The open-label, multi-center, active-controlled study is expected to enroll up to 114 bendamustine-naïve patients with a confirmed diagnosis of relapsed CLL and who have failed up to three previous treatments. The Phase Ib portion of the study will determine a safe and tolerable dose of TRU-016 in combination with bendamustine in up to 14 patients with relapsed CLL. The primary endpoint for the Phase Ib portion is the incidence of dose-limiting toxicities.

The Phase II portion of the study will evaluate the safety and efficacy of TRU-016 in combination with bendamustine compared with standalone bendamustine treatment in a total of 100 randomized patients. The primary endpoint for the Phase II portion of the study is an overall response rate as defined by 2008 International Workshop on Chronic Lymphocytic Leukemia (IWCLL) criteria. Secondary endpoints include complete and partial response rates as defined by the 1996 National Cancer Institute (NCI) criteria, progression-free survival, duration of response, and improvement in quality of life and disease symptoms.

The pharmacokinetics and pharmacodynamics of TRU-016 will be studied in both phases of the study.

“Given the strong TRU-016 preclinical combination data, and the positive clinical results from the single agent dose escalation study, we believe human clinical evaluation of TRU-016 in combination with bendamustine could yield meaningful results,” said Dr. W. James Jackson, chief scientific officer at Emergent BioSolutions. “The dose escalation study in CLL continues to demonstrate that TRU-016 is well tolerated and clinically active and we look forward to Phase I combination data from this study, as well as the planned Phase I combination study for follicular Non-Hodgkin’s Lymphoma.”

Additional information about this Phase Ib/II clinical study can be found on www.clinicaltrials.gov (protocol 16201).

In December 2010, data were presented at the 52^nd Annual Meeting of the American Society of Hematology (ASH) from a Phase I TRU-016 monotherapy, dose escalation trial involving 57 patients who have had a median of four previous therapies and a median of two prior anti-CD20 therapies. Of the 57 patients, 46% received their last treatment for CLL less than 6 months before entering the study. Genomic data were available for 53 patients, the majority of which (n=35) had high-risk genomic features for CLL, including del(17p) and/or del(11q).

Pharmacokinetic data demonstrated rapid clearance of TRU-016 in the lower dose cohorts. Accumulation was seen in the 3mg/kg TIW and 6mg/kg weekly and higher cohorts. Patients in the 3 mg/kg TIW cohort (n=8) generally maintained serum concentrations of 10 g/ml during treatment. Partial response was observed in seven patients, including two patients with the del(17p) genomic risk factor. The median reduction in absolute lymphocyte count was 73% in those patients with lymphocytosis at baseline. The responses, all partial responses, were observed in patients who had received 1 – 2 prior therapies (n=16) for an overall response rate of 44% (n=7) with a median reduction in lymphocytes of 80% in this population. No responses were observed in patients who had received prior treatment with three or more therapies (n=41), although a median reduction in lymphocytes of 54% was observed in these patients. The median reduction in lymphocytes regardless of baseline lymphocyte count or the number of prior therapies was 60%.

The most commonly reported adverse events were nausea, fatigue, diarrhea, chills, pyrexia, and neutropenia. Serious adverse events occurring in more than one patient were pneumonia, febrile neutropenia, infusion reaction, pyrexia and dyspnea. A maximum tolerated dose has not yet been reached. Additional data from all TRU-016 ASH presentations can be found at: www.truemergent.com.

About CLL

According to the Leukemia & Lymphoma Society, there are approximately 85,710 people in the U.S. living with CLL, and more than 15,000 new cases are diagnosed each year. Existing treatments for CLL have shown significant efficacy in treating indolent B-cell cancers. However, research suggests that many patients do not achieve an initial response and most eventually relapse, which suggests an acute need for differentiated treatments.

About TRU-016

TRU-016 uses a different mechanism of action than currently marketed CD20-directed therapies. As a result, TRU-016 may provide patients with improved therapeutic options and enhance efficacy when used alone or in combination with chemotherapy and/or other CD20-directed therapeutics.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc., led by Chairman and CEO Fuad El-Hibri, is a global biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and antibody therapies that assist the body’s immune system to prevent or treat disease. Emergent’s marketed and investigational products target infectious diseases, oncology, and autoimmune disorders. Additional information about the company may be found at www.emergentbiosolutions.com.

