Healthy Skepticism Library item: 3924

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Publication type: media release

Baker J.
U.K. Parexel International Statement Regarding Tegenero AG Phase I Trial at Northwick Park Hospital
Parexel International 2006 Apr 5
http://www.parexel.com/news_and_events/press_releasesSingle.asp?id=236

Abstract:

Parexel TEGENERO TGN1412

Notes:

Ralph Faggotter’s Comments:

Curiously, none of these press releases contain any hint of sorrow or apology on the part of the company.

The nearest we get to an expression of sorrow is from the 13th of March press release
“…this is an unfortunate and unusual situation.” where the word ‘unfortunate’ is used.

The rest of the series press releases are surprisingly upbeat.

“ Based upon our review, we believe that best practices were followed and the appropriate policies and procedures were adhered to. “

This seems an odd assessment, when at least on volunteer has described how he was given the infusion at a time when the research team were already aware that at least one other of the volunteers who had been injected earlier, was having a severe reaction.

On the other hand, perhaps they were just adhering to the company motto –

“WE APPROACH OUR WORK WITH THE GOAL OF REDUCING TIME, RISK AND COST ASSOCIATED WITH DEVELOPING AND COMMERCIALIZING NEW PRODUCTS.”

( see Parexel Home Page)

Full text:

Contact:
Jill Baker
Vice President of Investor Relations
PAREXEL International
Tel: (781) 434-4118
Fax: (781) 434-5033 Jennifer Baird
Director of Public Relations
PAREXEL International
Tel: 781-434-4409
Fax: 781-434-5033

MEDIA ADVISORY UPDATE
PAREXEL INTERNATIONAL STATEMENT REGARDING TEGENERO AG PHASE I TRIAL AT NORTHWICK PARK HOSPITAL, U.K.

BOSTON, MA, April 05, 2006 — We are extremely pleased to report that five of the patients have now been released from the hospital. We are also pleased that the sixth patient is making steady progress and has been moved out of critical care into another unit of the hospital. We appreciate all of the efforts of the hospital team and the excellent care the team has provided to the patients.

The Medicines and Healthcare products Regulatory Agency in the U.K. (MHRA) today released an interim report regarding the TeGenero Phase I trial. The MHRA found no deficiencies during its inspection of PAREXEL’s Phase I unit at Northwick Park Hospital that would have contributed to the adverse reactions experienced by the study volunteers. The MHRA has confirmed that the trial was run according to the approved protocol. These findings support our internal review that best practices and policies and procedures were correctly followed.

The MHRA believes that the adverse reactions in the study volunteers were most likely caused by an unpredicted biological action of the drug in humans, and that the adverse reactions did not involve errors in the manufacture of TGN1412 or in its formulation, dilution or administration to the study volunteers.

PAREXEL will not be issuing any further statements, unless there are significant developments.

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PAREXEL offers a range of services to assist the pharmaceutical, biotech, and medical device industries in developing new products, with a focus on first-in-man clinical evaluation through to product commercialization.
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For today’s press release from MHRA or to view the interim report, visit the MHRA website at http://www.mhra.gov.uk.
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For updates on the condition of the patients please visit The North West London Hospitals website at www.nwlh.nhs.uk.
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For updates from TeGenero AG, the drug developer and sponsor of the clinical trial, visit www.tegenero.com.
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Updates from Boehringer Ingelheim, the drug manufacturer, may be found in their “News Centre” at www.boehringer-ingelheim.com.
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For more information regarding Phase I clinical trials and clinical research in general please contact:

Association of Clinical Research Organizations
www.acrohealth.org
Tel: +1 202-543-4018
email: info@acrohealth.org

The Association of the British Pharmaceutical Industry (ABPI)
www.abpi.org.uk
Tel: +020 7930 3477

The Pharmaceutical Research and Manufacturers of America (PhRMA)
www.phrma.org
Tel: +1-202-835-3400

Tufts Center for the Study of Drug Development
http://csdd.tufts.edu/

U.S. Food and Drug Administration (FDA):
http://www.fda.gov/fdac/special/testtubetopatient/default.htm

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PREVIOUS STATEMENTS

BOSTON, MA, March 31, 2006 – We are very pleased to report that four of the patients have now been released from the hospital, having made an excellent recovery. We are also encouraged that the condition of the other two patients has continued to improve, and they have responded well to the treatment provided by the hospital staff.

