|Can-Fite Completes Patient Enrollment in its Phase II/III Psoriasis Trial; Nymox Pharma Offers Update on Nerve Sparing|
|By Staff and Wire Reports|
|Tuesday, 17 June 2014 20:06|
Can-Fite BioPharma Ltd. (NYSE MKT: CANF) (TASE:CFBI), a biotechnology company with a pipeline of proprietary small molecule drugs that address inflammatory and cancer diseases, announced today it has finalized enrollment in its Phase II/III trial of CF101 for the treatment of psoriasis with over 300 patients through 17 clinical centers in the U.S., Israel and Europe. Top line results from the trial are expected in the first quarter of 2015.
The psoriasis therapeutic market was worth $3.6 billion in 2010 and is forecast to grow to $6.7 billion by 2018, according to Global Data. The market is dominated by biological drugs that are primarily administered via intravenous injection (IV) and have potential side effects.
“Based on our studies to date, we believe that, if approved, CF101 would have the potential to offer an oral, safe and well-tolerated treatment alternative for people living with psoriasis,” stated Can-Fite CEO Dr. Pnina Fishman. “Now that we have completed patient enrollment, we hope that the upcoming conclusion of this Phase II/III trial will yield additional data which may prove the efficacy of CF101 in the treatment of psoriasis.”
About the Trial - The Phase II/III double-blind, placebo-controlled study is designed to test the efficacy of CF101 in 300 patients with moderate-to-severe plaque psoriasis. The first study cohort was comprised of three arms with patients receiving: 1 mg of CF101; 2 mg of CF101; and placebo. All patients receiving placebo were switched to either 1 mg or 2 mg of CF101 after 12 weeks. The primary efficacy endpoints are a statistically significant improvement in standard measures used by dermatologists to assess psoriasis including the Psoriasis Area Sensitivity Index (PASI) score and the Physicians’ Global Assessment (PGA) score as well as various safety parameters.
Interim safety and efficacy results were released from the first 103 patients who completed 24 weeks of treatment in the trial. The positive clinical effects of CF101 at the 2 mg dose relative to placebo were observed through PASI and PGA scores, with the responses accumulating steadily over the 24-week treatment period. To allow the trial to meet its full objectives, the study protocol has been amended to enroll patients for the 2 mg dose and placebo administration for an extended study period of 32 weeks.
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) is pleased to report new data supporting the positive sexual functional preservation profile of NX-1207, the Company's lead compound in Phase 3 development for the treatment of prostate enlargement (BPH or benign prostatic hyperplasia) and Phase 2 development for localized prostate cancer. A detailed study of prostate tissues from men who had received intraprostatic injections of NX-1207 2.5 mg or 15 mg found that nervous tissues in the prostate after treatment were left intact and showed no damage. These new results showing that NX-1207 is nerve-sparing add to the considerable body of evidence that treatment with NX-1207 does not lead to the debilitating sexual side effects often associated with existing prostate treatments.
Men who receive surgical or drug treatments for BPH or prostate cancer, not uncommonly suffer sexual side effects of a permanent nature. These long term effects can include impotence, retrograde ejaculation, loss of libido, and other disorders. For this reason, men are often reluctant to seek necessary treatment or to continue with drug therapy.
The nerve-sparing findings are consistent with results from earlier studies which have shown evidence of sexual functional preservation in men after NX-1207 treatment, including 1) patient reports of no significant new clinical sexual problems, 2) no change in blood testosterone levels, and 3) sexual function questionnaire data showing no sexual side effects from NX-1207 treatment.
NX-1207 is a novel patented drug developed by Nymox that is administered by a urologist in an office setting directly into the zone of the prostate to be treated. The procedure takes only a few minutes, does not require sedation, anesthesia or catheterization, and involves little or no pain or discomfort.
NX-1207 successfully completed a series of blinded controlled multi-center U.S. clinical trials for BPH where a single 2.5 mg dose of NX-1207 was found to produce at 90 days an average improvement in standardized symptom score about double that reported for currently approved BPH drugs without causing the sexual or cardiovascular side effects associated with those drugs. Follow-up studies showed evidence of long lasting benefit with a significant proportion of men who received a single dose reporting maintained improvement in BPH symptoms without other treatments for up to 5 years or more.
