Onxigene'sTrial of ZYBRESTAT Achieved Primary Efficacy Endpoint; Rexahn Announces Initial Results from Phase I Trial of Supinoxin™ (RX-5902) Print
By Staff and Wire Reports   
Tuesday, 11 March 2014 19:13
Below is a look at some of the headlines for companies that made news in the healthcare sector on March 11, 2014.

OXiGENE, Inc. (Nasdaq: OXGN)
, a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, today announced positive results from a randomized Phase 2 clinical trial evaluating Avastin® (bevacizumab) with or without ZYBRESTAT® (fosbretabulin; CA4P) to treat patients with recurrent ovarian cancer. The study, known as Gynecologic Oncology Group protocol 186I, met its primary endpoint of a statistically significant increase in progression-free survival (p < 0.05; hazard ratio 0.685) for the combination as compared to bevacizumab alone.

The Phase 2 study is being conducted by the GOG under the sponsorship of the Cancer Therapy Evaluation Program (CTEP) of the National Cancer Institute (NCI). It is the first and currently only randomized trial to test an antiangiogenic therapeutic agent combined with a vascular disrupting agent, without including any cytotoxic chemotherapy.

"These findings validate both the novel approach and the complementary mechanisms of combining the vascular disrupting agent fosbretabulin and an antiangiogenic agent like bevacizumab in patients with ovarian cancer," said Bradley J. Monk, M.D., FACS, FACOG, principal investigator for the trial, and professor and director, Division of Gynecologic Oncology and Department of Obstetrics and Gynecology at the University of Arizona Cancer Center. "This promising combination warrants further evaluation particularly given the significant need for new treatment options in relapsed ovarian cancer."

As previously reported, the GOG protocol 186I enrolled 107 patients with platinum-sensitive and -resistant recurrent ovarian cancer at 67 clinical sites in the U.S. Patients were randomized 1:1 into one of two treatment arms: one arm received Avastin, and the second arm received Avastin plus ZYBRESTAT. Both therapies were administered intravenously every three weeks and patients were treated until disease progression or until adverse effects prohibited further therapy.

Secondary endpoints in the study include safety, objective response rate (measured according to RECIST criteria) and overall survival. Patients receiving the combination of ZYBRESTAT and Avastin achieved a higher objective response rate, which was not statistically significant. All patients will continue to be followed for overall survival. Consistent with prior clinical experience with ZYBRESTAT, patients in the combination arm experienced a higher incidence of hypertension compared to the control arm. All cases of hypertension were managed with antihypertensive treatments, as specified in the study protocol. It is expected that the full study results will be submitted for presentation at a future scientific meeting.

For this study, ZYBRESTAT is provided to CTEP under a Cooperative Research and Development Agreement (CRADA) with OXiGENE and bevacizumab is being provided as an investigational agent under a CRADA with Genentech. Bevacizumab is not approved to treat women with ovarian cancer in the U.S.; however, it is approved in other countries for treatment of ovarian cancer.

"We are very excited about these positive results and greatly appreciate all the patients who enrolled in this study and the support, resources and commitment of GOG and CTEP to conduct this important program," said Peter Langecker, M.D., Ph.D., chief executive officer of OXiGENE. "ZYBRESTAT is the first vascular disrupting agent to show a statistically significant progression-free survival benefit, and we are evaluating next steps to advance this combination to patients in need."


Rexahn Pharmaceuticals, Inc. (NYSE MKT: RNN)
a clinical stage biopharmaceutical company announced today initial data for the Phase I dose-escalation clinical trial of Supinoxin™ (RX-5902) initiated in August 2013. This trial was designed to study safety and efficacy in patients with solid cancer tumors.

