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Genentech announces positive results from Phase II study of T-DM1

Genentech, Inc., a wholly owned member of the Roche Group, today announced positive results from a Phase II study of trastuzumab-DM1 (T-DM1). As assessed by independent review, T-DM1 shrank the tumors (also known as objective response) in 33 percent of women with advanced (metastatic) HER2-positive breast cancer that had worsened following previous treatment.

14 Dec 2009

Incyte announces positive results from ongoing Phase I/II clinical trial for INCB7839

Incyte Corporation announced today positive results from an ongoing Phase I/II clinical trial for its selective oral sheddase inhibitor, INCB7839, involving 46 patients with HER2 positive metastatic breast cancer.

14 Dec 2009

ImmunoGen announces the presentation of positive trastuzumab-DM1 clinical data

ImmunoGen, Inc., a biopharmaceutical company that develops targeted anticancer therapeutics, today announced the presentation of positive trastuzumab-DM1 (T-DM1) clinical data at the 32nd Annual San Antonio Breast Cancer Symposium (Abstract #710).

14 Dec 2009

Positive Phase 2 study results of CDX-011 reported by Celldex Therapeutics

Celldex Therapeutics, Inc. today announced the results of a positive Phase 2 study of CDX-011 (formerly CR011-vcMMAE), in patients with heavily pre-treated, locally advanced or metastatic breast cancers.

13 Dec 2009

Positive interim results of ARRY-380 in Phase 1 trial announced

Array BioPharma Inc. today announced positive interim results of its novel, small molecule HER2 (ErbB2) inhibitor, ARRY-380, in a Phase 1 trial in advanced cancer patients.

13 Dec 2009

Clinical trial of 2009 H1N1 influenza vaccine

HIV-infected adults currently are being recruited to participate in a clinical trial of 2009 H1N1 influenza vaccine. The study, sponsored by the National Institute of Allergy and Infectious Diseases (NIAID) of the National Institutes of Health, will enroll approximately 240 men and women between the ages of 18 and 64.

13 Dec 2009

Enrollment of patients for Phase IIb clinical trial of WBI-1001 commenced

Welichem today announced that the Company has begun to enroll patients in a Phase IIb clinical trial with its lead candidate, WBI-1001. The Phase IIb clinical trial is a double-blinded, placebo-controlled, 12-week-treatment study.

12 Dec 2009

Phase 1 clinical trial of iCo-007 demonstrates positive safety profile

iCo Therapeutics Inc. - iCo Therapeutics ("iCo") is pleased to announce that its Phase 1 clinical trial of iCo-007, having enrolled all patients in four cohorts of increasing concentration (110ug, 350ug, 700ug, 1000ug), has to date demonstrated a positive safety profile.

12 Dec 2009

Phase 2 pivotal trial of AC220 initiated by Ambit Biosciences

Ambit Biosciences Corporation announced today the enrollment and dosing at the University of Texas M. D. Anderson Cancer Center of the first patient in the ACE (AC220 Monotherapy Efficacy) Phase 2 pivotal trial in patients with relapsed or refractory acute myeloid leukemia (AML).

11 Dec 2009

Zevalin clinical data presented at 2009 ASH meeting

Spectrum Pharmaceuticals, Inc., a commercial stage biotechnology company with a primary focus in oncology, today announced that clinical data on ZEVALIN (ibritumomab tiuxetan) was presented at the 51st Annual Meeting of the American Society of Hematology (ASH), which was held December 5-8, 2009 at the Ernest N. Morial Convention Center in New Orleans, Louisiana.

11 Dec 2009

Genentech terminates dacetuzumab collaboration agreement with Seattle Genetics

Seattle Genetics, Inc. today reported that it has been notified by Genentech, a wholly owned member of the Roche Group, that Genentech has elected to terminate the companies’ collaboration agreement for dacetuzumab (SGN-40). Dacetuzumab is a monoclonal antibody targeting CD40 that has been investigated in clinical trials for non-Hodgkin lymphoma and multiple myeloma.

11 Dec 2009

Pfizer announces IES analysis of Aromasin in breast cancer recurrence

Pfizer today announced results from an exploratory analysis of the Intergroup Exemestane Study (IES) at a median follow-up of 91 months in estrogen-receptor positive (ER+) or estrogen-receptor unknown (ER-unknown) women that looked at breast cancer free survival (BCFS) and censored deaths that occurred prior to breast cancer relapse.

11 Dec 2009

ThromboGenics initiates Phase II trial of microplasmin for wet AMD

ThromboGenics NV, a biopharmaceutical company focused on innovative medicines for eye disease, vascular disease and cancer, announces today that it has started a Phase II trial of microplasmin for the treatment of exudative (wet) Age-related Macular Degeneration (AMD).

11 Dec 2009

Genentech and Biogen Idec report positive outcome from ocrelizumab-MTX combination study in RA

Genentech, Inc. a wholly owned member of the Roche Group, and Biogen Idec announced today a Phase III study (STAGE) of the investigational humanized anti-CD20 monoclonal antibody ocrelizumab given in combination with methotrexate (MTX) met its primary endpoint of improving signs and symptoms (as measured by American College of Rheumatology or ACR20 response) in rheumatoid arthritis (RA) patients who had an inadequate response to MTX at both 24 and 48 weeks.

11 Dec 2009

Tasigna demonstrates greater efficacy over Gleevec in chronic Ph+ CML patients

In a large Phase III clinical trial, Tasigna (nilotinib capsules) demonstrated greater efficacy over Gleevec (imatinib) in the treatment of adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The new clinical data were just presented as a late breaking abstract at the 51st annual meeting of the American Society of Hematology (ASH), in New Orleans, Louisiana.

11 Dec 2009

Initiation of multi-national Phase III study of Stimuvax announced

Merck KGaA, Darmstadt, Germany, today announced the initiation of its multi-national Phase III study of the investigational therapeutic cancer vaccine Stimuvax® (BLP25 liposome vaccine) in Asian patients with advanced non-small cell lung cancer (NSCLC).

11 Dec 2009

DMC recommends Novartis and Nordic Bioscience to continue oral calcitonin Phase III studies

Unigene Laboratories, Inc. (http://www.unigene.com) announced that an independent Data Monitoring Committee (DMC) has recommended that Novartis and its partner Nordic Bioscience proceed as planned with their ongoing oral calcitonin Phase III studies for osteoporosis and osteoarthritis.

11 Dec 2009

Fulvestrant 500 mg reduces risk of disease progression in women with metastatic breast cancer

AstraZeneca (NYSE: AZN) today announced that data from a Phase III study of postmenopausal women with hormone receptor-positive advanced breast cancer presented at the San Antonio Breast Cancer Symposium (Abstract 25) showed treatment with fulvestrant (FASLODEX) 500 mg reduced the risk of disease progression (assessed as time to progression (TTP)) by 20%

11 Dec 2009

Positive results from BioAlliance Pharma's acyclovir Lauriad phase III trial

BioAlliance Pharma SA, a company dedicated to the treatment and supportive care of cancer and AIDS patients, today announces final positive results of its pivotal phase III clinical study in immunocompetent patients with recurrent herpes labialis (LIP Study) treated with acyclovir Lauriad®. Primary and secondary endpoints have been met with marked efficacy and good tolerance.

10 Dec 2009

FDA approves Azaya Therapeutics' Taxotere for Phase I clinical study

Azaya Therapeutics, Inc. announced today that the Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for its lead product “ATI-1123,” a novel and improved formulation of Taxotere® (docetaxel), a leading chemotherapy drug with worldwide annual sales of over $2.8 billion.

10 Dec 2009