”), is an independent organic growth-oriented energy company engaged in the exploration and production of natural gas and oil through the development of a repeatable, low geological risk, high potential project in the active East Texas oil and gas region. Pegasi currently holds interests in properties located in Marion and Cass County, Texas, home to the giant Rodessa oil field, which has produced approximately 2.3 trillion cubic feet of gas and 400 million barrels of oil. The field has historically been the domain of small independent operators and is not a legacy field for any major oil company.
The Company is pleased to announce "the successful drilling of its first horizontal well in Cass County, Texas. The Morse Unit # 1-H is the first horizontal well in Pegasi's planned development of its extensive Cornerstone Project in East Texas."
The well "has been drilled and suspended with production liner set within the 2,000 foot horizontal section of the well. The Company is planning a multi-stage frack in the completion of the well, which will be performed within 60 to 90 days. This multi-stage frack will involve a sequence of dynamic fracturing conducted in pre-determined sections of the horizontal well bore." Pegasi is in the process of evaluating the data "acquired on the vertical pilot that penetrated all of the formation's potential target reservoirs to a vertical depth of 10,843 feet as well as the data acquired from the target zone of the horizontal lateral, which was drilled to a MD of 12,576 feet. This petrophysical and petrochemical information will be used to design a multi-stage frack that is specific to the target reservoir of the well."
Pegasi CEO Michael Neufeld commented,
"This is the first horizontal well targeting the oil bearing Bossier formations that has been drilled in Cass County, Texas. We are pleased with the results and will continue our drilling program for these reservoirs during 2012." Read more at Yahoo Finance.
Since May 1, Pegasi has shown a 31% increase in stock price. Last week especially saw the stock make a significant move up on increased volume. View the PGSI stock chart at Yahoo Finance.
Applied DNA Sciences Launches digitalDNA, Converging Bio and IT Technologies; $APDN
Applied DNA Sciences Inc. (OTCBB: APDN; Twitter: $APDN) sells patented DNA security solutions to protect products, brands and intellectual property from counterfeiting and diversion. SigNature DNA is a botanical mark used to authenticate products in a unique manner that essentially cannot be copied, and provide a forensic chain of evidence that can be used to prosecute perpetrators.
The Company announced that it has launched a new, DNA-secured form of the QR ('quick read') code: digitalDNA?. This new security tool "utilizes the flexibility of mobile communications, the instant accessibility of secure, cloud-based data, and the absolute certainty of DNA to make item tracking and authentication fast, easy and definitive, while providing the opportunity to create a new and exciting customer interface."
digitalDNA "uses forensic authentication of a botanical DNA marker, sequence-encrypted within a secure QR code, and physically included within the ink used to digitally print the code." The resulting pattern, called a "rune," can be scanned with an Apple-approved app on an iPhone to assure originality. These mobile scans can be performed anywhere along the supply chain without limit.
This technology provides robust protection against phishing scams to which non-secure QR codes are notoriously vulnerable, while simultaneously providing authentication, geolocation and time-stamping throughout the supply chain. Additionally, the iPhone platform's ubiquity allows quick and easy consumer participation. The technology could allow consumers to "confirm freshness and expiration, connect to real-time or video technical support, identify local resources, easily place reorders, and participate in peer-to-peer selling."
The digitalDNA platform is designed to meet compliance specifications defined by the PCI (Payment Card Industry) Security Standards Council, the new and strict standards developed for handling credit card transactions, and HIPAA (Health Insurance Portability and Accountability Act), the stringent requirements for protecting personal health information.
The technology "evolved from a partnership agreement signed with secure cloud-computing specialist DivineRune, Inc, on January 25th of this year. The partnership will enhance and extend APDN's core anti-counterfeiting, anti-diversion, and security systems into the digital track-and-trace sphere." Both companies described the agreement as "taking APDN's best-in-class anti-counterfeiting and authentication systems and marrying them to the best in secure mobile applications and advanced cloud computing."
President and CEO of APDN Dr. James A. Hayward commented that he sees "a terrific synergy" in the partnership with DivineRune, whose name derives from a reference to symbology typified by the rise in applications of QR codes. He added,
"Our products today uniquely offer our customers proven, uncopyable authentication of virtually any product or asset. We are now ready to leverage the expertise of DivineRune to offer enhanced authentication systems which are faster, even more accessible and innovative. I believe that you will see some truly imaginative technology emerging from this partnership."
Read the full article at Finance.Boston.com.
