Biotechnology Market News

Posted by Heidi N. Moore - Wall Street Journal Blogs

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Catumaxomab, Representing a New Generation of Antibodies, Proved Efficient and Safe in Malignant Ascites

MUNICH, Germany and CHICAGO, May 31 /PRNewswire/ --

- Data presented at 44th Annual ASCO Congress, Chicago, USA

Treatment with the trifunctional antibody catumaxomab significantly prolongs puncture-free survival in patients with malignant ascites, according to the results from a Phase II/III trial presented at the 44th American Society of Clinical Oncology (ASCO) congress. The prolonged time to next therapeutic puncture and reduced ascites signs and symptoms emphasize the clinical relevance of catumaxomab treatment. In addition, catumaxomab administered to patients of the control arm after study end showed a clear improvement in time to next puncture. Overall survival data indicate a survival benefit. Catumaxomab represents a new generation of antibodies in the field of oncology. A new drug application was submitted to EMEA in December 2007 for catumaxomab for the indication malignant ascites due to epithelial tumors (carcinomas).

"The development of trifunctional antibodies represents a new targeted therapy for treatment of tumors, and these results provide clear evidence for efficacy and safety of catumaxomab in the management of malignant ascites, one of the conditions being investigated with a trifunctional antibody," said lead investigator Simon L. Parsons, Nottingham City Hospital, UK, at the presentation of the trial results in Chicago.

The study involved 258 patients with malignant ascites due to epithelial tumors (carcinomas). Of those, 129 suffered from ovarian cancer while another 129 had non-ovarian cancers. Patients received either puncture (paracentesis) and four intraperitoneal infusions of catumaxomab within 11 days, or paracentesis alone (control group).

The trial met its primary endpoint with high statistical significance. Patients treated with catumaxomab showed a median puncture-free survival (primary endpoint) of 46 days compared with 11 days in the control group (p< 0.0001). Puncture-free survival was defined as the period between the last infusion and the first subsequent necessary puncture or death, whichever occurred first. The median puncture-free time - a secondary endpoint which did not include the data from patients who died before the next ascites puncture was due - was 77 days versus 13 days (p< 0.0001). Patients receiving catumaxomab had an overall survival of 72 days compared with 68 days in the control group. Improved overall survival of catumaxomab treated patients with ovarian cancer (110 vs. 81 days; p=0.1543) and gastric cancer (71 vs. 44 days, p=0.0313) indicate survival benefit.

The most common side effects observed during the trial, such as fever, nausea and vomiting were all due to catumaxomab's mode of action. These side effects were predictable, limited, manageable and mostly fully reversible.

Malignant ascites can be caused by different epithelial tumors. Abdominal spread of tumor cells leads to an accumulation of fluid in the abdominal cavity and is associated with a poor prognosis. The most commonly used treatment of malignant ascites is puncture (paracentesis), which has to be carried out on average every eleven days and can lead to complications such as infection and fluid or protein deprivation. The trifunctional antibody catumaxomab is known to kill tumor cells in the peritoneal cavity and therefore attacks the primary cause of ascites formation.

Trifunctional Antibody Catumaxomab

The therapeutic objective of trifunctional antibodies is to generate a stronger immune reaction against tumor cells. Catumaxomab has two different antigen binding sites: While one arm of the antibody recognizes and binds to T cells, the other arm binds EpCAM (epithelial cell adhesion molecule) that is overexpressed in many types of epithelial cancers. Immune effector cells with Fc receptors (macrophages, monocytes, dendritic cells and natural killer cells) can also bind the Fc region of trifunctional antibodies. This simultaneous binding subsequently results in the costimulation and activation of T cells and accessory cells, enabling the generation of a strong immune response against tumor cells. Preclinical and clinical data also suggest a potential long-lasting effect to prevent cancer recurrence. Catumaxomab is further developed in various indications (e.g. gastric and ovarian cancer) in the early stages of disease addressing the underlying tumor.

Trifunctional Antibodies

Trifunctional antibodies are proteins that activate different cell types of the immune system simultaneously and redirect them specifically to tumor cells which are killed. Trifunctional antibodies are therefore very effective in destroying cancer cells and show a therapeutic effect even at very low dosages. Apart from catumaxomab two other trifunctional antibodies targeting other cancer antigens are currently undergoing clinical development.

Trifunctional antibodies are being developed by TRION Pharma GmbH.

Fresenius Biotech - a company of the Fresenius health care group - is focused on the development, marketing and commercialization of biopharmaceuticals in the fields of oncology and transplantation medicine. For further information please visit http://www.fresenius-biotech.com.

Fresenius is a health care group with international operations, providing products and services for dialysis, hospital and outpatient medical care. In 2007, group sales were approx. EUR 11.4 billion. On March 31, 2008 the Fresenius Group had 116,203 employees worldwide. For further information please visit www.fresenius.de.

Trion Pharma is a biopharmaceutical company that develops and produces trifunctional antibodies based on a globally patented technology platform together with Fresenius Biotech in Munich. For further information please visit www.trionpharma.de.

