Novartis' LBH589 Met Primary Endpoint in Phase III Study; ZIOPHARM Announces Unanimous (RAC) Approval for Phase 1 Study of Ad-RTS-IL-12 Print E-mail
By Staff and Wire Reports   
Friday, 06 December 2013 20:29
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 6, 2013.

Novartis (NYSE: NVS)
announced that results of a Phase III trial of the investigational compound LBH589 (panobinostat) in combination with bortezomib and dexamethasone, met the primary endpoint of significantly extending progression-free survival (PFS) in patients with relapsed or relapsed and refractory multiple myeloma when compared to bortezomib plus dexamethasone alone.

Full results from the PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA) trial, continue to be evaluated and will be presented at an upcoming medical congress and discussed with regulatory authorities worldwide.

Multiple myeloma affects approximately 1 to 5 in every 100,000 people worldwide each year. The five year survival-rate for patients with the disease is about 44%[1].

LBH589 showed significant clinical benefit bringing it a step closer to becoming the first in its class of anticancer agents to be available to patients with multiple myeloma. As a pan-deacetylase (pan-DAC) inhibitor, LBH589 works by blocking a key cancer cell enzyme which ultimately leads to cellular stress and death of these cells[2].

"Results from this study show improved outcomes for these multiple myeloma patients who otherwise have few options to treat this incurable disease," said Alessandro Riva, Global Head, Oncology Development and Medical Affairs, Novartis Oncology. "Given its mechanism of action, LBH589 has the potential to be an important treatment option for multiple myeloma."

Prior data demonstrated that oral LBH589, when combined with bortezomib and dexamethasone, recaptures responses in heavily pretreated and bortezomib-refractory multiple myeloma patients, thereby providing these patients with a potential new option after failing prior standard treatments[3]. The compound's possible benefits and risks are also being explored in additional hematologic malignancies through ongoing clinical trials.


ZIOPHARM Oncology, Inc. (Nasdaq: ZIOP)
announced the unanimous approval of the National Institutes of Health's Recombinant DNA Advisory Committee (RAC) for the initiation of a Phase 1 study of Ad-RTS-IL-12, an adenoviral vector engineered to express interleukin-12 under the control of veledimex, an oral activator, in subjects with recurrent or progressive glioblastoma or grade III malignant glioma (brain cancer). ZIOPHARM has announced plans to launch a Phase 1 study of Ad-RTS-IL-12 in malignant glioma in the first half of 2014. The Company is currently studying Ad-RTS-IL-12 in Phase 2 studies in melanoma and breast cancer.

"Malignant gliomas remain one of the deadliest forms of cancer.  The stimulation of an immune response is a novel and intriguing therapeutic approach," said E. Antonio Chiocca, M.D., Ph.D., Chairman, Department of Neurosurgery, and Co-Director of the Institute for the Neurosciences, Brigham and Women's Hospital/ Dana Farber Cancer Institute, and Harvey Cushing Professor of Neurosurgery, Harvard Medical School.  "Important variables to the efficacy and safety of such therapies include the immune-privileged status of the central nervous system, the processes that contribute to the suppression of immune responses and the ability to modulate a brain tumor specific immune response.  In animal tumor models, Ad-RTS-IL-12 and veledimex demonstrate a significant ability to overcome these barriers by localizing and tightly controlling expression of the potent immune cytokine interleukin-12.  I look forward to seeing this promising therapeutic approach move quickly into clinical trials in patients with malignant brain tumors."

ZIOPHARM is developing Ad-RTS-IL-12 using Intrexon Corporation's (NYSE: XON) RheoSwitch Therapeutic System® (RTS®) platform to control the expression of interleukin-12 and enable its safe and effective delivery as an anti-tumor agent. ZIOPHARM and Intrexon recently presented preclinical study results at the 2013 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, supporting the capability of Ad-RTS-IL-12 in the treatment of glioma. These studies showed both the ability for veledimex to penetrate the blood brain barrier and a dose-related increase in survival in a mouse GL-261 glioma model. Animals treated with Ad-RTS-IL-12 survived throughout the duration of the study (100% survival at 75 days) with no significant adverse clinical signs observed.  In contrast, the mean survival in the control groups was 22 (±3) days. These findings support localized regulated IL-12 production as an approach for the treatment of malignant glioma.

