Verastem Reports Data from Phase 1 Study of VS-6063 (defactinib) in Japanese Patients; New Published Paper Shows Efficacy of Lpath's Lpathomab Print E-mail
By Staff and Wire Reports   
Wednesday, 05 March 2014 21:32

Below is a look at some of the headlines for companies that made news in the healthcare sector on March 5, 2014. Verastem, Inc. (NASDAQ: VSTM), focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, today presented preliminary data from an ongoing First-in-Asia Phase 1 trial of VS-6063 in Japanese patients with advanced solid tumors, including one patient with mesothelioma. The Phase 1 study assessed the safety and pharmacokinetics of single agent VS-6063.

“We are encouraged that the safety and pharmacokinetic profile observed in Japanese patients in this Phase 1 study is consistent with that seen in the US Phase 1 study,” said Dr. Joanna Horobin, Verastem Chief Medical Officer. “With these data in hand, we are speaking with the Japanese regulatory authorities about the potential for opening COMMAND trial sites in Japan later this year.”

Verastem's ongoing COMMAND trial is a randomized, double-blind, placebo controlled registration-directed study which is evaluating VS-6063 in patients with mesothelioma and is currently accruing patients in 8 countries.

The Japanese Phase 1 is an open-label, dose-escalation study that enrolled nine subjects who received single-agent VS-6063 (200, 400 or 600mg; n=3 in each dose cohort) BID. The study results demonstrated that VS-6063 was well tolerated at all dose levels. There were no serious adverse events or evidence of dose-limiting toxicity. Pharmacokinetic results from the recommended Phase 2 dose of 400mg BID were consistent with previously reported data in non-Japanese subjects. These safety and pharmacokinetic results support advancing the VS-6063 development program in Japanese patients.

“We have now completed full enrollment and VS-6063 was well tolerated at each dose level,” said Toshio Shimizu, M.D., Ph.D., Assistant Professor, Phase 1 Clinical Trials Program, Department of Medical Oncology, Kinki University Faculty of Medicine and Principal Investigator of the study. “The study was open to patients with all solid tumors and one of the patients has mesothelioma. This patient is enrolled in the 400mg BID dose cohort and is responding well to treatment, continues on trial and is currently in cycle 7 of treatment. At this point their disease remains stable and we have seen an improvement in clinical symptoms. These data are encouraging and we hope to continue development of VS-6063 in Japan in parallel with the United States and Europe.”


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Lpath, Inc. (NASDAQ: LPTN), the industry leader in bioactive lipid-targeted therapeutics, has brought scientists one step closer to finding a potential treatment for traumatic brain injury (TBI) with a recent publication showing that Lpathomab™, a therapeutic antibody, reverses much of the damage caused by trauma to the nervous system.

As published by the Journal of Neuroinflammation (vol. 11, article 37), Lpathomab can be used to reduce the size of a TBI and to improve functional behavioral outcomes in experimental animal models. The antibody works as a molecular sponge by soaking up lysophosphatidic acid (LPA), a molecule that can damage neurons and promote dangerous inflammatory responses in the central nervous system.

In collaboration with scientists at the University of Melbourne, the antibody was tested in mice that had TBIs. A key finding of the study was the significant efficacy of administering Lpathomab after an injury, thus demonstrating a potential therapeutic benefit. Also shown for the first time in this groundbreaking paper was that human patients with TBI exhibited substantial increases in the levels of LPA in the cerebrospinal fluid (CSF) after injury, a finding also seen in the injured mouse model of TBI; such data suggest that LPA is a valid target for therapeutic intervention.

Lpath and its Melbourne collaborators have recently shown that Lpathomab provides protection against neuronal cell death and scarring in experimental models of spinal cord injury (SCI), published recently in the American Journal of Pathology (Goldschmit et al., vol. 181, p. 978-992). Currently, there are no FDA-approved drugs for the treatment of neurotrauma such as TBI and SCI.

"This research provides new hope for therapeutic treatments for many forms of neurotrauma, including TBI and SCI as well as other forms of neurodegenerative disorders," said Roger Sabbadini, Ph.D., vice president and founder of Lpath and co-author on the paper. "We believe that LPA may be a biomarker that could be used to aid in the diagnosis of TBI, as the 'LPA pulse' that occurs in the injured brain can also be detected in blood."

The research team was comprised of Lpath scientists and collaborators from the University of Melbourne, Monash University and the University of Kentucky.

As a promoter of tumorigenesis, metastasis and fibrotic disease, LPA is a well-validated drug target and has been shown to play a significant role in neuropathic pain and now neurotrauma. The role of LPA in the nervous system has been described in a recent review published in the International Review of Cellular and Molecular Biology (Frisca et al., vol. 296, p. 273-322).

Lpathomab is currently in IND-enabling studies for neuropathic pain and neurotrauma.

Lpathomab was generated using Lpath's proprietary ImmuneY2™ technology, a drug-discovery engine that provides Lpath with a platform to generate antibodies against bioactive lipids, opening up a new array of drug-discovery possibilities. About 1,000 bioactive members of the lipidome are believed to exist, but the number could be considerably larger as the study of lipidomics continues to expand. Nature Reviews stated that bioactive lipids promise to occupy center-stage in cell biology research in the twenty-first century.

