Here’s another player in sepsis to compete with LLY’s Xigris. These early results look passable given the relatively low efficacy bar that Xigris represents.
>> AM-Pharma Announces Positive Results in its Double-Blind, Placebo Controlled Phase IIa Sepsis Trial With Alkaline Phosphatase
Friday October 20, 9:00 am ET
BUNNIK, Netherlands, October 20 /PRNewswire/ -- AM-Pharma B.V., a biopharmaceutical company engaged in the pre-clinical and early clinical development of novel compounds to treat infectious and inflammatory diseases, announces first positive results observed in its multi-center double blind, placebo-controlled pilot study in the treatment of sepsis with its patented Alkaline Phosphatase (AP) drug. The study was conceived as a first pilot clinical study to assess safety of a single treatment with 200 U Alkaline Phosphatase i.v./kg in patients suffering from severe sepsis. At the same time also efficacy parameters were recorded as secondary variables.
AM-Pharma is developing a unique therapy against sepsis, based on detoxification of the bacterial endotoxin LPS. This is an early mediator in the sepsis cascade, and one of the highest possible upstream targets, and therefore a promising approach for the development of a successful therapy.
Dr. Bruno Giannetti, President & Chief Executive of AM-Pharma: "These are very promising data, although obtained in relatively small patient numbers, particularly when considering the fact that the dose and the treatment schedule still needs to be optimized. We are now in the process of planning a dose finding pivotal trial to optimize the dosing regime and demonstrate the efficacy of the drug."
A total of 36 patients admitted to intensive care units with the diagnosis of severe sepsis were included in the study (25 Verum/11 Placebo, 2:1 randomization scheme). The treatment consisted in a bolus of 67.5 U/ kg infused in the first 10 minutes followed by a 23 hour and 50 minutes infusion of a total of 132.5 U/kg.
The primary aim of the study was to assess safety of the treatment. Next to (serious) adverse events (S)AEs also 28 and 90 days survival rates were recorded.
The treatment was well tolerated. No drug-related SAEs were reported in the Verum group. The 28 days survival rates were 19/25 in the Verum and 7/11 in the Placebo group. The 90 days survival rates were 18/25 in the Verum and 6/11 in the Placebo group. The reduction of the mortality risk due to sepsis is represented by the calculated absolute and relative risk reduction. After 28 days, the Verum group showed 12.4% absolute risk reduction and 34% relative risk reduction. After 90 days absolute risk reduction was 17.5% and relative risk reduction was 38.4%.
AM-Pharma is a clinical stage biopharmaceutical company based in Bunnik, the Netherlands. The company's business is focused on the preclinical and early clinical development of novel compounds in the field of severe infectious diseases and their consequences, as well as inflammatory diseases. AM-Pharma currently employs 22 staff and is financed by ABN-AMRO Capital Life Sciences and Inventages Venture Capital. <<
>> Fri Nov 3, 2006 4:09am ET By Mark Potter and Ben Hirschler
LONDON, Nov 3 (Reuters) - AstraZeneca Plc (AZN) has unveiled a delay in the development of an experimental drug for severe sepsis which it bought in just 11 months ago in a bid to bolster a depleted pipeline of new drugs.
The Anglo-Swedish drugmaker said on Friday it planned to conduct a further intermediate Phase II clinical trial for CytoFab, a treatment for sepsis it licensed from British biotechnology firm Protherics Plc (PTI.L) in a deal worth up to 195 million pounds ($372 million) last December.
The hope is that the new trial, lasting up to 21 months, could lead to quicker progress for the drug in final-stage trials. Industry analysts already view the project as risky, give the high failure rate of past sepsis drug candidates.
Shares in Protherics fell as much as 12 percent in early trade. AstraZeneca shares were little moved.
AstraZeneca, which has struck a string of deals aimed at bolstering a drugs pipeline hit by the failure of several of its own drugs, said the extra Phase II trial was likely to start in the second half of 2007.
AstraZeneca spokesman Steve Brown said the move could in theory delay the progress of CytoFab by 21 months. "But that 21 months might come down if we can shorten the timelines in Phase III, given what we do in the additional Phase II programme," he said.
AstraZeneca had originally hoped to start Phase III trials in 2007 and file the drug with regulators sometime after 2008.
ASTRAZENECA COMMITTED
Piper Jaffray analyst Sam Fazeli said a shorter Phase III trial could limit the delay to around 10-12 months.
Protherics Chief Executive Andrew Heath said AstraZeneca remained committed to CytoFab and that his company was guiding analysts not to change their forecasts for milestone payments due to be received by Protherics during 2007.
At 0855 GMT, Protherics shares were down 9.5 percent at 79 pence, off a low of 76-1/2 pence and valuing the business at about 204 million pounds. AstraZeneca was flat at 31.99 pounds.
"The company has recently completed consultations with regulators in the United States and EU," AstraZeneca said in a statement. "These consultations confirmed that a single Phase III study could be sufficient for regulatory approval. Furthermore, to meet the regulatory needs of both agencies, it is required that AstraZeneca implement a Phase II study programme to support the single global Phase III study," it said.
AstraZeneca said last month that experimental stroke drug NXY-059 had failed a key clinical trial, the latest in a series of blows to its drugs pipeline after earlier failures of cancer drug Iressa, anti-clot pill Exanta, and Galida for diabetes.
The rewards for a successful medicine to treat sepsis, or septic shock, which affects 3 million people a year worldwide, are likely to be substantial.
But the drug industry is littered with previous failures in the area, suggesting there is no guarantee that CytoFab will necessarily get to market. Eli Lilly and Co's (LLY) Xigris is currently the only licensed treatment for sepsis[and it is not a very good drug (#msg-12483101)]. <<
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