Latest news from Datamonitor
pharmafile | August 28, 2007 | News story | Research and Development, Sales and Marketing |
Alfacell reports promising results for cancer drug
Alfacell Corporation has reported the results of a preclinical study showing that its cancer drug Onconase reduces reactive oxygen intermediates in normal cell types and tumour cell lines, which could be important to its cytotoxic effect.
The preclinical in vitro research conducted by Alfacell and researchers at New York Medical College demonstrated that treatment of cells in cultures with Onconase reduced intracellular oxidative stress by suppressing reactive oxygen intermediates (ROI) generation and promoting their degradation.
The anti-oxidative function of Onconase may be an important element of its antiproliferative/cytotoxic activity towards cancer cells and a possible mechanism of its synergism with other anticancer agents, the company said.
Additionally, the data indicate that Onconase has a propensity to reverse the generation of ROI from asbestos exposure in mesothelial cells. New Jersey-based Alfacell is currently conducting a phase IIIb human clinical trial of Onconase for the treatment of patients suffering from unresectable malignant mesothelioma.
"The data further confirm the cytotoxic effect of Onconase on cancer cells," said Kuslima Shogen, Alfacell's chairman and CEO. "Onconase's therapeutic potential is broad. This study shows that Onconase has potential not only for cancer, but for conditions pathogenetically related to oxidative stress or the activation of NF-kappa B, such as inflammation, autoimmune diseases, atherosclerosis and septic shock."
Related links
AlfaCell Corporation: LSA Company Profile
Autoimmune and Inflammation – Autoimmune Diseases Drug Pipeline Report
Innovative and Targeted Cancer Therapies: Key technologies, new applications and leading players
Pipeline Insight: Therapeutic Cancer Vaccines – A turbulent path from bench to bedside
GSK accelerates review of Exelixis's cancer drug
GlaxoSmithKline has asked Exelixis to speed up its review of its cancer candidate so that the companies can take advantage of the drug's potential leadership position.
Exelixis confirmed that it has agreed to the request from GSK to initiate its review of XL880 before the compound reaches proof-of-concept. Exelixis expects to deliver the appropriate diligence information to GSK in mid-September, at which point GSK will begin its review to determine whether or not to select XL880 for further development and commercialisation.
Both GSK and Exelixis have agreed to expedite the review of XL880 in order to build on its position as a leading MET inhibitor, which the companies believe to be the most advanced in clinical development. Under the terms of the product development and commercialisation agreement between the parties, GSK's review period would have otherwise commenced once proof-of-concept data became available.
In addition, the companies have initiated preliminary transition activities in the event that GSK decides to select XL880 for further clinical development and commercialisation.
"We are extremely pleased that GSK has asked us to expedite its review process for XL880. This request reflects the high level of excitement around both the compound and the therapeutic potential of MET inhibition," said George Scangos, president and CEO of Exelixis. "Our recently reported data from the XL880 phase I trial at the 2007 ASCO Annual Meeting underscore our belief that XL880 is the most advanced MET inhibitor in clinical development, and we and GSK are committed to building upon this leadership position."
Related links
GlaxoSmithKline Plc: LSA company profile
Exelixis Pharmacetuicals: LSA company profile
Regulator Perceptions in Cancer – Evolving opinions about the oncology drug approval process
Commercial Insight: Top 20 Cancer Therapy Brands – Sales of targeted therapies
Molecular Targeted Cancer Therapies – More drugs on the market, more targets in the pipeline
Mid-stage HIV vaccine trial shows encouraging results
An HIV vaccine developed by the National Institutes of Health induced T-cell immune responses in up to 70% of the vaccine recipients in a phase IIa trial, according to manufacturer Vical.
The trials involved priming an immune response with three doses of a plasmid DNA (pDNA) vaccine over a two-month period, based on Vical's proprietary DNA technology, and boosting the response with a single dose of adenoviral vector vaccine at six months.
