News

Archive April 2007

30/04/07  Novartis Expands Portfolio Of Respiratory Medicines

Therapeutic vaccine CYT002-NicQb acquired from Cytos Biotechnology in worldwide licensing agreement - set to begin Phase III trials in 2008

Phase II data indicate potential for cessation of smoking, particularly in people with high antibody levels following vaccination

Novartis to make upfront payment of CHF 35 million, further payments contingent on development and commercialization milestones, and royalties on net sales
Smoking remains the world's leading cause of preventable death with about five million smoking-related deaths a year

Novartis has acquired the exclusive worldwide rights to a novel development compound from Cytos Biotechnology AG that combines elements of medicinal and vaccine technology and has been shown in clinical trials to help smokers overcome their addiction to nicotine.

30/04/07  Questions Over Zyprexa Clinical Trial Data

Today's news that the Food and Drug Administration is examining whether the maker of Zyprexa failed to submit clinical trial data about the harmful side effects of the antipsychotic drug underscores the urgent need for Congress to pass drug-safety legislation. The Senate is slated next week to vote on a package of reforms.

25/04/07  Ark Therapeutics Group plc: Phase III Cerepro Study Completes Recruitment

LONDON, 24 April 2007 -Ark Therapeutics Group plc ('Ark' or the 'Company') today announces that it has completed recruitment into the Phase III trial (Study 904) for CereproTM, its novel gene-based medicine for the treatment of operable high grade glioma (malignant brain tumour).

Study 904 is a standard care-controlled study to assess the efficacy and safety of CereproTM in 250 patients with high grade glioma. Patients are randomised in a 1:1 ratio, either to standard care alone, or to standard care plus CereproTM and patients are blinded to the point of treatment allocation. The multi-centre study is being conducted in Europe and Israel.

25/04/07  Exelixis Reinitiates Clinical Development Of XL999 In Patients With NSCLC

Exelixis, Inc. has been notified that the U.S. Food and Drug Administration (FDA) has completed its review of a clinical trial protocol for XL999 in patients with non-small cell lung cancer (NSCLC) and has agreed that the trial may be initiated.

23/04/07  Clinical Trial Coordinators Need More Financial Conflict-Of-Interest Training

Medical professionals conducting clinical trials should provide more information about financial conflicts of interest before they talk to patients about participating in the trials.

That is one of the main conclusions of a new survey by researchers from Duke University Medical Center and Johns Hopkins University. Their study found that 41 percent of the clinical trial coordinators surveyed had experience disclosing financial aspects of the trial to potential participants, and 28 percent of the coordinators had been asked by participants about potential financial conflicts.

20/04/07  Telcyta Phase III Results Do Not Support a Filing

DUBLIN, Ireland--(BUSINESS WIRE)--Apr 18, 2007 - Research and Markets (http://www.researchandmarkets.com/reports/c54406) has announced the addition of the Espicom Business Intelligence Ltd report: New Cancer Drug Tracker: Telcyta to their offering.

Long gone are the days when a drug successfully completing Phase III trials was virtually assured of launch.

20/04/07  AstraZeneca Addresses Lack Of Diversity In Clinical Trials For Medicines

To address the lack of ethnically diverse patients in clinical trials across the U.S., AstraZeneca announced today, in collaboration with the National Medical Association (NMA) and the Interamerican College of Physicians and Surgeons (ICPS), new efforts to increase ethnically diverse physician investigator participation in clinical trials. Through increased educational and clinical trial investigator certification opportunities, these efforts aim to educate and encourage diverse physicians to become investigators who can then successfully recruit and retain diverse patients to participate in future clinical trials.

18/04/07  Study Finds No Survival Benefit For Gastric Cancer Patients

A more intensive postoperative chemotherapy regimen for high-risk gastric cancer patients did not improve their survival, according to a randomized controlled trial in the April 18 Journal of the National Cancer Institute.

The five-year survival rate for gastric cancer patients who undergo radical surgery is typically between 15 and 32 percent. Efforts to improve survival with new therapies, including postoperative chemotherapy, have yet to yield statistically significant results.

18/04/07  New UK Gov, Industry Deal To Speed Clinical Trials

Pharmaceutical industry-sponsored clinical trials involving UK primary care patients will now be able to get underway more quickly, thanks to a new partnership between the National Health Service, the government and industry.

16/04/07  Phase III Trials To Start On GSK's Eltrombopag

GlaxoSmithKline is initiating Phase III trials of its investigational drug, eltrombopag, giving fresh hope to patients suffering from idiopathic thrombocytopenic purpura (ITP), a low platelet count disorder that leaves sufferers at risk of spontaneous bruising, mucosal bleeding and, in severe cases, intracranial hemorrhage.

The trial will investigate the drug's safety and efficacy in a double-blind, randomised, placebo-controlled, parallel group of 50 patients with previously-treated ITP. Sites for this multicentre study will involve 33 countries, including the US, UK, Canada and France.