Ventrus Biosciences Announces Positive Results From Pivotal Phase 3 Trial of Diltiazem (VEN 307) in Patients With Anal Fissures $VTUS
Treatment Arms Show Significant Improvement Over Placebo in Three Major Outcomes
Adverse Events Similar Between Treatment Arms and Placebo
Company to Host Conference Call and Presentation Today, May 14, at 10:00 a.m. ET
NEW YORK, May 14, 2012 (GLOBE NEWSWIRE) -- Ventrus Biosciences, Inc. (Nasdaq:VTUS - ventrusNews) today reported positive results from its Phase 3, randomized, double-blind, placebo-controlled clinical trial of diltiazem hydrochloride cream (VEN 307) in patients with anal fissures. Ventrus' development partner, S.L.A. Pharma, has completed most of the outputs for the statistical analysis plan of the Phase 3 trial, and Ventrus is pleased to communicate the data that they have generated.
The Phase 3 study randomized 465 subjects to diltiazem hydrochloride 4% or 2% w/w cream, or placebo, applied topically three times daily (TID) for 8 weeks, followed by a 4 week blinded observation period. Both 4% and 2% diltiazem treatment arms demonstrated significant improvements compared to placebo in the primary endpoint of average of worst anal pain associated with or following defecation (pain score improvement 0.44, p=0.0108, 4%; 0.43, p=0.0134, 2%) and in the secondary endpoints of overall anal-fissure-related pain (pain score 0.36, p=0.030, 4%; 0.40, p=0.0183, 2%) and anal fissure healing (32.7%, p=0.0181, 4%; 31.2%, p=0.0359, 2%). Pain endpoints were assessed using an 11-point numerical pain rating scale (Likert-like scale).
Adverse events (AEs) were similar for the three treatment arms. Gastrointestinal Disorders were the most common. Reports of headaches were similar in the three arms (14.7% of 4% diltiazem, 12.3% of 2% diltiazem, and 14.2% of placebo). There was one serious adverse event of surgery for hemorrhoid reported in this trial. The study was conducted in 31 centers in Europe by S.L.A. Pharma, the product candidate's licensor. Ventrus holds rights to diltiazem hydrochloride cream in North America.
Based on these results, Ventrus will request a meeting with the U.S. Food and Drug Administration (FDA) to discuss the Phase 3 diltiazem study, as well as steps to move forward toward a New Drug Application (NDA). Because diltiazem is approved in oral formulations for the treatment of angina and high blood pressure, it is eligible for the FDA's 505(b)2 registration pathway. The Company is also preparing to initiate a second pivotal Phase 3 study of VEN 307 in anal fissures in the second half of 2012.
"These results mark a watershed event for Ventrus, in that they highlight the potential for VEN 307 to be a treatment of choice for anal fissures and set off a potentially transformative period for the Company," said Russell H. Ellison, M.D., M.Sc., Chairman and Chief Executive Officer of Ventrus Biosciences, Inc. "The outcome of this study exceeded our expectations, demonstrating an improvement in all three measures of efficacy -- pain on defecation, average daily pain and healing -- results never before achieved in a single trial of a topical drug in this disorder. We look forward to next steps in the clinical and regulatory process, and to bringing VEN 307, as expeditiously as possible, to those suffering from anal fissures."
Dr. Ellison added: "We thank our partners and colleagues at S.L.A. Pharma for conducting a high quality, well executed study, and for their timely reporting of outcomes. These results come as Ventrus prepares for near-term pivotal data from a second pipeline product, VEN 309, in hemorrhoidal disease. Combined, these product candidates may represent very significant advancements for two of the most prevalent and underserved disorders in gastroenterology."
Results in Detail
I. Study Population
The study randomized 465 subjects 1:1:1 to three treatment arms, 4% or 2% diltiazem hydrochloride cream or placebo applied topically three times daily (TID) in and around the anus for 8 weeks. To be eligible for the study subjects must have had an average baseline Numerical Rating Scale (NRS), Likert Scale, score of >=4 for worst pain associated with or following defecation during the 7 day screening period. Baseline score for worst anal pain on defecation was the average of the last three NRS scores recorded during the 7 days prior to randomization; baseline score for the overall anal pain was the average of all recorded overall daily anal pain scores during the 7 day screening period. Subjects used a telephone Interactive Voice Response System (IVRS) daily to report pain.