This release contains forward-looking statements that are subject to various risks and uncertainties. Ac tual results could differ materially from those described in these forward-looking statements due to certain factors, including changes in business, economic and competitive conditions, regulatory reforms, foreign exchange rate fluctuations, uncertainties in litigation or investigative proceedings, and the availability of fi nancing. Fresenius does not undertake any responsibility to update the forward-looking statements in this release.

Joachim Weith, Corporate Communications Tel.: 49-6172-6082101 Fax: 49-6172-6082294 e-mail: pr-fre@fresenius.de http://www.fresenius-ag.com

Fresenius Biotech

Joachim Weith, Corporate Communications, Tel.: 49-6172-6082101, Fax: 49-6172-6082294, e-mail: pr-fre@fresenius.de

How To Construct A 'Firefly' Worm - Science Daily (press release)

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Bacteria good for bowels - Sarnia Observer

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NHGRI Director, Francis Collins, To Step Down - TheMedGuru

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Discovery set to freight Japanese science lab to ISS - AFP

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Patients With Pancreatic Cancer can Benefit From Avastin(R) Plus Tarceva(R)

BASEL, Switzerland, May 31 /PRNewswire/ --

- Results Confirm Previously Demonstrated Survival Advantages of Tarceva in This Difficult-to-Treat Disease

- ABSTRACT No: 4507

Adding Avastin (bevacizumab) to a combination of Tarceva (erlotinib) and chemotherapy significantly improves the time patients with metastatic pancreatic cancer live without their disease getting worse ("progression free survival"). These data, presented for the first time today at the 44th annual meeting of the American Society of Clinical Oncology (ASCO) in Chicago, also showed a trend towards extending life expectancy.

Pancreatic cancer is the sixth leading cause of cancer death in Europe(1) and is extremely difficult to treat because it spreads rapidly to other parts of the body and often shows resistance to chemotherapy and radiotherapy(2). It is also difficult to diagnose, with no effective early diagnostic test available(3) so the majority of patients are diagnosed with advanced disease.

"For patients with advanced pancreatic cancer, the treatment options are limited," commented Professor Eric Van Cutsem, Professor of Medicine, Gastrointestinal Oncology Unit, University Hospital Gasthuisberg, Leuven, Belgium. "The interesting results show the need for further exploring which patients benefit from the combination of gemcitabine plus Avastin and Tarceva in view of the statistically longer PFS which trends towards improved survival."

The results of the phase III AVITA (BO17706) study showed that the addition of Avastin to a Tarceva/gemcitabine combination resulted in:

- A 37% increase in the time patients live without their disease getting worse compared to Tarceva/gemcitabine alone - Almost 14% of patients experiencing a complete disappearance or shrinkage of their tumor - A trend towards improved overall survival - No new safety signals for Avastin

In addition, data from the Tarceva/gemcitabine control arm were consistent with previous results from the PA3 study, reinforcing the already established survival benefits of Tarceva in pancreatic cancer(4).

About AVITA

The AVITA (BO17706) study is a Roche-sponsored, randomized, double-blind, placebo-controlled phase III study that included 607 patients with metastatic pancreatic cancer. Study participants received first-line treatment with either gemcitabine, Tarceva and placebo or gemcitabine, Tarceva and Avastin (at 5mg/kg every two weeks).

The AVITA study did not meet its primary endpoint of overall survival (OS), however results showed that adding Avastin to a combination of Tarceva and chemotherapy significantly improved the time patients with pancreatic cancer lived without their disease getting worse (PFS). A trend towards improved OS was also observed.

In addition, the findings in the gemcitabine/Tarceva control arm of this trial were consistent with the efficacy observed in the metastatic patient population in the pivotal Phase III PA3 study led to the regulatory approval of Tarceva for the treatment of pancreatic cancer in the US in 2005 and in the EU in 2007.

Additional information

- Roche in Oncology: http://www.roche.com/pages/downloads/company/pdf/mboncology05e_b.pdf - Roche Health Kiosk, Cancer: http://www.health-kiosk.ch/start_krebs - Avastin: http://www.avastin-info.com

To access video clips about Avastin in broadcast standard, free of charge, please go to: http://www.thenewsmarket.com.

References

(1). Michaud. Minerva Chir, 2004; 59: 99-111.

(2). Khosravi Shahi. Anales de Medicina Interna, 2005; 22: 390-4.

(3). Stewart. et al. World Health Organisation and the International Agency for Research on Cancer, IARC Press/Lyon, 248-9.

(4). Moore et al. J Clin Oncol, 2007; 25: 1960-6.

Roche

For more information please contact: Erica Bersin, Roche, 41-79-618-7672 (mobile); Jon Harris, Galliard Healthcare, 44-20-7663-2261 (direct line)

Edson awards 00000 to companies designed by students - East Valley Tribune

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Democrats wage a bare-knuckle primary in the 40th Assembly District - Los Angeles Times

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