|Xenobiotica Publishes Article on Provectus' PV-10; Amgen Announces Positive Top-Line Results From Phase 3 LAPLACE-2 Trial|
|By Staff and Wire Reports|
|Tuesday, 28 January 2014 19:14|
Provectus Biopharmaceuticals, Inc. (OTCQB:PVCT), a development-stage oncology and dermatology biopharmaceutical company, and XenoTech, a preclinical CRO and pioneer in collaborative research surrounding in vitro drug metabolism and pharmacokinetics (DMPK) services, announced an article describing a study to determine the potential of rose bengal disodium to cause drug-drug interactions has been published by Xenobiotica, a peer-reviewed scientific journal that publishes comprehensive research papers on pharmacokinetics (the study of distribution, metabolism, disposition and excretion of drugs). The published research indicated that the risk of PV-10 causing clinically relevant drug-drug interactions is likely minimal. PV-10, a 10% solution of rose bengal that is currently under clinical investigation as a novel cancer therapeutic, is designed to selectively target and destroy cancer cells without harming surrounding healthy tissue, minimizing the potential for systemic side effects.
The study was undertaken prior to initiation of the now ongoing testing of PV-10 plus sorafenib (cohort 2) in a clinical trial of PV-10 intralesional injection in hepatocellular carcinoma patients taking a stable dose of sorafenib (ClinicalTrials.gov Identifier: NCT00986661). Sorafenib is a competitive inhibitor of cytochrome P450 (CYP) drug metabolism enzymes and is reliant on the UDP-glucuronosyltransferase (UGT) pathway for efficient clearance. CYP and UGT enzymes help to biotransform small lipophilic drugs like sorafenib into water-soluble excretable metabolites.
Provectus researchers collaborated with XenoTech’s experts to design the appropriate in vitro experiments necessary to assess the risk for potential liability when rose bengal is co-administered with other drugs in humans. Rose bengal, known for inducing singlet oxygen on exposure to light, can cause erroneous results in conventional in vitro test systems. These assay artifacts were shown to be test system dependent in DMPK studies. XenoTech scientists successfully tailored experiments to ascertain CYP and UGT inhibition potential in more appropriate model systems.
The lead author, Faraz Kazmi, a Senior Scientist at XenoTech said, “The FDA guidance for industry on drug-drug interactions requires an in vitro assessment of the potential liability for a new drug to engender drug-drug interactions. These experiments are important because they provide the basis for safe, rational clinical trial design and are important determinants toward the ultimate goal, which is patient safety.”
Dr. Craig Dees, PhD, CEO of Provectus said, "We were thrilled to collaborate with XenoTech on these important studies that not only support the PV-10 plus sorafenib study, but also have implications for treating melanoma patients. Provectus has been fortunate to work with many CROs with innovative scientists, but Xenotech stands out for their focus on the unique scientific problem as demonstrated in their rapid, expert assay development, suitable for publication in a peer reviewed journal.” Dr. Dees continued, “As we discuss our clinical results with regulatory authorities, we continue to be intensely committed to building all sections of the prescribing information for a future package insert for PV-10.”
Jason Neat, COO of XenoTech said, “We are very pleased with the expertise shown by our scientists. Rose bengal presented a unique challenge, but we rose up to meet that challenge and showed what XenoTech as a company is all about. Our customers get rapid results, but they also receive the context to be assured that those results will be meaningful in their development programs.”
The paper, titled “In vitro inhibition of human liver cytochrome P450 (CYP) and UDP-glucuronosyltransferase (UGT) enzymes by rose bengal: system-dependent effects on inhibitory potential,” was authored by Faraz Kazmi, Lois J. Haupt, Jennifer R. Horkman, Brian D. Smith and David B. Buckley from XenoTech, Eric A. Wachter, and Jamie M. Singer of Provectus.
Amgen (NASDAQ: AMGN) announced the Phase 3 LAPLACE-2 (LDL-C Assessment with PCSK9 MonoclonaL Antibody Inhibition Combined with Statin ThErapy-2) trial evaluating evolocumab in combination with statin therapy in patients with high cholesterol met its co-primary endpoints: the percent reduction from baseline in low-density lipoprotein cholesterol (LDL-C) at week 12 and the mean percent reduction from baseline in LDL-C at weeks 10 and 12. The mean percent reductions in LDL-C, or "bad" cholesterol, were consistent with the published results observed for the same doses in the Phase 2 LAPLACE-TIMI 57 (LAPLACE-Thrombolysis In Myocardial Infarction-57) trial for evolocumab compared to placebo; and in the Phase 2 MENDEL (Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Patients Currently Not Receiving Drug Therapy For Easing Lipid Levels) study for evolocumab compared to ezetimibe.1-2
Evolocumab is an investigational fully human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9), a protein that reduces the liver's ability to remove LDL-C from the blood.3
The LAPLACE-2 trial evaluated safety, tolerability and efficacy of evolocumab in combination with statin therapy compared to placebo and ezetimibe in 1,896 patients with high cholesterol. Patients were randomized to one of 24 treatment groups to compare subcutaneous evolocumab (140 mg every two weeks or 420 mg monthly) with subcutaneous placebo (every two weeks or monthly) or ezetimibe (10 mg daily) when added to different daily doses of statin therapies.
Safety was balanced across treatment groups. No adverse events (AEs) occurred in ≥ 2 percent of the evolocumab combined group. The most common AEs in the evolocumab combined group were back pain, arthralgia, headache, muscle spasms and pain in extremity.