There were 520 subjects screened, 465 randomized, and 440 subjects that completed the 12 week study period. Of the 25 subjects that discontinued, 15 were during the first 4 weeks (5 per arm), 9 during weeks 5-8 (4% diltiazem: 3, 2% diltiazem: 1, and placebo: 5), and 1 during weeks 9-12 in the 2% arm. Three of the subjects that discontinued during the first 4 weeks were due to an adverse event (headache, anal eczema, and pain in the anal region).
There were 465 subjects randomized to the study, 156, 154, and 155 subjects randomized to the 4% diltiazem, 2% diltiazem, and placebo arms respectively in the Intent to Treat (ITT) population as well as the Safety population. There were 402 subjects in the per-protocol population, 132, 134, and 136 to the 4% diltiazem, 2% diltiazem, and placebo arms respectively. The majority of the subjects were randomized in Romania with 309, 86 Bulgaria, 30 Germany, 17 Lithuania, 14 UK, and 9 from Spain. Mean age ranged from 42.5 to 44.2 years, with 56.6% females and 43.4% males. All subjects were Caucasian in the study except one Asian subject in the placebo arm.
II. Outcomes
The primary endpoint was change from baseline in average of worst anal pain associated with or following defecation ("worst anal pain") for Week 4 (7 treatment days preceding the Week 4 visit). The secondary endpoints included: Change from baseline in average of daily overall anal fissure (AF) -related pain ("daily overall anal pain") for each week, proportion of subjects who have complete healing of AF by Week 8, percentage of subjects achieving an average of >=30% reduction from baseline in the NRS for worst anal pain for Week 4, and Patient Global Impression of Improvement (PGI-I) by Week 4.
All randomized subjects were included in the analysis (ITT). Missing NRS scores were baseline observation carried forward (BOCF) for all missing pain scores due to discontinuation for AE or loss of efficacy (n=4) and last observation carried forward (LOCF) for all other missing pain scores. Mean baseline NRSs were balanced across the three treatment arms (4% diltiazem: 6.40, 2% diltiazem: 6.21, and placebo: 6.38). There was no treatment-by-center interaction for the primary endpoint analysis. The primary endpoint of Week 4 change in NRS for worst anal pain was analyzed using a model that included treatment, center, mean baseline NRSs and previous failure with GTN (glycerine trinitrate).
Primary Endpoint:
Both 4% and 2% diltiazem treatment arms demonstrated statistically significant improvement over placebo for change in Week 4 NRS for worst anal pain. Reduction in pain score was 0.44 (p=0.0108) and 0.42 (p=0.0134), for 4% and 2% diltiazem, respectively. The significant response started at Week 3 for both arms and continued to Week 8, with a reduction in pain score of 0.51 (p=0.006) and 0.41 (p=0.022) for 4% and 2% respectively at Week 8. As a sensitivity analysis, BOCF was used for all missing pain data, results were essentially unchanged with reduction in pain scores at Week 4 of 0.39 (p=0.017) and 0.41 (p=0.0118), for 4% and 2% diltiazem, respectively.
Secondary Endpoints:
The secondary endpoint of overall daily AF-related anal pain for Week 4 was significant for both the 4% and 2% diltiazem arms vs. placebo with a reduction in pain score of 0.36 (p=0.030) and 0.40 (p=0.0183) respectively. Mean baseline NRS were balanced across the three treatment arms (4% diltiazem: 5.84, 2% diltiazem: 5.93, and placebo: 6.04). The significant response started at Week 2 for the 2% diltiazem arm and continued to Week 8, with a reduction in pain score of 0.63 (p=0.001) at Week 8. The significant response started at Week 4 for the 4% diltiazem arm and continued to Week 8, with a reduction in pain score of 0.55 (p=0.004) at Week 8.
Healing at Week 8 was significantly improved for both 4% and 2% diltiazem arms compared to placebo, 32.7% (p=0.0181) and 31.2% (p=0.0359) vs. 23.9%, respectively. There was no significant difference from placebo in healing at Week 4.
Subjects were classified as responders if their Week 4 reduction in worst anal pain NRS was >=30% reduction from baseline. 56% of subjects on 4% diltiazem and 47% of subjects on placebo were classified as responders (p=0.048). There was no difference in the response rate in the 2% diltiazem and placebo.
There was no difference in the overall daily anal pain between arms for >=30% reduction in NRS from baseline to Week 4.
The PGI-I showed a significant difference between 2% diltiazem vs. placebo at Week 4 and 8 with p=0.0106 and 0.0328 respectively. There were no significant differences in the PGI-I with 4% diltiazem and placebo.