Safe Harbor Statement

This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans and objectives of management, including any potential future securities offering, estimates of results for 2010, expected revenue growth and net earnings for 2011, and any other statements containing the words “believes”, “expects”, “anticipates”, “plans”, “estimates” and similar expressions, are forward-looking statements. There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including our ability to obtain additional development funding for our product candidates; the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs, preclinical studies and clinical trials; the timing of and our ability to obtain and maintain regulatory approvals for our other product candidates; our ability to obtain sales contracts for products; our commercialization, marketing and manufacturing capabilities and strategy; our estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other factors identified in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2010 and subsequent reports filed with the SEC.

SOURCE: Emergent BioSolutions Inc.

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By Del Jones, USA TODAY, ROCKVILLE, Md. — Those who go to sleep at night with the threat of terrorism on their minds might be surprised to learn that Muslim CEOs are running companies that watch over our safety.

• Houssam Salloum is CEO of Axiolog, a Detroit firm developing a high-tech system for tracking international cargo into vulnerable U.S. ports.

• Nafa Khalaf is CEO of Detroit Contracting, which after the Sept. 11 attacks in 2001 secured the five major treatment plants that supply water to 4.5 million residents of the Detroit area. Khalaf, 50, emigrated from Iraq in 1986, and his company is now working to protect water plants in Iraq.

• Ahmad Mesdaq, owner of businesses in San Diego including a coffee lounge and cigar factory, this summer will launch an auto registration system in his native Afghanistan that will help authorities stop widespread shipments of explosives and drugs by warlords. Getting Afghanistan back on its feet brings security to the USA, he says.

The past three years have shown the war on terror is complicated. Just as sides can’t be drawn up by national boundaries, neither can the good guys and bad guys be identified based on their religion or national origin.

Throughout history corporate executives have played important roles in winning wars. President Franklin Roosevelt made Robert Wood Johnson, the late CEO of Johnson & Johnson, an Army general in World War II and put him in charge of bringing small business into the war effort. Executives will likely play a critical role in the war on terrorism as well. But they won’t all have names like Johnson. Some may have names like El-Hibri or Mesdaq.

“American Muslims are making endless efforts to stop evil,” Mesdaq says.

These executives are the antithesis of the celebrity CEO so common now in Corporate America. After all, these are times when Muslims running companies in homeland security could attract the attention of both Islamophobes and terrorists. It took months of searching trade associations, chambers of commerce and homeland security experts for USA TODAY to find a cadre of companies that contribute to the security of the U.S. and have a Muslim at the helm. When found, some said they were under contractual obligations not to talk to the media. Some, like Salloum, declined to be interviewed so as not to attract attention. Others were like El-Hibri, who agreed to an interview with reservation.

“Some successful business people in the Muslim community are worried that there are forces working against them,” he says, sitting in his office tucked away in a building with no exterior signage in this Washington, D.C., suburb.

“I’m trusting, not paranoid,” says El-Hibri, 46, who became a U.S. citizen in 1999. He was born in Germany and spent his childhood equally in Europe and the Middle East before coming to the USA to get an economics degree from Stanford and an MBA from Yale. “But there is a group who don’t think the anthrax vaccine should be in the hands of someone with an Arab or Muslim background.”

Scrutiny surrounds anthrax vaccine

Conspiracy-theory Internet sites have taken a special interest in El-Hibri’s formative years in Lebanon and Sudan, and a more recent three-year assignment in Saudi Arabia with Citibank. The sites imply crimes ranging from ties to Osama Bin Laden to being the mastermind behind the mailing of anthrax spores that killed five people in 2001. El-Hibri calls the Web sites annoying and jokes that he’s lucky to be in the vaccination business so that he can inoculate himself from the pain of accusers who can’t be confronted.

Even some members of Congress have objected to BioPort’s anthrax role. That criticism reflects ignorance, says retired admiral William Crowe, who served as chairman of the Joint Chiefs of Staff in the Reagan administration and the first George Bush administration and now is on BioPort’s board of directors. BioPort recruited Crowe, a friend of El-Hibri’s father. Crowe received 8% of BioPort’s stock to serve on its board, largely because of his expertise about the key customer, the Defense Department. But Crowe’s presence also mitigates the attention on El-Hibri.

BioPort keeps a small supply of anthrax spores under five layers of security to verify the potency of the vaccine, a requirement of the Food and Drug Administration. That makes El-Hibri a suspect of conspiracy theorists, who say the unsolved anthrax mail crime of 2001 increased demand for BioPort’s product while El-Hibri and his family were safely inoculated from the fatal bio-threat.

