On May 16, 2018 BioLineRx Ltd. (NASDAQ: BLRX)(TASE: BLRX)(BLRX) , a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that the European Patent Office (EPO) has issued a Decision to Grant a patent claiming the use of BL-8040 with cytarabine, a chemotherapeutic agent, for the treatment of acute myeloid leukemia (AML) (Press release, BioLineRx, MAY 16, 2018, View Source;p=RssLanding&cat=news&id=2349350 [SID1234526683]).

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This patent will be valid through March 2034, with the option of up to five years’ patent term extension. Member patents were also granted in Japan and Hong Kong. Additional corresponding patent applications are pending in China (a Notice of Acceptance was received), Israel (a Notice of Acceptance was received), the United States, India, Korea, Mexico, Brazil, Canada and Australia.

"The long-term patent exclusivity we have received from the European Patent Office for BL-8040 in combination with cytarabine provides us with significant additional patent protection in AML, one of BL-8040’s key indications," said Philip A. Serlin, Chief Executive Officer of BioLineRx. "In this regard, we are moving forward in full force with two ongoing trials in the AML space – a Phase 2b in consolidation AML and a Phase 1b/2 in maintenance AML, in addition to the continued follow-up on encouraging overall survival results shown in our recently completed relapsed/refractory AML study."

About BL-8040

BL-8040 is a short peptide for the treatment of acute myeloid leukemia, solid tumors, and stem cell mobilization. It functions as a high-affinity antagonist for CXCR4, a chemokine receptor that is directly involved in tumor progression, angiogenesis, metastasis and cell survival. CXCR4 is over-expressed in more than 70% of human cancers and its expression often correlates with disease severity. In a number of clinical and pre-clinical studies, BL-8040 has shown robust mobilization of cancer cells and immune-cells from the bone marrow, thereby sensitizing cancer cells to chemo- and bio-based anti-cancer therapy, as well as a direct anti-cancer effect by inducing cell death (apoptosis) and mobilizing immune-cells. In addition, BL-8040 has also demonstrated robust stem-cell mobilization, including the mobilization of colony-forming cells, T, B and NK cells. BL-8040 was licensed by BioLineRx from Biokine Therapeutics and was previously developed under the name BKT-140.

On May 16, 2018 BioLineRx Ltd. (NASDAQ: BLRX)(TASE: BLRX)(BLRX) , a clinical-stage biopharmaceutical company focused on oncology and immunology, reported it will release its unaudited financial results for the quarter ended March 31, 2018 on Tuesday, May 22, 2018, before the US markets open (Press release, BioLineRx, MAY 16, 2018, View Source;p=RssLanding&cat=news&id=2349376 [SID1234526682]).

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The Company will host a conference call on Tuesday, May 22, 2018 at 10:00 a.m. EDT featuring remarks by Philip Serlin, Chief Executive Officer. The conference call will be available via webcast and can be accessed through the Investor Relations page of BioLineRx’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

To dial into the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx’s website. A dial-in replay of the call will be available until May 25, 2018; please dial +1-877-456-0009 from the U.S. or +972-3-925-5942 internationally.

On May 16, 2018 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the first quarter ended March 31, 2018 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, MAY 16, 2018, View Source [SID1234526681]).

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"Throughout the first quarter of 2018, we made major strides advancing our RNAi nanoparticle drugs for the treatment of a variety of cancers with limited treatment options. Specifically, we were delighted to publish and present data in support of our DNAbilize technology in both peer-viewed journal articles and at key oncology medical meetings. In particular, we were delighted with the interim results from our ongoing Phase 2 clinical trial of prexigebersen for the treatment of AML, which showed 47% of evaluable patients demonstrated some degree of response to prexigebersen in combination with LDAC, representing a significant advance for de-novo patients previously untreated for AML who are not otherwise eligible for standard or high-intensity chemotherapy regimens or who have elected a low intensity regimen," said Peter Nielsen, President and CEO of Bio-Path Holdings.

