Key Developments For Keryx Biopharmaceuticals, Inc.
Keryx Biopharmaceuticals, Inc. (KERX.O) (Consolidated Issue listed on NASDAQ Capital Market)
AEterna Zentaris Inc. Announces Scientific Article Supports Perifosine's Development In Kidney Cancer; Keryx Biopharmaceuticals, Inc. Is AEterna Zentaris' Partner And Licensee For Perifosine
AEterna Zentaris Inc. announced publication of a scientific article in the renowned Journal of Urology, supporting the development of AEterna Zentaris's PI3K/Akt pathway inhibitor oral compound, perifosine, for the treatment of cancer. The article outlines the pivotal role of PI3K and Akt signaling pathways in renal cell carcinoma pathogenesis thus, representing an ideal target for therapeutic intervention. Perifosine is described as the most advanced PI3K/Akt pathway inhibitor, which has already proved to be clinically active, as well as an ideal compound to combine with other anticancer agents. Keryx Biopharmaceuticals, Inc., is AEterna Zentaris' partner and licensee for perifosine (KRX-0401) in the North American market. The extensive article focuses on the role of the PI3K/Akt pathway in renal cell carcinoma pathogenesis, and on preclinical and clinical activity of compounds specifically targeting this pathway. Clinical data and perspectives on several compounds at different stages of development were also reviewed. The authors' conclusions on perifosine as a single agent or in combination therapy were based on data from several Phase 1 and Phase 2 studies in multiple types of cancer, including renal cell carcinoma. The authors also mention the investigation of perifosine in sarcoma, pancreas, prostate and hepatocellular carcinomas, because of the pathogenetic relevance of the PI3K/Akt/mTOR signaling pathways in these cancers.
Keryx Biopharmaceuticals Announces Initiation Of Phase 2 Clinical Study To evaluate KRX-0401
Keryx Biopharmaceuticals announced the initiation of a Phase 2 clinical study to evaluate KRX-0401 (perifosine) as a single agent treatment for relapsed or refractory Chronic Lymphocytic Leukemia (CLL) and Small Lymphocytic Lymphoma (SLL). This Phase 2 study was designed by Daphne Friedman, MD, Instructor and Principal Investigator, in coordination with J. Brice Weinberg, Professor, and Mark Lanasa, Assistant Professor, Divisions of Medical Oncology and Hematology, Duke University Medical Center, and is currently open for enrollment at Duke University. This study is being externally funded. KRX-0401 (perifosine) is a potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway and several other key signal transduction pathways in both hematologic and solid tumor cancers. Keryx is preparing to initiate a Phase 3 trial by year-end, under Special Protocol Assessment (SPA), for patients with advanced multiple myeloma. CLL is characterized by the accumulation of circulating B cells which are resistant to apoptosis. CLL has been found to have aberrant signaling in several pathways including NF-kappaB, Akt/PI3K, and JNK/STAT pathways. Published data has demonstrated that Akt is important in promoting CLL survival and viability, as seen in vitro experiments where blocking its activity results in apoptosis.
AEterna Zentaris Inc.'s Partner Keryx Biopharmaceuticals Presents Updated Phase 2 Data on Perifosine (KRX-0401) For Treatment Of Advanced Metastatic Renal Cell Carcinoma
AEterna Zentaris Inc. announced that Keryx Biopharmaceuticals, its partner and licensee for perifosine in the North American market, reported updated clinical results from a Phase 2 study of perifosine, the company's PI3K/Akt pathway inhibitor for cancer, as a single-agent treatment for advanced metastatic renal cell carcinoma. Phase 2 study of perifosine in patients with metastatic renal cell carcinoma progressing after prior therapy with both a VEGF Receptor Inhibitor and an mTOR inhibitor", included results from a subgroup of patients who failed both a VEGF receptor inhibitor (sunitinib (Sutent) or sorafenib (Nexavar) and an mTOR inhibitor (temsirolimus (Torisel) or everolimus (Afinitor). Evaluable patients (n=16) were defined as those who had greater than 7 days of treatment (2 additional patients withdrew consent within 7 days). Patients received 100 mg of perifosine daily until progression or unacceptable toxicity. The primary endpoint of this study was clinical benefit, defined as response rate (CR/PR by RECIST) or percentage of patients progression-free for at least 3 months. Median progression-free survival (PFS) and overall survival were also analyzed for efficacy. Safety was a secondary endpoint. Perifosine was well tolerated with the most common adverse events being gastrointestinal discomfort and fatigue.
Keryx Biopharmaceuticals To Raise $20 Million In Registered Direct Offering
Keryx Biopharmaceuticals announced that it has entered into definitive agreements to sell eight million shares of its common stock at a price per share of $2.50 pursuant to a registered direct offering to several select institutional investors, representing gross proceeds of approximately $20 million. Investors will also receive warrants to purchase 2,800,000 shares of the Company's common stock. The warrants have an exercise price of $2.65 per share and are exercisable at any time on or after the closing date and prior to 366 days from such initial issuance date. The closing of the offering is expected to take place on or about Wednesday, September 30, 2009. The Company plans to use the net proceeds from the offering to fund the upcoming Phase 3 programs for its lead drug candidates, Perifosine, a novel, oral PI3K/AKT pathway inhibitor for oncology, and Zerenex, a differentiated, iron-based phosphate binder.
Keryx Biopharmaceuticals' Keryx Kidney Drug Shows Positive Long Term Data; To Sell Up To $40 Million In Stock and Warrants Periodically-Reuters
Reuters reported that Keryx Biopharmaceuticals said its drug candidate, Zerenex, was well tolerated and safe in a mid-stage study that was testing it for long-term use in patients with end-stage renal disease. Zerenex is an oral, iron-based compound that attaches itself to phosphates when food is broken down in the stomach to form non-absorbable complexes. The drug, which has been studied in five different mid-stage trials, is being tested as a treatment for hyperphosphatemia, a condition where the kidney is not able to absorb and excrete phosphorus. Data from the mid-stage trial indicated that Zerenex could maintain phosphorus content at a normal level when used over an extended period of time. The data did not show signs of potential iron overload in the blood. The late stage study for the kidney drug is expected to begin at the end of the year. Separately, the Company said in a regulatory filing that it would sell up to $40 million in stock and warrants periodically.
