‘She’s our little miracle’

July 17, 2009

‘She’s our little miracle’

Published Date: 17 July 2009
Dressed in pink from head to toe, two year-old Eva McLaughlin skips across the kitchen floor pushing a yellow toy shopping trolley.
“I’m going to the Spar,” chirps the blonde-haired Magilligan girl.
Seconds later, she sits by her pink toy piano and tells mum Cathy: “I’m going to play a song.”

Moments later Eva is off again, this time down the hall chatting.
Anyone meeting Eva for the first time would think she is just an ordinary toddler, full of energy and into everything.
But Eva is anything but ordinary.

“She’s a miracle, she really is,” says Cathy.

Eva was born with severe combined immune deficiency syndrome (SCID), a condition which means she had no white T blood cells which provide natural resistance against infection. Without these, infections spread and can be fatal.

At first, mum Cathy and dad Ryan had no reason to suspect anything was wrong with Eva but when their baby girl couldn’t shake coughs and infections, they knew something was wrong.

“It just wasn’t shifting,” recalls Cathy, explaining the weekly trips to the doctor.

On December 5, 2007, Eva became very ill, struggling for breath. The tot had severe pneumonia.

She was taken to the Royal Victoria Hospital in Belfast for a week where she was kept alive by a ventilator supplying her with life-saving oxygen.

“It was horrific, just complete panic,” says Cathy. “It was so hard to see and look at her in intensive care. She was just lying there.”
Miraculously, Eva was able to come off the ventilator within days. She was taken to Newcastle General Hospital for a bone marrow transplant after a match for her was found by the Anthony Nolan Trust in the USA.
“It was the only chance she had. The bone marrow transplant was the only thing she had to keep her alive,” says Cathy.

Prior to the transplant, Eva underwent eight days of gruelling chemotherapy.

“It was when her hair fell out and I picked it up from the pillow; that was just horrific,” says Cathy.

Just one day after her first birthday, Eva had a rest day. The next day she had the transplant and Cathy and Ryan were told they could not touch their child.

“They said if you kiss that child it could kill her,” recalls Cathy. “It was awful but it needed to be done but knowing I couldn’t even kiss my own daughter was hard.”

When Eva was in hospital, she lived in a tightly-controlled, 8ft x 8ft “bubble” to avoid threats to her non-existent immune system.
Almost 10 stressful months later, Eva and her parents were finally ready to go home.

“Eva was so near death and I wouldn’t wish it on anyone,” says Cathy, reflecting on the ordeal. “The doctors here and in Newcastle are miracle workers. What they did for Eva was unbelievable. It’s just unreal, just the most unbelievable experience. We handed our daughter over to the doctors and said: ‘Please cure her’.”

The trip home was an emotional one for Cathy and Ryan but the close-knit community lined the country road where they lived, wishing them well.

“Everyone was cheering and waving,” says Cathy. “Magilligan is a brilliant community. We had a brilliant reception.”

‘Lucky’

Cathy and Ryan travel to Newcastle on Monday for a check-up on Eva’s progress. They are hoping for an easing of restrictions on things she hasn’t been able to do before, like go to the beach or the zoo.
“The way Eva looks now compared to before is unreal,” says Ryan. “People can’t believe how she’s come on, running about like any other wee child. Looking back on it now with some perspective, you think, ‘We were lucky’.”

Cathy adds: “She’s a miracle, she really is.”

The family want to raise as much awareness as possible for the Anthony Nolan Trust and the Bubble Foundation and with the help of their close knit community have already raised almost £6,000 for research.
“Thank God Eva is here, and every day she’s going from strength to strength. It is a miracle,” adds Cathy.

For more information or to make a donation, go to http://www.anthonynolan.org.uk and http://www.bubblefoundation.org.uk

linkback url: http://www.derryjournal.com/journal/Shes-our-little-miracle-.5469463.jp

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Baxter and Halozyme Announce Completion of Patient Enrollment in Phase III Pivotal Trial of GAMMAGARD LIQUID™ with rHuPH20 Enzyme

July 15, 2009

Baxter and Halozyme Announce Completion of Patient Enrollment in Phase III Pivotal Trial of GAMMAGARD LIQUID™ with rHuPH20 Enzyme

(Nasdaq:HALO) today announced completion of patient enrollment in the Phase III pivotal study of GAMMAGARD LIQUID [Immune Globulin Intravenous (Human) 10%] (also known as KIOVIG outside of the United States) with rHuPH20 (recombinant human hyaluronidase enzyme) for the treatment of primary immunodeficiency disorder : (PID). Patients will receive monthly
subcutaneous (SC) injections of Halozyme’s rHuPH20 with Baxter’s GAMMAGARD LIQUID : .

“The achievement of complete Phase III enrollment is an important milestone of Baxter’s work with Halozyme to offer patients more advanced treatment options,” said Hartmut J. Ehrlich, M.D., vice president of Global Research and Development for Baxter’s BioScience business.