Analgesic usage was not increased in either active treatment arm compared to placebo. The average number of days/week for analgesic use was significantly lower for weeks 1-4 for the 2% diltiazem arm vs. placebo (p=0.034).
Safety and Tolerability:
Adverse events (AEs) were similar for the three treatment arms. Gastrointestinal Disorders were the most common (4% diltiazem: 65.4%, 2% diltiazem: 59.1%, and placebo: 54.2%). The majority of the Gastrointestinal Disorders were anal pain recorded as an AE (4% diltiazem: 42.3%, 2% diltiazem: 41.6%, and placebo: 45.2%). Reports of headaches were similar in the three arms (14.7% of 4% diltiazem, 12.3% of 2% diltiazem, and 14.2% of placebo). There were two subjects with an AE of cardiac disorder (palpitation); one in the 4% diltiazem arm and one in the placebo arm. There was one subject in the 2% diltiazem arm with an AE of hypotension.
There was one serious adverse event of surgery for hemorrhoid reported in this trial (4% diltiazem arm), which occurred during the post-treatment follow-up phase.
There was no difference in the skin irritation scores between arms.
Conference Call and Presentation
The Company is hosting a conference call and slide presentation to discuss results from the Phase 3 diltiazem (VEN 307) study today, May 14, at 10:00 a.m. Eastern Time. To participate in the call, interested parties may dial 1-888-330-6585 (Toll-Free/North America) or 1-253-237-1143 (International/Toll) and use Conference ID: 80689163 to register ten minutes before the call is scheduled to begin. The call and presentation will be broadcast live on the internet at http://www.ventrusbio.com.
The call will be archived for replay on May 14 at 1:00 p.m. ET and will remain available until May 21. The replay can be accessed at 1-855-859-2056 (Toll-Free/North America) or 1-404-537-3406 (International/Toll) using Conference ID: 80689163. An audio replay of the call will also be available on the Company's website, http://www.ventrusbio.com, for 30 days after 1:00 p.m. ET, May 14.
About Anal Fissures
Anal fissure is a tear in the lining of the anal canal. It is a common anal disorder characterized by severe anal pain, associated with or after bowel movements. The pathogenesis of anal fissure is hypothesized to be initiated by the passage of a hard fecal bolus, resulting in a split in the epithelium of the anal canal. Along with poor vascular supply of the anal epithelium, increased activity (tone) of the internal anal sphincter smooth muscle further compromises the anodermal blood supply and contributes to the pain and ischemia of the anal epithelium, perpetuating ulceration and preventing healing.
In 2010, it was estimated by SDI Health LLC that there were approximately 1.1 million office visits per year for anal fissures.
About VEN 307: Diltiazem Hydrochloride cream
Diltiazem hydrochloride is a calcium-channel blocker that has been marketed in oral formulations for the treatment of angina and high blood pressure for over two decades. Diltiazem hydrochloride cream is applied perianally to treat pain related to anal fissure. It has been shown to normalize internal anal sphincter pressure and reduce anal maximal resting pressure, or MRP, and its vasodilator activity has the potential to improve blood supply, thereby decreasing the pain associated with anal fissures.
About S.L.A. Pharma
S.L.A. Pharma is a privately held pharmaceutical company located outside Basel, Switzerland with an operations arm in the UK, which is focused solely on developing medicines for the prevention and treatment of gastrointestinal disorders including familial adenomatous polyposis, perianal Crohn's disease, opioid induced constipation, and anal fissures and fecal incontinence.
About Ventrus
Ventrus is a development stage pharmaceutical company focused on the development of late-stage prescription drugs for gastrointestinal disorders. Our lead products are: Iferanserin (VEN 309) for the topical treatment of hemorrhoidal disease, for which the first Phase 3 clinical trial began in August 2011 and has completed enrollment, and topical diltiazem (VEN 307) for the treatment of anal fissures for which the first Phase 3 trial was initiated in November 2010, and reported positive top line results in May 2012. Our product candidate portfolio also includes topical phenylephrine (VEN 308) intended to treat fecal incontinence. VEN 307 and VEN 308 are two molecules that were previously approved and marketed for other indications and that have been formulated into our in-licensed proprietary topical treatments for these new gastrointestinal indications. VEN 309 is a New Chemical Entity (NCE).
