TiGenix Reports Full Year 2011 Financial Results

LEUVEN, BELGIUM--(Marketwire -03/15/12)- TiGenix NV (EURONEXT: TIG) today gave a business update and announced financial results for the full year 2011.

Business highlights

Financial highlights

"TiGenix has created a new and strong basis in 2011 on which we can build going forward and we have strengthened our position as the European leader in cell therapy," says Eduardo Bravo, CEO of TiGenix. "We have delivered on our promises: we have obtained national reimbursement for ChondroCelect in Belgium and made progress in other European markets. We advanced all clinical stem cell programs on plan, and raised substantial funds from specialized healthcare investors and through non-dilutive financing. Today, TiGenix is well-positioned to reach the next value-enhancing inflection points."

Business Update

Successful integration of Cellerix reinforces leadership position in cell therapyIn May 2011, TiGenix closed the business combination with the stem cell therapy company Cellerix, creating the European leader in cell therapy. During 2011 the Company succeeded in rapidly integrating both entities. The Company now combines top line revenues with an advanced pipeline of clinical stage regenerative and immuno-modulatory products. TiGenix's operations are supported by a strong commercial and manufacturing infrastructure for advanced cell therapies, an experienced international management team and a solid cash position.

As a result of the merger, the Company's development focus has shifted from early stage preclinical programs towards a number of highly promising clinical stage products for inflammatory and autoimmune disorders of high unmet medical need, each addressing markets in excess of EUR 1 billion. TiGenix product pipeline is based on a proprietary stem cell platform that exploits expanded allogeneic (donor-derived) adult stem cells derived from human adipose (fat) tissue ('eASCs'). The platform has been extensively characterized in line with requirements of the European Medicines Agency (EMA) and is supported by exhaustive preclinical and CMC packages.

Given its focus on cell therapy, TiGenix is in the process of divesting its ChondroMimetic franchise, which is based on a biomaterial platform. To be able to concentrate on its core business and move forward with a clean slate, TiGenix has decided to write-off the intellectual property related to the OrthoMimetics acquisition.

ChondroCelect commercial roll-out progressing with first national reimbursementChondroCelect obtained reimbursement in Belgium in May 2011, and is today available in 22 specialized treatment centers.

TiGenix is selling ChondroCelect in the UK, the Netherlands, Germany, and Spain under managed access and private insurance schemes, while pursuing national reimbursement in these countries and France.

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TiGenix Reports Full Year 2011 Financial Results

Ottawa researchers to lead world-first clinical trial of stem cell therapy for septic shock

Public release date: 15-Mar-2012 [ | E-mail | Share ]

Contact: Jennifer Ganton jganton@ohri.ca 613-798-5555 x73325 Ottawa Hospital Research Institute

A team of researchers from the Ottawa Hospital Research Institute (OHRI) and the University of Ottawa (uOttawa) has been awarded $367,000 from the Canadian Institutes of Health Research (CIHR) and $75,000 from the Stem Cell Network to lead the first clinical trial in the world of a stem cell therapy for septic shock. This deadly condition occurs when an infection spreads throughout the body and over-activates the immune system, resulting in severe organ damage and death in 30 to 40 per cent of cases. Septic shock accounts for 20 per cent of all Intensive Care Unit (ICU) admissions in Canada and costs $4 billion annually. Under the leadership of Dr. Lauralyn McIntyre, this new "Phase I" trial will test the experimental therapy in up to 15 patients with septic shock at The Ottawa Hospital's ICU.

The treatment involves mesenchymal stem cells, also called mesenchymal stromal cells or MSCs. Like other stem cells, they can give rise to a variety of more specialized cells and tissues and can help repair and regenerate damaged organs. They also have a unique ability to modify the body's immune response and enhance the clearance of infectious organisms. They can be found in adult bone marrow and other tissues, as well as umbilical cord blood, and they seem to be easily transplantable between people, because they are more able to avoid immune rejection.

There has been a great deal of interest in using MSCs to treat disease, with most research so far focused on heart disease, stroke, inflammatory bowel disease and blood cancers. Hundreds of patients with these diseases have already been treated with MSCs through clinical trials, with results suggesting that these cells are safe in these patients, and have promising signs of effectiveness. MSCs are still considered experimental however, and have not been approved by Health Canada as a standard therapy for any disease.

In recent years, a number of animal studies have suggested that MSCs may also be able to help treat septic shock. For example, a recent study by Dr. Duncan Stewart, CEO and Scientific Director of OHRI (and also a co-investigator on the new clinical trial) showed that treatment with these cells can triple survival in a mouse model of this condition.

"Mesenchymal stem cell therapy appears promising in animal studies, but it will require many years of clinical trials involving hundreds of patients to know if it is safe and effective," said Dr. Lauralyn McIntyre, a Scientist at the OHRI, ICU Physician at The Ottawa Hospital, Assistant Professor of Medicine at uOttawa and a New Investigator with CIHR and Canadian Blood Services. "This trial is a first step, but it is a very exciting first step."

