DGAP-News: Biotest AG / Key word(s): Miscellaneous Biotest AG: Clinical development of BT-062 in multiple myeloma expands into combination therapy

12.12.2011 / 16:30

Clinical development of BT-062 in multiple myeloma expands into combination therapy

? Efficacy and tolerability data from monotherapy studies 969 and 975 presented at 53rd annual conference of the American Society of Hematology ? Clinical benefit already seen in more than 50 % of patients receiving repeat single-dose regimen ? Good tolerability confirmed with multi-dose regimen at doses up to at least 100 mg/m2 ? Application for phase I/IIa combination therapy study (no. 983) in multiple myeloma will be submitted to FDA

Dreieich, 12 December 2011. Biotest AG is pursuing an innovative therapeutic strategy using the antibody drug conjugate BT-062 to treat multiple myeloma, an aggressive malignant hematologic disease.

New clinical data with BT-062 in the indication multiple myeloma were featured in an oral presentation at the 53rd annual meeting of the American Society of Hematology (ASH) in San Diego.

The clinical data were obtained from two ongoing studies assessing BT-062 as monotherapy: A phase I repeated single-dose trial (study no. 969) and a phase I/IIa multiple-dose trial (study no. 975). In both trials, patients suffering from multiple myeloma receive repeated treatments with BT-062 until progression of the underlying disease or occurrence of unacceptable toxicities.

In study 969, 32 patients with relapsed or relapsed/refractory multiple myeloma were treated with BT-062 administered once every three weeks. Preliminary findings reveal that more than 50 % of the treated, heavily pretreated patients benefited from the therapy. Among these is a patient who achieved a sustained clinical benefit for more than one and a half years and is still under treatment with BT-062. Data show that BT-062 is well tolerated at doses of up to 160 mg/m², even when administered over a long treatment period of currently 26 treatment cycles.

Based on these results study 975 is underway to treat about 50 patients with relapsed or relapsed/refractory multiple myeloma in an intensified dose schedule. BT-062 is given on days 1, 8 and 15 of 4-week cycle. At the first 5 dose levels of up to 100 mg/m² per dose tested so far, BT-062 was well tolerated and initial evidence of efficacy was observed. To date, no dose limiting toxicities have been observed and escalation towards higher doses is ongoing.

Based on the promising clinical results from these two monotherapy studies and supported by the preclinical combination studies, Biotest will submit its first clinical BT-062 combination study in multiple myeloma to the FDA. The phase I/IIa study (study no. 983) will investigate BT-062 in combination with lenalidomide and dexamethasone in relapsed or relapsed/refractory patients. Combination therapies are widely used in oncology to improve overall response rates, in particular in multiple myeloma. Preclinical studies using in vitro und in vivo model systems show a strong increase of efficacy when combining BT-062 with widely used multiple myeloma drugs such as lenalidomide and bortezomib, suggesting a synergistic effect of such combinations in human.

About BT-062: BT-062 is an antibody drug conjugate consisting of a monoclonal antibody and a highly potent cytotoxic maytansine derivative (DM4) using the Targeted Antibody Payload (TAP) technology developed by ImmunoGen, Inc. The antibody binds specifically to the antigen CD138, which is over-expressed on multiple myeloma cells and a variety of solid tumors.

Once the conjugate is internalized into the target cell, the DM4 is released from the targeting molecule, thereby restoring its original cytotoxic potency. This combination of high efficacy and specificity with low systemic toxicity sets BT-062 apart from most therapies currently used to treat multiple myeloma.

Disclaimer

This document contains forward-looking statements on overall economic development as well as on the business, earnings, financial and assets position of Biotest AG and its subsidiaries. These statements are based on current plans, estimates, forecasts and expectations of the company and are thus subject to risks and elements of uncertainty that could result in significant deviation of actual developments from expected developments. The forward-looking statements are only valid at the time of publication. Biotest does not intend to update the forward-looking statements and assumes no obligation to do so.

About Biotest

Biotest is a provider of pharmaceutical and biotherapeutic drugs. With a value added chain that extends from pre-clinical and clinical development to worldwide sales, Biotest has specialised primarily in the areas of application of clinical immunology, haematology and intensive medicine. In its Plasma Protein segment, Biotest develops and markets immunoglobulins, coagulation factors and albumins based on human blood plasma. These are used for diseases of the immune and haematopoietic systems. In the Biotherapeutic segment, Biotest researches into the clinical development of monoclonal antibodies, including in the indications of rheumatoid arthritis and cancer of plasma cells. Biotest has more than 1.600 employees worldwide. The preference shares of Biotest AG are listed in the SDAX on the Frankfurt stock exchange.

Biotest AG, Landsteinerstr. 5, D-63303 Dreieich, www.biotest.de Dr. Monika Buttkereit tel.: +49 (0) 6103 801-4406, e-mail: investor_relations@biotest.de fax: +49 (0) 6103 801-347

Securities' ID No., ISIN ordinary shares: 522720, DE0005227201 Securities' ID No., ISIN preference shares: 522723, DE0005227235 Listing: Prime Standard Open Market: Berlin-Bremen, Düsseldorf, Frankfurt, Hamburg, Hannover, München, Stuttgart

End of Corporate News

12.12.2011 Dissemination of a Corporate News, transmitted by DGAP - a company of EquityStory AG. The issuer is solely responsible for the content of this announcement.

DGAP's Distribution Services include Regulatory Announcements, Financial/Corporate News and Press Releases. Media archive at www.dgap-medientreff.de and www.dgap.de

Language: English
Company: Biotest AG
Landsteinerstraße 5
63303 Dreieich
Germany
Phone: 0 61 03 - 8 01-0
Fax: 0 61 03 - 8 01-150
E-mail: investor_relations@biotest.de
Internet: http://www.biotest.de
ISIN: DE0005227235, DE0005227201
WKN: 522723, 522720
Listed: Regulierter Markt in Frankfurt (Prime Standard);
Freiverkehr in Berlin, Düsseldorf, Hamburg, Stuttgart


End of News DGAP News-Service

149434 12.12.2011