“That’s a terrible stretch,” says Crowe, who says El-Hibri is straightforward and honest and is one who has “never entertained even the slightest idea of fooling the government” and “bends over backward to make sure the Defense Department is aware.”

Muslim executives were careful and measured when responding to most questions but became noticeably uneasy when asked how devout they were to Islam. A typical response: “I attend mosque when I have time,” Khalafsaid. “My philosophy is to be good, to live with others and to be equal with others.”

“I don’t drink alcohol or gamble,” said Mesdaq, 32. “I go to mosque,” but he emphasized: “I’m not a political Muslim. I’m a normal American. I like to drive nice cars, go out and have fun and dance. I’m very blessed.”

El-Hibri says he attends mosque once a year. His mother is German and Catholic. He adopted the faith of his Lebanese father. Islam, Christianity and Judaism are essentially the same, El-Hibri says, with a “belief in one God, what’s right and what’s wrong. Do the best things in the eyes of God, that’s most important.”

That there are Muslims fighting terrorism comes as no surprise to Daniel Lubetzky, the Jewish CEO of Peaceworks, a New York company that fosters joint ventures in regions of conflict. For example, Peaceworks markets Meditalia food products made in cooperation among Israelis, Palestinians, Egyptians and Turks; and Bali Spices made by Muslims, Buddhists and Christians working as partners in Indonesia.

Lubetzky finds that business leaders are usually moderates who see extremism as the enemy to solving poverty. The majority of Muslims have the most to lose from terrorism, because the moderates always pay for the backlash against the extremists, Lubetzky says. “Terrorists hurt their own people the most.”

Making Afghanistan safer helps the USA

Mesdaq is the son of a brigadier general in the Afghani air force who immigrated to the USA as a 9-year-old after the Soviet Union invaded Afghanistan. After the Sept. 11 attacks and the subsequent U.S. war in Afghanistan, he returned a year ago to his native country to visit family. He found a country with more than 500,000 vehicles and no efficient system of registration and licensing. SUVs with tinted windows and diplomatic plates from Iran, Pakistan and the former Soviet republics are everywhere,loaded with explosives or drugs and driven by warlords, he says.

Mesdaq had an idea for a registration system using license plates with holograms. The U.S. State Department approved his plan last month, and he says it will be launched this summer. A one-time registration fee of $100 a car will generate $50 million for the country.

Mesdaq says it’s important that Afghanistan not become dependent on aid from the U.S. “They need to lift themselves if they love their country,” he said.

Salloum is a former captain for the Italian merchant marine who left Lebanon at 17. He has lived in the USA since 1998 and is developing a tracking system that uses satellites to monitor U.S.-bound cargo.

Under the present system, if authorities become suspicious about U.S.-bound cargo, the U.S. Coast Guard boards the arriving ship six miles out at sea, checks the paperwork and, if necessary, examines individual crates. The Axiolog system aims to let enforcement agents worldwide use intelligence more efficiently to flag questionable shipments.

For example, a shipment of books might be inspected if Axiolog finds no record of that company ever receiving paper to publish books. Axiolog would allow such anomalies to be examined by computer while the cargo is en route, cutting down on expensive delays to legitimate shipments.

Such a system could prove invaluable. Even the threat of a dirty bomb could close the port of Los Angeles for a week. It would then take nearly two months to clear the backlog of incoming ships, economic terrorism that could cost billions of dollars.

El-Hibri says it’s a myth that a belief in Islam interferes with being good in business. A study last year by Marcus Noland at the Institute for International Economics supports El-Hibri’s position. Noland found no evidence that Islam was a drag on economic development in countries with large Muslim populations — outside of oil-rich regions where extremist views often interfere with education.

“The Islamic religion promotes hard work and the idea that there’s nothing wrong with being a financial success as long as you do it in an ethical and moral way,” says El-Hibri, an avid polo player whose father’s company built telecommunication networks in Saudi Arabia, Russia, Poland, Venezuela and El Salvador.

Khalaf, who took just 18 months to get a civil engineering degree from Wayne State University when he came to the USA in 1986, then earned an MBA from George Washington University, agrees that Muslim executives have their priorities straight.

“When you become an American citizen your priority is to protect Americans,” he says.

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Posted in El-Hibri Fuad, Emergent BioSolutions, Emergent BioSolutions Inc, Fuad El-Hibri, USA Taoday
Tags: United States, Saudi Arabia, World War II, Osama Bin Laden, George W Bush, US, Iraq, Barack Obama, Middle East

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