Cetuximab News and Research

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Cetuximab is an investigational IgG1 monoclonal antibody designed to target and block the Epidermal Growth Factor Receptor (EGFR), which is expressed on the surface of certain cancer cells in multiple tumor types. Cetuximab is designed to bind to EGFR and prevent natural ligands called growth factors from binding to the receptor and inducing phosphorylation, i.e., activation of signaling to the tumor. The most common drug-related adverse events reported in clinical trials of cetuximab have been an acne-like rash and asthenia. Severe allergic reactions may occur in a small percentage of patients.

FDA grants Keryx Biopharmaceuticals Fast Track designation for perifosine

Æterna Zentaris Inc., a late-stage drug development company specialized in oncology and endocrine therapy, today announced that its partner, Keryx Biopharmaceuticals, was granted Fast Track designation by the U.S. Food and Drug Administration for perifosine (KRX-0401), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, for the treatment of refractory advanced colorectal cancer.

5 Apr 2010

Phase 1/2 human clinical trial of Symphogen's Sym004 initiated in the US

Symphogen A/S today announced that it has initiated a Phase 1/2 human clinical trial in the US to evaluate the safety, tolerability and efficacy of its drug candidate Sym004 for the treatment of advanced solid tumors. Sym004 is composed of two anti-epidermal growth factor receptor monoclonal antibodies targeting different nonoverlapping EGFR epitopes.

1 Apr 2010

Erbitux can now be used in Japan as 1st-line treatment for mCRC: Merck Serono

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, announced today that Erbitux® (cetuximab) can now be used in Japan in combination with chemotherapy in the 1st-line treatment for patients with epidermal growth factor receptor -expressing, curatively unresectable (inoperable), advanced or recurrent colorectal cancer carrying the KRAS wildtype gene.

29 Mar 2010

Latest treatment options for colorectal cancer highlighted at NCCN Annual Conference

Despite statistics stating that colorectal cancer is the fourth most frequently diagnosed cancer in men and women in the United States, mortality from colon cancer has decreased slightly over the past 30 years, possibly because of earlier diagnoses through screening and better treatment modalities.

15 Mar 2010

GTC Biotherapeutics reports total net loss of $1.7M for fourth-quarter 2009

GTC Biotherapeutics, Inc. today reported its financial results for the fourth quarter and fiscal year ended January 3, 2010. The total net loss for the fourth quarter was $1.7 million, or $0.09 per share, compared with $6.2 million, or $0.60 per share, for the fourth quarter of 2008. The total net loss for 2009 was $27.9 million, or $2.18 per share, compared to $22.7 million, or $2.31 per share, for 2008.

12 Mar 2010

Comprehensive development strategy yields two potential drugs that block cancer-promoting pathways

A comprehensive drug development strategy that starts with extensive screening of potential targeting agents and then narrows down to a small-molecule prototype has yielded two potential drugs that block cancer-promoting pathways in novel ways, a team led by scientists at The University of Texas M. D. Anderson Cancer Center reports in two papers published back-to-back online at the Proceedings of the National Academies of Science.

26 Feb 2010

New genetic 'hotspots' may help doctors devise therapies for bowel cancer patients

Cancer Research UK scientists have identified the frequency of new genetic 'hotspots' which could help doctors to tailor therapies to as many as 3,000 additional bowel cancer patients each year, according to research published in the British Journal of Cancer today.

11 Feb 2010

Keryx Biopharmaceuticals reaches agreement with FDA on SPA for Phase 3 trial of KRX-0401

Keryx Biopharmaceuticals, Inc. announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) on the design of a Phase 3 trial for its PI3K/Akt pathway inhibitor, KRX-0401 (perifosine), in patients with refractory metastatic colorectal cancer.

3 Feb 2010

Erbitux improves survival of mCRC patients with KRAS wild-type tumors

Merck Serono, a division of Merck KGaA, Darmstadt, Germany, today announced that Erbitux® (cetuximab) provided an improvement in overall survival (OS) when added to the standard 1st-line FOLFIRI chemotherapy regimen for metastatic colorectal cancer (mCRC) patients with KRAS wild-type tumors in the CRYSTAL study.

