Vion Pharmaceuticals: Onrigin application accepted but barriers remain

Vion Pharmaceuticals is seeking approval for Onrigin in elderly, poor-risk acute myeloid leukemia patients based on results from two pivotal Phase II trials. Given the unmet need for effective, tolerable agents in this patient population, FDA approval is likely. However, Onrigin must overcome considerable barriers to successful uptake in order to achieve an acceptable return on development costs.

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Vion Pharmaceuticals: FDA allows leukemia trial to resume

The clinical hold on a Phase III trial of Vion Pharmaceuticals' Cloretazine in acute myelogenous leukemia has been lifted by the FDA after the company agreed to trial modifications. Vion now hopes that the new trial design will not reduce the efficacy of its lead anticancer pipeline drug.

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Vinka alkaloids: market to fall 17% by 2007

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Vicuron: dalbavancin in phase III trials

A phase III comparator trial for Vicuron's [VERS] dalbavancin has been initiated for the treatment of skin infections involving resistant pathogens. The critical dosing advantages of dalbavancin may help Vicuron to overcome both its limited marketing capability and restrictions on the use of novel products.

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Vical: modified Leuvectin trials could do better

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Vertex: Positive results for cystic fibrosis drug

Vertex has completed a Phase II trial of a small-molecule oral drug, VX-770, which targets the basic defect that occurs in cystic fibrosis (CF). The trial has only been performed in 20 patients from a small, genetically distinct subset of the CF population. However, the results are encouraging and indicate an alternative approach to traditional reactive management of CF.

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Vertex: next-generation hepatitis drugs within reach

Vertex has launched a major phase II clinical trial to test a new hepatitis C drug candidate, with a second trial scheduled to begin in June. This is a significant advance in the development of much-needed treatments for hepatitis C. By drawing parallels with similar HIV treatments, Datamonitor's Morris Paterson outlines the pitfalls and prospects for this new drug.

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Vertex: dipping into the non-responders pool

Vertex has unveiled encouraging results from a phase Ib trial evaluating VX-950 in hepatitis C. Although investors have reacted well to the news, sending the company's stock to a new 52-week high, the battle is by no means won as continued uncertainty regarding class-specific toxicity demands caution. Indeed, it may well be too early for Vertex to celebrate just yet.

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Vertex Pharmaceuticals: strong evidence for VX-770 as a potential novel treatment method

Vertex Pharmaceuticals' novel cystic fibrosis treatment VX-770 has demonstrated strong efficacy in a Phase III trial, meeting the primary endpoint and key secondary endpoints. VX-770 targets the underlying cause of the disease, and, if approved, would offer a novel treatment approach.

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Verta/SciClone: new drug could limit TB spread

According to preliminary results, Russian pharma company Verta's new immune system enhancing drug may have a significant impact on TB contagion. Although the treatment regime is arduous, involving five daily injections, there could be a significant market for SCV-07 in locations where Directly Observed Treatment can be implemented.

Published By Datamonitor