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BioLineRx to Present at the 12th Annual Needham Healthcare Conference in New York on April 30, 2013

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BioLineRx to Present at the 12 th Annual Needham Healthcare Conference in New York on April 30, 2013

JERUSALEM–(BUSINESS WIRE)– BioLineRx (NAS: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today that its Chief Executive Officer, Kinneret Savitsky, Ph.D., and its Chief Financial and Operating Officer, Philip Serlin, will be presenting at the 12th Annual Needham Healthcare Conference in New York.

Dr. Savitsky and Mr. Serlin are scheduled to present at 3:40 P.M. EST on Tuesday, April 30, 2013.

A live Webcast of the presentation will be available on the BioLineRx Website at http://biolinerx.com/default.asp?pageid=63&itemid=181. A replay will be available one hour after the presentation ends and will be accessible for three months following the presentation.

Investors attending the conference that wish to meet with Dr. Savitsky and Mr. Serlin for a one-on-one meeting should contact the Needham Conference Team at conferences@needhamco.com.

About BioLineRx

BioLineRx is a publicly-traded biopharmaceutical development company. BioLineRx is dedicated to building a portfolio of products for unmet medical needs or with advantages over currently available therapies. BioLineRx’s current portfolio consists of six clinical stage candidates: BL-1040, for prevention of pathological cardiac remodeling following a myocardial infarction, which has been out-licensed to Ikaria Inc., is currently undergoing a pivotal CE-Mark registration trial; BL-5010 for non-surgical removal of skin lesions has completed a Phase I/II study; BL-7040 for treating inflammatory bowel disease (IBD) has completed a Phase IIa trial; BL-8040 for treating acute myeloid leukemia (AML) and other hematological cancers will shortly commence a Phase II study; BL-1021 for neuropathic pain is in Phase I development; and BL-1020 for schizophrenia. In addition, BioLineRx has six products in various pre-clinical development stages for a variety of indications, including central nervous system diseases, infectious diseases, cardiovascular and autoimmune diseases.

BioLineRx’s business model is based on acquiring molecules mainly from biotechnological incubators and academic institutions. The Company performs feasibility assessment studies and development through pre-clinical and clinical stages, with partial funding from the Israeli Government’s Office of the Chief Scientist (OCS). The final stage includes partnering with medium and large pharmaceutical companies for advanced clinical development (Phase III) and commercialization. For more information on BioLineRx, please visitwww.biolinerx.com, the content of which does not form a part of this press release.

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From: http://www.dailyfinance.com/2013/04/18/biolinerx-to-present-at-the-12th-annual-needham-he/

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BioLineRx Receives Regulatory Approval to Commence Phase II Clinical Trial for BL-8040, for Treatmen

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BioLineRx Receives Regulatory Approval to Commence Phase II Clinical Trial for BL-8040, for Treatment of Leukemia


Partial results expected in Q4 2013


Final results expected in H2 2014

JERUSALEM–(BUSINESS WIRE)– BioLineRx (NAS: BLRX) (TASE:BLRX), a biopharmaceutical development company, announced today that it has received all necessary regulatory approvals in the US to commence a Phase IIa trial for BL-8040, for the treatment of Acute Myeloid Leukemia (AML).

The study is a multicenter, open-label study under an IND, designed to evaluate the safety and efficacy profile of repeated escalating doses of BL-8040 in adult subjects with relapsed/refractory AML. The primary endpoints of the study are the safety and tolerability of the drug. Secondary endpoints will include the pharmacokinetic profile of the drug and an efficacy evaluation, as assessed by various parameters, such as the response rate by bone marrow biopsy. The study is also designed in a way that will enable the investigators to evaluate the capabilities of BL-8040 in mobilizing cancer cells from the bone marrow to the peripheral blood, and in inducing their cell death. The study is expected to be conducted in the U.S. and Israel, and will enroll up to 50 patients.

“This program is generating a lot of enthusiasm from our clinical research partners, and we are very pleased that several renowned and respected investigators will be leading our study in the U.S. and Israel,” said Kinneret Savitsky, PhD, CEO of BioLineRx. “AML is one of the most common types of leukemia in adults, yet survival rates continue to be low relative to other leukemias. In particular, treatment options for patients with relapsed or refractory AML are extremely limited, and in many cases, only palliative care is offered. We look forward to the partial results expected towards the end of this year, and have sincere hopes that BL-8040 will be a significant and efficient addition in the battle with this devastating disease.”

