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BioLineRx, Ltd. (BLRX) Message Board

  • techxen techxen Feb 4, 2013 1:42 PM Flag

    BL-1020 is significantly more effective

    From Q3 results last year:
    "Kinneret Savitsky, Ph.D., CEO of BioLineRx, remarked, “We are pleased with the progress achieved in our portfolio during the third quarter with respect to our clinical and pre-clinical therapeutic compounds. With regard to our leading compound, BL-1020 for schizophrenia, we are especially excited by the recent re-analysis of the Phase IIb EAGLE study by an outside group of leading scientists. According to the re-analysis, when taking into account the effects of the circadian rhythm (i.e., 24-hour time cycle), BL-1020 is significantly more effective in improving cognitive function than previously discovered. The ramifications of this re-analysis have been taken into account in the execution of the on-going CLARITY Phase II/III trial for BL-1020, and these findings, along with other analyses we have previously performed, have motivated us to initiate an interim analysis of the short-term cognitive effects of BL-1020 within the CLARITY trial. We are hopeful the interim analysis will reinforce our confidence regarding the cognitive benefits of BL-1020, and potentially accelerate our commercialization efforts for the further development of this promising therapeutic candidate.”

    Nothing has changed, if anything this recent press release by the company is an attempt to stem all the speculation that is out there. I don't agree with Seeking Alpha that the price correction was a result of anticipated "less-than-stellar results" - where did they come up with this analysis?? On the contrary I believe the run up is because of speculation based on the above comments by the company back in Q3 and the announcement of the March 18th cognitive signal measurement. Don't forget the company is presenting next Tuesday at the BIO Investor conference. Additional remarks by the executives at that conference could re-ignite and extend this recent rally.

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    • From BLRX PR QIV 2012: Reasons why the study could be finished earlier than designed ....

      Jerusalem – October 9, 2012 – BioLineRx (NASDAQ: BLRX; TASE: BLRX), a biopharmaceutical development company, announced today that a recent analysis of the results from the Phase IIb EAGLE trial for BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia, indicates that BL-1020 demonstrated a significant increase in efficacy at improving cognitive impairment associated with this condition, as compared to the original analysis of the study.

      The findings pertain to the results of the Phase IIb EAGLE study, first published in September 2009, for determining safety, efficacy, and tolerability of BL-1020 compared to Risperidone, an approved atypical antipsychotic drug, and placebo. Results of the study showed that BL-1020 was significantly better than the placebo and comparable with Risperidone in both PANSS and CGI scores, which are widely recognized measures of severity and improvement in schizophrenia. In addition, the results showed a statistically significant improvement in cognitive function as assessed by BACS (Brief Assessment of Cognition in Schizophrenia), when compared to both placebo and Risperidone.

      Recently, an outside research group performed a further analysis of the results of the EAGLE study, which specifically take into account effects of the circadian rhythm (i.e., 24-hour time cycle) on cognitive function of the subjects. Results of the re-analysis clearly show that when the time of day for administration of the neurocognitive BACS test was consistent between visits, the beneficial effect of BL-1020 on cognitive function was even more pronounced than the original analysis. Specifically, the original analysis for all patients in the study showed an effect size of 0.40 for BL-1020 versus placebo and an effect size of 0.39 for BL-1020 versus Risperidone. However, according to the re-analysis, for the subset of patients with consistent testing times, the effect size increased significantly, to 0.97 for BL-1020 versus placebo and 0.57 for BL-1020 versus Risperidone. These results mean that the beneficial effect of BL-1020 on cognitive function, when compared to the original analysis, more than doubled versus placebo and increased by almost 50% versus Risperidone.

      Dr. Kinneret Savitsky, CEO of BioLineRx, stated, "Cognitive functioning is influenced by circadian rhythms over the course of the day, and patients with schizophrenia are known to have profoundly disturbed circadian rhythms that can affect their cognitive functioning. Therefore, a new analysis was performed to determine whether taking into account consistency in the timing of neurocognitive testing between the baseline and endpoint visits could affect assessment of the efficacy of BL-1020. This analysis found that when the baseline and endpoint visits were conducted at the same time of day, there was a significantly more robust treatment response as compared to those patients where the timing of the visits was inconsistent. These findings indicate that BL-1020 is even more efficient at improving cognitive function than was previously shown.”

      "We are very excited with these new findings by an outside group of leading scientists relating to the EAGLE trial. The results not only show an increased efficacy of BL-1020 in improving cognitive function in schizophrenia patients, but also have positive implications on conducting and analyzing the ongoing CLARITY trial, which is specifically designed for assessing BL-1020’s cognition enhancement effect," concluded Dr. Savitsky.

      About BL-1020
      BL-1020 is a first-in-class GABA-enhanced antipsychotic that combines dopamine antagonism with GABAergic activity. BL-1020 has demonstrated high efficacy and safety with minimal EPS and no metabolic side effects. Most importantly, BL-1020 may have the potential to improve cognition, which is a significant unmet medical need in schizophrenia and other neurological/psychiatric disorders. Three clinical studies have confirmed the safety and efficacy of BL-1020, while pre-clinical studies have also shown that BL-1020’s GABA enhancement may provide the basis for improved cognition.

      In June 2011, BioLineRx announced commencement of the Phase II/III CLARITY clinical trial of BL-1020. This 450-patient trial aims to determine the short-term (6 weeks) and the long-term (24 weeks) cognitive benefit and anti-psychotic efficacy, safety and tolerability of BL-1020 in schizophrenia patients, compared with Risperidone (one of the leading schizophrenia treatments). The CLARITY trial is proceeding at approximately 30 sites in Romania and India.

      Sentiment: Strong Buy

    • Today's press release was almost the complete opposite. I mean, if everything was so great, and BL-1020 really is much more effective, then why come out today and talk it down?

    • What interests me personally is something that is almost untouched in the medical field: That is the effects of the circadian rhythm, which improves cognitive function.
      This little piece of information can tell us one heck of a lot here. Many people in multiple diseases suffer from cognitive dysfunctions from disruptions in Circadian Rhythms. If BL-1020 actually does this; we are talking about treating multiple conditions: ME/CFS, Seasonal Affective Disorder, Schizo among others.
      I was recently urged to look at this company from another Yahoo Board member and what I am discovering I like so far.

    • Yes, at $4 per share the company is cheap on shares outstanding. In the PR today they mention not to accept statements by others (hype statements):

      "The Company hereby emphasizes that as the CLARITY trial is on-going and given the double-blind trial design, BioLineRx at present has no insight into the results of the interim analysis. Any media reports or comments by those outside of the Company regarding the outcome of the interim results of the CLARITY trial are merely based on speculation."

      They wanted to protect people from false statements. Nothing else has changed and they will mention on Feb. 12 and we will get an inkling on March 18th.

      It looks like they have enough cash for some time, or they could have maybe sold shares 75 cents higher (just a thought).

      The data looks good and for this low float company, I am expecting rebound. Roughly $60 million market cap with $27 million in cash at $4 per share, I am buyer. That is cheap for a Phase 2/3 compound with a potentially better looking metabolic profile and improved cognition vs. Risperidol.

    • Good points. The fact that another company paid 30 million up front based on prior results is a tell. Also, yes, no actual results will be revealed. However, isn't a good sign if the DMC says that you do not need additional patients to achieve results or in fact you need less patients??? That I think was the point of some of the statements by management. My general understanding is that based on "new" results from prior study which demonstrated better cognitive results if measured in the morning, the company asked for an interim look at current trial.

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