FDA Grants Orphan Drug Designation to Omeros' OMS721 for Complement-Mediated Thrombotic Microangiopathies

-- Phase 2 Program Expected to Begin Next Quarter --

Omeros Corporation (OMER) today announced that OMS721, the company's lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (MASP-2), the key regulator of the lectin pathway of the immune system, has received orphan drug designation from the U.S. Food and Drug Administration (FDA) for prevention of complement-mediated thrombotic microangiopathies (TMAs).

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BioLineRx Announces Promising Initial Phase 2 Results of Acute Myeloid Leukemia Treatment

- Initial results for BL-8040 show substantial mobilization of cancer cells and signs of robust cancer cell death (apoptosis) -

BioLineRx (NASDAQ: BLRX; TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, announced today promising initial results for its BL-8040 drug candidate in a Phase 2 clinical trial for patients with relapsed or refractory acute myeloid leukemia (AML). The early results show that BL-8040, as a stand-alone therapy and in combination with high-dose Cytarabine (Ara-C), is safe at all doses tested to date, and triggers substantial mobilization of cancer cells from the bone marrow to the peripheral blood, thereby increasing the vulnerability of the cells to chemotherapy treatment.

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Positive Phase 2 Results from Agenus’ Brain Cancer Vaccine Published in Neuro-Oncology

    Results Show Improved Survival Against Aggressive Brain Cancer; More Than 90% of Patients Alive After Six Months

Agenus Inc. (AGEN), a biotechnology company developing novel immune system activating treatments for cancers and infectious diseases, today announced results published from a Phase 2 study demonstrated that more than 90% of the patients treated with Prophage Series G-200 were alive at six months after surgery and 30% were alive at twelve months. Additionally, the median overall survival was approximately eleven months. This compares favorably to the expected median survival for recurrent Glioblastoma multiforme (GBM) patients of three to nine months1-7. The primary objective of this multi-center, single arm Phase 2 trial was to assess the survival rate at six months.

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Endo to Acquire Specialty Pharmaceutical Company NuPathe

  • Accretive transaction furthers Endo's transformation into leading specialty healthcare company
  • Builds on Endo's leadership in pain management through addition of ZECUITY® (sumatriptan iontophoretic transdermal system), the first and only FDA approved patch to treat migraine
  • Proven Endo branded pharmaceuticals commercial team to execute ZECUITY launch, expected in first half 2014

Endo Health Solutions (ENDP) today announced it has entered into a definitive agreement under which Endo will acquire NuPathe Inc. (PATH) for $2.85 per share in cash, or approximately $105 million. 

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Celsion Corporation Announces Combined Clinical Data from Two Phase I Trials at the 2013 San Antonio Breast Cancer Conference

Combined Safety and Efficacy Results with ThermoDox® plus Hyperthermia for Recurrent Breast Cancer at the Chest Wall

Celsion Corporation (CLSN), an oncology drug development company, today announced the presentation of the combined clinical study results from the Company's Phase I DIGNITY study and the Duke University sponsored Phase I trial of ThermoDox® plus hyperthermia in Breast Cancer Recurrences at the Chest Wall (BCRCW) at the 2013 San Antonio Breast Cancer Conference during Poster Session #4 on Friday, December 13, 2013 between 7:30 am to 9:00 am (local time).

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