Replies to post #76302 on Biotech Values

[DewDiligence]

Biolex Presents Locteron U.S. Phase 2a Results at EASL

http://finance.yahoo.com/news/Biolex-Therapeutics-iw-15021088.html

›On Friday April 24, 2009, 1:30 am EDT

PITTSBORO, NC--(MARKET WIRE)--Apr 24, 2009 -- Biolex Therapeutics, Inc. announced that the results from its United States Phase 2a clinical trial (the "PLUS" trial) of Locteron® will be presented today at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL) in Copenhagen, Denmark. Locteron, controlled-release interferon alpha 2b, is designed to improve patient care by providing a more convenient once-every-two week dosing schedule and by reducing the side effects, including flu-like symptoms, associated with pegylated interferons, the current standard of care. Biolex announced earlier this week the commencement of patient dosing in the SELECT-2, a Phase 2b trial of Locteron in the United States and Europe.

The PLUS Phase 2a clinical trial was conducted in 32 chronic hepatitis C patients in the United States who had failed prior treatment. The PLUS trial was designed to evaluate the safety and tolerability of Locteron, and to directly compare Locteron with pegylated interferon. Patients were randomized to receive either Locteron (administered once every two weeks) or PEG-Intron® (administered once per week). The Locteron doses evaluated in the PLUS trial include 320 µg, the lowest dose to be evaluated in the SELECT-2 trial, and 640 µg, the highest dose of Locteron evaluated to date. All patients also received oral, weight-based ribavirin. Patients were treated for four weeks with an additional two weeks of follow up evaluation.

Flu-like symptoms were reported to be less frequent and milder in both of the Locteron cohorts of the PLUS trial. The total severity score for flu-like symptoms for patients in the 320 µg cohort of Locteron was 80 percent lower than the severity score for the PEG-Intron control cohort (severity score was based on number of occurrences adjusted for severity rating of adverse event). The total severity score for patients in the 640 µg cohort of Locteron was 30 percent lower than the severity score for the PEG-Intron cohort. Injections site reactions and common hematological parameters among both of the Locteron cohorts and the PEG-Intron cohorts were comparable. Anti-viral effects were comparable among the Locteron and PEG-Intron cohorts, although three of the four patients achieving undetectable virus were in the 640 µg cohort.

"The PLUS trial clearly met its objectives and sets the stage for extended evaluation of Locteron in larger patient populations," said Eric Lawitz, MD, Alamo Medical Research, San Antonio, Texas, lead author on the trial. "As the treatment for hepatitis C evolves there continues to be a need for a next-generation interferon that can improve patient compliance through a combination of improved tolerability and convenience."

Locteron is an investigational therapeutic candidate and has not been approved for sale by the United States Food and Drug Administration or by any international regulatory agency.

Locteron Overview

Locteron is a controlled-release interferon alpha designed to improve patient care in the treatment of hepatitis C through a more favorable side-effect profile and dosing convenience compared to existing pegylated interferon products. In contrast to Locteron's controlled-release mechanism, the currently approved products, Pegasys® and PEG-Intron®, and the investigational product Albuferon®, are immediate-release products that lack a controlled-release mechanism. Interferon alpha serves as the foundation of current combination therapy for hepatitis C patients, and all major hepatitis C drug candidates currently in clinical trials are being studied in combination with interferon alpha. It is estimated that worldwide sales of interferon products for the treatment of hepatitis C will approach $6 billion by 2016.

Locteron combines BLX-883, a recombinant interferon alpha produced by Biolex in its patented LEX System(SM), with PolyActive®, an advanced controlled-release drug delivery technology developed by OctoPlus N.V. of Leiden, the Netherlands. Locteron is configured to allow dosing once every two weeks, more convenient than Pegasys® and PEG-Intron®, each of which require dosing every week. More importantly, Locteron's controlled-release mechanism results in the gradual release of interferon alpha 2b to patients over the duration of two weeks and avoids the early peak plasma levels of the active interferon that characterize the pegylated interferons and Albuferon. This controlled-release mechanism is designed to reduce the frequency, duration and severity of side effects, including flu-like symptoms, commonly experienced by patients treated with pegylated interferons and with Albuferon. The Company has completed three clinical trials of Locteron, and a Phase 2b trial is currently ongoing in 100 chronic genotype-1 hepatitis C patients in the United States and Europe.