"The NIH Committee's decision is an important step forward in bringing Ad-RTS-IL-12, a potentially transformative new DNA-based therapeutic, to the treatment of gliomas," said Francois Lebel, M.D., Senior Vice President, Clinical Development and Medical Operations at ZIOPHARM. "In tumor models, Ad-RTS-IL-12 and veledimex demonstrate a unique ability to overcome these barriers by localizing and tightly controlling expression of the potent cytokine interleukin-12. Our preclinical data to date demonstrate both a precisely controlled biologic response using this gene expression system as well as a remarkable effect on these tumors, suggesting further evaluation in the clinic. We expect to initiate a multicenter Phase 1 study in the first half of next year, and look forward to understanding the clinical potential of this therapy in brain cancers."

Also Friday:

Allerayde SAB, Inc. (OTCQB:ASAB)
today announced that the company has secured a grant from the European Space Agency for costs associated with the patent process and creating a working prototype of a new integrated communicator device to be used in conjunction with AAA Pen®.

Assured Pharmacy, Inc. (OTCQB: APHY)
, today announced that it has extended the expiration of its previously announced tender offer to exchange 16% Senior Convertible Debentures (the "Eligible Debentures") and warrants to purchase common stock (the "Eligible Warrants") (collectively the "Eligible Securities")

Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL)
, a fully integrated specialty biopharmaceutical company, announced today that the U.S. Food and Drug Administration (FDA) has approved XIAFLEX® (collagenase clostridium histolyticum, or CCH), an in-office, biologic for the treatment of Peyronie's disease (PD).

Baxano Surgical, Inc. (Nasdaq:BAXS)
, a medical device company focused on designing, developing and marketing minimally invasive products to treat degenerative conditions of the spine affecting the lumbar region, today announced the publication of two clinical studies focused on two of its core technologies: the AxiaLIF® Plus presacral access and interbody fusion system and the iO-Flex® minimally invasive decompression instrument.

BioSpecifics Technologies Corp. (NASDAQ: BSTC)
, a biopharmaceutical company developing first in class collagenase-based products marketed as XIAFLEX (collagenase clostridium histolyticum or CCH) in the U.S and XIAPEX® in the EU, today announced that the U.S. Food & Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) submitted by BioSpecifics' partner Auxilium Pharmaceuticals, Inc. (Auxilium) for XIAFLEX, an in-office, biologic for this treatment of Peyronie's disease.

Boston Therapeutics, Inc. (OTCQB: BTHE)
today announced its December 5th presentation is now available for on-demand viewing.  

Celator Pharmaceuticals, Inc. (Nasdaq:CPXX)
, a pharmaceutical company developing new and more effective therapies to treat cancer, today announced that Scott Jackson, chief executive officer, will present an overview of the Company at the upcoming Oppenheimer 24th Annual Healthcare Conference.

Edwards Lifesciences Corporation (NYSE: EW)
, the global leader in the science of heart valves and hemodynamic monitoring, announced today that The Edwards Lifesciences Fund will grant approximately $5.6 million this year to support health- and community-focused charitable initiatives.

Innovus Pharmaceuticals, Inc., (OTCBB:INNV)
today announced that the Company received the approval of its product license for its over the counter ("OTC") benzocaine-based topical premature ejaculation treatment EjectDelay™ in Canada.

Lipocine Inc. (OTCQB:LPCN)
, a specialty pharmaceutical company, today announced that the underwriters of its previously announced public offering have fully exercised their option to purchase an additional 223,800 shares of Lipocine common stock at a price of $8.25 per share, for additional gross proceeds of approximately $1.8 million.

today announced the launch of iSpO2™ Rx Pulse Oximeter with M-LNCS™ connector, enabling adhesive sensor use on newborns for accurate and cost-effective screening with mobile devices in low-resource settings. iSpO2 Rx features Masimo SET® technology -- shown through studies to be the most accurate pulse oximetry during challenging conditions and proven to help clinicians identify life-threatening conditions in newborns.

