|Gilead Reports Updated Phase 2 Results for Investigational GS-9973; PV-10 Data Presented at the ASCO Annual Meeting|
|By Staff and Wire Reports|
|Tuesday, 03 June 2014 19:38|
Gilead Sciences, Inc. (NASDAQ: GILD) announced updated interim results of a Phase 2 study (Study 102) evaluating GS-9973, its investigational oral inhibitor of spleen tyrosine kinase (Syk), for the treatment of patients with relapsed chronic lymphocytic leukemia (CLL). In this study, single-agent treatment with GS-9973 achieved an overall response rate of 49 percent, with an estimated progression-free survival (PFS) rate at 24 weeks of 70 percent. Detailed results will be presented today during an oral session at the 50th Annual Meeting of the American Society of Clinical Oncology (ASCO) in Chicago (Abstract #7007).
“Most CLL patients eventually relapse following treatment, underscoring the need for novel therapies targeting survival pathways that may enable patients to obtain control of their disease without requiring chemotherapy,” said Jeff Sharman, MD, lead study author and Medical Director of Hematology Research for the US Oncology Network. “The strong response rates and acceptable safety profile seen in this study suggest that GS-9973 has the potential to provide therapeutic benefit for relapsed CLL patients.”
The efficacy analysis focuses on a cohort of 41 CLL patients with a median exposure of 32 weeks (range 1-53) in Study 102. Among this cohort, the Kaplan-Meier estimated PFS rate at 24 weeks was 70 percent (95 percent CI: 51-83 percent). Median PFS and median duration of response were not reached. At the time of data snapshot, 46 percent of patients (n=19) continued GS-9973 treatment. There was a 49 percent (n=20) overall response rate, of which all were partial responses. Ninety-five percent of evaluable patients (n=37/39) experienced tumor shrinkage, including all 25 patients with a chromosome 17p deletion and/or a mutation in the TP53 gene or other genetic abnormalities that have been linked to poor prognosis. Sixty-two percent of evaluable patients (n=24) achieved at least a 50 percent tumor reduction.
The safety of GS-9973 was also assessed in a larger population of 145 CLL or non-Hodgkin lymphoma (NHL) patients with an overall median exposure of 13 weeks at the time of data snapshot. Non-hematologic Grade ≥3 adverse events included fatigue (6.9 percent); dyspnea (6.2 percent); pneumonia (4.1 percent); nausea (3.4 percent); atrial fibrillation, chest pain, dehydration, febrile neutropenia and hypoxia (2.8 percent each); and back pain, hypotension, pyrexia and sepsis (2.1 percent each). Reversible Grade ≥3 transaminase elevations (a measure of liver function) were reported in 14 percent of patients.
Based on these data, Gilead plans to initiate new CLL study cohorts to include patients who have relapsed following treatment with other inhibitors of the b-cell receptor (BCR) pathway.
Provectus Biopharmaceuticals, Inc. (NYSE MKT: PVCT), a development-stage oncology and dermatology biopharmaceutical company, announced today that data on its investigational agent PV-10 for intralesional (IL) treatment of solid tumors were featured in two presentations in the Poster Highlights Session, Melanoma/Skin Cancers, on June 2, 2014 during the American Society of Clinical Oncology (ASCO) annual meeting in Chicago, IL.
The first highlighted abstract, presented by Sanjiv S. Agarwala, MD, of the St. Luke's Cancer Center, Bethlehem, PA, entitled "Efficacy of intralesional rose bengal in patients receiving injection in all existing melanoma in phase II study PV-10-MM-02" (abstract 9027), may be viewed at: http://abstracts.asco.org/144/AbstView_144_132320.html.
The second highlighted abstract, presented by Amod A. Sarnaik, MD, of Moffitt Cancer Center, Tampa, FL, entitled "Assessment of immune and clinical efficacy after intralesional PV-10 in injected and uninjected metastatic melanoma lesions" (abstract 9028), may be viewed at: http://abstracts.asco.org/144/AbstView_144_132288.html.
In the phase 2 PV-10 trial, when all existing lesions were injected with PV-10, tumors were no longer detectable (complete response) in 50% of the patients (Confidence Interval: 31-69%). This subgroup analysis supports the potential of PV-10 as a single agent and provides a rationale for a PV-10 phase 3 randomized controlled trial in locally advanced melanoma patients.
This phase 3 randomized controlled trial of PV-10 in patients with unresectable locally advanced cutaneous melanoma will assess response to PV-10 vs that of systemic chemotherapy in patients who have disease limited to cutaneous and subcutaneous sites and who have failed or are ineligible for systemic immunotherapy. Progression-free survival and complete response rate will be assessed using standard criteria (RECIST 1.1). Overall survival and exploratory assessment of patient reported outcomes related to lesion pain and other melanoma symptoms will also be assessed. The study is expected to commence this year, and will allow for interim assessment when 50% of the required events have occurred (i.e., disease progressions).
The Moffitt abstract provided interim results of a pilot clinical trial designed to investigate the local and immunologic effects of tumor ablation with PV-10. Lead author, Dr. Sarnaik, noted “In the peripheral blood of patients after PV-10 injection, we saw a significant increase in circulating T-cells, including CD3+ and cytotoxic CD8+ cells. This suggests an immunologic-mediated antitumor response is engendered by PV-10. We are hoping to undertake combination trials that combine PV-10 with the promising systemic immunotherapies being developed by our medical oncology colleagues.”
