News Column

Nymox Reports New Prostate Cancer Clinical Trial Results; Provectus Appoints Brendan O’Brien to Strategic Advisory Board

May 6, 2014



Below is a look at some of the headlines for companies that made news in the healthcare sector on May 6, 2014.



{nfg}Nymox Pharmaceutical Corporation (Nasdaq: NYMX)
announced today new positive outcome results from the Company's ongoing prospective trial of NX-1207 for the treatment of low grade localized prostate cancer. These are the first clinical patient treatment outcome results for this trial. A controlled comparison was conducted of patients who required and received radiation and surgery treatments for their cancer based on blinded post-treatment upgraded evaluations of their pre-treatment initially positive lower grade cancers. The study found after up to 22 months for NX-1207 single-injection treated patients there was an 85% reduction compared to controls in the proportion of patients who had upgraded blinded biopsy results in the treated area and went on to require and receive radiation therapy and/or prostatectomy (surgery).



Long-term clinical outcome is considered to be a highly important measure of drug treatment efficacy. 146 patients were enrolled in the NX03-0040 Phase 2 U.S. trial and either randomized to one of two doses of NX-1207 (2.5 mg or 15 mg) or to active surveillance (no treatment). The drug was injected into the area of the prostate where the cancer was detected and repeat biopsies were then performed on all patients, treated and controls. Follow-up studies are being conducted of all patients in the study to monitor outcome and safety data. The patients in the new study results were followed for up to 22 months post-treatment.



Previously reported study results showed that patients with NX-1207 treatment had significantly less Gleason grade progression, lower average PSA levels, lower numbers of biopsy cores showing greater malignancy, and lower total volume of more malignant cancer compared to controls.



To date, NX-1207 has had an excellent safety profile as both a treatment for benign prostatic hyperplasia (BPH) and localized low-risk prostate cancer. In the current trial, a new high dose of drug (15 mg) was safely used without drug-related adverse effects. NX-1207 has shown safety in repeat injection studies (NX02-0020 and NX02-0022). The drug does not lead to immune responses such as antibody formation which can cause significant drug toxicity and/or limit usage to single treatments due to drug neutralizing effects.



Paul Averback MD, CEO of Nymox, said, "These new results show the potential of NX-1207 to offer men with low-risk prostate cancer a significant tangible benefit in terms of avoidance of radiation and/or surgery and the related risks, discomforts, and permanent side effects. We emphasize that these results are based on a single injection only. A similar convenient treatment regimen with multiple injections is to be expected to offer even more benefit, which we hope to be able to demonstrate as soon as possible. If these positive results can be further validated, NX-1207 may prove to offer a new safe option for a painless way to deal with a major problem for many men."



NX-1207 is in Phase 3 development in the U.S. and Europe for benign prostatic hyperplasia (BPH) also referred to as prostate enlargement, a common affliction of middle-aged and elderly men, affecting up to half of men over the age of 50. The Company's European partner for BPH is Recordati S.p.A.







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Provectus Biopharmaceuticals, Inc. (OTCQB:PVCT)
(http://www.pvct.com), a development-stage oncology and dermatology biopharmaceutical company, announced today that it has appointed Brendan O’Brien to its strategic advisory board.



Brendan O’Brien, age 48, is currently VP of Strategic Planning & Analysis for North American Pharmaceuticals at Sanofi. In this role, he is responsible for business planning and strategy development; he leads both the three-year strategic planning and one-year operating planning processes for Sanofi US, the North American affiliate of Sanofi SA.



Brendan started his career in healthcare, working for ten years in sales, marketing and planning for managed care organizations in the Pacific Northwest. In 1998, he moved on to work in pharmaceuticals at Smithkline Beecham Pharmaceuticals in London, UK where he directed development of strategic plans for 14 European markets. From there, Mr. O’Brien went to Pfizer spending the next 13 years in roles with increasing levels of management responsibility in many European countries, including managing director/general manager of Pfizer’s country organizations in both Slovakia and Romania.



Mr. O’Brien received his B.A. degree cum laude from Bowdoin College in Brunswick, ME, and he holds a Master’s degree in Business Administration from London Business School in London, UK.



Dr. Craig Dees, PhD, CEO of Provectus said, “Brendan brings real world experience of business planning and strategy development to the table, and Provectus values that expertise greatly. As we work through the regulatory process to put PV-10 for locally advanced cutaneous melanoma and other indications, and other preparations on the market, we anticipate relying heavily on Brendan’s knowledge.”



Mr. O’Brien said, “Provectus is approaching a very important phase in its strategic business development. PV-10 for melanoma and other cancers offers patients new hope, and I view it as my job to ensure that the plans are in place to allow Provectus to get its treatment to the people who need it without delay on the corporate side. I am looking forward to the opportunity to be part of the process.”







Also Tuesday:







BioTelemetry, Inc. (Nasdaq:BEAT)
, the leading wireless medical technology company focused on the delivery of health information to improve quality of life and reduce cost of care, today reported results for the first quarter ended March 31, 2014.



Hyperion Therapeutics, Inc. (Nasdaq:HPTX)
today reported net revenue of $19.5 million for the first quarter of 2014 from the sales of its two products for the treatment of urea cycle disorders, RAVICTI® (glycerol phenylbutyrate) Oral Liquid and BUPHENYL® (sodium phenylbutyrate) Tablets and Powder.



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 reported financial results for its fiscal 2014 third quarter and the nine months ended March 31, 2014.



MacroGenics, Inc. (Nasdaq:MGNX)
, a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer and autoimmune diseases, today provided a corporate progress update and reported financial results for the quarter ended March 31, 2014.



Myriad Genetics, Inc. (Nasdaq:MYGN)
today announced financial results for the fiscal third quarter and nine months ended March 31, 2014, increased its fiscal year 2014 guidance, and provided an update on recent business highlights.



OXiGENE, Inc. (Nasdaq:OXGN)
, a clinical-stage biopharmaceutical company developing novel therapeutics to treat cancer, reported financial results for the quarter ended March 31, 2014.



Stereotaxis, Inc. (Nasdaq:STXS)
today reported financial results for the first quarter ended March 31, 2014.



Tornier N.V. (Nasdaq:TRNX)
, a global medical device company focused on providing surgical solutions to orthopaedic extremity specialists, reported today its financial results for the first quarter ended March 30, 2014.



Urologix®, Inc. (OTCQB:ULGX)
, the leading provider of in-office procedures for the safe, durable and effective treatment of BPH, today reported financial results for its fiscal third quarter ended March 31, 2014.



Urologix, Inc. (OTCQB:ULGX)
, the market leader for In-Office BPH Therapy, today announced that data demonstrating the cost-effectiveness of high energy Transurethral Microwave Therapy (TUMT) versus low energy alternatives will be presented at the American Urological Association (AUA) 2014 Annual Meeting to be held May 16 – 21, 2014, at the Orange County Convention Center in Orlando, Florida.


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Source: BioMed Reports


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