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Health Canada Approves ADCETRIS® (Brentuximab Vedotin) for the Treatment of Relapsed or Refractory Hodgkin Lymphoma (HL) and Systemic Anaplastic Large Cell Lymphoma (sALCL

On February 1, 2013 Seattle Genetics reported that Health Canada has issued a Notice of Compliance with conditions (NOC/c), authorizing marketing of ADCETRIS for two lymphoma indications: (1) the treatment of patients with Hodgkin lymphoma (HL) after failure of autologous stem cell transplant (ASCT) or after failure of at least two multi-agent chemotherapy regimens in patients who are not ASCT candidates, and (2) the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one multi-agent chemotherapy regimen (Press release Seattle Genetics, FEB 1, 2013, View Source;p=irol-newsArticle&ID=1780634&highlight= [SID:1234500570]). The indications for ADCETRIS were authorized based on promising response rates demonstrated in single-arm trials. No data demonstrate increased survival with ADCETRIS.

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(Filing, 10-Q, Champions Oncology, JAN 31, 2013, View Source [SID:1234504159])

Teva Announces Termination of Agreements with CureTech

On January 31, 2013 Teva reported the termination of its collaboration with CureTech Ltd (Press release Teva, JAN 31, 2013, View Source;p=irol-newsArticle&ID=1779781 [SID:1234500813]).

"We are in the process of conducting a disciplined review of our pipeline. As we looked closely at CT-011 and the most recent clinical and biochemical data, we have made the strategic decision to invest our resources elsewhere where we can have the most impact for patients," stated Dr. Michael Hayden, President and CEO of R&D and Chief R&D Officer.

CT-011 is a humanized monoclonal antibody being developed as a treatment for hematological malignancies and solid tumors. CT-011 was assessed in several phase I and II clinical studies in various cancer indications including diffuse large B-cell lymphoma (DLBCL), colon cancer, metastatic melanoma and additional investigator initiated studies.

Teva entered into agreements with CureTech in 2006. Teva intends to book a noncash net charge of $109 million as a result of the impairment of its investment in CureTech.

(Filing 10-Q , Lion Biotechnologies, JAN 25, 2013, View Source [SID:1234501579])

Positive results from the BI-505 phase I study in multiple myeloma

On January 24, 2013 BioInvent reported the first results from the BI-505 phase I study in patients with multiple myeloma (Press release BioInvent, JAN 24, 2013, http://www.bioinvent.com/investors/press-releases/release.aspx?releaseid=736831 [SID:1234500561]). The study has reached a final stage and the preliminary analysis shows that BI-505 has an advantageous safety profile. In cohorts where extended therapy was available, 24 % of the patients had stable disease for at least two months, indicating effect of BI-505. The final conclusions of the study will be available at a later time-point. The optimal dose has been defined according to the study protocol and will be used in the next clinical trial which is approved by the health authorities.
BI-505 is a human antibody selected from the n-CoDeR-library and fully owned by BioInvent. It is directed against the ICAM-1 adhesion protein, which is highly expressed on multiple myeloma cells. BI-505 has demonstrated significant anti-tumor activity in several relevant models of multiple myeloma.
Thirty-five patients with relapsed or refractory disease after at least two previous regimens with other drugs are included in the phase I, dose escalation study. The primary objective is to determine the safety and tolerability of BI-505 in patients with advanced disease. Pharmacokinetics and pharmacodynamic variables including relevant biomarkers for tumor response are also being evaluated in order to determine the optimal dose for further clinical development. The study is being conducted at seven sites in the US and Europe.
Groups of patients are treated with increasing doses of BI-505 (0,0004 – 20 mg/kg; eleven dose levels) every second week over a four-week period, with a possibility of extended therapy every two weeks until disease progression for patients at dose level six and onwards.
The preliminary assessment demonstrates that BI-505 has a favorable safety profile with a low number of reported adverse events. Temporary infusion-related reactions were observed when the first dose was given which is commonly seen. Despite advanced disease, 7 of the 29 patients on extended therapy (at dose level six and onwards) had stable disease for at least two months. A dosing regimen of 10 mg/kg every second week resulted in complete saturation of the ICAM-1 epitopes on the patient´s bone marrow myeloma cells. The 10 mg/kg dose will thus be used in the next clinical trial which has already been approved by the health authorities.