"Moving forward, we continue to leverage our DNAbilize RNAi nanoparticle technology to develop treatments for other cancers with high unmet medical need. To that end, we have gathered a team of leading cancer and biotechnology experts to guide our current and future clinical programs. We remain committed to our mission of advancing novel treatments for oncology patients with limited treatment options and will continue to drive the advancement of Bio-Path’s exciting drug candidates," continued Mr. Nielsen.

Recent Corporate Highlights

Reported interim results from Phase 2 study of prexigebersen in combination with LDAC for the treatment of AML. In April 2018, Bio-Path announced interim data from its ongoing Phase 2 clinical trial of its lead drug candidate prexigebersen. Of the 17 evaluable patients, 4 patients achieved complete responses, 1 patient achieved a leukemia free status, 1 patient had significantly reduced bone marrow blasts and 3 patients achieved stable disease. In total, 47% of the evaluable patients showed some form of response to the combination treatment, including 4 patients with complete remission (23%) and 4 patients with stable disease.

Presented preclinical data on prexigebersen at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting (AACR) (Free AACR Whitepaper). In April 2018, Bio-Path presented promising data at AACR (Free AACR Whitepaper) 2018 on prexigebersen for the treatment of solid tumors in gynecologic malignancies. Prexigebersen decreased tumor burden eighty six percent (86%) and multinodular burden in mice compared to control, with no apparent toxicity.

Published data in The Lancet Haematology. In March 2018, Bio-Path announced that data from its Phase 1/1b study of prexigebersen as a treatment for hematological malignancies was published in The Lancet Haematology in an article titled, "Liposomal Grb2 antisense oligodeoxynucleotide (BP1001) in patients with refractory or relapsed haematological malignancies: a single-center, open-label, dose-escalation, phase 1/1b trial."

Strengthened the Scientific Advisory Board (SAB) with the addition of Anas Younes, MD. In May 2018, Bio-Path announced the appointment of Dr. Anas Younes to the SAB. Dr. Younes is a Professor and Chief of Lymphoma Service at Memorial Sloan Kettering Cancer Center, and one of the world’s leading lymphoma experts. His expertise will be especially invaluable in guiding Bio-Path’s BP1002 through the clinic for lymphoma and solid tumors.

Enhanced leadership with the appointment of Paul Aubert to Board of Directors. In February 2018, Bio-Path announced the appointment of Paul Aubert to the Company’s Board of Directors. Paul Aubert is the sole shareholder at Paul Aubert PLC and was previously General Counsel at a specialty pharmaceutical company. His transactional experience and expertise in corporate law will provide valuable insight to the Bio-Path team.
Financial Results for First Quarter Ended March 31, 2018

The Company reported a net loss of $1.9 million, or $0.17 per share, for the three months ended March 31, 2018, compared to a net loss of $0.4 million, or $0.04 per share, for the three months ended March 31, 2017. The increase in net loss in 2018 was primarily due to other income of $1.6 million recognized in 2017 related to the change in the fair value of the Company’s warrant liability.

Research and development expenses for the three months ended March 31, 2018 decreased to $0.9 million, compared to $1.0 million for the three months ended March 31, 2017 primarily due to decreased stock-based compensation expense.

General and administrative expenses for both the three months ended March 31, 2018 and March 31, 2017, were $1.0 million.

As of March 31, 2018, the Company had cash of $4.3 million, compared to $6.0 million at December 31, 2017. Net cash used in operating activities for the three months ended March 31, 2018 was $1.7 million compared to $1.8 million for the comparable period in 2017.
Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these first quarter 2018 financial results and to provide a general update on the Company. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to the conference ID 1096178. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com

On May 16, 2018 Aclaris Therapeutics, Inc. (NASDAQ:ACRS), a dermatologist-led biopharmaceutical company committed to identifying, developing, and commercializing innovative therapies to address significant unmet needs in aesthetic and medical dermatology and immunology, reported data of interest featured in posters at the International Investigative Dermatology (IID) 2018 Meeting in Orlando, Florida (Press release, Aclaris Therapeutics, MAY 16, 2018, View Source [SID1234526680]). Two posters relate to ESKATA (hydrogen peroxide) topical solution, 40% (w/w), known formerly as "A-101", and one poster describes pre-clinical studies of soft Janus kinase 1/3 inhibitors synthesized by Aclaris and designed for high skin permeability with minimal systemic stability.