Please Note: The information provided herein contains estimates and other forward-looking statements regarding future events. Such statements are just predictions and are subject to risks and uncertainties that could cause the actual events or results to differ materially. These risks and uncertainties include, among others: the timing, cost and results of clinical trials and other development activities involving our product candidates; the unpredictability of the clinical development of our product candidates and of the duration and results of regulatory review of those candidates by the FDA and foreign regulatory authorities; the unpredictability of the size of the markets for, and market acceptance of, any of our products, including VEN 309; our anticipated capital expenditures, our estimates regarding our capital requirements, and our need for future capital; our ability to retain and hire necessary employees and to staff our operations appropriately; and the possible impairment of, or inability to obtain, intellectual property rights and the costs of obtaining such rights from third parties. The reader is referred to the documents that we file from time to time with the Securities and Exchange Commission.
Contact:
Ventrus Biosciences, Inc.
David Barrett
646-706-5208
dbarrett@ventrusbio.com
Argot Partners
David Pitts
212-600-1902
david@argotpartners.com
The Green Baron Report Upgrades SunSi Energies to New “Stock Pick”; $SSIE
SunSi Energies Inc's (OTC: SSIE) goal is to become one of the world's largest producers of trichlorosilane ("TCS"). The Company plans to achieve this objective by acquiring and developing a portfolio of high-quality, scalable, strategically located TCS production facilities that possess a potential for future growth and expansion. U.S. based SunSi controls approximately 55,000 metric tons of TCS production in China.
The Green Baron has released a report on SunSi Energies, naming it the 104th Green Baron "Stock Pick" and encouraging Green Baron members to acquire the stock as soon as possible.
The report states:
"The Green Baron Report officially upgrades and selects SunSi Energies, Inc. (OTCQB:
SSIE) today as our 104th Green Baron “Stock Pick” since inception, and we strongly
suggest members accumulate the stock as close to our profile price as possible...We
have very aggressive price projections for SSIE and believe the stock has huge upside potential based on several positive fundamental factors."
The report lists the following reasons for its recommendation:
* Low Cost Manufacturing Capabilities
* Pending Synergistic Key Acquisition into Multi-Billion Dollar Renewable Energy Market
* Upcoming Money Show Representation
* Low Stock Price
View the full report below.
Ssie green baron_upgraded_stock_pick_profile_05-08-12
GP Strategies Revenue Grew 46%; Operating Income Increased 70%; EBITDA up 67%
Overview of First Quarter 2012 Results:
¦Revenue of $93.6 million for first quarter of 2012 compared to $64.3 million for first quarter of 2011
¦Operating income of $7.3 million for first quarter of 2012 compared to $4.3 million for first quarter of 2011
¦Diluted earnings per share of $0.23 for first quarter of 2012 compared to $0.14 per share for first quarter of 2011
¦EBITDA of $9.2 million for first quarter of 2012 compared to $5.5 million for first quarter of 2011
¦Cash flow from operations of $7.0 million for first quarter of 2012
The Company's revenue increased 46% or $29.3 million during the first quarter of 2012 compared to the first quarter of 2011. The RWD consulting business, which was acquired from RWD Technologies in April 2011, contributed $17.7 million of revenue during the first quarter of 2012. All of the Company's operating segments achieved organic growth during the quarter, resulting in total organic revenue growth of 13% for the Company during the first quarter of 2012. The growth was driven by increased services for both new and existing customers across a variety of industries. Operating income increased 70% to $7.3 million for the first quarter of 2012 from $4.3 million for the first quarter of 2011. Net income was $4.4 million for the first quarter of 2012 compared to $2.6 million for the first quarter of 2011.
"I am pleased to report that our trend of extremely strong financial results continued into 2012," commented Scott N. Greenberg, Chief Executive Officer of GP Strategies. "We achieved double-digit organic revenue growth, led by solid performance across all of our operating segments. These positive results, combined with the successful execution of our acquisition strategy, continue to reinforce the Company's long-term growth prospects."
Balance Sheet and Cash Flow Highlights
As of March 31, 2012, the Company had cash and cash equivalents of $8.3 million compared to $4.2 million as of December 31, 2011. The Company had no short-term borrowings or long-term debt outstanding as of March 31, 2012. Cash provided by operating activities was $7.0 million for the quarter ended March 31, 2012 compared to $2.4 million for the same period in 2011.