24 Jan 2010

BioNumerik Pharmaceuticals commences patient treatment in Tavocept Phase III trial

BioNumerik Pharmaceuticals, Inc. today announced the treatment of the first patients in a global multi-center Phase III clinical trial of Tavocept (BNP7787) in patients with primary adenocarcinoma of the lung, the most common type of lung cancer. In previous studies, Tavocept demonstrated the potential to substantially increase overall and one year patient survival while concurrently preventing and reducing the incidence and severity of common chemotherapy side-effects as compared to other currently available treatments for advanced lung cancer.

21 Jan 2010

Medco Health Solutions launches Medco TRC for oncology patients

Medco Health Solutions, Inc. today announced the launch of the Medco Therapeutic Resource Center® (TRC) for oncology patients headquartered in Whitestown, Ind., where specialist pharmacists will manage the company's more than 850,000 patients currently living with cancer, one of the fastest growing segments of healthcare.

21 Jan 2010

Fc engineering enhances antibody half-life

A Nature Biotechnology article published online January 17 reveals that Xencor Inc.’s proprietary Fc engineering extends the half-life of antibodies while maintaining their potency and extending duration of action. These results, published in an article entitled, “Enhanced antibody half-life improves in vivo activity” demonstrate the potential of Fc engineering to impact the flexibility of route, schedule and dose for nearly any antibody.

20 Jan 2010

Merck’s initiation of EMD 1201081-cetuximab combination Phase 2 trial triggers €3.0M milestone payment

Idera Pharmaceuticals, Inc., today announced that it has achieved a milestone under its worldwide licensing and collaboration agreement with Merck KGaA, Darmstadt, Germany. The milestone was achieved upon initiation of a Phase 2 trial by Merck KGaA of EMD 1201081, a novel agonist of Toll-like Receptor 9 (TLR9), in combination with cetuximab (Erbitux®) in second-line cetuximab-naïve patients with recurrent or metastatic squamous cell carcinoma of the head and neck.

20 Jan 2010

Eli Lilly provides financial guidance for 2010

At its annual meeting today with the investment community, Eli Lilly and Company highlighted how its innovation-based strategy will enable it to better serve patients and compete effectively in a challenging health care environment. The company also detailed the progress being made in its labs and across its five new business units on an expanding pipeline of innovative molecules and marketed medicines, and provided investors with the company's financial guidance for 2010.

10 Dec 2009

Updated NCCN Guidelines include maintenance therapy for patients with metastatic disease

The National Comprehensive Cancer Network (NCCN) recently updated the NCCN Guidelines for Non-Small Cell Lung Cancer (NSCLC) to incorporate a new section about maintenance therapy, a number of new indications for specific therapies for advanced NSCLC, and the recently revised staging system for lung cancer.

10 Dec 2009

Erbitux drug can reverse rare stomach disorder, report researchers

A drug used to treat colorectal cancer also can reverse a rare stomach disorder and should be considered first-line therapy for the disease, researchers at Vanderbilt University Medical Center report this week.

25 Nov 2009

New Brunswick's colorectal cancer screening program lauded by CCAC

The Colorectal Cancer Association of Canada (CCAC) applauds the decision of the New Brunswick's Minister of Health Mary Schryer to implement a province wide colorectal cancer screening program and to provide funding for Avastin (bevacizumab) for patients with metastatic colorectal cancer.

25 Nov 2009

Erbitux recognized as one of the major clinical cancer advances of 2009

The American Society of Clinical Oncology (ASCO) has once again recognized Erbitux® (cetuximab) as one of the major clinical cancer advances of 2009. This year Erbitux was selected by ASCO for providing the first significant increase in survival for 30 years in the treatment of patients with 1st-line recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN).

16 Nov 2009

PIKAMAB announces the development of ADCC Therasight, a novel theragnostic product

PIKAMAB, a stratified medicine biopharmaceutical company, announced today that it is developing ADCC TherasightTM, a novel theragnostic product that can help guide the drug development process and patient treatment protocols for the cancer therapeutic antibodies that use ADCC (antibody-dependent cellular cytotoxicity) as the major mechanism of action.

12 Nov 2009

Bristol-Myers announces availability of ERBITUX for metastatic colorectal cancer treatment

Bristol-Myers Squibb Canada is pleased to announce that the Ontario government has made ERBITUX(TM) (cetuximab) available to patients suffering from metastatic colorectal cancer. This decision makes Ontario the second province, after British Columbia, to introduce funding for this important treatment option and represents encouraging news for those patients who rely on provincial drug coverage and stopped responding to standard treatments for metastatic colon cancer.

1 Oct 2009