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Source: http://www.prnewswire.com/
SAN DIEGO, Jan. 5, 2017 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported topline results from the combined analysis of Stages 1 and 2 and Stage 2 alone of its HALO 202 study, a Phase 2 randomized, multi-center clinical trial of lead investigational drug PEGPH20 in combination with ABRAXANE® (nab-paclitaxel) and gemcitabine in stage IV pancreas cancer patients.

Among the findings, the overall study population showed a statistically significant increase in progression-free survival (PFS) in patients with high levels of hyaluronan (HA-High) treated with PEGPH20 plus ABRAXANE and gemcitabine when compared to HA-High patients receiving ABRAXANE and gemcitabine alone. Stage 2 of the study, which completed enrollment in February 2016, showed a 91 percent improvement in median PFS for HA-High patients in the PEGPH20 arm, 8.6 months compared to 4.5 months in the control arm, and achieved its primary endpoint to evaluate and demonstrate a reduction in the rate of thromboembolic events in the PEGPH20 arm.

"These findings confirm our confidence in the development of PEGPH20 in this difficult to treat cancer," said Dr. Helen Torley, president and CEO. "We are pleased by the overall consistency of both the efficacy and safety data which are supportive of our ongoing Phase 3 clinical trial, HALO 301, currently underway at more than 160 sites worldwide."

Read more: http://www.prnewswire.com/news-releases/halozyme-announces-phase-2-study-in-advanced-pancreas-cancer-meets-key-endpoints-300386090.html

Source: https://globenewswire.com/

SAN RAMON, Calif., Jan. 05, 2017 (GLOBE NEWSWIRE) -- Galena Biopharma, Inc. (NASDAQ:GALE), a biopharmaceutical company committed to the development and commercialization of hematology and oncology therapeutics that address unmet medical needs, today provided a corporate and clinical outlook for 2017 and announced that Mark W. Schwartz, Ph.D., President and Chief Executive Officer will give a company presentation at the Biotech Showcase 2017. The presentation will take place on Wednesday, January 11, 2017 at 10:30 a.m. PT at the Hilton San Francisco Union Square. The presentation will be webcast and available on the Investors section of the Company's website at http://investors.galenabiopharma.com/events.cfm.

“2017 looks to be promising for Galena Biopharma as we prepare to initiate our Phase 3 clinical trial in patients with essential thrombocythemia (ET) with GALE-401, our controlled release version of anagrelide,” said Mark W. Schwartz, Ph.D., President and Chief Executive Officer. “After a productive meeting with the U.S. Food and Drug Administration (FDA) last month, we were pleased to confirm that the GALE-401 development program is appropriate for a New Drug Application (NDA) filing using the 505(b)(2) regulatory pathway in patients who are intolerant to or failed to achieve an optimal response with hydroxyurea. In the U.S., ET has a prevalence of approximately 150,000 people and we estimate up to 25% of those patients who receive initial treatment with hydroxyurea may be candidates for the GALE-401 trial. We expect to finalize the details of the Phase 3 clinical trial protocol including the trial size, endpoints, and dosing this quarter and initiate the trial in the second quarter of 2017.”

Read more: https://globenewswire.com/news-release/2017/01/05/903607/0/en/Galena-Biopharma-to-Provide-Corporate-and-Clinical-Update-and-2017-Outlook-During-Presentation-at-Biotech-Showcase-2017.html

Source: http://www.businesswire.com/
CHARLESTON, S.C.--(BUSINESS WIRE)--Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”) today announced that the confirmatory Phase 3 clinical trial of Macrilen™ (macimorelin) failed to achieve its objective of validating a single oral dose of macimorelin for the evaluation of growth hormone deficiency in adults (“AGHD”), using the insulin tolerance test (the “ITT”) as a comparator. The Company is evaluating the outcome of the trial and will determine in the near future whether it will continue with the development of Macrilen™.

Dr. Richard Sachse, the Company’s Chief Scientific Officer, stated, “We are, of course, very disappointed about the outcome of the trial. Based on an analysis of top-line data, macimorelin did not achieve equivalence to the ITT as a means of diagnosing AGHD. Under the study protocol, the evaluation of AGHD with Macrilen™ would be considered successful, if the lower bound of the two-sided 95% confidence interval for the primary efficacy variables was 75% or higher for “percent negative agreement” with the ITT, and 70% or higher for the “percent positive agreement” with the ITT. While the estimated percent negative agreement met the success criteria, the estimated percent positive agreement did not reach the criteria for a successful outcome. Therefore, the results did not meet the pre-defined equivalence criteria which required success for both the percent negative agreement and the percent positive agreement. After a thorough internal review and understanding of this data, the Company will decide upon the appropriate future course of action with respect to macimorelin.”

Read more: http://www.businesswire.com/news/home/20170104006480/en/Aeterna-Zentaris-Announces-Top-Line-Results-Confirmatory-Phase

Source: http://www.b3cnewswire.com/
Geneva, Switzerland, January 05, 2017 / B3C newswire / -- Xigen, a Swiss Company developing therapeutic peptides for the treatment of inflammatory diseases announces today the online publication of successful Phase II results for its lead compound Brimapitide (XG-102) in the American Journal of Ophthalmology.