We expect that the MHRA will conclude its inquiry in respect to PAREXEL in the near future. Our internal review continues to support that best practices and policies and procedures were correctly followed.

PAREXEL will not be issuing any further statements, unless there are significant developments.

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BOSTON, MA, March 24, 2006 – PAREXEL International provided an update today related to the TeGenero AG Phase I study that was conducted at Northwick Park Hospital in the U.K. last week.

The status of all of the patients has continued to improve. Four of the men have been moved out of Critical Care into another unit of the hospital, and are continuing to make a good recovery. Two other men are still in critical condition, but have made a sustained improvement in response to treatment. PAREXEL staff at the Phase I unit continue to work with the patients, their family members, and the hospital team to provide assistance.

There has been no update from the MHRA at this time.

TeGenero AG, the developer of TGN 1412 and sponsor of the Phase I study, has posted an updated “Frequently Asked Questions” document regarding the compound, the preclinical and clinical testing of the drug, and other related items on their website. A link to the document may be found at the end of this statement.

PAREXEL will not be issuing any further statements, unless there are significant developments.
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BOSTON, MA, March 22, 2006 – PAREXEL International provided an update today related to the TeGenero AG Phase I study that was conducted at Northwick Park Hospital in the U.K. last week.

The status of all of the patients has continued to improve. Four of the men have been moved out of Critical Care into another unit of the hospital, are responding very well to treatment, and are making a good recovery. Two other men are still in critical condition, but are showing positive signs of improvement in response to treatment. PAREXEL staff at the Phase I unit continue to work with the patients, their family members, and the hospital team to provide assistance.

The MHRA is continuing inquiries of the various parties involved with the compound developed by TeGenero AG, but has found no reason to recommend the discontinuation of trials at PAREXEL’s Phase I unit. PAREXEL’s internal Quality Assurance department has completed a preliminary audit which continues to support that the protocol approved by the MHRA and the Ethics Committee was adhered to properly, and that best practices and policies and procedures were correctly followed.

On March 20, 2006 Boehringer Ingelheim confirmed that the company is the contract manufacturer of the biologic that was being studied in TeGenero AG’s Phase I clinical trial. According to a statement posted on the company’s website, a review of the manufacturing documentation and the pharmaceutical release procedure has confirmed that the material supplied by them to TeGenero AG complied with all relevant requirements. Their comments may be found by following a link at the end of this statement.

TeGenero AG, the developer of TGN 1412 and sponsor of the Phase I study, has posted a “Frequently Asked Questions” document regarding the compound, the preclinical and clinical testing of the drug, and other related items on their website. A link to the document may be found at the end of this statement.

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BOSTON, MA, March 20, 2006 – PAREXEL International provided an update today related to the TeGenero AG Phase I study that was conducted at Northwick Park Hospital in the U.K. last week.

The hospital’s latest press statement, which was issued this morning, reported that the status of all of the patients has continued to improve. Four of the men continue to respond well to their treatment, and are making a steady recovery. Two others are still in critical condition, but are showing positive signs of improvement in response to treatment. PAREXEL staff continues to be in close contact with the patients’ family members and the hospital team to assist and answer any questions, and are greatly encouraged by the reports of the patients’ continuing health improvement.

The MHRA is carrying on their inquiry of the various parties involved with TeGenero’s compound, and has not yet provided a timeline for the completion of their inquiry. The Phase I unit remains operational. PAREXEL’s internal review continues to support that the protocol approved by the MHRA and the Ethics Committee was adhered to properly, and that best practices and policies and procedures were correctly followed.

