ISTH 2011 - Japan

The XXIII Congress of the International Society on Thrombosis and Haemostasis and 57th SSC Meeting will be held in Kyoto for 2011. 

Innovative Urological Hemostat Applications

Stanford's ideas generate $65.1 million in revenues

A new report card for one of the nation's most powerful innovation engines shows that Stanford-based inventions generated $65.1 million in income for the university in 2009 despite the recession -- up from $62.5 million the previous year.
Stanford's total earnings from inventions were $1.1 billion during the past four decades, with more than half coming from just two inventions: the hypertext searching used by Google and groundbreaking DNA-splicing technology, according to an annual survey by the Association of University Technology Managers.
No longer isolated "ivory towers," schools like Stanford harvest great ideas and then try to send them out in the world. There they can be turned into commercial products -- and reward the campus with royalty income from licensing rights.
The two most lucrative inventions are decades old and are no longer producing revenue. Recombinant DNA, a 1974 invention, creates artificial DNA through gene splicing and brought in $225 million; Google's "PageRank" tool, patented in 1996, brought in $336 million.
Every school dreams of the next Gatorade -- a simple mixture of water, sugar, lemon juice, sodium, potassium, and phosphate that has yielded the University of Florida more than $80 million since 1973.
But instead of bringing home the bacon, many universities throw money into the void with little hope of return.
There's a chasm between a good idea and a product, termed "the valley of death."
Patents are expensive, with fees and legal costs involved in obtaining a single patent range from $20,000 to $25,000. Because it takes so long to bring a product to market, the royalties are based on license deals done 10 to 15 years ago.
Stanford ranks 10th in annual earnings among the nation's campuses, according to the new survey. By comparison, the University of California system had 47 startup companies and $103 million in royalties.
Nationally, scientific research from about 150 universities created 555 startup companies and resulted in more than 4,500 patent optioning and licensing deals last year, earning $1.8 billion in payouts.
Stanford's royalty revenue in 2009 came from 517 different technologies, generating from $3 million to $38 million. Its current big money-maker is an antibody invention, which led to the development of many valuable drugs.
But the statistics are sobering: After Google's PageRank and recombinant DNA inventions, "the rest of it is a bunch of technologies that generated much less income," said Katharine Ku, Stanford's Director for Technology Licensing, in a rare public presentation to the school's faculty senate last year. Only 19 inventions brought in more than $5 million. About 58 earned about $1 million, she said.
Fewer than half of the 300 research universities actively seeking patents have managed to break even from technology transfer efforts. Instead, two-thirds of the revenue tracked by the association has gone to only 13 institutions, including Stanford and UC.
Stanford's other best ideas, among the 7,400 inventions total, are FM Sound Synthesis, which led to the ringing of cell phones; recombinant DNA, used to make vast amounts of proteins like insulin, among other products; MINOS, an optimization software program; functional antibodies and DSL, which provides digital data transmission over the phone wires.
Ku recalled when Stanford engineering students Larry Page and Sergey Brin took their research project, based on a new search technology, to her office in hopes of finding a company interested in licensing their invention. Stanford marketed it to every potential licensee it could think of -- without success. So Page and Brin created their own company, and licensed the PageRank tool from Stanford. In exchange, Stanford was given Google stock.
Further reading

German Plant-based Hemostatic Innovation HaemoCer Receives CE Approval

BAYREUTH;Germany, December 16, 2010 /PRNewswire/ -- BioCer Entwicklungs GmbH, a Bayreuth, Germany-based medical device manufacturer, are pleased to announce the CE approval of HaemoCer(TM), an Absorbable Polysaccharide Hemostat (APH). Introduction of HaemoCer(TM) APH will commence this month in the European Union and other selected international markets.

HaemoCer(TM) is an absorbable, surgical hemostatic technology created via a Polysacharide Ultra-hydrophilic Resorbable Engineering (PURE) process. PURE processing utilizes sophisticated, plant-based polymer crosslinking that creates ultra-hydrophilic, biocompatible, polysaccharide compounds. The PURE technology format of HaemoCer(TM) is a powder; alternate novel product formats are planned for release Q2 2011. A family of customized, single-use application instruments will enhance the delivery of HaemoCer(TM) particles to the wound site for the control of capillary, venous and arteriolar bleeding in both open and minimally invasive surgical procedures. There is no thrombin, collagen, or other human or animal components in HaemoCer(TM) particles.

