Posted by Mike Sweeney on Thu, Jul 22, 2010 @ 02:22 PM
While KERX has been making noise in the scientific work and the stock market, they continue to develop their infrastructure with the appointment of Dr. Feczko:
"Joseph Feczko, M.D., 61, a seasoned pharmaceutical executive, joins the Keryx Board with broad industry experience across the spectrum of medical, regulatory and operational affairs. Dr. Feczko was, until his retirement in May 2009, Senior Vice President and Chief Medical Officer (CMO) of Pfizer Inc and member of the Executive Leadership Team with global responsibilities for all aspects of the company's medical, regulatory and safety activities. Following a time in private practice, he joined Pfizer in 1982 in New York, and then worked for ten years in the United Kingdom for both Pfizer and Glaxo where his responsibilities included supervising clinical research, regulatory affairs, data management and safety reporting. He returned to Pfizer in New York in 1996, where he held positions of increasing responsibility in clinical research and regulatory affairs and safety, culminating in the role of CMO. Dr. Feczko is board-certified in Internal Medicine and a specialist in Infectious Diseases. He has a B.Sc. degree from Loyola University Chicago, and an M.D. from the University of Illinois College of Medicine.
"We are very pleased to have Dr. Feczko join our board of directors," said Michael P. Tarnok, Chairman of the Board. "Dr. Feczko brings to our Board nearly 30 years of global pharmaceutical industry experience in Clinical Development, Regulatory Affairs and Licensing, and we believe that his expertise will be invaluable as we continue to develop our drug candidates with the hope of getting them to those patients that can benefit from them."
Dr. Feczko is currently chairman of the board of directors of Cardoz Pharmaceuticals AB. Additionally, Dr. Feczko is a member of the Board of Directors of the Foundation for the National Institutes of Health, Research!America and the International Longevity Center as well as the New York Academy of Medicine. He is also a member of the Board of Directors of the Accordia Global Health Foundation and the Technical Expert Committee for Trachoma on the International Trachoma Initiative of the Task Force for Global Health, as well as a member of the governing board of the Technology Strategy Board of the United Kingdom."
Full Press Release
Posted by Mike Sweeney on Wed, Jul 14, 2010 @ 03:41 PM
Keryx Biopharmaceuticals Inc. (Nasdaq: KERX) jumped on reports it received FDA orphan designation for Perifosine drug for treatment of neuroblastoma. The stock was up over 15% on the day, closing at $4.11.
"Drugmakers Aeterna Zentaris Inc (AEZ.TO) and Keryx Biopharmaceuticals Inc (KERX.O) said on Wednesday their experimental cancer drug, KRX-0401, has received orphan drug status from U.S. health regulators for the treatment of a type of childhood cancer.
The U.S. Food and Drug Administration approved KRX-0401, also known as perifosine, for the treatment of neuroblastoma, a tumor that affects developing nerve tissue and which accounts for about 7 percent of all cancer deaths in children. There are currently no FDA approved treatments available.
The FDA's orphan drug status is reserved for new treatments that are being developed for diseases or conditions that affect fewer than 200,000 people in the United States."
Full Release
Posted by Mike Sweeney on Tue, Jun 22, 2010 @ 02:23 PM
With each passing day, Keryx Biopharmaceuticals (NASDAQ:KERX) slips under another key support level.... moving averages, straight-line support, previous lows.... there simply seems to be no help - the result of a small cap stock that got too far ahead of itself with the strong bullish move in April and early May.
As of right now (today), Keryx Biopharmaceuticals is back under the 10-day average (black), just got pushed lower by a falling resistance line (blue), and fell under the modest support at $4.18. There's just no foothold for the bulls to even get a chance to stop the bleeding. I foresee a revisit to February's lows around $2.20 before it's all said and done.
It stinks, as I know a lot of you were married to this biopharma name. The chart is what it is though.
Interesting chart @ SmallCap Network.
Posted by Mike Sweeney on Mon, Jun 07, 2010 @ 12:34 PM
Keryx Biopharmaceuticals, Inc. (Nasdaq:
KERX) today announced that Phase 1
data of KRX-0401 (
perifosine) in recurrent pediatric
solid tumors
was presented yesterday in the pediatric solid tumor poster discussion session held at the 46th Annual Meeting of the
American Society of Clinical Oncology (ASCO) taking place in Chicago, IL. Perifosine is the Company's novel, potentially first-in-class, oral
anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway. This study, conducted by the
Memorial Sloan-Kettering Cancer Center pediatric group, marks the first time that perifosine has been administered in a pediatric patient setting.