Investor Call
The Company has scheduled an investor conference call for 10:00 a.m. ET on May 3, 2012. In addition to prepared remarks from management, there will be a question and answer session on the call. The dial-in numbers for the live conference call are 800-681-1608 or 303-223-2690, using conference ID number 21590137. A telephone replay of the call will also be available beginning at 12:00 p.m. on May 3rd, until 12:00 p.m. on May 17th. To listen to the replay, dial 800-633-8284 or 402-977-9140, using conference ID number 21590137.
Global performance improvement solutions provider GP Strategies Corporation (NYSE: GPX) announced that it will release its financial results for the first quarter ended March 31, 2012 on Thursday, May 3, 2012.
The Company has scheduled an investor conference call for 10:00 a.m. ET on May 3, 2012. In addition to prepared remarks from management, there will be a question and answer session on the call. The dial-in number for the live conference call will be 800-681-1608 or 303-223-2690 using conference ID number 21590137. A telephone replay of the call will also be available beginning at 12:00 p.m. on May 3rd and will be available until 12:00 p.m. on May 17th. To listen to the replay, dial 800-633-8284 or 402-977-9140, using conference ID number 21590137. A replay will also be available on GP Strategies' website shortly after the conclusion of the call.
About GP Strategies - GP Strategies Corporation (NYSE: GPX) is a global performance improvement solutions provider of sales and technical training, eLearning solutions, management consulting and engineering services. GP Strategies' solutions improve the effectiveness of organizations by delivering innovative and superior training, consulting and business improvement services, customized to meet the specific needs of its clients. Clients include Fortune 500 companies, manufacturing, process and energy industries, and other commercial and government customers.
For further information: Scott N. Greenberg, Chief Executive Officer, +1-410-379-3640, or Sharon Esposito-Mayer, Chief Financial Officer, +1-410-379-3636, or Ann M. Blank, Investor Relations, +1-410-379-3725
Recent Highlights:
* Supplying pharmaceutical companies with shipments of the Unifill ready-to-fill (prefilled) syringe.
* Further expansion of the Unilife AutoInfusor platform of wearable, disposable pumps for the self-administration of large-volume dose. Supplied devices to multiple pharmaceutical companies for evaluation and user studies during the March Quarter, with favorable results.
* Successful development of Unilife's first specialized device for targeted organ delivery, which is ready for supply to a global pharmaceutical customer for use in human clinical drug trials scheduled to occur later this year. Unilife recognized revenue of $566,000 during the March Quarter as part of the initial stage of this program.
* Continuing positive developments with pharmaceutical customers for other proprietary devices including the EZMix dual chamber prefilled syringe and Rita Auto-Injector.
* Sponsorship of Safe in Common's Needlestick Safety Advocacy Tour.
* Successful Analyst and Shareholder Day held in New York in March 2012.
* Unilife CEO Alan Shortall completed open market purchases of the Company's common stock totaling approximately $1.0 million from January to February of 2012.
Unilife CEO Alan Shortall commented, "Unilife remains fully on track to deliver upon several key business milestones this year. We look forward to driving future shareholder value by building partnerships with our expanding network of pharmaceutical customers, accelerating the commercialization of our diversified portfolio of advanced drug delivery systems, and expanding our production capabilities.
"Unilife continues to supply the Unifill prefilled syringe to current and new pharmaceutical customers. We look forward to the signing of commercial supply contracts for Unifill, which we anticipate throughout the second half of 2012.
"We have aggressively increased our investment in R&D, as well as existing production capacities in anticipation of several new development and supply agreements that we expect to secure starting in the second half of 2012. Our increase in R&D has already generated many positive developments.
Coronado Biosciences Promotes Karin Hehenberger, M.D., Ph.D., to Executive Vice President and Chief Medical Officer
Karin Hehenberger, M.D., Ph.D., formerly Senior Vice President of Scientific Affairs, to Executive Vice President and Chief Medical Officer. In this new capacity, Dr. Hehenberger will be responsible for providing strategic scientific input and oversight of the company's clinical development programs and medical affairs, which expands upon her previous role of broadening the scope of proof of concept trials in autoimmune diseases for the company's lead compound TSO (Trichuris suisova or CNDO-201)
Dr. Bobby W. Sandage, Jr., Coronado's President and CEO said, "Karin's extensive clinical and industry expertise makes her an outstanding choice for Chief Medical Officer. Since joining Coronado, she has been instrumental in increasing awareness of TSO within the medical community. We look forward to Karin's leadership in our continued development of TSO for the treatment of autoimmune diseases and CNDO-109 for the treatment of cancer."