Nymox recently announced the completion of its second pivotal Phase 3 trial of NX-1207 for BPH, NX02-0018, and top-line results for its Phase 2 trial of NX-1207 for localized low risk prostate cancer, NX03-0040.
BPH is one of the most commonly diagnosed diseases in older men. The condition can have a significant negative impact on a man's health and quality of life and can lead to acute urinary retention, incontinence and other serious consequences. It is estimated that 50% of men in their 50s have pathological signs of prostatic hyperplasia and from 26 to 46% of men between the ages of 40 to 79 years suffer from moderate to severe urinary problems and symptoms associated with BPH.
ActiveCare, Inc. (OTCQB:ACAR), a leader in diabetes management and wellness services for self-insured employers nationwide, today announced the appointment of Mr. Earl Hurst as Senior Vice President of Business Development.
athenahealth, Inc. (Nasdaq:ATHN), a leading provider of cloud-based services for electronic health record (EHR), practice management, and care coordination, and Epocrates, an athenahealth service, today announced the findings from the third annual Epocrates Mobile Trends Report, which examines mobile technology adoption and use patterns among health care providers.
Cerulean Pharma (Nasdaq:CERU), a leader in Dynamic Tumor Targeting™, today announced that Christopher D. T. Guiffre, J.D., Senior Vice President and Chief Business Officer, will present at the JMP Securities Healthcare Conference in New York City on Tuesday, June 24, 2014, at 3:30 p.m. ET.
Chimerix, Inc. (Nasdaq:CMRX), a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, today announced that M. Michelle Berrey, M.D., M.P.H., President, CEO, and Chief Medical Officer of Chimerix, will present at the JMP Securities Health Care Conference 2014 on Tuesday, June 24, 2014 at 4:30pm EST at The Westin New York Grand Central in New York.
Durata Therapeutics (Nasdaq:DRTX) announced today that members of the executive team will participate in three upcoming investor conferences.
Endocyte, Inc., (Nasdaq:ECYT) today announced that it has regained the worldwide rights to vintafolide in all indications from Merck, known as MSD outside the United States and Canada.
Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced positive topline clinical trial results from a Phase 2a synovial fluid PK study of FX006, which demonstrated, for the first time, that a single intra-articular (IA) injection of FX006 can provide therapeutic concentrations of drug in joint fluid for at least 12 weeks.
IPC The Hospitalist Company, Inc. (Nasdaq:IPCM) today issued the following statement regarding the complaint filed on June 16, 2014 by the U.S. Department of Justice: The complaint is in connection with a civil investigative demand (CID) issued by the Department of Justice (DOJ) in June 2010 concerning claims for reimbursement that IPC submitted primarily to Medicare and Medicaid.
Marrone Bio Innovations, Inc. (Nasdaq:MBII), a leading global provider of bio-based pest management and plant health products announced it has funded a $10 million loan with Five Star Bank under the U.S. Department of Agriculture (USDA) Business and Industry Guaranteed Loan (B&I) program.
Nymox Pharmaceutical Corporation (Nasdaq:NYMX) is pleased to report new data supporting the positive sexual functional preservation profile of NX-1207, the Company's lead compound in Phase 3 development for the treatment of prostate enlargement (BPH or benign prostatic hyperplasia) and Phase 2 development for localized prostate cancer.
RadioIO, Inc. (OTCQB:RAIO) today announced it has added five Spa and Wellness music channels to its Be Well Radio business and consumer lineups to further its expansion in the exploding health and wellness market.
Sucampo Pharmaceuticals, Inc. (Nasdaq:SCMP), a global biopharmaceutical company, today announced that the United Kingdom's (U.K.) National Institute of Health and Care Excellence (NICE) has released a Final Appraisal Determination with guidance for the recommendation of the use of AMITIZA® (lubiprostone) in the treatment of chronic idiopathic constipation (CIC) and associated symptoms in adults who have failed laxatives.