About Biolex Therapeutics

Biolex is a clinical-stage biopharmaceutical company that uses its patented LEX System(SM) to develop hard-to-make therapeutic proteins and to optimize monoclonal antibodies. The LEX System is a novel technology that genetically transforms the aquatic plant Lemna to enable the production of biologic product candidates. The company's product candidates are designed to provide superior efficacy/tolerability profiles and to address large, proven pharmaceutical markets. Biolex's lead product candidate, Locteron®, is in Phase 2b clinical testing for the treatment of chronic hepatitis C. Biolex has also developed two other product candidates that capitalize on the benefits of the LEX System which it is advancing toward clinical trials: BLX-155, a direct-acting thrombolytic designed to dissolve blood clots in patients; and BLX-301, an anti-CD20 antibody it is optimizing for the treatment of non-Hodgkin's B-cell lymphoma and other diseases.‹

[DewDiligence]

Biolex completes enrollment of phase 2b Locteron trial in HCV:

http://finance.yahoo.com/news/Biolex-Therapeutics-Announces-iw-2990286556.html

It took Biolex only two months to enroll 100 patients, which is quite impressive. This trial will continue for another two years or so; however, as mentioned in #msg-37178496, Biolex plans to start phase-3 while the phase-2b trial is still running. The viral-load data at 12 weeks will be used to select the dose(s) to be tested in phase-3.

[DewDiligence]

Biolex Announces Presentation at EASL of Interim Results From Select-2 Phase2b Trial of Locteron in Chronic Hepatitis C

[Note: Biolex reported data at EASL from two different phase-2b Locteron studies.]

http://finance.yahoo.com/news/Biolex-Announces-Presentation-iw-4178924376.html?x=0&.v=1

›Locteron Dosed Once-Every-Two-Weeks Demonstrated a Comparable Reduction in Viral Load Compared to Once-Weekly Standard of Care With a 65% Reduction in Flu-Like Adverse Events

April 15, 2010, 2:01 am EDT

PITTSBORO, NC--(Marketwire - 04/15/10) - Biolex Therapeutics, Inc. announced that interim results from its SELECT-2 Phase 2b dose-finding trial of Locteron® are being presented today at the 45th Annual Meeting of the European Association for the Study of the Liver (EASL) in Vienna, Austria. Locteron, controlled-release interferon alpha 2b, is designed to improve patient care by providing a more convenient once-every-two week dosing schedule and by reducing the flu-like symptoms associated with pegylated interferons, the current standard of care. Through 36 weeks of treatment in the trial, Locteron achieved the Company's objective by demonstrating viral kinetics and response rates that were comparable to the PEG-Intron® control while also achieving a 65% reduction in flu-like adverse events.

The SELECT-2 Phase 2b trial is being conducted in the United States and Europe in 116 treatment-naive, genotype-1, chronic hepatitis C patients. Patients were randomized into one of four dosing cohorts, the 320, 480 or 640 ug dose of Locteron (administered once every two weeks) or a control arm consisting of PEG-Intron (1.5 ug/kg, administered every week), with all patients receiving weight-based ribavirin. Patients will be treated for 48 weeks and will be followed for an additional 24 weeks to determine the sustained virologic response (SVR) rate. All patients in the trial have completed at least 36 weeks of study.

Through 36 weeks of treatment in SELECT-2, Locteron administered once every two weeks in the 640 and 480 ug dose cohorts demonstrated reductions in viral loads (mean changes in HCV RNA from baseline) that were comparable to that achieved with PEG-Intron administered once per week. Although the reduction in mean HCV RNA for the 320 ug dose of Locteron were comparable to PEG-Intron after 36 weeks of treatment, patients treated with this lower dose of Locteron demonstrated a slower viral kinetics (compared to the Locteron 480 and 640 ug doses and PEG-Intron) at earlier time points.

Rates of undetectable HCV RNA achieved in each cohort are outlined in the table below:


SELECT-2 Interim Results
% of Patients with Undetectable HCV RNA

Locteron
------------------------
640 ug 480 ug 320 ug PEG-Intron
------ ------ ------ ----------
(n=29) (n=29) (n=28) (n=30)
12 Weeks 41% 38% 39% 40%
36 Weeks 52% 41% 46% 50%

A substantial proportion of patients treated with interferon experience flu-like adverse events, particularly during the first three months of treatment. Market research shows that flu-like symptoms are associated with hesitation to initiate therapy, lack of adherence during therapy, and significant discomfort and dissatisfaction with the current standard of care. A major objective of the SELECT-2 trial was to further test the hypothesis that Locteron's controlled-release mechanism would reduce the flu-like adverse events experienced by patients.

