<<BS, hype and pure speculation warning>>
I am really bummed by this result, but.... I've been looking at the tissue distribution of CD2, and...... first blush, we could benefit from the new hurdles that anti-CD40L will need to clear. There are years of experience in humans with 507 and its murine predecessor..... the initial MEDI results in psoriasis now take on even greater significance? Will MEDI start to drool at the concept of applying Dumont et al.-like observations to the markets that BGEN used to cite?
Tuesday November 2, 4:05 pm Eastern Time
Company Press Release
SOURCE: Biogen, Inc.
Biogen Says it Has Stopped Ongoing Trials of
Anti-CD40 Ligand Monoclonal Antibody
CAMBRIDGE, Mass., Nov. 2 /PRNewswire/ -- Biogen, Inc. (Nasdaq: BGEN - news) today announced that it has halted the
ongoing clinical trials of its anti-CD40 ligand monoclonal antibody until the Company has completed its review of issues relating
to adverse events. The Company said it had taken this measure in the interests of patient safety and that one additional
thrombo-embolic event had taken place since October 21. At that time, the Company announced it was halting some trials and
continuing several others. The Company said it is working closely with the Food and Drug Administration (FDA) on this issue.
( Photo: newscom.com )
Jim Vincent, Biogen's Chief Executive Officer, said, ''While this is a disappointing development, the situation has not changed
from our earlier announcement. We need further study of the reasons for these adverse events, and in the interests of patient
safety, we feel it is appropriate to put a hold on all the trials at this time. In our research to date, we have seen early evidence of
biological efficacy and activity across several indications. Based on our clinical experience so far, we believe that if we can
safely block this pathway, the drug may have significant therapeutic benefit in important diseases. However, there is work that
must be done before we can return to the clinic.''
On October 21, 1999, the Company announced that studies in Factor VIII inhibitor syndrome, islet cell transplantation and
multiple sclerosis had been placed on hold. The Company has now stopped trials in renal transplantation, ITP (Immune
Thrombocytopenic Purpura) and lupus nephritis.
Humanized anti-CD40 ligand monoclonal antibody (hu5c8) is a novel immunomodulator that selectively binds to CD40 ligand,
an important co- stimulatory molecule found on activated T cells.
In addition to historical information, this press release contains forward-looking statements within the meaning of the ''safe
harbor'' provisions of the Private Securities Litigation Reform Act of 1995. Reference is made in particular to statements
regarding re-commencement of Phase II trials of hu5c8 and its potential therapeutic benefit. These statements are based on the
Company's current beliefs and expectations as to such future outcomes. Drug development involves a high degree of risk.
Factors which could cause actual results to differ materially from the Company's current expectations include the risk that the
Company may not be able to solve technical and medical hurdles related to safe use of the drug or that other issues may arise in
the conduct of clinical trials, as well as the other risks and uncertainties described from time to time in the Company's periodic
reports filed with the Securities and Exchange Commission.
Biogen, Inc., winner of the 1998 U.S. National Medal of Technology, is a biopharmaceutical company principally engaged in
discovering and developing drugs for human healthcare through genetic engineering. Headquartered in Cambridge, MA, the
Company's revenues are generated from worldwide sales of AVONEX® (Interferon beta-1a) for treatment of relapsing forms
of multiple sclerosis, and from the worldwide sales by licensees of a number of products, including alpha interferon and hepatitis
B vaccines and diagnostic products. Biogen's research and development activities are focused on novel products for multiple
sclerosis, inflammatory, respiratory, kidney and cardiovascular diseases and in developmental biology and gene therapy. For
copies of press releases and additional information about the Company, please consult Biogen's Homepage on the World Wide
Web at www.biogen.com.
SOURCE: Biogen, Inc. |