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BOSTON, MA, March 17, 2006 – A statement from Professor Herman Scholtz, MD, Head of PAREXEL International Clinical Pharmacology

“We are pleased to learn from the hospital that the status of all of the patients in the TeGenero study has further improved, and they are showing signs of response to treatment. We remain in close contact with Northwick Park Hospital and the families of the patients, during this difficult and challenging time.

We are continuing to work with the Medicines and Healthcare products Regulatory Agency in the U.K. (MHRA) which has collected further information and data from the Phase I unit as expected. Based upon our review, we believe that best practices were followed and the appropriate policies and procedures were adhered to. We are fully cooperating with the regulatory authorities, and the unit remains operational.

The MHRA has indicated that next week they expect to expand the scope of their review to include additional parties involved with TeGenero’s compound. The MHRA has not yet provided a timeline for the completion of its inquiry.”

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BOSTON, MA, March 16, 2006 – A statement from Herman Scholtz, MD, Head of PAREXEL International Clinical Pharmacology:

“We remain in close and constant contact with the Northwick Park Hospital concerning the medical status of the six volunteers who took part in the TeGenero Phase I study. We are encouraged that the medical condition of the patients has improved. We have been informed that all six remain in the intensive care unit of the hospital, with four of the men showing signs of improvement, while two men remain critical. Our thoughts are with the patients and their families.

An initial review at the site to date has shown that best practices were followed and all of the appropriate policies and procedures were adhered to. Furthermore, we commend the staff for their swift reactions with the volunteers when the adverse reaction occurred. This type of reaction is extremely rare, and is a very unusual event.

We are working with the Medicines and Healthcare products Regulatory Agency in the U.K. (MHRA), to review in detail all of the policies and procedures that were followed. The MHRA has commended PAREXEL’s support of their review, and we will continue to provide our full cooperation for the ongoing investigation.”

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BOSTON, MA, March 13, 2006 – On March 13, 2006, all six volunteers who received a test biologic in a clinical pharmacology (Phase I) study conducted for biopharmaceutical company TeGenero AG, Würzburg, Germany experienced an unexpected adverse reaction. This is the first time the drug had been introduced into humans. The biologic, TGN 1412 is an immunomodulatory humanized agonistic anti-CD28 monoclonal antibody being developed by sponsor TeGenero AG for the treatment of autoimmune/inflammatory diseases and hemato-oncological malignancies.

TeGenero contracted with PAREXEL International to study the new substance in PAREXEL’s Clinical Pharmacology Unit located in Northwick Park Hospital in London, England. Phase I clinical trials are conducted according to strict ethical and regulatory requirements and involve a small group of healthy volunteers in whom a substance is introduced for the first time with the goal of evaluating tolerability.

“These events were completely unexpected and do not reflect the results we obtained from initial laboratory studies which enabled us to progress investigations into human volunteers ”, commented Dr. Benedikte Hatz, Chief Executive Officer of TeGenero AG. “The clinical trial performed by PAREXEL adhered to standard clinical research guidelines.”

“When the adverse reaction occurred, the PAREXEL clinical pharmacology medical team responded swiftly to stop the study procedures immediately and notified authorities. We worked in cooperation with the hospital intensive care doctors and the sponsor to have the volunteers given the best possible care, and to explore all possible treatment options,” said Professor Herman Scholtz, MD, Head of PAREXEL International Clinical Pharmacology.

“Such an adverse reaction occurs extremely rarely and this is an unfortunate and unusual situation. We have a high quality medical team in our Northwick Park unit. Since our unit is located within the hospital, we had immediate access to the intensive care unit of the hospital, and we did everything possible to get the volunteers treated as quickly as possible,” said Dr. Scholtz.

The patients are now in the care of Northwick Park Hospital.

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Healthy Skepticism Library item: 3924

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