HGS-ETR1 aka Mapatumumab (previously known as TRAIL-R1 mAb) is a human monoclonal antibody
- From: J <pitstop@xxxxxxxx>
- Date: Thu, 18 Aug 2005 18:42:11 -0400
HGS-ETR1 aka Mapatumumab (previously known as TRAIL-R1 mAb) is a human
monoclonal antibody that specifically binds to TRAIL (tumour necrosis
factor-related apoptosis-inducing ligand) Receptor-1.
http://money.cnn.com/2005/08/18/news/midcaps/genome/
Glaxo bets on experimental cancer drug
Glaxo partners with Human Genome on cancer drug; analysts point to
blockbuster potential.
August 18, 2005: 12:06 PM EDT
By Aaron Smith, CNN/Money staff writer
NEW YORK (CNN/Money) - GlaxoSmithKline has thrown its big pharma weight
behind an experimental anti-cancer drug being tested by Human Genome
Sciences.
Glaxo (up $0.55 to $48.46, Research) and Human Genome (up $0.28 to $12.78,
Research), which have partnered on various projects since 1996, will split
costs and potential profits on HGS-ETR1, a drug that is being tested to
kill tumor cells. If successful as a multi-use drug, it could be used to
fight non-small cell lung cancer, non-Hodgkin's lymphoma and colorectal
cancer.
"It could be the next Avastin," said Hanzhong Li, analyst for Suntrust
Robinson Humphrey, referring to a Genentech cancer treatment that had $447
million in sales in the first half of 2005. Avastin sales have grown
rapidly since its debut in February 2004 and could hit the $1 billion mark
this year.
Li said that HGS-ETR1 has strong sales potential because it is being
tested to treat "a broad spectrum of cancers." However, the drug still
faces two or three years worth of testing so it is difficult to project
sales, said Li. Even if the drug successfully completes clinical trials
and is rapidly approved by the Food and Drug Administration, it would not
enter the market earlier than 2008.
"It does have blockbuster potential," said Alexander Hittle, analyst for
A.G. Edwards. "[Glaxo] may have seen something in the data that leads them
to be particularly optimistic about this."
Hittle said that if HGS-ETR1 is successful, it could one day be used to
prolong the life of cancer patients by managing the disease, just as the
HIV virus is currently managed through drugs.
Glaxo spokeswoman Gaile Renegar said this is latest agreement a
"long-standing relationship" with Human Genome. "We obviously wouldn't be
exercising our licensing options if we didn't have confidence in it," said
Renegar.
Human Genome spokesman Jerry Parrott said his company would benefit from
Glaxo's financial strength, drug developing expertise, marketing force and
global presence.
Mark Monane, biotech analyst for Needham, said the 50-50 split is a
win-win and demonstrates the growing importance of biotechs.
"It's another example of biotech, the home of innovation, and big pharma,
which has been very successful in marketing, getting together," said
Monane. "Gone are the days where biotechs would give things away for
single-digit royalties."
London-based Glaxo is one of the world's largest drug companies, with $39
billion in 2004 sales. Founded in 1992, Human Genome is based in
Rockville, Maryland and does not have significant revenues.
The analysts do not own shares in the companies mentioned.
Suntrust trades Human Genome shares.
A.G. Edwards owns Human Genome stock.
http://www.clinicaltrials.gov/ct/show/NCT00094848?order=1
Study of TRM-1 (TRAIL-R1 Monoclonal Antibody) in Subjects with Relapsed or
Refractory Non-Hodgkin's Lymphoma (NHL)
This study is currently recruiting patients.
Verified by Human Genome Sciences October 2004
Lymphoma, Non-Hodgkin Drug: TRAIL-R1 mAb (TRM-1; HGS-ETR1)
Phase II
Study Type: Interventional
Study Design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single
Group Assignment, Safety/Efficacy Study
Official Title: A Multi-Center, Open-Label, Dose-Escalation Study to
Evaluate the Safety, Efficacy, and Exposure to TRM-1 (Fully Human
Monoclonal Antibody to the TRAIL-R1) in Subjects with Relapsed or
Refractory Non-Hodgkin?s Lymphoma
Eligibility
Ages Eligible for Study: 18 Years and above, Genders Eligible for
Study: Both
Criteria
Primary Inclusion Criteria:
* Relapsed or refractory histologically confirmed Non-Hodgkin's
Lymphoma
* Previously treated with at least 1 therapeutic regimen and relasped
or progressed or failed to achieve a response after the last regimen
* 18 years of age or older
Primary Exclusion Criteria:
* Received a non-FDA approved investigational agent within the last 4
weeks
* Received cancer therapies (chemotherapy, biological therapy
[including hormonotherapy], radiation therapy or immunosuppressants within
the last 3 weeks, 8 weeks for monoclonal antibodies, radioimmunotherapy or
nitrosourea
* Eligible for a hematopoietic stem cell transplant (HSCT) or have had
an autologous HSCT within the last 16 weeks
* Prior history of an allogeneic HSCT
* HIV, AIDS-related lymphoma, central nervous system (CNS) lymphoma,
Hepatitis-B or Hepatitis-C
* Infection requiring antibiotics within the last 4 weeks
* Major surgery within the last 4 weeks
* Pregnant or breast-feeding women
* History of other cancers within the past 5 years
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00094848
Thomas Platek 1-866-447-9749 Thomas_Platek@xxxxxxxx
Minnesota
Mayo Clinic, Rochester, Minnesota, 55905, United States; Not yet
recruiting
Nebraska
University of Nebraska Medical Center, Omaha, Nebraska, 68198,
United States; Recruiting
New York
Roswell Park Cancer Institute, Buffalo, New York, 14263, United
States; Recruiting
Memorial Sloan Kettering, New York, New York, 10021, United
States; Recruiting
Pennsylvania
Fox Chase Cancer Center, Philadelphia, Pennsylvania, 19111,
United States; Recruiting
Tennessee
Sarah Cannon Research Institute, Nashville, Tennessee, 37203,
United States; Not yet recruiting
Texas
MD Anderson Cancer Center, Houston, Texas, 77230, United States;
Recruiting
More Information
Study ID Numbers: TRM1-HM01
Last Updated: August 1, 2005
Record first received: October 27, 2004
ClinicalTrials.gov Identifier: NCT00094848
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