Eric Wachter, Ph.D., Chief Technology Officer of Provectus, observed that these results delineate two development paths to generate data sufficient for a new drug application (NDA) for PV-10 in melanoma.
Dr. Wachter concluded, “Our focus this year will be initiation of the phase 3 randomized controlled trial. We also expect to begin the more exploratory combinatorial work that potentially addresses the needs of patients with more advanced metastatic disease.”
Abiomed, Inc. (Nasdaq:ABMD), a leading provider of breakthrough heart support technologies, today reported that physicians have implanted more than 20,000 Impella® pumps in U.S. patients requiring hemodynamic support.
Align Technology, Inc. (NASDAQ: ALGN) today provided an update on the status of the final determination and cease and desist orders issued by the International Trade Commission (ITC) against the ClearCorrect entities (ClearCorrect Operating, LLC, based in Houston, Texas and ClearCorrect Pakistan (Private) Ltd., based in Lahore, Pakistan).
Ambit Biosciences (Nasdaq: AMBI), a biopharmaceutical company focused on discovery and development of drugs targeting unmet needs in oncology, autoimmune and inflammatory disease, today announced two poster presentations at the Annual Meeting of the American Society of Clinical Oncology, held May 30 through June 3, 2014, at McCormick Place in Chicago.
Cerulean Pharma Inc. (Nasdaq:CERU), a leader in Dynamic Tumor Targeting™, announced today that three abstracts on its lead candidate, CRLX101, were included in the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago from May 30 through June 3.
Cancer Genetics, Inc. (Nasdaq:CGIX) a DNA-based diagnostics company focused on developing genomic-based oncology tests and services, announced today that it has entered into a multi-year agreement to collaborate and provide PathAdvantage Associated with Cancer Genetics' proprietary FHACT®, a FISH-based genomic test for the detection and management of cervical cancer.
Cesca Therapeutics Inc. (Nasdaq:KOOL), an autologous cell-based regenerative medicine company, announced today it will present at the LD Microcap Conference on Wednesday, June 4, 2014 at the Luxe Sunset Boulevard Hotel in Los Angeles.
EDAP TMS SA (Nasdaq:EDAP), a global leader in therapeutic ultrasound, today announced the closing on June 2, 2014 of a $9.3 million registered direct offering of ordinary shares in the form of American Depositary Shares ("ADSs"), at a price of $3.11 per share, with no warrants.
Hemispherx Biopharma (NYSE MKT:HEB) announced that it has confirmed that one of its advanced stage biological products, Alferon® N, inhibits replication of the MERS virus in vitro.
Hyperion Therapeutics, Inc. (Nasdaq:HPTX) today announced that the validation period is complete for its New Drug Submission (NDS) to Health Canada for RAVICTI (glycerol phenylbutyrate) Oral Liquid for the treatment of urea cycle disorders (UCDs), and that the RAVICTI NDS was granted Priority Review.
Insulet Corporation (NASDAQ: PODD) today announced its intention to offer, subject to market and other conditions, $175 million principal amount of convertible senior notes due 2019 (the "notes") pursuant to an effective shelf registration statement filed with the Securities and Exchange Commission ("SEC") today.
Kelyniam Global Inc, (OTC: KLYG), a prominent manufacturer of custom cranial implants, today reported that the company generated net income of $71,205 in the first quarter of 2014.
MELA Sciences, Inc. (Nasdaq:MELA), developer of the MelaFind® system, an optical diagnostic device approved for use in the United States and the European Union to assist dermatologists in melanoma diagnosis, today announced that it has initiated a study to examine the real-world clinical impact of MelaFind on dermatologists' decision to biopsy pigmented skin lesions that are suspicious for melanoma. Darrell Rigel, MD, MS, Clinical Professor of Dermatology at New York University Langone Medical Center, will be the Principle Investigator for the study.
Myriad Genetics, Inc. (Nasdaq:MYGN) announced today that Peter D. Meldrum, president and CEO of Myriad, is scheduled to present at the 35th annual Goldman Sachs Global Healthcare Conference, at 10:40 a.m. Pacific on June 10, 2014, at the Terranea Resort in Rancho Palos Verdes, California.
NeoStem, Inc. (Nasdaq:NBS), a leader in the emerging cellular therapy industry, today announced that it has filed today with the U.S. Securities and Exchange Commission a prospectus supplement to its shelf registration statement enabling it to access its new equity facility with Aspire Capital Fund, LLC which replaced the prior agreement under which the Company received the full $20 million in equity funding.
The Netherlands--uniQure N.V. (Nasdaq:QURE), a leader in human gene therapy, today announced the full analysis of the six-year follow-up data for patients treated once with Glybera® (alipogene tiparvovec), uniQure's gene therapy product for the treatment of lipoprotein lipase deficiency (LPLD).
PuraMed BioScience®, Inc., (PMBS: OTCBB), a researcher, developer, and marketer of over-the-counter (OTC) medicinal and healthcare products, announced today that Patricia McMurtrie will hold the positions of COO, President, and Director, effective May 27, 2014.