Delcath Receives Approval To Expand Global Phase 2 HCC Program; Pfizer Phase 3 Study Of Inotuzumab Ozogamicin Meets Primary Endpoint Print E-mail
By Josh Gee   
Tuesday, 21 April 2015 18:43
Below is a look at some of the headlines for companies that made news in the healthcare sector on April 21, 2015.   
Delcath Systems, Inc. (NASDAQ: DCTH) announces approval of amendments to its Clinical Trial Authorizations (CTAs) filed with the U.K.'s Medicines and Healthcare Products Regulatory Agency (MHRA) and Germany's Federal Institute for Drugs and Medical Devices (BfArM) for the expansion of the Company's global Phase 2 program for the treatment of patients with unresectable hepatocellular carcinoma (primary liver cancer, or HCC), to include a cohort of patients with intrahepatic cholangiocarcinoma (ICC).
ICC is a tumor in the bile duct that arises within the liver. It is the second most common primary liver tumor and represents approximately 15% of new HCC cases diagnosed annually. Surgical resection, the standard of care, is not possible for an estimated 80% to 90% of patients diagnosed with ICC.
The ICC cohort of the Phase 2 trial will investigate the safety and efficacy of Melphalan/HDS treatment in patients with unresectable ICC confined to the liver. The study will be conducted at the same hospitals in Europe participating in the Company's Phase 2 HCC trial, and is expected to enroll 11 patients. The ICC cohort will evaluate tumor response (objective response rate) as measured by modified Response Evaluation Criteria in Solid Tumor (mRECIST), and will assess progression-free survival and safety. Additional analyses will be conducted to characterize the systemic exposure of melphalan administered by Melphalan/HDS, as well as to assess patient-reported clinical outcomes, or quality-of-life.
"We believe our Melphalan/HDS treatment may offer significant clinical benefit for ICC patients who face limited treatment options, and look forward to enrolling patients in this cohort beginning this quarter," said Jennifer Simpson, Ph.D., Interim President and CEO of Delcath Systems. "A positive efficacy signal may provide a regulatory path to a U.S. registration trial and consolidated safety data from the HCC and ICC cohorts of this global Phase 2 trial will offer valuable information for us to provide to the FDA."
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Pfizer (NYSE: PPE) announced the Phase 3 study investigating the treatment of inotuzumab ozogamicin met its first primary endpoint of demonstrating a higher complete hematologic remission rate in adult patients with relapsed or refractory CD22-positive acute lymphoblastic leukemia (ALL) compared to that achieved with standard of care chemotherapy.
The Phase 3 study has two primary endpoints, complete hematologic remission rate and overall survival. Pfizer is continuing the study to allow for the data on overall survival to mature.
"We are excited about the results of the INO-VATE ALL study especially since relapsed and refractory acute lymphoblastic leukemia is a particularly difficult disease to treat in adults. The top-line results show that inotuzumab ozogamicin has the potential to be an important new treatment option for patients with relapsed or refractory disease," said Dr. Mace Rothenberg, senior vice president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. "We look forward to discussing these data with the FDA and other regulatory authorities."
No new or unexpected safety issues were identified. Efficacy and safety data from this study will be submitted for presentation at an upcoming medical meeting.
Also Tuesday:  
 
Advaxis, Inc. (Nasdaq:ADXS), a cancer immunotherapy company, today announced the data of one clinical and two preclinical studies highlighting the survival outcomes and anti-tumor effects of its proprietary Lm-LLO cancer immunotherapy technology at the American Association for Cancer Research (AACR) Annual Meeting 2015, held April 18 – 22 in Philadelphia, Pennsylvania. 
Argos Therapeutics Inc. (Nasdaq:ARGS), a biopharmaceutical company focused on the development and commercialization of fully personalized immunotherapies for the treatment of cancer based on the Arcelis® technology platform, today announced that data from a Phase 2 clinical trial of AGS-003, the company's lead product candidate for the treatment of metastatic renal cell carcinoma (mRCC), have been published in the Journal for ImmunoTherapy of Cancer. 
Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company primarily focused on the development of therapeutics for cancer and other life threatening diseases, today announced data from three posters supporting the ongoing clinical development program for lead compound onapristone at the American Association for Cancer Research (AACR) Annual Meeting 2015, being held April 18-22 in Philadelphia, Pa.
Avant Diagnostics, Inc. (OTCBB:AVDX), a diagnostic company with a primary focus on the commercialization of a proprietary microarray-based diagnostic test for the early detection of ovarian cancer called OvaDx® is pleased to announce that it has retained the professional legal services of Sichenzia Ross Freidman Ference LLP ("SRFF") as the Company's general corporate counsel.
ERBA Diagnostics, Inc. (NYSE MKT:ERB), a fully integrated in vitro diagnostics company, announced today that, on April 17, 2015, the Company received a letter from NYSE MKT LLC (the "Exchange") stating that the Exchange has determined that the Company is not in compliance with Sections 134 and 1101 of the Exchange's Company Guide (the "Company Guide") due to the Company's failure to timely file its Annual Report on Form 10-K for the year ended December 31, 2014 with the Securities and Exchange Commission (the "SEC"). 
GeneThera Inc. (OTC:GTHR) announced today that has appointed Bruce Winsett and Jorgen Frandsen as members of the Company's Board of Directors
Harvard Bioscience, Inc. (Nasdaq:HBIO), a global developer, manufacturer and marketer of a broad range of solutions to advance life science, will announce results for its first quarter 2015 before market trading hours on Thursday, April 30, 2015. 
