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Employers cut 533K jobs in Nov., most in 34 years- Skittish employers slashed 533,000 jobs in November, the most in 34 years, catapulting the unemployment rate to 6.7 percent, dramatic proof the country is careening deeper into recession.
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Thailand reopens main international airport- Dancers, drummers and apologetic tourism officials greeted travelers Friday at the official reopening of Thailand's main international airport, which was shut down for a week by anti-government protesters.
US general spells out Iraq mission under new pact- A security pact that sets a timetable for troops to leave Iraq requires a shift in how the U.S. carries out combat missions during its remaining time in the country, the top U.S. military commander in Iraq said Friday.
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Auto bailout could be tied to gov't-run overhaul- The government would order a major restructuring of Detroit's struggling Big Three auto companies in exchange for a multibillion-dollar bailout under a plan circulating in Congress.
- Barack Obama, who rewrote the book on presidential fundraising, amassed more than $745 million during his marathon campaign, more than twice the amount obtained by his rival, Republican John McCain.
Hollywood's No. 1 women: Winfrey and Jolie- Oprah Winfrey tops The Hollywood Reporter's Power 100 list, an annual ranking of the most influential women in the entertainment industry.
- Armed robbers - some dressed in drag - made off with euro80 million ($100 million) in loot from a lightning-fast jewelry store theft in central Paris, in what police Friday called one of France's costliest jewel heists.
Giants' Pierce to meet with NYC investigators- Antonio Pierce is finally going to talk to investigators about what he did on the night Plaxico Burress shot himself.
Early Results of Phase 2 Trial of Perifosine (KRX-0401) for the Treatment of Recurrent Malignant Gliomas Presented at the 12th Annual Scientific Meeting of Society for Neuro-Oncology
NEW YORK
(Map)
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Ph II Study - Interim Results
Twenty-five patients with advanced malignant gliomas were treated with a loading dose of 600 mg (150mg x 4) followed by 100 mg daily dose of perifosine. Patients must have failed prior radiation therapy and have shown unequivocal evidence for tumor progression by MRI or CT scan. There was no limitation on the number of prior relapses or prior therapies and patients with a KPS greater than or equal to 50 were eligible. Patients were not allowed to take enzyme-inducing anti-epileptic drugs (EIAED's). Response was measured by the MacDonald Criteria (PR greater than or equal to 50% decrease in bidirectional tumor area and SD = between 25% worse to 50% better). Patients were broken out into two groups with results as follows:
Malignant Glioma N Evaluable Partial Stable Overall (PR
Response Disease + SD)
All Patients 25 20 2 (10%) 4 (20%) 6 (30%)
Glioblastoma 16 14 0 2 (14%) 2 (14%)
Anaplastic
Glioma 9 6 2* (33%) 2 (33%) 4 (66%)
*1 Patient with Anaplastic Astrocytoma and 1 Patient with Anaplastic
Oligodendroglioma
The median Progression Free Survival (PFS) and Overall Survival (OS) in the Anaplastic Glioma group was 9 wks (range 2 - 50 wks) and 49 wks respectively. Toxicity was minimal with the following reported events (n): grade 1 nausea (1), grade 1 diarrhea (1), grade 2 pain (1) and grade 4 gout exacerbation (1). The study was designed to enroll at least 12 evaluable GBM patients and at least 10 evaluable AA patients. If at least 1 patient achieves 6 month PFS, the study would continue to enroll an additional subset of patients. Therefore, the GBM arm has been halted and the AA arm will continue to enroll. Final study updates will be reported at a future meeting.
I.
For copies of the poster which was presented during the meeting, please contact Keryx Biopharmaceuticals.
Perifosine (KRX-0401) Mechanism of Action and Profile
Perifosine has been shown to inhibit or otherwise modify signaling through a number of different signal transduction pathways including Akt, MAPK, and JNK. Akt isoforms have been found to be overexpressed in renal, breast, prostate, and pancreatic cancers. Elevated levels of pAkt have been correlated with poor prognosis in patients with gastric, hepatocellular, endometrial, prostate, renal cell and head and neck cancers, as well as glioblastoma. The majority of tumors expressing high levels of pAkt were high-grade, advanced stage or had other features associated with poor prognosis.
The effects of perifosine on Akt are of particular interest because of 1) the importance of this pathway in the development of most cancers; 2) the evidence that it is often activated in tumors that are resistant to other forms of anticancer therapy; and 3) and the difficulty encountered thus far in the discovery of drugs that will inhibit this pathway without causing excessive toxicity.
To date, over 1,500 patients have been treated with perifosine in trials
conducted both in the US and
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc.
(Nasdaq: AEZS; TSX: AEZ) in the
About Malignant Gliomas
The American Cancer Society estimates that 20,500 malignant tumors of the
brain or spinal cord (11,170 in men and 9,330 in women) will be diagnosed
during 2007 in the
About Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, Inc. is focused on the acquisition, development
and commercialization of medically important, novel pharmaceutical products
for the treatment of life-threatening diseases, including diabetes and cancer.
Keryx's lead compound under development is Sulonex(TM) (sulodexide oral
gelcap), previously referred to as KRX-101, a first-in-class, oral heparinoid
compound for the treatment of diabetic nephropathy, a life-threatening kidney
disease caused by diabetes. Sulonex is in a pivotal Phase 3 and Phase 4
clinical program under a Special Protocol Assessment with the Food & Drug
Administration. Additionally, Keryx is developing Zerenex(TM), an oral, iron-
based compound that has the capacity to bind phosphate and form non-absorbable
complexes. Zerenex is currently in Phase 2 clinical development for the
treatment of hyperphosphatemia (elevated serum phosphorous levels) in patients
with end-stage renal disease. Keryx is also developing clinical-stage oncology
compounds, including KRX-0401, a novel, first-in-class, oral anti-cancer agent
that modulates Akt, a protein in the body associated with tumor survival and
growth, and a number of other key signal transduction pathways, including the
JNK and MAPK pathways, which are pathways associated with programmed cell
death, cell growth, cell differentiation and cell survival. KRX-0401 is
currently in Phase 2 clinical development for multiple tumor types. Keryx also
has an active in-licensing and acquisition program designed to identify and
acquire additional drug candidates. Keryx is headquartered in
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future the financial performance and clinical and business prospects for KRX-0401, may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully complete the Phase 1 and Phase 2 clinical trials for KRX-0401; we may not be able to meet anticipated development timelines for KRX-0401 due to recruitment, clinical trial results, manufacturing capabilities or other factors; and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not intend to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at http://www.keryx.com. The information in our website is not incorporated by reference into this press release and is included as an inactive textual reference only.
KERYX CONTACT:
Lauren Fischer
Director - Investor Relations
Keryx Biopharmaceuticals, Inc.
Tel: 212.531.5965
E-mail: lfischer@keryx.com
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