As with all "Phase I" trials, the main goal of this study is to evaluate the safety of the therapy and determine the best dose for future studies. The 15 patients in the treatment group will receive standard treatments (such as fluids, antibiotics and blood pressure control), plus a planned intravenous dose of 0.3 to 3 million MSCs per kg of body weight. The MSCs will be obtained from the bone marrow of healthy donors and purified in the OHRI's Good Manufacturing Practice Laboratory in the Sprott Centre for Stem Cell Research. The researchers also plan to evaluate 24 similar septic shock patients who will receive standard treatments only (no MSCs). All patients will be rigorously monitored for side effects, and blood samples will be taken at specific time points to monitor the cells and their activity. This trial will not be randomized or blinded and it will not include enough patients to reliably determine if the therapy is effective. It will be conducted under the supervision of Health Canada and the Ottawa Hospital Research Ethics Board, and will have to be approved by both of these organizations before commencing.

"The OHRI is rapidly becoming known as a leader in conducting world-first clinical trials with innovative therapies such as stem cells," said Dr. Duncan Stewart, CEO and Scientific Director of OHRI, Vice-President of Research at The Ottawa Hospital and Professor of Medicine at uOttawa. "This research is truly pushing the boundaries of medical science forward, and is providing the citizens of Ottawa with access to promising new therapies."

"The Canadian Institutes of Health Research (CIHR) is very pleased to support this clinical trial," said Dr. Jean Rouleau, Scientific Director of the CIHR Institute of Circulatory and Respiratory Health. "The work of Dr. McIntyre and her colleagues will not only add to our growing knowledge of the benefits of stem-cell therapies, but will hopefully lead to treatments that can help save the lives of patients where currently, our treatment options are less than optimal."

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Ottawa researchers to lead world-first clinical trial of stem cell therapy for septic shock

Ottawa researchers receive grant to test stem-cell therapy for septic shock

OTTAWA A team of Ottawa researchers has been awarded $442,000 to test the worlds first experimental stem-cell therapy aimed at patients who suffer from septic shock, a runaway infection of the bloodstream thats notoriously difficult to treat.

The federal grant will allow researchers from the Ottawa Hospital Research Institute to use mesenchymal stem cells, found in the bone marrow of healthy adults, to treat as many as 15 patients with septic shock.

The deadly infection occurs when toxic bacteria spreads rapidly throughout the body and over-activates the immune system, leading to multiple organ failure and death in up to 40 per cent of cases.

One in five patients admitted to intensive-care units suffers from septic shock, making it the most common illness among a hospitals sickest of the sick.

Existing treatments focus on early diagnosis and intervention before organs start to fail. Patients with septic shock require aggressive resuscitation measures, large doses of intravenous antibiotics and, often, ventilators to help them breathe.

Yet because the infection can creep up on patients rapidly and cause unpredictable complications, death from septic shock remains relatively common.

The experimental therapy aims to use donor stem cells, grown and purified at the Ottawa laboratory, to dial down the bodys hyperactive immune response and reduce the cascade of inflammation that leads to organ failure.

Early results from animal studies even raise the possibility that mesenchymal cells could eliminate the bacteria that causes septic shock, although the impact on humans is not yet known.

Its a unique feature of the stem cells, said Dr. Lauralyn McIntyre, the intensive-care physician who is leading the trial. Certainly no other therapy in the past, other than antibiotics, has impacted the bacterial load in the system.

Like other stem cells, mesenchymal cells can turn into a variety of more specialized cells and tissues that help repair and regenerate damaged organs. And because mesenchymal cells are derived from adults, they sidestep the ethical issues arising from the destruction of human embryos needed to make embryonic stem cells.

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Ottawa researchers receive grant to test stem-cell therapy for septic shock

Red Blood Cell Growth Linked to Leukemia?

(Ivanhoe Newswire)-- Yale researchers have discovered how megakaryocytes or giant blood cells that produce wound healing platelets grow 10 or more times bigger than other blood cells and how they may cause a form of leukemia.

"A failure of these cells to grow might be an initial trigger for megakaryoblastic leukemias," Diane Krause, senior researcher for the Yale Cancer Center, professor of laboratory medicine, cell biology, and pathology and associate director of the Yale Stem Cell Center, was quoted as saying.

Megakaryocytes grow so large because the DNA within the cell duplicates over and over again but without the cell undergoing cell division. A megakaryoblastic can house more than 120 sets of nuclear DNA before it becomes the biological equivalent of a supernova, undergoing significant changes to break apart into thousands of platelets needed for normal blood clotting.

A Yale team led by postdoctoral associate Yuan Gao discovered that two proteins called guanine exchange factors (GEF-H1) halt endomitosis. They found that without GEF-H1, nuclear DNA couldn't go from two internal nuclei to four. Additional divisions of nuclear DNA within the cell could not occur unless there was reduced expression of ECT2.

The team was intrigued by the results because a gene implicated in malignant leukemias, MKL1, also seems to be necessary to promote normal megakaryocyte maturation. The Krause lab is now studying whether mutant forms of MKL1 may keep levels of GEF-H1 high, therefore, making it impossible for megakaryocytes to undergo endomitosis and building the foundation for development of cancer.

"These findings reveal another important step toward the formation of functional platelets, which are necessary for normal blood clotting," Krause said. "But they also provide a clue regarding what may go away to transform normal megakaryocytes into malignant leukemia cells."

SOURCE: Developmental Cell, March 2012.

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Red Blood Cell Growth Linked to Leukemia?