Prior to joining Coronado Biosciences, Dr. Hehenberger was Senior Vice President for Strategic Alliances at the Juvenile Diabetes Research Foundation (JDRF). She was responsible for advancing the JDRF's involvement with scientific, financial, and commercial partners in the diabetes community. Dr. Hehenberger joined the JDRF from Johnson & Johnson, where she served as Vice President of Metabolic Strategy and Business Development. Dr. Hehenberger holds M.D. and Ph.D. degrees from the Karolinska Institute in Stockholm, Sweden. She continued her research as a JDRF post-doctoral fellow at the Joslin Diabetes Center at Harvard Medical School and then moved into the business aspect of medicine, as a strategic management consultant at McKinsey & Co. Dr. Hehenberger also has experience in public and private equity, having been a partner in Scandinavian Life Science Venture, a Scandinavian-based venture capital company, a buy-side healthcare equity analyst at Brummer & Partners and Argus Partners, and on the senior management team of Eyetech Pharmaceuticals.
GP Strategies' ($GPX) corporate fact sheet and 2011 Annual Report are now available
GP Strategies Corporation (NYSE: GPX) is a global performance improvement solutions provider of sales and technical training, eLearning solutions, management consulting and engineering services. GP Strategies' solutions improve the effectiveness of organizations by delivering innovative and superior training, consulting and business improvement services, customized to meet the specific needs of its clients. Clients include Fortune 500 companies, manufacturing, process and energy industries, and other commercial and government customers. GP Strategies Corporation is the new name of General Physics Corporation, which merged with its parent company (also called GP Strategies) on December 31, 2011 and changed its name.
The company recently distributed their corporate fact sheet and annual report. www.gpstrategies.com
MuGard Interim Analysis Demonstrates Statistically Significant Reduction in Pain Associated With Oral Mucositis and Reduction in the Use of Opioid Pain Medication
Access Pharmaceuticals (OTCBB: ACCP) announced interim results from its ongoing MuGard Phase 4 clinical trial in oral mucositis. An interim analysis from the first forty (40) patients enrolled in the trial showed that patients using MuGard experienced a statistically significant reduction in mouth and throat soreness and a reduction in the use of opioid pain medication compared to patients in the control arm. Other highlights from today's press release:
• The trial is continuing to enroll patients and Access anticipates presenting clinical data at a leading oncology supportive care conference this summer.
• Access initiated the Phase 4 clinical trial of MuGard in 2010 with first sites opened and subjects enrolled in the first quarter of 2011. The rigorously designed trial is a prospective, randomized, multi-center, double-blind, placebo-controlled study to evaluate the efficacy of MuGard in controlling symptoms caused by oral mucositis in subjects receiving chemoradiation therapy for the treatment of cancers of the head and neck.
• The protocol, whose primary contributor was Stephen T. Sonis, DMD, DMSc, a thought leader in oral mucositis, is designed to evaluate MuGard with a rigor that is typically associated with drugs or biological.
• Access believes this trial design is the first to be used to evaluate a device for an oral mucositis indication and distinguishes Access and MuGard from competing companies and products.
• Access Pharmaceuticals intends on presenting final data, and having the data published in peer reviewed publications, in 2012.
See the full press release @ Access Pharmaceuticals investor relations site.
Oral mucositis (“OM”) is a debilitating side effect of some radiation and chemotherapy cancer treatments, characterized by sores and ulcers in the mouth and throat that make swallowing and continued cancer therapy difficult or impossible. It is estimated that 97% of patients receiving radiation for head and neck cancer, 70% of patients receiving stem cell transplantation and up to 40% of patients receiving conventional chemotherapy develop oral mucositis. The NIH estimates that there are 400,000 patients diagnosed with OM in the US annually, but OM is often under-diagnosed and the population at risk is significantly higher. Oral mucositis can lead to pain and the need for strong pain medication, difficulty or the inability to talk, swallow, eat and drink, weight loss, infection, and in the most severe instances the interruption or stoppage of cancer treatment.
MuGard is a novel; ready-to-use mucoadhesive oral wound rinse and coating for the management of oral mucositis, a debilitating side effect of many anticancer treatments. Updated clinical practice guidelines for the prevention and treatment of mucositis recommend the use of a preventive oral care regimen as part of routine supportive care along with a therapeutic oral care regimen if mucositis develops. The market for the treatment of oral mucositis is estimated to be in excess of $1 billion world-wide. For more information, please visit www.MuGard.com.