The study is still ongoing and the maximal tolerated dose (MTD) has not yet been achieved. Three dosing cycles have been completed (25, 50 and 100 mg) and no drug related adverse events have been reported. The fourth dosing cycle (150 mg) has been initiated. Two patients have received 2 cycles of treatment and one patient has received 6 cycles of treatment. Pharmacokinetic analysis has shown that Supinoxin™ displays dose-proportional exposure and an estimated oral bioavailability of 51%. The pharmacokinetic profile of Supinoxin is similar to what has been seen in preclinical studies.

Peter D. Suzdak, Ph.D., Rexahn’s Chief Executive Officer commented, “We are encouraged that Supinoxin is safe and well-tolerated over the dose range tested in cancer patients with solid tumors who have received multiple cycles of treatment. In addition, the pharmacokinetic profile and oral bioavailability of Supinoxin is consistent with preclinical studies. These data are very encouraging, and we look forward to sharing additional data from the trial when it is completed later this year.”

The Phase I trial of Supinoxin, which was initiated in August 2013, is a dose-escalation study which will evaluate the safety, tolerability, dose-limiting toxicities and MTD in patients with solid cancer tumors that have previously failed treatment with approved therapies and shown progression of disease. Secondary endpoints include pharmacokinetic analysis and evaluating the preliminary anti-tumor effects of Supinoxin. This trial is being conducted in three clinical oncology centers in the United States. Each patient has the ability to continue on the drug up to six cycles of treatment (a dosing cycle is defined as 3 weeks of drug treatment followed by and 1 week off) if no disease progression is seen. Patients are assessed by CT or MRI prior to the start of therapy and after every two cycles of therapy to assess tumor progression. The trial is using an accelerated dose-escalation design: one patient is treated per dose cycle until a grade 2 related adverse event occurs then three patients will be treated per dose cycle. The decision to escalate dose is made by the DMSB after completion of one cycle of treatment based on safety and tolerability. Patients have the possibility to receive up to 6 cycles of treatment if the disease does not progress. Tumor biopsy samples are taken to assess the biomarker phospho-P68.

Also Tuesday:

AngioDynamics (Nasdaq:ANGO),
a leading provider of innovative, minimally invasive medical devices for vascular access, surgery, peripheral vascular disease and oncology, today announced the U.S. Food and Drug Administration (FDA) cleared an expanded indication for its AngioVac cannula for venous drainage during extracorporeal bypass for up to six hours to include removal of fresh, soft thrombi or emboli.

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, announced today that it has entered into a definitive agreement with entities affiliated with two institutional investors in connection with a private placement of approximately $10 million aggregate principal amount of subordinated convertible debentures and warrants to purchase 9,428,000 shares of common stock.

BG Medicine, Inc. (Nasdaq:BGMD)
today announced that it has received correspondence from The NASDAQ Stock Market LLC confirming that the Company has evidenced compliance with the requirements for continued listing on The NASDAQ Capital Market. Accordingly, the NASDAQ compliance matter has been closed.

Celsus Therapeutics Plc (Nasdaq:CLTX)
, an emerging growth, development-stage biotech company, announced today that it held a pre-Investigational New Drug (pre-IND) meeting with the U.S. Food and Drug Administration (FDA) on February 12th, 2014, to discuss the regulatory pathway for the development of MRX-6 cream in atopic dermatitis, also known as eczema, an inflammatory skin disorder affecting 5% to 20% of children world-wide.

Chelsea Therapeutics International, Ltd. (Nasdaq:CHTP)
today reported financial results for the fourth quarter and full year ended December 31, 2013.

Codexis, Inc. (Nasdaq:CDXS)
, a leading developer of biocatalysts for the pharmaceutical and fine chemical industries, today announced its financial results for the fourth quarter and year ended December 31, 2013.

Egalet Corporation (Nasdaq:EGLT)
today announced the appointment of Timothy P. Walbert, chairman, president and chief executive officer of Horizon Pharma, to its board of directors. 

Fate Therapeutics, Inc. (Nasdaq:FATE)
, a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, today announced that the Company will host a conference call and live audio webcast on Monday, March 17, 2014, at 5:00 p.m. EDT to report its fourth quarter and full year 2013 financial results and provide a corporate update.