“We are honored to collaborate with BioLineRx on this exciting project,” said Dr. Gautam Borthakur, the principal investigator of the trial at the MD Anderson Cancer Center …read more

Source: FULL ARTICLE at DailyFinance

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BioLineRx Announces Results from Interim Analysis of Phase II/III CLARITY Trial of BL-1020 for Schiz

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BioLineRx Announces Results from Interim Analysis of Phase II/III CLARITY Trial of BL-1020 for Schizophrenia

Management call scheduled for Wednesday, March 20 th , at 11:00 a.m. EDT

JERUSALEM–(BUSINESS WIRE)– BioLineRx (NAS: BLRX)  (TASE: BLRX), a biopharmaceutical development company, today announced that results from a pre-planned interim analysis of the Phase II/III CLARITY trial of BL-1020, a first in class, orally available, GABA-enhanced antipsychotic for the treatment of schizophrenia, indicate that the trial would not meet the pre-specified primary efficacy endpoint. After conferring with the study’s independent Data Monitoring Committee (DMC), the Company has decided to discontinue the CLARITY study. No additional patients will be enrolled in the trial.

“These disappointing results underscore the difficulty of treating cognition in schizophrenia, which remains an unmet medical need,” stated Kinneret Savitsky, PhD, Chief Executive Officer of BioLineRx. “We would like to thank the patients and investigators for their participation and engagement in the study. While we certainly would have preferred to see a positive outcome on this trial, the decision to perform the interim analysis, without waiting until the end of the study, provides us with the opportunity to allocate additional resources to our other projects in order to accelerate their development. This confirms the advantage of our business model, which is based on a broad pipeline with a number of compounds, at different stages of development, and for multiple indications.”

As a result of the CLARITY study termination, the Company anticipates that planned research and development expenses will decrease for the remainder of 2013 and part of 2014 by approximately $6 to $7 million, thus allowing the Company’s current cash reserves of approximately $28 million to fund its expected operations into 2015. The Company expects to meet a number of significant clinical milestones related to other pipeline assets in the next 12-18 months.

About Phase II/III CLARITY Study Interim Analysis

The interim analysis included data on 230 subjects, of which 168 were evaluable for analysis on the primary (six-week) cognitive endpoint. The analysis indicated no efficacy of BL-1020, in comparison to Risperidone, relative to the cognitive primary and secondary (12-week and 24-week) endpoints. However, in several statistical parameters specified in the statistical analysis plan (SAP), positive trends in cognition were observed. The Company intends to perform a complete analysis of the un-blinded study data on all patients enrolled to date in order to ascertain …read more
Source: FULL ARTICLE at DailyFinance

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BioLineRx Receives Approval from French Regulatory Authorities to Commence a Phase I/II Clinical Tri

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BioLineRx Receives Approval from French Regulatory Authorities to Commence a Phase I/II Clinical Trial for BL-8020, an Oral, Interferon-Free Treatment for Hepatitis C


– Interim results are expected by the end of 2013 –

JERUSALEM–(BUSINESS WIRE)– BioLineRx (NAS: BLRX) (TASE:BLRX), a biopharmaceutical development company, announced today that it has received approval from the French regulatory authorities to commence a Phase I/II trial for BL-8020, an orally available, interferon-free treatment for the Hepatitis C virus (HCV). The study is an open-label trial to evaluate the efficacy, safety and tolerability of BL-8020 in patients infected with HCV. It will be conducted at two clinical sites in France and will include HCV-infected patients of any genotype who have previously failed or relapsed following treatment with the standard-of-care.

“We are excited about the upcoming initiation of clinical trials for our first anti-HCV agent, BL-8020. The Phase I/II trial will be led by Prof. Stanislas Pol, M.D., Ph.D, from Hôpital Cochin in Paris, and Prof. Marc Bourliere, M.D., from Hôpital Saint Joseph in Marseille, both prominent international leaders in the HCV field,” stated Dr. Kinneret Savitsky, CEO of BioLineRx. “Based on BL-8020’s pre-clinical results, its unique mechanism of action and synergistic effect, we have high hopes for this drug especially when combined with other available Hepatitis C drugs. We look forward to the interim results from the Phase I/II trial expected towards the end of 2013.”

BL-8020 is an orally available HCV treatment with a unique mechanism of action, as compared to other currently used anti-HCV agents. This suggests pan-genotypic efficacy and the ability to be combined with other HCV therapeutics as part of an interferon-free regimen. BL-8020’s mechanism of action involves the inhibition of HCV-induced autophagy in the host cells. Autophagy is a mechanism by which cells degrade damaged or unnecessary cellular components, including invading viruses. However, HCV has found a way to take advantage of this mechanism in order to replicate inside the cell. By inhibiting this mechanism, BL-8020 reduces the ability of HCV to replicate.

BL-8020’s safety and efficacy have been demonstrated in a number of pre-clinical studies. These studies have shown that BL-8020 has a synergistic effect with other anti-HCV agents. This effect on other therapies is likely to increase their potency and reduce the numerous adverse effects often associated with these drugs by enabling utilization of lower dosages. …read more
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BioLineRx Reports Year End 2012 Financial Results

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BioLineRx Reports Year End 2012 Financial Results

JERUSALEM–(BUSINESS WIRE)– BioLineRx Ltd. (NAS: BLRX) (TASE: BLRX), a biopharmaceutical development company, today reported its results for the year ended December 31, 2012.

