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DewDiligence

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DewDiligence

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Thursday, 10/25/2007 2:37:16 PM

Thursday, October 25, 2007 2:37:16 PM

Post# of 252431
FLML Announces Positive Top Line Results
of a Clinical Trial of IFN-alpha-XL versus
PegIntron in Patients with Chronic HCV

[They say the results are positive but they aren’t showing the data yet. Note, however, the use of the waffle word “marked” in the discussion below.]

http://biz.yahoo.com/bw/071025/20071025005626.html?.v=1

>>
Thursday October 25, 9:15 am ET

LYON, France--(BUSINESS WIRE)--Flamel Technologies (NASDAQ: FLML ) today announced positive preliminary data from a trial comparing the safety, tolerability, and long-acting activity of IFN-alpha-XL versus ViraferonPeg™, marketed in the U.S. as PegIntron™, in patients with chronic hepatitis C virus (HCV) infection. Results from the trial show:

• A marked reduction in side effects for patients given IFN-alpha-XL compared with those who received PegIntron;

• A statistically significant reduction in viral load for the group of patients infected with the Genotype 1 strain of HCV (comprising non-responder patients, relapsed patients and patients who are naive to standard Peg Interferon/ribavirin treatment) who received 27 MIU of IFN-alpha-XL compared with similar patients who received PegIntron; and

• A marked [i.e. not statsig] reduction in viral load for “non-responder” genotype 1 patients who received IFN-alpha-XL compared with similar patients who received PegIntron.

Flamel plans to present the full data from this clinical trial at a medical conference and is seeking a licensing partner for this product.

The lead investigator of the study, Professor Christian Trepo (Hotel Dieu Hospital - Lyon), remarked, “The results of this study are especially encouraging given the favorable responses in genotype 1 patients, a population that is typically the most difficult to treat. In this study, a statistically significant reduction in viral load was observed in patients who received 27 MIU of Interferon-alpha XL compared with patients administered the standard dose of Peg-Intron. Moreover, the trend we observed in the study suggests that the advantages of Interferon-alpha XL with respect to viral load reduction are cumulative and may become more pronounced during longer treatment regimens.”

Dr. Trepo continued, “I also am very encouraged that the benefit in viral load reduction in patients receiving Interferon-alpha-XL was achieved with fewer adverse events compared with PegIntron. Side effects associated with interferon treatment are frequently debilitating and treatment limiting. These side effects often necessitate dose reduction, which negatively affects treatment outcome. Many patients even choose to discontinue therapy. These data suggest that IFN-alpha-XL may provide patients with a more tolerable regimen that has potentially better efficacy compared with existing interferon-alpha based therapies. This would be a significant advance in the treatment of a disease that has reached pandemic proportions in the United States and around the world.”

Stephen Willard, Flamel’s chief executive officer, said: “We are very pleased with the results of this second trial. They confirm the results of our earlier trial with respect to reduced side effects as compared with currently marketed products. The viral load results compared head to head against the pegylated product suggest exciting potential benefits in efficacy. A top priority for Flamel will be to engage the right partner to work with in taking this product forward.”

Trial Design

Patients enrolled in the open-label, multi-center trial were randomized into three groups of 12 to 14 patients and received treatment consisting of:

1) IFN-alpha XL 18 MIU, dosed twice at 7 day interval; or

2) IFN-alpha XL 27 MIU, dosed twice at 7 day interval; or

3) Peg-Intron 1.5 micrograms / kg, dosed twice at 7 day interval.

Viral load was measured regularly until 7 days after the second injection. Adverse events observed in all three arms included fever, flu-like symptoms, headache, white blood count abnormalities, as well as other adverse events. Local tolerance was also assessed. No serious adverse events were reported and no patients withdrew from the study due to adverse events.

About IFN-alpha-XL

IFN-alpha-XL is a new formulation of recombinant Interferon alpha-2b based on Flamel’s proprietary Medusa® nanoparticle delivery system. Medusa® is a versatile protein carrier for the development of a wide range of novel and second-generation long-acting native protein and peptide products. IFN-alpha-XL is designed to provide patients with a longer acting and more tolerable approach to interferon therapy compared with approved interferon regimens.
<<

“The efficient-market hypothesis may be
the foremost piece of B.S. ever promulgated
in any area of human knowledge!”

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