Access Pharmaceuticals, Inc. (OTCBB: ACCP) is an emerging biopharmaceutical company that develops and commercializes proprietary products for the treatment and supportive care of cancer patients. Access' products include MuGard™ (www.MuGard.com), which has received FDA marketing clearance for the management of patients with mucositis, ProLindac™, a second generation platinum chemotherapeutic drug and Thiarabine™, a novel nucleoside analog that has demonstrated both pre-clinical and clinical activity in certain cancers; currently in a Phase 1/2a trial in hematological malignancies at M.D. Anderson Cancer Center in Houston, Texas. The company also has other advanced drug delivery technologies including CobaCyte™-mediated targeted delivery and CobOral-oral drug delivery, its proprietary nanopolymer delivery technology based on the natural vitamin B12 uptake mechanism.
Agreed I think this company has extreme potential.
CytoSorbents Corporation (OTCBB: CTSO) is a critical-care focused therapeutic device company using blood purification to treat life-threatening illnesses. These are common, major conditions seen in the intensive care unit (ICU), such as sepsis and infection, severe trauma, burns, lung injury, and pancreatitis, that afflicts millions of people each year yet lacks effective therapies, leading to a mortality rate that often exceeds 30%. Failure of multiple organs, such as the lungs, heart, kidneys and liver, is the leading causes of death from these conditions, for which very little can be done today. Hospital acquired infections are another leading cause of death in the ICU. CytoSorbents is developing novel and advanced blood purification therapies designed to actively prevent, mitigate, or reverse the development of organ failure and infection, thereby potentially reducing illness severity and helping patients to heal and recover faster.
The Company announced that "it has established its wholly-owned European subsidiary, CytoSorbents Europe GmbH, with offices in Berlin, Germany. The subsidiary will manage distribution, sales and marketing, and customer support throughout Germany and other European countries."
Dr. Phillip Chan, Chief Executive Officer, stated,
"Setting up our European subsidiary with a physical office in Germany represents a key step and commitment towards the commercialization of CytoSorb™ in the European Union. This base of operations will enable us to be close to, and support interactions with customers and businesses in real-time, and will provide a central location for our sales and marketing efforts. We are excited to move forward with our strategy to make CytoSorb™, a first-in-class treatment of cytokine storm, available to patients and physicians in intensive care units throughout Europe."
Read more at MarketWatch.com.
BillMyParents, Inc. the leader in teen spending solutions, provides modern families with innovative products and services that promote responsible teen spending habits that last. Its flagship product, the BillMyParents SpendSmart MasterCard card, is a reloadable prepaid card for teens 13+.
The Company announced the addition of William Hernandez to the BillMyParents Strategic Advisory Board. Mr. Hernandez joins the board with more than 30 years of experience in the global financial services industry, "with particular focus in the payments, card programs, transaction processing, global card networks, global consumer bank, and brokerage categories."
Mike McCoy, BillMyParents Chairman and Chief Executive Officer, commented,
"We look forward to the deep knowledge and expertise Mr. Hernandez brings to our strategic advisory board. His perspective, insights and relationships will be very valuable as we further build and improve our payments solutions for teens."
Prior to joining BillMyParents, Mr. Hernandez "served as Executive Vice President of First Data Corporation directing Strategic Financial Services for the U.S. card, processing and output services businesses." Additionally, he served as the Senior Vice President of the Americas for MasterCard International for more than 7 years, "where he managed sales and business relationship teams nationally for the largest U.S.-based financial institutions including Bank of America, Wells Fargo, U.S. Bancorp, USAA Savings, and GE Capital, among others. He has also held various international senior executive positions at Citigroup, where he spent more than a decade spearheading global consumer banking and consumer card product and access channel advancements." Mr. Hernandez was also the Executive Vice President at Epana/Unidos, a telecommunications and financial services company, "delivering products including prepaid debit, money transfer, bill payment and more to Hispanics in the U.S. and Mexico."
Mr. Hernandez stated,
"I am very excited to join the exceptionally knowledgeable and experienced BillMyParents team. I look forward to the opportunity to leverage my financial services skills to help continue to build the premier responsible teen spending company. BillMyParents is devoted to promoting smart and responsible spending among teens while enhancing communication between parents and those teens through industry leading product innovation. I am delighted to be part of that process. The opportunity for BillMyParents prepaid product to play a significant and consumer-valued role in the $40 billion annual teen segment spend is clearly exciting."
Read more at MarketWire.com.