“BioLineRx is rapidly approaching a significant landmark in the evolution of the Company,” stated Kinneret Savitsky, Ph.D., CEO of BioLineRx. “We are eagerly anticipating the interim analysis of the on-going CLARITY Phase 2/3 trial for our lead compound, BL-1020 for schizophrenia, which we expect to receive next week. The analysis will include a recommendation by an independent Data Monitoring Committee (DMC) regarding the number of additional patients needed in order to reach statistical significance on the cognitive effect of BL-1020 compared to Risperidone. Although the data from the ongoing study is completely confidential, based on promising evidence received in previous clinical and pre-clinical trials, we hope the information received will provide a clear indication regarding the strength of the cognition improvement signal, thereby putting us in a stronger position to out-license BL-1020 and move towards commercializing the compound.”

“The PRESERVATION I pivotal CE mark registration trial for our other lead compound, BL-1040 for ventricular remodeling post-AMI, which is being carried out by Ikaria, Inc., continues to progress on an accelerated basis. Currently, there are 15 sites recruiting in Australia, Belgium, Canada, Israel and Spain, and results from the trial are expected in 2014.”

“In addition, our Phase 2 proof-of-concept study for BL-7040, an oral treatment for Inflammatory Bowel Disease (IBD), is nearing completion. This is an open-label study to evaluate the efficacy, pharmacodynamics, safety and tolerability of BL-7040 in up to 30 patients with moderately active ulcerative colitis, a type of IBD. This trial is being carried out at five sites in Israel, and we are expecting to announce results in April 2013.”

“During 2012, we in-licensed several high-profile therapeutic compounds that are already advancing towards clinical testing. This includes BL-8040, a Phase 2-ready drug for the treatment of acute myeloid leukemia (AML) and other hematological cancers. The interest in this program is high, and we have recently signed an agreement with one of the premier cancer centers in the world, MD Anderson Cancer Center in Houston, Texas, to be the lead site in the trial. We are currently in negotiations with two other U.S.-based, world-class facilities for their participation in the trial as well,” continued Dr. Savitsky.

“At the beginning of 2012, we entered the competitive HCV market with the in-licensing of two orally-available compounds for the treatment of Hepatitis C from world renowned experts …read more
Source: FULL ARTICLE at DailyFinance

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BioLineRx's EDP-14, for Treatment of Severe and Persistent Asthma, to Enter the Company's Main Thera

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BioLineRx’s EDP-14, for Treatment of Severe and Persistent Asthma, to Enter the Company’s Main Therapeutic Pipeline as BL-9010


Preclinical data shows that EDP-14 significantly blocks allergic responses

JERUSALEM–(BUSINESS WIRE)– BioLineRx (NAS: BLRX) (TASE: BLRX), a biopharmaceutical development company, announced today that following promising pre-clinical data, EDP-14, for the treatment of severe and persistent asthma, has been added to the Company’s main therapeutic pipeline. The project is now named BL-9010. Previously, the project was developed under BioLineRx’s Early Development Program.

BL-9010, a novel bi-specific antibody treatment for severe and persistent asthma, targets and links together two immunological modulators – IgE and CD300a. Allergen-bound IgE activates cells involved in allergic responses, such as mast cells, while CD300a inhibits immune responses. Professor Francesca Levi-Schaffer from the Hebrew University of Jerusalem, the inventor of BL-9010, found that CD300a is expressed on mast cells and that linking IgE with CD300a using a bi-specific antibody leads to potent inhibition of allergic reactions characteristic of asthma. In murine models of experimental asthma, BL-9010 significantly blocked allergic responses. Importantly, this could be reproduced in human mast cells, where BL-9010 was shown to inhibit the allergic reaction of these cells in-vitro. The human mast cells were activated by IgE molecules from allergic patients and by specific allergens, mimicking the human disease, while BL-9010 prevented the release of allergy-mediating substances by the cells.

“Asthma is a highly prevalent disease with no satisfactory cure that affects millions of people around the world,” said Dr. Kinneret Savitsky, CEO of BioLineRx. “The results of the pre-clinical trials were extremely impressive and convincing, and raise hopes that BL-9010 will be an effective treatment. As a result, the project is now being advanced to our main product pipeline and will be further developed at an accelerated pace. Due to its unique mechanism of action, promising in-vivo results and the true unmet medical need, this project, although still in pre-clinical stages of development, is already attracting the interest of potential partners.”

BL-9010 was developed to treat severe and persistent asthma patients, but may also potentially treat chronic urticaria as well as additional allergic conditions.

About Asthma

Acute asthma, also known as allergic asthma, is triggered by allergens activating mast cells located beneath the …read more
Source: FULL ARTICLE at DailyFinance