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A-101 (hydrogen peroxide) topical solution Safety and Efficacy in Patients with Seborrheic Keratoses: Results from two Identical Randomized, Double-blind, Placebo-controlled, Phase 3 Studies
Abstract 465
Authors: L. Baumann, A. Blauvelt, Z. Draelos, S. Kempers, M. Lupo, J. Schlessinger, S. Smith, D. Wilson, M. Bradshaw, E. Estes and S.D. Shanler
Study sponsored by Aclaris
Ex-vivo Evaluation of Cytotoxicity and Melanocyte Viability of Fitzpatrick V Skin after A-101 hydrogen peroxide topical solution 40% or Cryosurgery Treatment in Seborrheic Keratosis Lesions
Abstract 1281, E-poster Discussion I, 5/17/18, 12:15 – 1:15 PM
Authors: S. Kao, A. Kiss, T. Efimova, A. Friedman (Department of Dermatology at The George Washington University School of Medicine & Health Sciences)
Supported by an independent grant from Aclaris
JAK Kinase Inhibitors Efficacious in Models of Murine Contact Hypersensitivity
Abstract 1064
Authors: P. Changelian, S. Mnich, C. Xu, S. Hockerman, D. Anderson, J. Jacobsen and J. Monahan
Authors are employees of Aclaris
The abstracts are available in the Journal of Investigative Dermatology, Volume 138, Issue 5, Supplement, May 2018.

About ESKATA
ESKATA (hydrogen peroxide) topical solution, 40% (w/w), is the first and only FDA-approved medication for the treatment of raised seborrheic keratoses (SKs).

Important Safety Information and Approved Use

ESKATA can cause serious side effects, including:

Eye problems. Eye problems can happen if ESKATATM (hydrogen peroxide) topical solution, 40% (w/w) gets into your eyes, including: ulcers or small holes in your eyes, scarring, redness, irritation, eyelid swelling, severe eye pain, and permanent eye injury, including blindness.
If ESKATA accidentally gets into your eyes, your healthcare provider will tell you to flush them well with water for 15 to 30 minutes. Your healthcare provider may send you to another healthcare provider if needed.
Local skin reactions. Skin reactions have happened in and around the treatment area after application of ESKATA. Severe skin reactions can include: breakdown of the outer layer of the skin (erosion), ulcers, blisters and scarring. Tell your healthcare provider if you have any skin reactions during treatment with ESKATA.
The most common side effects of ESKATA include: itching, stinging, crusting, swelling, redness and scaling.

Your healthcare provider will not apply another treatment of ESKATA if your treated area is still irritated from the previous treatment.

Tell your healthcare provider right away if ESKATA gets into your eyes, mouth or nose during application. ESKATA is for topical use on the skin only, and is not for use in your eyes, mouth or vagina.

These are not all the possible side effects of ESKATA.

Approved Use for ESKATA

ESKATA is a prescription medicine used to treat seborrheic keratoses that are raised.

ESKATA is for use as an in-office treatment. ESKATA is applied by your healthcare provider and is not for use at home.

You are encouraged to report negative side effects of prescription drugs to the FDA. Contact Aclaris Therapeutics, Inc. at 1-833-ACLARIS or 1-833-225-2747 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

On May 16, 2018 Tiziana Life Sciences plc (AIM: TILS), a clinical stage biotechnology company developing targeted drugs for cancer and inflammatory diseases, reported that the independent data monitor committee (IDMC) completed a second, interim analysis of tolerability data from the first eleven treated patients and recommended expansion of the initial cohort to continue enrolment of an additional 20 patients to complete the trial (Press release, Tiziana Life Sciences, MAY 16, 2018, View Source;intolerable-Unresectable-or-Metastatic-Hepatocellular-Carcinoma-HCC-Patients [SID1234526674]).