Heinz-Josef Schmies, Managing Director of BioCer Entwicklungs Gmbh commented, "In conjunction with clinical trial results due Q1 2011, the introduction of HaemoCer(TM) APH and its proprietary, integrated PURE technology represents the next generation of polysaccharide hemostatic agents. Complete production of HaemoCer(TM) is conducted in Germany and has been warmly received by multi-disciplinary surgical specialists. Our technology has been favorably received in multiple international markets and fields."

BioCer Entwicklungs GmbH is a privately held medical device company and develops novel materials and uses them to create new or modified medical devices and manufacturing technologies. BioCer Entwicklungs current solutions incorporate ceramic, polysaccharide, polymer and other composite materials developed with leading Bavarian scientific expertise in collaboration the University of Bayreuth. The proprietary, patent-pending technology platform for HaemoCer(TM) and PURE processing will focus on the worldwide, hemostasis, wound care, hernia repair and orthopedic marketplaces. For information, distribution inquiries, and licensing options, visit http://www.biocer-gmbh.de/en/ Contact:info@biocer-gmbh.de

Blood disease attacks body’s ability to stop bleeding

A 16-year-old Paducah boy and a 72-year-old Hickory woman share a condition that could leave them unable to stop bleeding from a major wound.

Dr. Danny Butler of Paducah said  Derek Willett and Phyllis Dublin suffer from idiopathic thrombocytopenic purpora. He described the disease as an assault by the body’s own immune system on blood platelets. Platelets are the component of the blood that gather at wound sites and form blood clots, stopping the body from bleeding to death. Different from hemophilia, the body suffers only from sudden acute drops in platelet levels, not in clotting factor.

“Common side effects are bruising, nosebleeds, a black spot in the mouth and bleeding into the gums,” Butler said. “We usually diagnose with a platelet count.”

Butler said the cause of the disease is unknown. Some patients, like Dublin, experience severe bleeding. Dublin bled into her lungs, which could have caused her to drown. The condition is treated by suppressing the entire immune system through anti-inflammatory steroids such as prednisone. Once treated, Dublin’s lungs re-absorbed the blood.

“We don’t know why some people choose to bleed from a certain location.” Butler said. “It could be life-threatening. We have to always look at the platelet levels. If it’s low, we would not like to operate and have to treat.”

If blood platelet levels are low or a patient has suffered severe bleeding, a blood transfusion remains an option. Butler warned that even with a transfusion, the body’s immune system could attack blood platelets. In severe cases, surgeons could remove a patient’s spleen. The spleen removes blood platelets attacked by antibodies.

“It’s a little more common in women than men and people 65 or older,” Butler said. “A lot can trigger the immune system. For every organ, we’re finding auto-immune disorders. We have a lot of work to do.”

Willett said his physician discovered the disease in a routine blood screening in 2009. The junior at St. Mary High School in Paducah said he was undergoing a physical for cross-country running when doctors noted his low platelet count. He’s reported no major episodes of bleeding, but monitors his platelet count closely.

“Doctors say I should avoid head and other serious trauma, but I’m not on steroids at this point,” Willett said. “They won’t do that unless my platelet count falls below 20,000 because steroids affect other organs in a bad way.”

Willett said he has conducted several fundraisers for Vanderbilt University Medical Center to research ITP. He’s raised $600 with a bake sale, selling bracelets and with a donation jar. For now, he is mindful of potential risks and hopes he grows out of his condition.

Dublin said she’s had no major episodes since August, but blames ITP for periods of weakness and fatigue earlier in the year.

“It was difficult to breathe, no worse than that,” Dublin said. She said the difficulty hit her one day about 11 a.m. “By 12:30, I was in the ER fighting for my life,” Dublin said.

Dublin said she stopped at the Mayfield Fire Department for oxygen. An ambulance took her to Western Baptist Hospital for treatment.