"As statins continue to be an important treatment option in patients with high cholesterol, we are very encouraged by the Phase 3 data from the LAPLACE-2 study," said Sean E. Harper, M.D., executive vice president of Research and Development at Amgen. "Adding evolocumab to statin therapy may help patients control their LDL cholesterol levels when high doses of statins are not sufficient."
Details of the Phase 3 LAPLACE-2 study results will be submitted to a future medical conference and for publication.
According to the Centers for Disease Control and Prevention, more than 71 million American adults have high LDL-C.4 Elevated LDL-C is recognized as a major risk factor for cardiovascular disease.5-6 A multinational survey of almost 10,000 patients with high cholesterol on statin therapy found approximately one-third of patients did not attain their LDL-C goal.7
Amgen (NASDAQ: AMGN) today announced financial results for the fourth quarter and full year of 2013.
BG Medicine, Inc. (Nasdaq:BGMD), the developer of the BGM Galectin-3® Test, welcomed today the publication of results of a clinical research study that demonstrate and validate the analytical and clinical performance of the automated VIDAS® Galectin-3 assay that was developed by bioMérieux SA, a world leader in the field of in vitro diagnostics and one of BG Medicine's automation partners.
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Dehaier Medical Systems Ltd. (Nasdaq:DHRM), an emerging leader in the development, assembly, marketing and sale of medical devices and homecare medical products in China, today announced that the Beijing Zhongguancun Enterprises Credit Promotion Association has awarded Dehaier an A- credit rating.
GeoVax Labs, Inc. (OTCQB: GOVX) announced today that its Chief Scientific Officer, Dr. Harriet Robinson, presented information on the selection of antigens and antigen combinations for the elicitation of protective antibody responses for HIV at the Phacilitate Vaccine Forum 2014 on January 27, 2014 in Washington, DC.
Healthcare Services Group, Inc.'s (Nasdaq:HCSG) Board of Directors has declared a quarterly cash dividend of $0.17125 per common share, payable on March 28, 2014 to shareholders of record at the close of business on February 21, 2014.
Hemispherx Biopharma (NYSE MKT:HEB) announced today that the ASM Biodefense Meeting is scheduled for January 27-29, 2014 at the Washington Marriott Wardman Park Hotel, Washington DC.
Idenix Pharmaceuticals, Inc. (Nasdaq:IDIX), a biopharmaceutical company engaged in the discovery and development of drugs for the treatment of human viral diseases, today announced that it has entered into a definitive agreement with certain entities managed by The Baupost Group, L.L.C. (Baupost) for the sale of 16,420,241 shares of its common stock.
Medical Marijuana, Inc. (OTC Pink:MJNA) is pleased to inform shareholders and the general public that its wholly owned subsidiary, Wellness Managed Services, has reached an agreement with MPS Security to launch a new company, MPS International (MPSI), as the nation's first security and armored transport service provider to the cannabis industry.
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that it has published details of its myVision™ Myriad Variant Classification Program in the journal Clinical Genetics.
National Research Corporation (Nasdaq:NRCIA) (Nasdaq:NRCIB) today announced that it will provide an online Web simulcast of its 2013 fourth quarter conference call on Wednesday, February 12, 2014.
NeoStem, Inc. (Nasdaq:NBS), a leader in the emerging cellular therapy industry, announced today the appointment of Dr. David Altarac as Vice President, Regulatory Affairs.
NovaBay® Pharmaceuticals, Inc. (NYSE MKT:NBY) In the latest issue of the journal Cell, scientists at the Hebrew University of Jerusalem's Faculty of Medicine showed that Streptococcus pyogenes, an ordinarily benign to mildly infectious bacteria, sometimes begins to produce bacterial toxins when it gets under the skin.
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) today provided updates on pivotal Phase 3 development activities for NX-1207, the Company's Phase 3 drug for benign prostatic hyperplasia (BPH), a common affliction of older men.
OraSure Technologies, Inc. (Nasdaq:OSUR) today announced that its 2014 Annual Meeting of Stockholders is scheduled to be held on Thursday, May 22, 2014.
Pegasus Pharmaceuticals (OTC Pink: PGUZ), MoldGuardian™ has been developed using "Quality by Design" approach to create a protective barrier on any surface to eliminate the ability of mold spores to penetrate the pores and for any spores existing on a surface to grow.
Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX), an oncology company focused on the development of innovative approaches to targeting and treating prostate cancer, will webcast a discussion of phase 2 data from two of its PSMA targeting late stage prostate cancer compounds.
PositiveID Corporation (OTCQB:PSID), a developer of biological detection and diagnostics solutions, today announced that its homeland security and medical diagnostics products, M-BAND and Firefly, are featured in Government Security News and Homeland Security Today.
Sharps Compliance Corp. (Nasdaq:SMED), a leading full-service provider of solutions for the cost-effective management of medical waste, used healthcare materials and unused dispensed medications, today reported financial results for the second quarter and first six months of fiscal year 2014 ended December 31, 2013.
Solos Endoscopy, Inc. (OTC Pink: SNDY), a provider of quality innovative healthcare instruments to hospitals across the country, is pleased to announce that the Company has received its ISO 13485:2003 Certification from TUV SUD America.
TESARO, Inc. (Nasdaq:TSRO) announced today that it has commenced an underwritten public offering of $100 million of its common stock.
Wellness Center USA, Inc. (OTCQB:WCUI), a Schaumburg IL based healthcare solutions provider, today announced the signing of an agreement to acquire National Pain Centers, Inc (NPC), a Nevada corporation based in Illinois that focuses on diagnosis, treatment, research, advocacy, education, and setting standards and protocols within interventional and multi-modal pain management.