Product Development Update
pharmafile | April 12, 2007 | News story | Research and Development, Sales and Marketing |
Product news round-up from Datamonitor
ChemGenex begins CML trial
ChemGenex Pharmaceutical has treated the first patient in a new phase II/III clinical study (CML-203) evaluating Ceflatonin in patients with chronic myeloid leukemia.
The trial is designed to test the efficacy of Ceflatonin in patients who have failed or were intolerant to treatment with prior tyrosine kinase inhibitors.
CML patients routinely receive treatment with the approved tyrosine kinase inhibitors Glivec, developed by Novartis and Sprycel, manufactured by Bristol-Myers Squibb. Patients who are resistant or intolerant to the approved TKIs have limited treatment options. The CML-203 study is designed to evaluate whether Ceflatonin can provide clinical benefit to such patients.
The primary endpoint for the study will be haematologic response rate, and the cytogenetic response rate will be one of the secondary endpoints assessed. Interim data from the study will be released in the first half of 2008.
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Cell Genesys says prostate drug better than rival
Cell Genesys has said that updated data from a phase II trial of its GVAX immunotherapy for prostate cancer showed that patients experienced better survival rates than those who took the current standard of care.
The study showed that 22 patients who received the immunotherapy had a median survival rate of 35 months. The company previously reported final median survival results from its first multi phase II trial of GVAX immunotherapy for prostate cancer in 34 patients showed an overall median survival of 26.2 months.
The survival results from the two phase II trials compare favorably to the previously published median survival of 18.9 months for prostate cancer patients treated with Taxotere chemotherapy plus prednisone, the current standard of care for these patients. The company's ongoing phase III program is designed to confirm this potential survival benefit for GVAX immunotherapy for prostate cancer.
GVAX immunotherapy for prostate cancer is currently being studied as a single agent and in combination with docetaxel chemotherapy in two phase III clinical trials. Cell Genesys has also received fast track designation for the product.
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CytoGenix avian influenza vaccine shows promise
CytoGenix has successfully completed a pilot study with its synDNA vaccine which demonstrated its efficacy in protecting against the avian (H5N1) influenza virus.
The study clearly demonstrated a robust protective effect in mice treated with the synDNA vaccine whereas all the untreated control animals died after both groups were challenged with a highly virulent strain of avian influenza virus. The lethal challenge testing was conducted by recognized collaborators in the field under a sponsored research agreement with the company.
"This novel DNA vaccine was produced using a unique combination of novel gene sequences and our proprietary synDNA production technology. We are extremely excited about this initial robust response in an animal challenge model," stated Dr Yin Chen, chief scientific officer.
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GSK combination migraine pill better than single therapy
GlaxoSmithKline has said findings from two efficacy studies in migraine sufferers have demonstrated that the combination of two migraine medicines provides superior headache relief compared to either of the drugs alone.
The combination drug, known as Trexima, contains the treatments Imitrex and naproxen sodium, and is being developed by GlaxoSmithKline and Pozen.
"Recent research suggests that migraine is more complex than previously believed, consisting of multiple mechanisms that each contribute to migraine pain in different ways," said lead author Jan Lewis Brandes, assistant clinical professor at Vanderbilt University School of Medicine.
"These studies found that Trexima, which is the first migraine-specific product designed to treat both inflammation and vasodilation in a single tablet, provided superior efficacy compared to placebo and its individual components."
These studies were included in the new drug application currently under review by the FDA.
Imitrex is a prescription medication indicated for the acute treatment of migraine in adults. Naproxen sodium is a non-steroidal anti-inflammatory drug (NSAID) and is indicated for the treatment of rheumatoid arthritis, osteoarthritis, ankylosing spondylitis and juvenile arthritis. It is also indicated for the treatment of tendonitis, bursitis, acute gout and for the management of pain and primary dysmenorrhea.
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NicOx begins late stage trial of osteoarthritis drug
NicOx has initiated a second phase III trial for naproxcinod in patients with osteoarthritis of the knee in order to evaluate the drug against other products on the market.
The objective of the study is to confirm naproxcinod's efficacy and provide additional blood pressure data, a key factor to differentiate naproxcinod from existing treatments. The company also is aiming to make NicOx the drug-of-choice for treating the signs and symptoms of osteoarthritis. Efficacy results are expected in mid-2008.
"The initiation of this second pivotal phase III trial is in line with our development plan for naproxcinod, which foresees the filing of a New Drug Application in the US during the first quarter of 2009," said Michele Garufi, chairman and CEO of NicOx.
The start of this trial follows the successful results obtained for naproxcinod in previous phase II and phase III trials, which showed superior efficacy to placebo and no detrimental effect on blood pressure, when compared to existing non-steroidal anti-inflammatory drugs (NSAIDs). It has been suggested that NSAIDs carry cardiovascular side effects.
NicOx plans to initiate a third phase III trial in the first half of 2007, which will assess naproxcinod's efficacy and safety in patients with osteoarthritis of the hip.
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