Ventrus Biosciences Announces Positive Results From Pivotal Phase 3 Trial of Diltiazem (VEN 307) in Patients With Anal Fissures - $VTUS

Ventrus Biosciences, Inc. (Nasdaq:VTUS - News) 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."

See the full press release.

GP Strategies to Attend 13th Annual B. Riley & Co. Investor Conference - $GPX

Global performance improvement solutions provider GP Strategies Corporation (NYSE: GPX) announced that Scott Greenberg, Chief Executive Officer, and Sharon Esposito-Mayer, Chief Financial Officer, are scheduled to present at the 13th Annual B. Riley & Co. Investor Conference on Tuesday, May 22, 2012 at 2:30 pm PDT. The conference will be held at the Loews Santa Monica Beach Hotel in Santa Monica, California.  The presentation slides will be available on the Investors section of the company's website at http://investors.gpstrategies.com/events.aspx.

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.

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

Organic Growth and Successful Acquisition Strategy Result in Strong 1Q12 Results for GP Strategies $GPX

GP Strategies Corporation (NYSE:GPX) is a global performance improvement solutions provider of sales and technical training, e-Learning solutions, management consulting and engineering services. $GPX has offices located worldwide (2,500 employees) and is poised to capitalize on the growing shift towards e-Learning within the training industry as companies from a variety of industries shift from traditional in-person training to more efficient, flexible and convenient e-Learning applications.

The Company is organized into five business segments;

• Learning solutions (e-Learning, training BPO and training and curriculum development across a wide range of industries);
• Professional & technical services (e.g. training and technical services for manufacturing and petrochemical industries, design/build services in the alternative fuels industry and training and engineering services for government clients); 
• Sandy training & marketing (custom product sales training to auto industry); RWD (IT consulting and human capital management); and
• Energy services (products and services to electric power utility companies).

On May 3, 2012, $GPX reported strong financial results for 1Q12 with the following highlights:

• Reported 1Q12 diluted earnings per share (EPS) of $0.23 vs. $0.14 in the year-ago period w/ net income of $4.4M during 1Q12 compared to $2.6M in the year-ago period
• Reported 46% revenue growth to $93.6 M vs. $64.3M in the year-ago period
• Organic growth was achieved by all of the Company’s operating segments, resulting in total organic revenue growth of 13% for the first quarter of 2012 resulting from increased services to new and existing customers across a variety of industries
• Earnings Before Interest, Taxes, Depreciation and Amortization (EBITDA) increased by 67% to $9.2M vs. $5.5M in the year-ago period, resulting in cash flow from operations of $7M during 1Q12
• As an example of successful acquisition strategy, RWD consulting business (which was acquired last April) contributed $17.7M of revenue during 1Q12
• As of March 3, 2012, reported cash/equivalents of $8.3M with no debt compared to $4.2M cash/equivalents and no debt at year-end 2011
• Approximately 19M shares of common stock outstanding on a fully diluted basis

The Company highlighted its successful strategic acquisition strategy in the highly fragmented $59.7 billion training industry (with 16 acquisitions completed since 2006) as a key element to the growing, record profit, revenue and cash flow (EBITDA) during 1Q12 as evidenced by the strong results in RWD consulting business which accounted for about 19% of revenue.

In addition, $GPX is poised to benefit from a resurgent US/global auto manufacturing industry with General Motors (NYSE:GM) representing the Company’s largest client (accounting for 7% of revenue during 1Q12) in addition to contracts with other US and global auto manufacturers for auto dealership sales training.

The Company entered the financial services sector with a major contract win in 2011, resulting in a new top 10 customer, and in early 2012, they won a large contract with another financial institution which is expected to become a top 20 customer. Most recently, the Company was awarded another contract from a financial services company for a pilot program in Europe.

The outlook for $GPX appears positive based on a 53% growth in contract backlog to a level of $212M at the end of 1Q12 compared to $139M in the year-ago period, with approximately 25% of the increase in year-over-year backlog due to organic growth. The Company continues to expand globally (as illustrated by recent contract awards in Europe) and also has exposure to the alternative fuel industry through its design/build of liquefied natural gas (LNG) fueling stations as an expected source of future growth and enhanced shareholder value.

GP Strategies to Attend Barrington Research Industrial & Business Services Conference #GPX

Global performance improvement solutions provider GP Strategies Corporation (NYSE: GPX) announced that Scott Greenberg, Chief Executive Officer, and Sharon Esposito-Mayer, Chief Financial Officer, are scheduled to attend the Barrington Research Industrial & Business Services Conference on Wednesday, May 16, 2012 at the Four Seasons Hotel in Chicago, IL. The conference schedule will comprise a series of one-on-one and small group meetings with participating investors. The presentation slides will be available on the Investors section of the company's website at http://investors.gpstrategies.com/events.aspx.

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.

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

GP Strategies' case study: Fort Polk firefighters conduct Tiger team training ($GPX)

We often get the question, "What does GP Strategies do?

The excerpt below is from a story "Fort Polk firefighters conduct Tiger team training" in the Leesville Daily Leader. It gives a good example of what the professions at GP Strategies are capable of in a post-9/11 world:

Students practice setting up a decontamination shelter as of the training GP Strategies conducted at Fort Polk.

"A package is delivered to an office building on Fort Polk. The recipient opens the package and discovers a white powder and broken vial containing an unidentified liquid. No one knows where it came from, what it is or if it’s hazardous. Multiple people have been exposed to the chemical. Someone calls Fort Polk Fire and Emergency Services to report the incident. Firefighters arrive on scene, but what happens next?

Fort Polk Emergency Services firefighters train often for every possibility. From March 5-9, the firefighters participated in “Tiger Team Training” with GP Strategies, an organization contracted by the Army.

“We bought some high-tech equipment recently that we needed outside help with," said Jose Fejarang, the assistant chief of operations for Fort Polk Fire and Emergency Services. "Because of these folks’ (GP Strategies) knowledge of the equipment, we asked them to come and address our issues."

Cliff Brown and Angus MacIver, training specialists for GP Strategies from Pine Bluff, Ark., were the instructors for the Tiger Team Training.

“We hold a classroom and theory portion, followed by practical application," Brown said. "We try to discuss previous events and lessons learned to develop basic components for the future. Then, we let them use what they’ve learned with hands-on application."

In support of the TACOM Life Cycle Management Command Consequence Management Team, GP Strategies has trained more than 12,700 firefighters at different installations around the world since May 2010. Other trainings included using gas monitors, detecting chemical weapons, using radiation detectors, learning HAZMAT identification and infrared technology and more. Brown said that the organization tries to focus on hands-on scenarios, so the responders know how to use the equipment.
 

“If we aren’t training on (HAZMAT) for a class or doing it often, we can forget that stuff," said firefighter Charles Stemler, of Fort Polk DES. "The hands-on parts make it like you’re solving the problem for real. Some day you may actually be doing it and you need to know how."

See the full story here.

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.