FutureWorld (OTCQB: FWDG),
a U.S. Diversified Holding Company formed to capitalize on the burgeoning technology markets globally, announces today that HempTech will start rolling out CannaTRAK; an Enterprise Asset Management System that manages governance Licensing, Seed Sourcing, cultivation, harvesting, processing, point of sales and compliance of the legal medicinal marijuana.

Hemp, Inc. (OTC:HEMP)
applauded California's Democratic Party as it voted on March 8, 2014 to support legalizing marijuana for recreational use, parallel to Colorado and Washington states.

IntelGenx Corp. (TSX-V:IGX) (OTCQX:IGXT)
today announced financial results for its fiscal year ended December 31, 2013 and provided an update on operational developments. All amounts are in U.S. Dollars, unless otherwise stated.

LDR Holding Corporation (Nasdaq:LDRH)
, a global medical device company focused on designing and commercializing novel and proprietary surgical technologies for the treatment of patients suffering from spine disorders, announced today that the Current Procedural Terminology (CPT) Editorial Panel has accepted the addition of Category I code 22858X as an add-on code to support two-level cervical arthroplasty procedures.

LifeVantage Corporation (Nasdaq:LFVN)
, a company dedicated to helping people achieve healthy living through a combination of a compelling business opportunity and scientifically validated products, today announced that its Board of Directors approved an initial $6 million that will be used for an accelerated debt pay down and common stock repurchase program.

M Line Holdings, Inc. (OTCQB:MLHC)
, a leading provider of products, assemblies and services to the precision high tech segment of both the aerospace and medical industries as well as a seller of high end pre-owned Japanese Computer Numerically Controlled Equipment, today announced that the Company successfully pursued and reactivated new orders from one of its largest former customers.

Nuvilex, Inc. (OTCQB:NVLX)
, an international biotechnology company providing cell and gene therapy solutions for the treatment of deadly diseases, announced today that its subsidiary, Medical Marijuana Sciences, Inc., has appointed Brian Salmons, Ph.D., CEO and President of Nuvilex's partner Austrianova, to its Scientific Advisory Board.

OXiGENE, Inc. (Nasdaq:OXGN)
, a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, announced that the company's presentation and webcast at the ROTH Capital Partners 26th Annual Growth Stock Conference will take place on Wednesday, March 12 at 9:30 a.m. PT at The Ritz Carlton Hotel in Dana Point California.

OXiGENE, Inc. (Nasdaq:OXGN)
, a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, today announced positive results from a randomized Phase 2 clinical trial evaluating Avastin® (bevacizumab) with or without ZYBRESTAT® (fosbretabulin; CA4P) to treat patients with recurrent ovarian cancer.

Spine Pain Management, Inc. (OTCQX:SPIN)
, a technology-driven, medical service, device and healthcare solution company servicing the multi-billion dollar spine injury sector, today announced its wholly owned Quad Video Halo, Inc. (QVHInc) subsidiary will be exhibiting its latest version of its proprietary Quad Video Halo 3.0™ System (QVH3S) at the American Academy of Orthopedic Surgeons (AAOS) Annual Meeting Convention in New Orleans, March 12-14 at the Morial Convention Center, booth #2739.

TG Therapeutics, Inc. (Nasdaq:TGTX)
, today announced it has priced an underwritten sale of 2,702,809 shares of its common stock at $6.71 per share, the closing price on March 11, 2014, to JP Morgan Asset Management's Global Healthcare Fund.

Ultragenyx Pharmaceutical Inc. (NASDAQ: RARE)
, a biopharmaceutical company focused on the development of novel products for rare and ultra-rare diseases, announced the first patient enrolled in the Phase 2 study of triheptanoin (UX007) for the treatment of glucose transporter type-1 deficiency syndrome (Glut1 DS), at Columbia University.

"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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