Nutra Pharma Corp. (OTCQB: NPHC)
, a biotechnology company that is developing treatments for Adrenomyeloneuropathy (AMN), HIV and Multiple Sclerosis (MS), is announcing that MyNyloxin, a new Network Marketing company that has the exclusive rights to market and distribute Nutra Pharma's over-the-counter (OTC) pain reliever, Nyloxin®, in the Network Marketing channel is launching their distributor website over the coming weekend.

Nuvilex, Inc. (OTCQB:NVLX)
, an international biotechnology company providing cell and gene therapy solutions for the treatment of diseases, announced today that its wholly-owned subsidiary, Medical Marijuana Sciences, Inc. (MMS), has appointed Mark L. Rabe, M.D., as Chairman of its Scientific Advisory Board.

Progenics Pharmaceuticals, Inc. (Nasdaq:PGNX)
an oncology company focused on the development of innovative approaches to targeting and treating prostate cancer, announced that findings from a Phase I study of its Imaging Agent, 1404, were presented today at the meeting of the Society for Urologic Oncology in Rockville, Maryland.

Progenics Pharmaceuticals, Inc., (Nasdaq:PGNX)
an oncology company focused on developing innovative approaches to targeting and treating prostate cancer, today announced that it has completed enrollment of chemotherapy experienced patients in a Phase II trial to assess the anti-tumor activity and tolerability of its antibody drug conjugate, PSMA ADC in patients with metastatic castrate resistant prostate cancer (mCRPC).  

Q4 Systems Corporation (OTCQB:QFOR)
today launched their 1nvoice® unified billing system for its healthcare exchange platform.

Stereotaxis, Inc. (Nasdaq:STXS)
today announced that William Mills, Chief Executive Officer, and Martin Stammer, Chief Financial Officer, will present at the Oppenheimer 24th Annual Healthcare Conference on Wednesday, December 11th at 3:20 p.m. ET. The conference is being held at the Crowne Plaza Times Square in New York City.

Tauriga Sciences, Inc. (OTCQB:TAUG)
, a diversified company focused on generating profitable revenues through license agreements and the development of a proprietary technology platform in the nanorobotics space, has today announced it has successfully retired the outstanding $281,250 USD senior convertible note issued to MAGNA Group LLC affiliate fund Hanover Holdings I, LLC.   

TG Therapeutics, Inc. (Nasdaq:TGTX)
, an innovative, clinical-stage biopharmaceutical company today announced that it has initiated a multi-center Phase 2 clinical trial to evaluate the safety and efficacy of the combination of TG-1101 (ublituximab) and ibrutinib (IMBRUVICA®) for patients with Chronic Lymphocytic Leukemia (CLL) and Mantle Cell Lymphoma (MCL).

Vision-Sciences, Inc. (Nasdaq:VSCI)
, a leading provider of unique flexible endoscopic products utilizing its proprietary sterile disposable EndoSheath® technology, today announced the full launch of the Company's official and authorized fiber and video endoscope repair center for Europe through an exclusive agreement with Rescope, a Netherlands-based facility dedicated to the technical management and repair of endoscopes.

ZIOPHARM Oncology, Inc. (Nasdaq:ZIOP)
today announced the unanimous approval of the National Institutes of Health's Recombinant DNA Advisory Committee (RAC) for the initiation of a Phase 1 study of Ad-RTS-IL-12, an adenoviral vector engineered to express interleukin-12 under the control of veledimex, an oral activator, in subjects with recurrent or progressive glioblastoma or grade III malignant glioma (brain cancer).

"Featured Content" profiles are meant to provide awareness of these companies to investors in the small-cap and growth equity community and should not in any way come across as a recommendation to buy, sell or hold these securities. BiomedReports is not paid or compensated by newswires to disseminate or report news and developments about publicly traded companies, but may from time to time receive compensation for advertising, data, analytics and investor relation services from various entities and firms. Full disclosures should be read in the 'About Us Section'.

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