First Glycoengineered, Humanized, Type II CD20 Monoclonal Antibody to Enter Clinical Trials Could Offer Hope for Difficult to Treat Lymphoma Patients

Basel, Switzerland (ots/PRNewswire) -

- For Non-US Media Only

- Abstract 234

- Roche and GlycArt Showcase Promising Early Results for its
Next-Generation Lymphoma Treatment, R7159/GA101

Data presented for the first time today, at the 50th Annual
Meeting of the American Society of Hematology (ASH), show that
R7159/GA101, a new monoclonal CD20 antibody in development, could
offer powerful benefits in treating patients with relapsed or
refractory types of CD20 positive non-Hodgkin's lymphoma (NHL),
recognised as a difficult to treat patient population.

Results from the phase I, dose escalation portion of this phase
I/IIa study demonstrate that of the 21 heavily pre-treated B-cell NHL
patients that were enrolled (3 median prior therapies), nine showed
an objective response to treatment with R7159/GA101 monotherapy. Of
these, four patients were regarded as being in complete remission
following treatment, and five experienced a partial response. A
further five showed stabilization of their disease. Of the 11
patients whose treatment had included prior hematopoietic stem cell
transplant (transplant of stem cells from the bone marrow to produce
new blood cells), six were responders. As well as demonstrating
strong efficacy data, the results also indicate that R7159/GA101 is
well tolerated.

"There are undoubtedly excellent lymphoma treatments already in
existence, but some patients still fail to be cured," said Professor
Gilles Salles, Centre Hospitalier Lyon-Sud, France and lead
investigator of the study. "We need to continue to look to the future
so that we can offer patients innovative treatments for every stage
of lymphoma. R7159/ GA101 is the first in a new class of anti-CD20
antibodies to enter clinical trials and, so far, the results are
really very encouraging indeed. We are eager to pursue clinical
trials with R7159/GA101, as single agent or combined with
chemotherapy, to further characterize its activity in B-cell
lymphoma."

This data presented at ASH will be supplemented by further dosing
studies and further clinical data is expected in 2009.

"Although GA101 is still in the early stages of development, we
are excited by these early data," said Manfred Heinzer, Head
Strategic Marketing Oncology, Roche. "MabThera has revolutionised the
management of NHL, with over 1.5 million people treated with the drug
to date and we hope that R7159/ GA101 will provide another option for
those patients requiring more therapeutic choices."

About the study

The study is a phase I/IIa study designed to assess R7159/GA101
in patients with CD20+ malignant disease. 21 NHL patients, 20 of whom
previously received MabThera (rituximab) have been involved the phase
I dose escalation portion of the study. The endpoints in the phase I
portion included safety and tolerability, dose-limiting toxicity,
pharmacokinetics, preliminary efficacy. The phase II portion in NHL
is now recruiting.

A dose escalation in CLL patients has been performed separately
in this study and will be reported later. The safety profile of
R7159/GA101 has been shown to be very similar to that of rituximab.

About R7159/ GA101

R7159/GA101 is the first humanised and glycoengineered monoclonal
anti-CD20 antibody to enter clinical trials. It is a novel type II
anti-CD20 antibody with increased direct cell death vs rituximab and
enhanced ADCC. R7159/GA101 has shown a similar safety profile to
MabThera (rituximab) and promising efficacy in patients with
CD20-positive malignant disease. Preclinical in vivo lymphoma models
show that R7159/GA101 has superior efficacy to MabThera.

All trademarks used or mentioned in this release are legally
protected.

Further Information:

- Roche in Oncology:
http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf

- Lymphoma: http://www.lymphoma-net.org

- The Lymphoma Coalition: http://www.lymphomacoalition.org

- Cancer: http://www.health-kiosk.ch/start_krebs.htm

- World Health Organization: http://www.who.int

For more information, please contact:
Peter Bayliss
Roche
Mobile: +41-7957-25193
Email: peter.bayliss@roche.com
Natalie Fairbank
Ketchum
Phone: +44-207-611-3660
Email: natalie.fairbank@ketchum.com

ots Originaltext: Roche Pharmaceuticals
Im Internet recherchierbar: http://www.presseportal.de

Contact:
For more information, please contact: Peter Bayliss, Roche, Mobile:
+41-7957-25193, Email: peter.bayliss@roche.com; Natalie Fairbank,
Ketchum, Phone: +44-207-611-3660, Email: natalie.fairbank@ketchum.com