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pharmafile | July 16, 2007 | News story | Research and Development, Sales and Marketing |Â Â Â
Antisoma drops ovarian cancer drug
Cancer drug developer Antisoma says new data from its Phase II trial of ASA404 showed that the experimental ovarian cancer drug did not increase the median time to tumour progression when added to chemotherapy.
Additionally, one-year survival rates were 74% for the ASA404 arm and 92% for the control arm. Since the majority of patients in both arms were alive after one year, median survival values have not been determined.
Based on these data, development in ovarian cancer will not be a priority for the company.
Antisoma has been testing ASA404 in several cancer types and previously reported a 5-month increase in median survival when the drug was added to chemotherapy in non-small cell lung cancer.
Antisoma licensed ASA404 to Novartis in April 2007. Novartis plans to start enrolling patients into a Phase III trial in non-small cell lung cancer early in 2008 and to explore the potential benefits of the compound in various other solid tumours.
Glyn Edwards, Antisoma's CEO said: "Our ovarian cancer trial has not produced positive results like those seen with ASA404 in lung cancer. More broadly, we're very pleased with the progress made by Novartis to date with ASA404 in lung cancer and look forward to working with them to fully evaluate the drug in other cancers."
Related links
Novartis AG: LSA company profile
Molecular Targeted Cancer Therapies – More drugs on the market, more targets in the pipeline
Stakeholder Opinions: Gynecological Cancers – Niche opportunities in advanced disease
Innovations in Cancer: Novel therapeutics, new diagnostics and future R&D strategies
Cell Therapeutics lymphoma drug lowers side-effects
Cell Therapeutics says interim results from its Phase II/III trial show its pixantrone drug for aggressive non-Hodgkin's lymphoma produced a major objective anti-tumour response in patients.
Additionally, the drug reduced severe side-effects, such as heart damage, compared to a standard doxorubicin-based treatment.
"We are excited by these results demonstrating that pixantrone is living up to the promise of preventing the severe cardiac damage that accompanies the use of standard doxorubicin treatment while retaining the potent anti-lymphoma activity of this class of drug," said James Bianco, president and CEO of CTI.
"Pending results from this and other studies, these findings could have major implications for treating patients with breast cancer, lymphoma, and leukaemia, where debilitating cardiac damage from doxorubicin might be prevented," he added. The company is planning to report the trial's results in December.
Related links
Cell Therapeutics Inc: LSA company profile
Stakeholder Opinions: Non-Hodgkin's Lymphoma – Immunotherapy Stimulates the Market
Acute Leukaemias – Persistent unmet needs confer significant commercial opportunity
Depomed's shingles pain drug fails in pivotal trial
Depomed has reported disappointing Phase III results for its gabapentin GR drug for the treatment of postherpetic neuralgia, or pain caused by shingles.
Results from the trial, which involved 407 postherpetic neuralgia (PHN) patients, did not demonstrate statistically significant efficacy relative to placebo in patients receiving an 1,800mg total daily dose of gabapentin GR given once or twice-daily.
The primary endpoint of the study was to assess the efficacy of gabapentin GR compared to placebo in reducing average daily pain scores from baseline to endpoint.
The primary endpoint was not achieved with statistical significance for either active treatment regimen, as compared to placebo, over the ten-week treatment period of the trial.
"The Phase III results we received today were very surprising and disappointing to us in light of the encouraging safety and efficacy data that we observed in our Phase II clinical trial, in which we achieved statistically significant results in a four-week period as compared to placebo," said John Fara, chairman, president and CEO of Depomed.
Gabapentin GR is an investigational extended release and gastric retained form of gabapentin, an FDA-approved Pfizer product for the treatment of PHN.
Related links
Depomed Inc: LSA company profile
The Pain Market Outlook to 2011
Generex enters licensing agreement for insulin spray
Generex Biotechnology has entered into an exclusive product licensing and distribution agreement with the Armenian Development Agency and Canada Armenia Trading for the commercialisation of Generex Oral-lyn, the company's proprietary oral insulin spray product.
The agreement covers the Republic of Armenia, Georgia, and the Republic of Kazakhstan. ADA and CATH will bear any and all costs associated with the procurement of governmental approvals for the sale of the product, including any clinical and regulatory costs.
It is estimated that more than 8.1% of the people in Armenia, 9% of the people in Georgia, and 5.5% of the people in Kazakhstan suffer from diabetes and its complications.
Anna Gluskin, the company's president and CEO said: "We hope that with the growing prevalence of diabetes that more than one million people in Armenia, Georgia and Kazakhstan will eventually treat their diabetes with Generex Oral-lyn. We will continue to pursue international governmental approvals of Generex Oral-lyn around the world as we proceed with the Phase III trials in the United States, Canada, and Europe."
Related links
Generex Biotechnology Corporation: LSA company profile
Antidiabetics – Patent expiries and cost containment initiatives balanced by pipeline products
Pipeline Insight: Insulins – Inhalable insulins unlikely to become blockbusters