Xigen’s innovative technology platform enables the design and synthesis of long-acting therapeutic peptides with a very high metabolic stability. The peptides, including the lead compound Brimapitide (XG-102), are designed to allow the efficient delivery of the active element to intracellular targets. In the case of Brimapitide this means the ability to selectively reach and inhibit c-Jun N-Terminal Kinase. Ophthalmology was chosen as a gateway to the treatment of more complex inflammatory diseases.

The phase II study of 145 patients was designed as a controlled, multi-center, randomized, double-blind, parallel-group study to assess the efficacy and safety of a single sub-conjunctival injection of Brimapitide (XG-102) in comparison with repeated administration of dexamethasone eye drops in post-surgical intraocular inflammation. The study took place in France in six referral centers in the field of Ophthalmology in Paris, Grenoble, Dijon, Nancy, and Lyon. The overall development of Xigen’s lead product was carried out by Solid Drug Development SA, a specialized firm based in Geneva.

Read more: http://www.b3cnewswire.com/201701051515/xigens-brimapitide-an-innovative-jnk-inhibitor-delivers-positive-phase-ii-results-in-inflammatory-eye-disease.html

Source: http://www.businesswire.com/
WATERTOWN, Mass.--(BUSINESS WIRE)--Tarveda Therapeutics, Inc., a biopharmaceutical company discovering and developing Pentarins™ as a new class of potent and selective anti-cancer medicines, today announced that a Phase 1/2a clinical trial evaluating PEN-221 in patients with advanced neuroendocrine tumors and small cell lung cancer expressing the somatostatin receptor 2 (SSTR2) is underway, with patients enrolled and treated. The somatostatin receptor is highly expressed in neuroendocrine cancers. PEN-221 is a novel, miniaturized drug conjugate designed to selectively target SSTR2 and then internalize and release its potent DM1 payload in the tumor cell.

“Pentarins are engineered to rapidly penetrate and kill solid tumors that have proven challenging for treatment modalities such as antibody drug conjugates and chemotherapeutics,” said Gordon B. Mills, M.D., Ph.D., Professor and Chair, Department of Systems Biology, at The University of Texas MD Anderson Cancer Center, Houston, TX. “The miniaturized size, unique design and potent payloads of Pentarins allow for sustained payload release in solid tumors to drive potential efficacy while sparing normal tissue.

Read more: http://www.businesswire.com/news/home/20170104005507/en/Tarveda-Therapeutics-Announces-Phase-12a-Clinical-Trial

Source: https://www.astrazeneca.com/
AstraZeneca and Eli Lilly and Company today announced a worldwide agreement to co-develop MEDI1814, an antibody selective for amyloid-beta 42 (Aβ42), which is currently in Phase I trials as a potential disease-modifying treatment for Alzheimer’s disease (AD). This agreement builds on the existing collaboration related to AZD3293, a BACE inhibitor in two pivotal Phase III trials.

The build-up of plaques in the brain containing the peptide amyloid-beta (Aβ) is one of the characteristics of AD. MEDI1814 binds selectively to Aβ42, a form of Aβ which is particularly associated with the disease. MEDI1814 dose-dependently reduces levels of this peptide, potentially slowing the progression of AD.

Mene Pangalos, Executive Vice President, IMED Biotech Unit and Business Development, AstraZeneca, said: “We are excited to build on an already productive collaboration with Lilly, which combines the expertise of our two companies, with a new programme focused on the amyloid beta pathway. MEDI1814 has a unique mechanism among antibodies in clinical development and could provide a distinct approach to treating Alzheimer’s disease.”

Read more: https://www.astrazeneca.com/media-centre/press-releases/2016/Astrazeneca-and-Lilly-to-develop-second-potentially-disease-modifying-treatment-for-alzheimers-disease-09122016.html

Source: OPKO Health Inc. & reported by https://globenewswire.com/
MIAMI, Dec. 30, 2016 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) announced it has commenced data analysis in the phase 3, double-blind, placebo-controlled study of its investigational long-acting human growth hormone product (hGH-CTP) in adults with growth hormone deficiency (GHD). The multinational, multi-center study, which utilized a 2:1 randomization between hGH-CTP and placebo, enrolled 203 subjects, 198 of whom received at least one dose of study treatment. Treatment was administered through a weekly injection.

On the primary endpoint of change in trunk fat mass from baseline to 26 weeks, there was no statistical difference between hGH-CTP and placebo. However, after unblinding the study, OPKO identified one or more outliers that may have affected the primary outcome. As a result, OPKO is undertaking further review of the study population as promptly as possible. The safety profile observed in this study was consistent with that known for growth hormone treatments. A greater percentage of subjects on hGH-CTP normalized serum concentrations of insulin-like growth factor-I compared to placebo. Additional efficacy and safety data and analyses from the study will be released once available.

Read more: https://globenewswire.com/news-release/2016/12/30/902328/0/en/OPKO-Health-Provides-Update-on-hGH-CTP-Clinical-Programs.html