"These recent vaccine trials contribute to the growing body of knowledge demonstrating plasmid DNA priming as a key factor in achieving significant immune responses against HIV, a particularly difficult target pathogen, bringing us one step closer to evaluating the effectiveness of a prime-boost HIV vaccine regimen in a prophylactic setting," said Vijay Samant, Vical's president and CEO.
Related links
Vical Inc: LSA company profile
Commercial Insight: HIV – Change of guard
Commercial Insight: HIV – Reshaping Treatment Paradigms
The Global HIV/AIDS Market Outlook to 2012
NICE recommends MabThera for rheumatoid arthritis
UK drugs cost watchdog NICE has recommended Genentech's MabThera in combination with methotrexate as a treatment for rheumatoid arthritis.
The drug, which is marketed by Roche in the EU, can now be prescribed to patients in England and Wales who have had an inadequate response to or intolerance of other disease-modifying anti-rheumatic drugs, including treatment with at least one tumour necrosis factor alpha inhibitor therapy.
NICE also said the drug should only be continued in patients who had demonstrated an adequate response following therapy. The committee, which makes decisions on the costs and benefits of approved drugs for use on the NHS, recently rejected a rival arthritis drug Orencia on the basis that it was too expensive.
The cost to the NHS of a single course of MabThera (rituximab) is £3,492, according to the NICE, with patients receiving treatment at no less than six-month intervals. In comparison, the agency said that for an average patient on Bristol-Myers Squibb's Orencia, the annual drug cost will be £10,584 in the first year and £9,828 in subsequent years.
Patient groups have welcomed the decision. Arthritis Care's chief executive, Neil Betteridge, said: "Anti-TNF drugs don't work for everyone. Left untreated, the disease can be severely disabling, so pinpointing the right drug is a race against time to match a given individual to what's most suitable, so the more options available, the better."
A second drug, Abbott Laboratories's Humira, (adalimumab), was approved as a treatment option for psoriatic arthritis, which is associated with the skin disease psoriasis.
Related links
Roche Holdings Ltd: LSA company profile
Autoimmune and Inflammation – Rheumatoid Arthritis Drug Pipeline Report
Stakeholder Insight: Rheumatoid Arthritis – Biologics battle up the treatment algorithm
Disease Modification in Rheumatoid Arthritis – Competition for the anti-TNF failure
The FDA has granted Nexavar priority review for hepatocellular carcinoma.
Bayer and Onyx's Nexavar has been granted priority review for hepatocellular carcinoma from the FDA and a final decision regarding its approval is now expected in the next few months. The drug has been shown to significantly extend overall survival in previously untreated patients, a population with a high unmet need, ensuring adoption as the standard of care for this patient group.
Following the submission of a supplemental New Drug Application (sNDA) in June 2007, the FDA has now granted Nexavar (sorafenib) priority review for hepatocellular carcinoma (HCC), the most common form of liver cancer. The sNDA was based on data from the Phase III SHARP (Sorafenib HCC Assessment Randomised Protocol) trial in which Nexavar significantly extended overall survival by 44% in previously untreated HCC patients versus those taking placebo.
Median overall survival was 10.7 months in Nexavar-treated patients compared to 7.9 months for those taking placebo in this pivotal trial which involved 602 advanced HCC patients. As a result, Bayer and its US partner Onyx Pharmaceuticals halted the trial in February 2007 and allowed all enrolled patients to continue receiving Nexavar treatment.
Priority review status is intended to expedite the regulatory review process for agents that address unmet medical needs. Based on this designation, the FDA reviews the application with a goal of taking action within six months from the date on which they received the sNDA. If approved, Nexavar would be the first FDA-approved therapy for HCC.
Related links
Onyx Pharmaceuticals: LSA company profile
Innovations in Cancer: Novel therapeutics, new diagnostics and future R&D strategies
Commercial Insight: Top 20 Cancer Therapy Brands – Sales of targeted therapies