“I am pleased with the efficiency and dedication Baxter has demonstrated toward our collaboration and their exemplary ability to manage and carry out the clinical objectives,” stated Jonathan Lim, M.D., Halozyme’s president and CEO. “Completion of patient enrollment in this Phase III registration study marks a significant and timely accomplishment for the GAMMAGARD LIQUID-rHuPH20 development program.”

This Phase III clinical trial is a prospective, open-label, non-controlled design underway in 15 centers in the U.S. and Canada. The study will evaluate the safety and efficacy of GAMMAGARD LIQUID administered SC with rHuPH20 in the prevention of acute serious bacterial infections over 12 months and will also assess pharmacokinetic parameters of SC GAMMAGARD LIQUID with rHuPH20 compared to intravenous (IV) administration of GAMMAGARD LIQUID alone. Patient Quality of Life (QOL) parameters will also be measured. Subcutaneous administration of GAMMAGARD LIQUID with rHuPH20 in this investigational study will determine if it will allow PID patients to receive a full monthly dose in a single injection site in the home setting. GAMMAGARD LIQUID is currently only approved for IV administration. Additional information about this Phase III study can be found at clinicaltrials.gov : .

About GAMMAGARD LIQUID

GAMMAGARD LIQUID is indicated for the treatment of primary immunodeficiency disorders associated with defects in humoral immunity.

These include but are not limited to congenital X-linked agammaglobulinemia, common variable immunodeficiency, Wiskott-Aldrich syndrome, and severe combined immunodeficiencies.

Important Safety Information

GAMMAGARD LIQUID is contraindicated in patients with known anaphylactic or severe hypersensitivity responses to Immune Globulin (Human).

Patients with severe selective IgA deficiency (IgA < 0.05 g/L) may develop anti-IgA antibodies that can result in a severe anaphylactic reaction.

Immune Globulin Intravenous (Human) products have been reported to be associated with renal dysfunction, acute renal failure, osmotic nephrosis, and death. IGIV products should be administered at the minimum concentration available and the minimum rate of infusion practicable in at risk patients.

GAMMAGARD LIQUID is made from human plasma. It may carry a risk of transmitting infectious agents, e.g. viruses, and theoretically, the Creutzfeldt-Jakob disease (CJD) agent. Some viruses, such as B19V or hepatitis A, are particularly difficult to remove or inactivate.

GAMMAGARD LIQUID should only be administered intravenously.

Immediate anaphylactic and hypersensitivity reactions are a remote possibility.

IGIV products can contain blood group antibodies which may act as hemolysins and induce in vivo coating of red blood cells with immunoglobulin causing a positive direct antiglobulin reaction and, rarely, hemolysis. Hemolytic anemia can develop subsequent to IGIV therapy due to enhanced red blood cell sequestration.

There have been reports of noncardiogenic pulmonary edema (Transfusion Related Acute Lung Injury [TRALI]) in patients administered IGIV.

Thrombotic events have been reported in association with IGIV. The potential risks and benefits of IGIV should be weighed against those of alternative therapies.

Aseptic meningitis syndrome (AMS) has been reported to occur infrequently in association with GAMMAGARD LIQUID treatment.

Discontinuation of IGIV treatment has resulted in remission of AMS within several days without sequelae.

For full prescribing information, please visit: http://www.baxter.com/products/biopharmaceuticals/downloads/gamliquid_P .. :

About Baxter

Baxter International Inc., through its subsidiaries, develops, manufactures and markets products that save and sustain the lives of people with hemophilia, immune disorders, infectious diseases, kidney disease, trauma, and other chronic and acute medical conditions. As a global, diversified healthcare company, Baxter applies a unique combination of expertise in medical devices, pharmaceuticals and biotechnology to create products that advance patient care worldwide.

About Halozyme Therapeutics, Inc.

Halozyme is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company’s portfolio of products and product candidates is based on intellectual property covering the family of human enzymes known as hyaluronidases and additional enzymes that target the extracellular matrix. Halozyme’s Enhanze ™ Technology is a novel drug delivery platform designed to increase the absorption and dispersion of biologics. The company has key partnerships with Roche to apply Enhanze Technology to Roche’s biological therapeutics for up to 13 targets and with Baxter BioScience to apply Enhanze Technology to Baxter’s biological therapeutic compound, GAMMAGARD LIQUID ™ . The product candidates in Halozyme’s research pipeline target multiple areas of significant unmet medical need. For more information visit http://www.halozyme.com : .

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the GAMMAGARD-rHuPH20 clinical development program) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in each company’s reports on Forms 10-K, 10-Q, and other filings with the Securities and Exchange Commission.

Baxter Media ContactsChris Bona, 847-948-2815Laura
Grossmann, 847-948-3026orBaxter Investor ContactsMary
Kay Ladone, 847-948-3371Clare Trachtman, 847-948-3085orHalozyme
ContactRobert H. Uhl, Senior Director, Investor Relations,

858-704-8264 ruhl@halozyme.com : mailto:ruhl@halozyme.com

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