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This phase 2a multi-centre and multi-country clinical trial (CDKO-125A-010) in sorafenib-refractory or -intolerable patients with unresectable or metastatic HCC is being conducted in Greece, Italy and Israel. Since, this was the first trial with milciclib in HCC patients, a second, interim analysis was scheduled following completion of treatment for the first 11 patients before initiating enrolment of the next 20 patients. Thus, demonstration of good tolerability with acceptable incidence of serious adverse events is an important milestone to initiate a phase 2b trial evaluating combination of milciclib with sorafenib (Nexavar; Bayer Germany (BAYN.GR)) in HCC patient.

Major findings were as follows:

Milciclib treatment was well-tolerated with manageable drug-related toxicities. The IDMC concluded that there were no major signals of tolerability concerns and therefore favours proceeding to expand enrolment.

Four patients have completed the study per protocol (6 cycles of treatment in 6 months). Two of these patients and their care provider opted to continue receiving milciclib at full dose as part of compassionate use. A third patient is awaiting ethical committee (EC) approval.

Gabriele Cerrone, Chairman of Tiziana Life Sciences, commented: ”Establishment of tolerability of milciclib as a single agent in HCC patients is a key pre-requisite to initiate the phase 2b trial to evaluate dosing, tolerability and clinical activity of milciclib in combination with sorafenib (Nexavar; Bayer Germany) in HCC patients”.

Kunwar Shailubhai, CEO & CSO of Tiziana Life Sciences, commented: "We are pleased with the conclusion of IDMC that milciclib treatment showed no major signals of tolerability concerns in sorafenib-refractory or -intolerable HCC patients. These findings are consistent with the findings reported earlier on the long-term tolerability and clinical activity of milciclib in thymic carcinoma, thymoma1 and other solid cancers2. Results from these clinical studies strongly warrant further clinical development of milciclib for treatments of HCC and other cancers".

Cited References

1. Press Release on announcement of clinical data in thymoma and thymic carcinoma.
www.tizianalifesciences.com

2 . Aspeslagh, S., Shailubhai, K., Bahleda, R. et al. (2017). Phase I dose-escalation study of Milciclib in combination with gemcitabine in patients with refractory solid tumors. Cancer Chemother Pharmacol. 79:1257-1265

About Hepatocellular Carcinoma

Hepatocellular cancer is the 5th most common cancer and the 3rd cause of cancer mortality worldwide. In 2007 the approval by the European Medical Agency (EMA) and Food and Drug Administration (FDA) of sorafenib in HCC represented the first systemic therapy for improving outcome in patients unsuitable for loco-regional and surgical therapies and created a new standard of treatment for the disease. However, although significant in respect to placebo, the benefits of sorafenib are modest; the response rate is less than 3%, the improvement in median survival is 2-3 months and the drug-related symptoms are not ordinary. Therefore, more effective systemic therapy is required for both naive patients presenting with unresectable, advanced stage and those who suffer recurrence after curative treatments (resection, ablation and transplantation).

About Milciclib

Milciclib (PHA-848125AC) is a small molecule inhibitor of several cyclin dependent kinases (CDKs) such as CDK1, CDK4, CDK5 and CDK7. CDKs are serine threonine kinases that play crucial roles in progression of the cell cycle from G1 to S phase. Overexpression of CDKs and other downstream signalling pathways that regulate cell cycles have been frequently found to be associated with development of resistance towards chemotherapies. In a phase I study, oral treatment with Milciclib was found to be well-tolerated and the drug showed promising clinical responses in patients with advanced solid malignancies such as in thymic carcinoma, pancreatic carcinoma and colon cancer.

About Sorafenib

Sorafenib (co-developed and co-marketed by Bayer and Onyx Pharmaceuticals as Nexavar) is a small molecular multi tyrosine kinase inhibitor drug approved for the treatment of primary kidney cancer (advanced renal cell carcinoma), advanced primary liver cancer (HCC), and radioactive iodine resistant advanced thyroid carcinoma. Treatment with sorafenib induces autophagy, which may suppress tumor growth. However, autophagy can also cause drug resistance.