Health Insurance Innovations, Inc. (Nasdaq:HIIQ), a leading developer of affordable health plans, released the results of a nationwide poll that surveyed Americans' awareness that health insurance may no longer be purchased on exchanges for 2015 without special qualifications. 
ICU Medical, Inc., (Nasdaq:ICUI), a leader in the development, manufacture and sale of innovative medical devices used in infusion therapy, oncology and critical care applications, today announced the time of its first quarter 2015 earnings release conference call.
iKang Healthcare Group, Inc. (Nasdaq:KANG), China's largest private preventive healthcare services provider, today announced that it will attend the 6th Annual dbAccess Asia Conference to be held on May 18 to May 22, 2015 at the Marina Bay Sands in Singapore.
Kite Pharma, Inc. (Kite) (Nasdaq:KITE), a clinical-stage biopharmaceutical company focused on developing engineered autologous T cell therapy (eACT™) products for the treatment of cancer, today announced that Owen Witte, M.D., director of the Eli & Edythe Broad Center of Regenerative Medicine & Stem Cell Research at UCLA, is being honored at this year's AACR conference as he receives the prestigious G.H.A. Clowes Memorial Award. 
Loxo Oncology, Inc. (Nasdaq:LOXO), a biopharmaceutical company focused on the discovery, development, and commercialization of targeted cancer therapies, today announced the presentation of initial Phase 1a safety and pharmacokinetic data for LOXO-101, the only selective inhibitor of the TRK family of tyrosine kinase receptors in clinical development, in a poster session at the American Association for Cancer Research (AACR) 2015 Annual Meeting in Philadelphia, PA. 
Macrocure Ltd. (Nasdaq:MCUR), a clinical-stage biotechnology company focused on developing a novel therapeutic platform to address chronic and hard-to-heal wounds, will announce financial results for the first quarter ended March 31, 2015 after the close of the U.S. financial markets on Monday, May 11, 2015. 
MedAssets (Nasdaq:MDAS) today announced that Simone Joye, Executive Director of Young People Matter, a 501(c)3 not-for-profit organization based out of Atlanta, Ga., was named the 2014 Norman Borlaug Humanitarian Award recipient during its annual Healthcare Business Summit. 
MediciNova, Inc., (Nasdaq:MNOV) and the JASDAQ Market of the Tokyo Stock Exchange (Code Number: 4875), announced that Dr. Benjamin Rix Brooks, principal investigator, presented interim safety data from the ongoing clinical trial of MN-166 (ibudilast) in amyotrophic lateral sclerosis (ALS) today at the American Academy of Neurology (AAN) 67th Annual Meeting in Washington, DC. 
Merge Healthcare Incorporated (Nasdaq:MRGE), a leading provider of innovative enterprise imaging, interoperability, and clinical systems that seek to advance healthcare, announced today the scheduling of its first quarter 2015 earnings call, which will be held at 8:30 AM ET on Tuesday, April 28, 2015.
Natural Health Trends Corp. (Nasdaq:NHTC), a leading direct selling company that markets premium quality personal care, wellness and "quality of life" products under the NHT Global brand, today announced that management will conduct a conference call to discuss its financial results for the quarter ended March 31, 2015.
OncoMed Pharmaceuticals, Inc. (Nasdaq:OMED), a clinical-stage company developing novel therapeutics that target cancer stem cells (CSCs), or tumor-initiating cells, today announced data from seven poster presentations at the American Association of Cancer Research (AACR) Annual Meeting.
OncoMed Pharmaceuticals Inc. (Nasdaq:OMED) will present new data related to its clinical and preclinical anti-cancer stem cell and immuno-oncology candidates at the upcoming American Society of Clinical Oncology (ASCO) 2015 Annual Meeting.
Onconova Therapeutics, Inc. (Nasdaq:ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, today announced the highlighting of data from its lead and other proprietary compounds at the 2015 AACR Annual Meeting being held April 18-22, 2015 at the Pennsylvania Convention Center in Philadelphia, PA.
Pain Therapeutics, Inc. (Nasdaq:PTIE) today reported it had recently resumed responsibility for REMOXY® under the terms of a letter agreement with Pfizer. 
Pazoo, Inc. (OTC Pinks:PZOO) (German WKN#: A1J3DK) Pazoo's partner, MA & Associates, LLC, is very excited to announce that it has joined the inaugural Nevada Cannabis Laboratory Association (NVCLA). 
Perseon Corporation (Nasdaq:PRSN), a leading provider of medical systems that utilize energy to treat cancer, today announced its participation as a presenter last week at STM 2015: The 32nd Annual Meeting of the Society for Thermal Medicine, held in Orlando, Florida.
Rexahn Pharmaceuticals, Inc. (NYSE MKT:RNN), a clinical stage biopharmaceutical company developing best-in-class therapeutics for the treatment of cancer, today announced that it presented preclinical data on Supinoxin™ (RX-5902) at the 2015 American Association for Cancer Research (AACR) Annual Meeting in Philadelphia.
TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG), a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics in oncology and infectious diseases, today announced that research describing birinapant's preclinical activity in a mouse model of chronic human hepatitis B virus (HBV) has been published in the journal Proceedings of the National Academy of Sciences.
Xenetic Biosciences, Inc. (OTCBB:XBIO), a biopharmaceutical company focused on developing next-generation biologic drugs and novel oncology therapeutics, announces the resignation of Chairman Mark Leuchtenberger.



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