Lpath utilized ImmuneY2 to discover an antibody against another bioactive lipid, sphingosine-1-phosphate (S1P). This antibody, sonepcizumab, is formulated as iSONEP™ for ocular delivery and as ASONEP™ for systemic delivery. In addition, the ImmuneY2 platform was used to generate Altepan™, an antibody against key leukotrienes that have been implicated in various respiratory diseases, including asthma.



Also Wednesday:



Arno Therapeutics, Inc. (OTCQB:ARNI)
, a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, today announced that Chief Executive Officer Glenn Mattes is scheduled to present at the 26th Annual ROTH Conference, being held March 9-12, 2014 at the Ritz-Carlton, Laguna Niguel in Dana Point, CA.

Authentidate Holding Corp. (Nasdaq:ADAT)
, a provider of secure web-based software applications and telehealth products and services for healthcare organizations, today announced that Authentidate was rated one of the top 10 telehealth vendors worldwide in the recently published IHS World Market for Telehealth 2014 Edition study.

Biocept, Inc. (Nasdaq:BIOC)
, an oncology diagnostics company focused on improving individual patient treatment, announced today that the Company's President and Chief Executive Officer, Michael Nall will be presenting at the 26th Annual ROTH Conference, being held March 10-12, 2014 at the Ritz-Carlton in Dana Point, California.

BioMarin Pharmaceutical Inc. (Nasdaq:BMRN)
announced today the pricing on March 4, 2014 of an underwritten public offering of 1,500,000 shares of its common stock.

Caliber Imaging & Diagnostics (OTCQB:LCDX)
, formerly Lucid, Inc., has named Robert T. Kelley to Vice President of U.S. Sales, effective immediately.

Cancer Genetics, Inc. (Nasdaq:CGIX)
announced today the results of a collaborative study conducted with The Cleveland Clinic to validate CGI's kidney cancer microarray test.

Celladon Corporation (Nasdaq:CLDN),
a clinical-stage biotechnology company focused on developing novel therapies by applying its leadership position in the field of SERCA enzymes, today announced that Krisztina Zsebo, Ph.D., President and Chief Executive Officer, will present a corporate overview at the Barclays Global Healthcare Conference on Wednesday, March 12 at 2:00 p.m. Eastern Time.

CollabRx, Inc. (Nasdaq:CLRX)
today announced the appointment of Clifford Baron, PhD as Vice President and Chief Operating Officer.

Elite Pharmaceuticals, Inc. (OTCBB:ELTP)
announced today successful results from a pivotal bioequivalence study initiated in January 2014 for Elite's undisclosed abuse deterrent opioid product, ELI-200.

Karyopharm Therapeutics Inc. (Nasdaq:KPTI),
a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases, reported financial results for the year ended December 31, 2013, and also provided an update on its clinical development plans.

Lexaria Corp. (OTCQB:LXRP) (CSE:LXX)
reports that its board of directors has decided to make a strategic entry into the medical marihuana business by way of an important Joint Venture with Enertopia Corp. (CSE:TOP) (OTCQB:ENRT)

Lipocine Inc. (OTCQB:LPCN)
, a specialty pharmaceutical company, today announced Mahesh Patel, President and CEO, and Morgan Brown, Executive Vice President and CFO, will present a company overview at the 26th Annual ROTH Conference on Wednesday, March 12, 2014 at 1:00 p.m. ET.

Medgenics, Inc. (NYSE:MDGN) (AIM:MEDU) (AIM:MEDG)
, the developer of BioPump™, a novel platform technology for the sustained production and delivery of therapeutic proteins in patients using ex-vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced that Michael Cola, President and CEO, will present a corporate overview at the 26th Annual ROTH Capital Growth Conference in Laguna Niguel on Tuesday, March 11, 2014 at 8:00am PDT.

Prosensa Holding N.V. (NASDAQ: RNA)
today announced that the Company will host a conference call and live audio webcast on Tuesday, March 18, 2014 8:00am Eastern Time (1:00pm Central European Time) to report its full year 2013 financial results and provide a corporate update.

Reliv International, Inc. (Nasdaq:RELV)
, a maker of nutritional supplements that promote optimal health, today reported its financial results for the fourth quarter and full year of 2013.

Revance Therapeutics, Inc. (Nasdaq:RVNC)
, a specialty biopharmaceutical company which develops botulinum toxin products for use in aesthetic and therapeutic indications, today announced that Angus C. Russell has been appointed as Chairman to its Board of Directors, effective immediately.

Rockwell Medical, Inc. (Nasdaq:RMTI),
a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that it will host a Key Opinion Leader Breakfast on Thursday, March 6, 2014, beginning at 8:00am Eastern Time, in New York City.

Sabra Health Care REIT, Inc. (Nasdaq:SBRA) (Nasdaq:SBRAP)
announced today that it has exercised its option to purchase and completed the acquisition of two skilled nursing facilities with a total of 254 licensed beds for $24.5 million (the "Chai Acquisition").

StemCells, Inc. (Nasdaq:STEM)
, a leading stem cell company developing and commercializing novel cell-based therapeutics and tools for use in stem cell-based research and drug discovery, announced today that it will release financial results for the fourth quarter and full year ended December 31, 2013 after the market close on Wednesday, March 12.




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