In SELECT-2, flu-like adverse events were predefined to include arthralgia, chills, fever, headache, and myalgia. A substantial reduction in flu-like adverse events for patients treated with Locteron was evident even in the first week of the trial and continued through the 36-week time point available for evaluation. Under the statistical analysis plan for the trial, the reductions in flu-like adverse events were tested after four and 12 weeks of treatment and were statistically significant for all three Locteron doses. After 36 weeks of treatment, total flu-like adverse events reported in each of the three Locteron cohorts were 35% of the total events reported in the PEG-Intron control group, a 65% reduction. The percentage reduction in total flu-like adverse events reported for each cohort of Locteron versus those reported for PEG-Intron are summarized in the table below:


SELECT-2 Interim Results
Reduction in Flu-Like Adverse Events Compared to PEG-Intron Control

Locteron
------------------------------------
640 ug 480 ug 320 ug
---------- ---------- ----------
Through 12 Weeks 53% 55% 59%
p < 0.001 p < 0.001 p < 0.001

Through 36 Weeks 65% 65% 65%

The SELECT-2 results were presented by the lead author, Eric Lawitz, MD, Medical Director and Principal Investigator, Alamo Medical Research, in the form of a poster titled "Early Viral Response of Controlled-Release Interferon Alpha2b and Ribavirin vs. Pegylated-Interferon Alpha2b and Ribavirin in Treatment-Naive Genotype-1 Hepatitis C: 12 Week Results (Select-2 Trial)."

"The interim results from the SELECT-2 trial are certainly consistent with the promise of this drug candidate," said Dr. Lawitz. "I look forward to seeing the development of Locteron expanded to larger trials and to testing in combination with direct-acting anti-viral agents."

Total serious adverse events reported for Locteron 640, 480 and 320 ug doses, and for PEG-Intron, were two, two, four and one, respectively. All serious adverse events were expected and consistent with labeled events for interferon alpha. Higher rates of mild or moderate (Grade 2 and Grade 3) reductions in hematological measurements (white blood cell counts, platelets, hemoglobin, and neutrophils) were observed on the 640 and 480 ug doses of Locteron in comparison to PEG-Intron but did not lead to higher rates of discontinuation or lower rates of viral response. There were no Grade 4 reductions in hematological measurements in any of the Locteron doses, and only one Grade 4 reduction in the PEG-Intron arm (one neutrophil count < 500). There were no novel toxicities identified in any cohort of the trial.

Locteron is an investigational therapeutic candidate and has not been approved for sale by the United States Food and Drug Administration or by any international regulatory agency.

Locteron Overview

Locteron is a controlled-release interferon alpha designed to improve patient care in the treatment of hepatitis C through a more favorable side-effect profile and dosing convenience compared to existing pegylated interferon products. In contrast to Locteron's controlled-release mechanism, the currently approved products, Pegasys® and PEG-Intron, and the investigational product Zalbin™, are immediate-release products that lack a controlled-release mechanism. Interferon alpha serves as the foundation of current combination therapy for hepatitis C patients. It is estimated that worldwide sales of interferon products for the treatment of hepatitis C will approach $6 billion by 2016.

Locteron incorporates an advanced controlled-release drug delivery technology that allows dosing once every two weeks, more convenient than Pegasys and PEG-Intron, each of which require dosing every week. More importantly, Locteron's controlled-release mechanism results in the gradual release of interferon alpha 2b to patients over the duration of two weeks and avoids the early peak plasma levels of the active interferon that characterize the pegylated interferons and Zalbin. This controlled-release mechanism is designed to reduce the frequency, duration and severity of flu-like symptoms commonly experienced by patients treated with pegylated interferons and with Zalbin.

About Biolex Therapeutics

Biolex is a biopharmaceutical company that uses its patented LEX System(SM) to develop follow-on biologics, hard-to-make therapeutic proteins and to optimize monoclonal antibodies. The LEX System is a novel technology that genetically transforms the aquatic plant Lemna to enable the production of biologic product candidates. The company's product candidates are designed to provide superior efficacy/tolerability profiles and to address large, proven pharmaceutical markets. Biolex's lead product candidate, Locteron®, is in Phase 2b clinical testing for the treatment of chronic hepatitis C. Biolex has also developed two other product candidates that capitalize on the benefits of the LEX System. BLX-301 is a humanized anti-CD20 antibody glyco-optimized for the treatment of non-Hodgkin's B-cell lymphoma and other diseases. BLX-155 is a direct-acting thrombolytic designed to dissolve blood clots in patients.‹