Study Design: This
Phase I Study of Perifosine for Recurrent Pediatric Solid Tumors is a single center,
open-label, dose-escalating study to assess safety, tolerability,
pharmacokinetics (PK), and to identify any dose limiting toxicity (
DLT) of single agent perifosine in pediatric patients with any solid tumor that has failed standard therapy. Eleven patients (4 males, 7 females), at a median age of 13 years (5-18) were treated in this study to date. The following tumor types were treated thus far: high-grade
glioma (5),
medulloblastoma
(2),
neuroblastoma (3), and
ependymoma (1). Most patients were heavily pretreated, with a median of three prior lines of therapy.
Cohorts of three patients were treated at three dose levels: 25mg/m2/day, 50mg/m2/day and 75mg/m2/day using 50mg tablets of perifosine after a
loading dose on day 1, and taking into
account the drug's long half-life (>100hrs). No DLTs were observed at any of the three dose levels; dose level 4 is currently open for
accrual. PK data thus far suggests similar
drug absorption
by pediatric patients relative to adult patients treated with single agent perifosine.
Of particular interest are the early signs of clinical activity observed in two of the three patients with Stage 4 refractory neuroblastoma. Both patients were refractory to prior treatments upon entering the
study
and achieved stable disease for 48 weeks and 55+ weeks (ongoing). The investigators concluded that perifosine is well-tolerated in children with recurrent solid tumors and that these early signals of activity warrant further investigation in patients with advanced neuroblastoma and select
brain tumors. Recently,
NCI investigators published in
vitro and in vivo data demonstrating that perifosine targets the activation of Akt in neuroblastoma cells and
xenografts, significantly inhibits tumor growth in vivo and improves the survival of mice bearing neuroblastoma tumors.
Ron Bentsur, Chief
Executive Officer of Keryx Biopharmaceuticals, commented, "We are pleased at the safety and tolerability of single agent perifosine in pediatric patients and encouraged by the early signals of clinical
benefit in neuroblastoma, as noted by the investigators. We are grateful to the researchers and we look forward to exploring perifosine's potential in future pediatric settings, including neuroblastoma."
Perifosine is currently in
Phase 3 clinical development
for refractory advanced
colorectal cancer and
multiple myeloma, both of these Phase 3 programs being conducted under
Special Protocol Assessment (SPA) agreements with the FDA with Fast Track designations obtained for both indications. Perifosine is also in Phase 1 and 2 clinical development for several other tumor types.
Posted by Mike Sweeney on Thu, Jun 03, 2010 @ 01:24 PM
Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX) today announced that Ron Bentsur, the Company's Chief Executive Officer, will be presenting at the following June Investor conferences:
Wednesday, June 9, 2010 - 1:20 p.m. EDT
9th Annual Needham Healthcare Conference
New York Palace Hotel
New York City
Thursday, June 10, 2010 - 9:00 a.m. EDT
Jefferies Global Life Sciences Conference
New York City
A live audio webcast of Mr. Bentsur's presentations will be accessible from the Investor Information page of the Company's Website at http://investors.keryx.com. An archived version of each webcast will be available following the conclusion of the live presentation.
ABOUT KERYX BIOPHARMACEUTICALS, INC.
Keryx Biopharmaceuticals is focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of life-threatening diseases, including cancer and renal disease. Keryx is developing KRX-0401 (perifosine), a novel, potentially first-in-class, oral anti-cancer agent that inhibits Akt activation in the phosphoinositide 3-kinase (PI3K) pathway, and also affects a number of other key signal transduction pathways, including the JNK pathway, all of which are pathways associated with programmed cell death, cell growth, cell differentiation and cell survival. KRX-0401 has demonstrated both safety and clinical efficacy in several tumor types, both as a single agent and in combination with novel therapies. KRX-0401 is currently in Phase 3 clinical development for both refractory advanced colorectal cancer and multiple myeloma, and in Phase 1 and 2 clinical development for several other tumor types. Each of the KRX-0401 Phase 3 programs are being conducted under Special Protocol Assessment (SPA) agreements with the FDA. Keryx is also developing Zerenex(TM) (ferric citrate), an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes. The Phase 3 clinical program of Zerenex in the treatment for hyperphosphatemia (elevated phosphate levels) in patients with end-stage renal disease is being conducted pursuant to an SPA agreement with the FDA. Keryx is headquartered in New York City.
KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
www.Keryx.com
Tel: 212.531.5965
Posted by Mike Sweeney on Tue, Jun 01, 2010 @ 01:01 PM
Keryx was rated as one of the top five most-efficient companies in the Biotechnology industry as ranked by Revenue Per Employee (RPE). Analysts use RPE as a measure to compare the productivity of companies in the same industry.
Full Article
Posted by Michael Sweeney on Sun, May 23, 2010 @ 07:05
An experimental colorectal cancer drug being developed by Keryx Biopharmaceuticals Inc. showed it improved overall survival and slowed cancer progression in patients with advanced colorectal cancer, according to a summary of final data from a mid-stage study.
Researchers said the drug KRX-0401, also known as perifosine, was well tolerated and showed "promising activity" over chemotherapy as a second or third-choice drug for patients with colorectal cancer that has spread.
The study was one of thousands of abstracts, or brief summaries, of studies released on Thursday ahead of presentation at the American Society of Clinical Oncology (ASCO) next month in Chicago.
The study looked at the safety and effectiveness of perifosine in combination with chemotherapy drug capecitabine in 38 patients with advanced colorectal cancer.
All of the patients had already failed to improve on one or two other treatments.
Of the 35 patients evaluated, 20 percent who got the perifosine combination responded to treatment, compared to 7 percent who got chemotherapy plus a dummy pill.
Patients in the treatment group lived 18 months, compared with 11 months among those who got chemotherapy plus a placebo.
The drug, being developed jointly with Canadian drugmaker Aeterna Zentaris, blocks the activation of Akt, a new pathway thought to be linked with cell death and survival.
High levels of activated Akt are seen frequently in many types of cancer, and are often a sign of poor prognosis.
Last month, U.S. regulators granted the drug fast-track approval, a designation that speeds the regulatory approval process. A late-stage study of the drug is expected to begin this quarter.
Posted by Michael Sweeney on Fri, May 21, 2010 @ 12:26 PM
Another interesting piece by GekkoWire:
"Back in January the company reported updated survival data that focused on 35 patients (20 patients taking perifosine and 15 taking the placebo). Perifosine was given in conjunction with capecitabine (a drug manufactured by Roche) while patients on the placebo arm were given capecitabine alone. The primary endpoint results for Time To Progression, which is one of the harder cancer endpoints to meet, was startling to say the least. Patients taking perifosine had their TTP increase to 28 weeks compared to a measly 11 weeks for patients on the placebo."
Full article @ GekkoWire
Posted by Michael Sweeney on Mon, May 17, 2010 @ 07:49 PM
Very interesting analysis of Keryx market postential by Gekko Wire:
"In this analysis I’ll cover the U.S. market only, it is much simpler to gauge the U.S. market share because we have actual statistics that are reliable. According to the American Cancer Society there were 106,100 new cases of colon cancer in the U.S. in 2009. And there were 49,920 deaths as a result of the disease (data here). We can safely assume a large portion of the patients that die are patients that would receive Perifosine as part of treatment in relapsed or refractory patients. Usually these two patient groups consist largely of the 49,920 deaths that will be seen each year. So it is safe to assume that some percentage would definetly receive Perifosine as therapy since the drug is currently being tested for that indication. Keep in mind though, that not all of 49,920 deaths will receive the drug. "
Full report at Gekko Wire.
Posted by Michael Sweeney on Mon, May 10, 2010 @ 02:29 PM
May 10, 2010 (SmarTrend(R) News Watch via COMTEX) -- SmarTrend has detected shares of Keryx Biopharmaceuticals (NASDAQ:KERX) have bullishly opened above the pivot of $5.51 today and have reached the first resistance level of $5.72.
They are watching for a cross of the next upside pivot targets of $6.12 and $6.73. Also, the shares are currently trading above the 50-day moving average of $3.64 and above the 200-day moving average of $2.56.
SmarTrend alerted subscribers to buy shares of Keryx Biopharmaceuticals on November 30, 2009 at $2.54. Since the call, the stock has risen 125.6%.
More about SmarTrend