News from Datamonitor
pharmafile | August 13, 2007 | News story | Research and Development, Sales and Marketing |
Alnylam lands $38.6 million federal government contract
Alnylam Pharmaceuticals has been awarded a $38.6 million contract over 33 months from the US defence threa-reduction agency to develop a broad spectrum RNAi anti-viral therapeutic for the treatment of viral haemorrhagic fever.
Viral haemorrhagic fevers are considered by federal agencies to be high priority agents that pose a risk to national security because they can be easily disseminated from person to person, result in high mortality rates, and require special action for public health preparedness.
Alnylam claims its biodefence initiative has the potential to create near-term value from the company's RNAi therapeutic platform, such as obtaining FDA approval for products in an accelerated timeframe and revenues from government stockpiling.
"This funding represents continued federal government support of RNAi as a potential therapeutic platform for biodefense and biopreparedness, while allowing us to continue to develop our technology as we advance our pipeline programmes," said Barry Greene, COO of Alnylam. "Combined with our ebola contract from the national institutes of health for $23 million awarded in September 2006 and other sources of federal funding, we have now been granted more than $63 million in federal contracts for Alnylam Biodefense."
The goal of this research programme is to develop an RNAi therapeutic for the treatment of haemorrhagic fever virus infection. Alnylam's programme will investigate the silencing of endogenous host targets believed to be involved in viral pathogenesis and disease progression. This new contract fully supports all activities from program initiation through phase I trials.
With this programme, as with its ebola programme, Alnylam is working with the US Army Medical Research Institute of Infectious Diseases (USAMRIID). Alnylam will be producing drug candidates which will be sent to USAMRIID for in vitro and in vivo testing against viral hemorrhagic fevers.
Related links:
Alnylam Pharmaceuticals Inc: LSA company profile
Outlook for RNAi, 2007: siRNA and miRNA in biology, diagnostics and therapeutics
Aveo completes discovery agreement for novel cancer drugs
Aveo Pharmaceuticals has completed its multi-year collaborative agreement with Merck & Co. using its proprietary cancer models to identify and validate tumour maintenance genes which are attractive targets for the development of small molecule oncology agents.
"Working with Merck in this discovery collaboration, we identified and successfully validated essential tumour maintenance genes suitable for development of small molecule agents in multiple AVEO cancer models," stated Tuan Ha-Ngoc, president and chief executive of AVEO.
Merck says its first collaboration with AVEO led to the discovery of novel candidate drug targets and contributed significantly to its oncology therapeutics discovery efforts.
"We look forward to continuing to work with AVEO on our second collaborative effort, which is focused on identifying genetic profiles that correlate with drug response to more effectively guide the clinical development of Merck's cancer compounds," said Giulio Draetta, head of oncology basic research.
Related links:
Merck & Co Inc: LSA company profile
Commercial Insight: Top 20 Cancer Therapy Brands Sales of targeted therapies
Innovations in Cancer: Novel therapeutics, new diagnostics and future R&D strategies
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DOV Pharmaceutical reports successful Phase Ib results
DOV Pharmaceutical has reported successful phase Ib results for its lead triple re-uptake inhibitor for the treatment of depression and obesity.
Preliminary analysis of the study results indicates DOV 21,947 was safe and well-tolerated at the doses examined and produced a significant decline in plasma triglyceride levels. The company intends to initiate a phase II study for the treatment of depression in the fourth quarter of this year.
Prior studies with DOV 21,947 at up to 100mg per day demonstrated the safety and tolerability of the compound over dosing periods of up to 10 days. The goal of the phase Ib study was to confirm DOV 21,947's safety and tolerability over an eight-week period at escalating doses of up to 150mg per day.
DOV says the significant reductions in plasma triglyceride levels observed during the conduct of this study are consistent with preclinical evidence that the compound is able to produce a significant and sustained reduction in both triglyceride levels and body weight in animal models of obesity.
"These findings underscore the therapeutic versatility of triple re-uptake inhibitors such as DOV 21,947," said Dr Phil Skolnick, president and chief scientific officer of DOV.
This double-blind, placebo-controlled phase Ib study enrolled 46 male and female subjects. Following a one-week placebo run-in, subjects received either escalating daily doses of 50mg, 100mg and 150mg of DOV 21,947 (31 subjects) or placebo (15 subjects), for a total of eight weeks. The study demonstrated that the compound was safe and well-tolerated in this dose range with no reported serious side-effects.
The proportion of patients with treatment-emergent adverse events was similar in the two treatment groups, with 36% and 47% in the DOV 21,947 and the placebo treated group, respectively.
Related links:
DOV Pharmaceuticals: LSA company profile
Commercial and Pipeline Perspectives: Obesity – Lack of Reimbursement Limits Market Potential
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FDA clears Spectrum's new drug application
Spectrum Pharmaceuticals has reported that the FDA has cleared the investigational new drug application for its adjuvent therapy in patients with recurrent or progressive carcinoma.
SPI-1620 is being developed as an adjunct to chemotherapy. The highly selective endothelin-B agonist has demonstrated in experimental animal models a transient and selective increase in blood flow to tumours by more than 300%, and an increased delivery of anticancer drugs to the tumour, while essentially sparing normal tissues and organs, thereby increasing the efficacy and the therapeutic index of these drugs.
"SPI-1620 has shown preclinical evidence of increasing a cancer tumour's uptake of doxorubicin and other anticancer agents. We believe SPI-1620 could have a broad range of applications as an adjunct to chemotherapy in the treatment of solid tumours," said Rajesh Shrotriya, president and chief executive of Spectrum Pharmaceuticals.
The phase I trial is an open label, dose-escalation study assessing the safety, tolerability, pharmacokinetics and pharmacodynamics in patients with recurrent or progressive carcinoma. The trial is expected to begin enrolling patients once the Investigational Review Boards approve the study.
Related links
Spectrum Pharmaceuticals Inc: LSA company profile
Innovations in Cancer: Novel therapeutics, new diagnostics and future R&D strategies
Shareholders approve Peptech-EvoGenix merger
EvoGenix shareholders have voted in favour of a proposed merger with Peptech, which the companies say will form "one of the strongest biotechnology companies in Australia".
Peptech will acquire 100% of the issued shares in EvoGenix for A$0.15 cash and 0.5055 Peptech shares for each EvoGenix share held.
The merged entity, to be renamed, will focus on developing antibody/protein-based products for the treatment of inflammatory diseases, bone disease and cancer.
Peptech's lead antibody derivative, PN0621, entered phase I human clinical trials in May this year, with a further two products from the EvoGenix pipeline expected to be ready for clinical development next year.
The merged company will have in excess of A$167 million in cash to advance product development and will receive on-going revenue streams from Abbott and Johnson & Johnson in relation to anti-inflammatory antibody drugs Humira and Remicade.
Dr John Chiplin will be the chief executive of the merged company, while a restructured board will oversee the next stage of its development. Two EvoGenix directors – the current chairman, Chris Harris, and non-executive director, Robin Beaumont – will replace two current Peptech directors. Current Peptech chairman, Mel Bridges, will retire from the board following the recruitment of a new non-executive chairman.
The management and scientific staff of EvoGenix will continue with the company, while Dr Merilyn Sleigh, chief executive of EvoGenix, will be retained in a senior advisory role.
EvoGenix chairman, Chris Harris, commented: "I believe I speak for all of the EvoGenix board and management in saying that we will be 100% behind the merged company in building what we believe will be one of Australia's biotechnology flagships of the future."
Related links:
Peptech Inc: LSA company profile
