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pharmafile | November 29, 2007 | News story | Research and Development |Â Â Â
Medivir to initiate Phase IIa study of hepatitis C
Medivir has announced that a Phase IIa study for its investigational hepatitis C protease inhibitor will start shortly in Europe by Tibotec Pharmaceuticals, who are collaborating with Medivir on the development of the drug.
The Phase IIa proof-of-concept trial is designed to assess the effectiveness, safety, tolerability, and pharmacokinetics of four different dose regimens of the drug, TMC435350 (25mg daily, 75mg daily, 200mg daily and 400mg daily). In the trial, 96 treatment-naive and 24 treatment-experienced patients with chronic genotype-1 hepatitis C virus (HCV) infection will be enrolled at more than 20 sites in Europe.
Patients will receive either TMC435350 or placebo once-daily for 28 days. Standard of care treatment, peginterferon alpha-2a (Pegasys) and ribavirin (Copegus), will be provided for 48 weeks or, optionally, for 24 weeks for those patients with an undetectable HCV viral load at week four and who remain undetectable at week 20. Patients will be followed-up for 24 weeks after the end of SoC to allow evaluation of sustained virologic response.
In the Phase I study, TMC435350 was administrated at 200mg qd for five days to patients chronically infected with genotype-1 hepatitis C virus. The viral load reductions met the target set for the trial.
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Affiris receives European patent for Alzheimer's vaccine
Austrian company Affiris has been granted a Europe-wide patent for a pool of peptide sequences that are of key importance to an innovative Alzheimer's vaccine.
The company will be able to use these newly patented components to manufacture an optimized vaccine against beta-amyloid, the peptide responsible for the onset of Alzheimer's disease. The tolerability of the first Affiris vaccine, Affitope AD01, is currently being tested as part of a Phase I clinical trial.
Walter Schmidt, CEO of Affiris, said: "This patent is an ideal addition to the Affiris patent portfolio. Our protected Affitome technology enables us to target the relevant structures of human rogue proteins. Our individual active substances are known as Affitope, while the entire spectrum of possible substances is referred to as Affitome.
"This new patent grants us the commercial rights of use for this technology in relation to Alzheimer's disease. Furthermore, Affiris is now the only company entitled to develop an optimized Alzheimer's vaccine that will overcome the problem of potential autoimmune reaction."
Avexa to start Phase III program for HIV drug
Biotechnology company Avexa has received positive feedback from both North American and European regulatory authorities allowing immediate progression into a Phase III program of apricitabine for the treatment of drug-resistant HIV patients.
Avexa will move forward with two pivotal clinical trials which have been reviewed and will form the basis for future approval. The end point of the trials will be the percentage of patients that reach less than 400 copies of the virus per milliliter of blood after 24 weeks. The start dates of the trials will be staggered as the company is required to assess two dose levels in the first trial to confirm the optimum dose.
The second trial will study the optimum dose only. The patient population and clinical end points will be very similar to those of the current Phase IIb 24-week timepoint, the results of which were announced in September 2007. Avexa further advised that there are now 37 patients on the Phase IIb extension study, with some patients having been treated with apricitabine (ATC) for over two years.
Julian Chick, CEO of Avexa, said: "We have plenty of work ahead of us but we have a clear path forward towards approval and subsequent marketing of ATC. Furthermore, we are encouraged by the very positive results from the 24-week study, which have direct relevance to the planned Phase III studies.
"In addition, the number of patients requesting to continue ATC treatment gives us further confidence that ATC is providing patients with an effective new treatment in the fight against HIV and making a significant difference to their lives."
FDA to review NexMed's erectile dysfunction drug
Pharmaceutical firm NexMed said that its new drug application for its erectile dysfunction product, a topically applied alprostadil cream, was accepted for review by the FDA.
The acceptance for review is an indication that the FDA has determined that the filing is sufficient to complete a substantive review of the application, which customarily takes a minimum of eight months, should the FDA not require any additional studies or information.
Vivian Liu, president and CEO of NexMed, said: "We have already begun working with the agency and with our partner, Warner Chilcott, and look forward to gaining regulatory approval for this important new therapy. With their proven success in building new markets, Warner Chilcott is a great partner for launching this product, upon its approval."
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