The U.S. Patent and Trademark Office (USPTO) recently issued a new U.S. patent to BioLineRx, Ltd. 's ( BLRX ) BL-8040 (Patent No. 8,455,450).
The patent, which will expire in Nov 2029, will cover BL-8040 for using its composition for obtaining hematopoietic precursor cells (e.g. stem cells) for use in bone marrow transplantation.
This new patent boosts the existing patent portfolio of BL-8040 which has 6 issued patents and 29 patents applications for new indications across the globe.
BioLineRx' BL-8040 is in a phase II study for the treatment of acute myeloid leukemia (AML). The multicenter, open-label, phase II study is evaluating the safety and efficacy of repeated escalating doses of BL-8040 in adults suffering from relapsed/refractory AML.
Primary endpoints include safety and tolerability of BL-8040. Secondary endpoints include the pharmacokinetic profile of the candidate and an efficacy evaluation.
Last month, BiolineRx announced that BL-8040 showed positive pre-clinical results for the treatment of thrombocytopenia (reduced platelet production). The data was published in the British Journal of Hematology.
The effect of repeated doses of BL-8040 on healthy as well as chemotherapy-induced thrombocytopenic mice was evaluated in the pre-clinical study.
The number of megakaryocytes within the bone marrow improved significantly with the repeated administration of BL-8040. Megakaryocytes are the cells that produce platelets.
Moreover, BL-8040 increased the number of hematopoietic progenitor cells in the bone marrow and blood. These cells generate platelets as well as red and white blood cells. The severity and duration of chemotherapy-induced thrombocytopenia and cytopenia also declined significantly.
Thrombocytopenia is a frequent side effect of chemotherapy. The candidate's ability to reduce thrombocytopenia makes it more attractive for the use of blood cancer treatment.
We remind investors that in Sep 2012, the rights to BL-8040 were in-licensed by BioLineRx from Biokine Therapeutics Ltd.
Some of the candidates developed by BioLineRx include BL-5010 for the treatment of skin lesions, BL-7040 for the treatment of inflammatory bowel disease (IBD) and BL-1021 for the treatment of neuropathic pain.
In Apr 2013, BiolineRx announced encouraging results from a phase IIa study on BL-7040. Results from the study revealed that BL-7040 was safe and effective for treating patients suffering from ulcerative colitis which is a form of IBD.
BioLineRx carries a Zacks Rank #3 (Hold). Companies that currently look well-positioned include Actelion Ltd. ( ALIOF ) and Gilead Sciences Inc. ( GILD ) with a Zacks Rank #1 (Strong Buy), and Jazz Pharmaceuticals ( JAZZ ) with a Zacks Rank #2 (Buy).