“I haven’t had any problems since, and the doctor started me on 90 mg of prednisone,” Dublin said. “He moved me from 90 to 60 to 40 and 10. Now I take 5 mg every other day. The thing is, this can affect anyone at any age, and comes on with no warning.”

Willett told teens and people of all ages to have complete blood count exam to determine if platelet levels are low.

Novo Nordisk presents positive clinical data on two investigational compounds within bleeding disorders

New data presented at American Society of Hematology annual meeting highlight promising treatments that may help patients with bleeding disorders to better manage their condition than today.
Orlando, US – (7 December 2010) – Novo Nordisk presented data from a phase 2 trial evaluating the safety, pharmacokinetics and efficacy of a recombinant factor VIIa (rFVIIa) analogue, designed to have a faster action profile than NovoSeven® (rFVIIa) in haemophilia patients with inhibitors (antibody formation against factor preparations). The company also presented data from a phase 3 trial investigating a recombinant compound in patients with congenital factor XIII deficiency, a rare, inherited bleeding disorder. The data were presented at the 52nd American Society of Hematology (ASH) Annual Meeting and Exposition.
rFVIIa analogue (NN1731)[1]: phase 2 results
Results were presented from a phase 2 trial, adept™1, in which haemophilia patients aged 12 years or older experiencing a joint bleed were randomised to  receive up to three doses of NN1731 or NovoSeven®. The trial showed that NN1731 was safe and no antibody formation against NN1731 was seen in the trial. Evaluation of patients who received NN1731at the two highest dose levels showed that 96% of the joint bleeds were well-controlled with the product; the efficacy of NovoSeven® was similar to that observed in previous clinical studies (efficacy in approximately 90% of bleeds).
In addition, the number of adverse events (AEs), including serious adverse events (SAEs), was lower in patients being treated with NN1731 compared to those in the control group. A total of 12 SAEs were reported and all occurred 16 days or longer after exposure to NN1731.
“There were no safety concerns observed in patients at any dose level of NN1731,” said Dr Erich de Paula, of the State University of Campinas in São Paulo, Brazil, who presented the trial during the meeting. “Additionally, the phase 2 trial results demonstrated the potential of the rFVIIa analogue to stop joint bleeds quickly and effectively. These results further support the distinct fast action profile of the rFVIIa analogue in treating bleeds in haemophilia patients with inhibitors.”
NovoSeven® was used as a control in the trial due to its proven efficacy and safety profile. NovoSeven®was specifically developed to treat people with haemophilia A or B with inhibitors to factor VIII or IX replacement.
rFXIII compound: phase 3 results
Results were presented from mentor™1[2], a phase 3 trial examining the efficacy and safety of a recombinant factor XIII (rFXIII) compound for the prevention of bleeds associated with congenital FXIII deficiency, a rare bleeding disorder with about 600–1,000 diagnosed patients worldwide.
In the trial, 41 patients were treated for one year, with rFXIII administered as a preventative, once-monthly replacement therapy for congenital FXIII deficiency. FXIII-deficient patients with no previous history of FXIII treatment were used as a control. Currently, the only treatment available is derived from human blood plasma, which carries an inherent risk of infections.[3]
The trial results demonstrated that treatment with monthly recombinant FXIII injections significantly decreased the number of bleeding episodes requiring treatment compared to the historic control group. Over the course of the treatment period, a total of five bleeding episodes were observed in four patients. All five events were associated with trauma, and were not related to low FXIII activity levels in patients. Additionally, no thromboembolic events or fatal adverse events were reported.
“These data show the potential for rFXIII to become a safe and effective treatment option for patients who would otherwise use treatments at risk for contamination,” said Prof Aida Inbal of the Hemostasis Unit and Hematology Clinic in the Institute of Hematology at Rabin Medical Center in Tel Aviv, Israel. “We think this is an extremely important milestone in the development of a treatment that is not sourced from human plasma for patients suffering from congenital FXIII deficiency.”
Novo Nordisk plans to file for US Food and Drug Administration approval of the rFXIII in the first half of 2011.