16/04/07  Gleevec Decreases Cancer Recurrence For Patients

Preliminary results from a large, randomized, placebo-controlled clinical trial for patients with primary gastrointestinal stromal tumor (GIST), a type of tumor usually found in the stomach or small intestine, showed that patients who received imatinib mesylate (Gleevec {R}) after complete removal of their tumor were significantly less likely to have a recurrence of their cancer compared to those who did not receive imatinib. The clinical trial was sponsored by the National Cancer Institute (NCI), part of the National Institutes of Health (NIH), and conducted by a network of researchers led by the American College of Surgeons Oncology Group (ACOSOG).

12/04/07  Trials Halted After Bowel Drug Linked To Heart Risk

GlaxoSmithKline (GSK) and Adolor have halted development of an innovative drug designed to improve pain relief, amid concerns that the drug could cause heart problems.

Entereg (alvimopan) was being evaluated in a Phase III clinical trial of over 800 patients. A full analysis of the trial data has now revealed that a significant number of patients on Entereg suffered serious side effects, such as heart attacks and neoplasms - unusual cellular growth, which can be benign, malignant, skin cancers and unspecified.

12/04/07  Data Available From ERBITUX Phase III Study

ImClone Systems Incorporated (Nasdaq: IMCL) and Bristol-Myers Squibb Company (NYSE: BMY) today announced that a Phase III study of ERBITUX(R) (Cetuximab) plus gemcitabine (a chemotherapy) in patients with locally advanced unresectable or metastatic pancreatic cancer did not meet its primary endpoint of improving overall survival.

10/04/07  Immtech Initiates Phase IIb Clinical Trial

ImClone Systems and its partners Bristol-Myers Squibb and Merck KGaA are celebrating after the latter presented promising data suggesting that Erbitux can be a first-line treatment for head and neck cancer.

10/04/07  INC Research Enters India; PPD Expands Reach

INC Research has become the latest contract research organisation (CRO) to dive into India, whilst Pharmaceutical Products Development (PPD) has opened offices in Athens and Seattle.

The move into India was facilitated for INC Research through an equal joint venture relationship that the US-based CRO has formed with Indian firm GVK Biosciences, called INC GVK BIO.

04/04/07  Erbitux Hits Primary Endpoint In Head And Neck Cancer Trial

ImClone Systems and its partners Bristol-Myers Squibb and Merck KGaA are celebrating after the latter presented promising data suggesting that Erbitux can be a first-line treatment for head and neck cancer.

04/04/07  EGFr-Targeted Drugs: Vectibix Setback, EGFr Testing

LAKE FOREST, Calif., April 03, 2007 /PRNewswire/ -- Amgen's recent discontinuation of treatment with Vectibix (panitumumab), the first fully human IgG2 monoclonal antibody (MAb) targeting the epidermal growth factor receptor (EGFr), in the phase IIIb Panitumumab Advanced Colorectal Cancer Evaluation (PACCE) trial is a disappointing setback. PACCE was evaluating the addition of Vectibix to a regimen of standard oxaliplatin- or irinotecan-based chemotherapy and bevacizumab (Avastin; Genentech), an antiangiogenic vascular endothelial growth factor (VEGF) inhibitor, for first line treatment of metastatic colorectal cancer (CRC). The trial was halted after preliminary review of data from a pre-planned interim efficacy analysis, scheduled after the first 231 events (death or disease progression), revealed a statistically significant difference in progression-free survival (PFS) and overall survival in favor of the control arm and higher toxicity in the Vectibix arm. Total enrollment of this trial had reached 1,054. Amgen is continuing phase III trials of Vectibix as a single biologic combined with chemotherapy as a first- or second-line treatment. No other clinical trials are being modified at this time, however, Amgen is evaluating data across all trials. Vectibix is approved as a third line treatment for metastatic, refractory CRC expressing EGFr.

02/04/07  Isis Cholesterol Drug Makes Sense

Antisense drug developers received a boost today with the news that Isis Pharmaceuticals' cholesterol lowering drug is showing good results in clinical trials.

Isis-301012 was shown to reduce levels of low density lipoprotein (LDL) - also called 'bad' cholesterol as it is linked to increased heart disease and stroke. The results from three separate Phase II clinical trials were presented this week at the American College of Cardiology Annual Scientific Session (ACC) in New Orleans.

02/04/07  Black Raspberries May Slow Growth Of Colon, Other Cancers

For several years, our laboratories have studied the ability of freeze-dried berries (black raspberries, strawberries and blackberries) to inhibit cancer in the esophagus, colon and oral cavity. Berries contain a number of agents that prevent cancer including vitamins A, C, and E; calcium and selenium; ß-carotene, α-carotene and lutein; and many phenolic compounds which have high anti-oxidant potential. The most abundant phenols are the anthocyanins which give berries their color. In general, dark berries have higher contents of anthocyanins and anti-oxidant potential than light berries.

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