Keryx Biopharmaceuticals Announces Poster Presentations Highlighting Clinical Activity of KRX-0401 (Perifosine) at the Upcoming Annual Meeting of the American Society of Clinical Oncology
* On Monday May 18, 2009, 8:29 am EDT
Results Will be Reported from Phase 2 Studies Evaluating KRX-0401 in Advanced Renal Cell Carcinoma, Colorectal Cancer and Gastrointestinal Stromal Tumors (GIST)
NEW YORK, May 18 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. (Nasdaq: KERX - News) today announced that four abstracts on KRX-0401 (Perifosine), the Company's Akt-inhibitor for cancer, were accepted for presentation during poster sessions taking place at the 45th Annual Meeting of the American Society of Clinical Oncology (ASCO), to be held in Orlando, Florida from May 29 to June 2.
All of the clinical data to be presented demonstrates the potential clinical efficacy of KRX-0401, both as a single agent and in combination with other approved agents, in the treatment of patients with advanced renal cell carcinoma, colorectal cancer and GIST.
die vorzeitig das Handtuch geworfen haben dürften sich mittlerweile schwarzärgern da Keryx mittlerweile die 3 USD im Visier hat, jetzt stellt euch mal vor wen die Firma eventuell mal von einem der großen geschluckt wird wo der Kurs dann hingeht.
Keryx Receives FDA Fast Track Designation for KRX-0401 (Perifosine) for the Treatment of Relapsed/Refractory Multiple Myeloma
NEW YORK, Dec. 2 /PRNewswire-FirstCall/ -- Keryx Biopharmaceuticals, Inc. today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for KRX-0401 (perifosine), the Company's novel, potentially first-in-class, oral anti-cancer agent that inhibits the phosphoinositide 3-kinase (PI3K)/Akt pathway, for the treatment of relapsed/refractory multiple myeloma.
The Fast Track program of the FDA is designed to facilitate the development and expedite the review of new drugs that are intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical needs. Fast Track designated drugs ordinarily qualify for priority review, thereby expediting the FDA review process.
A Phase 3 trial investigating perifosine in combination with bortezomib (VELCADE®) and dexamethasone for the treatment of patients with relapsed/refractory multiple myeloma is expected to commence by year-end under a Special Protocol Assessment (SPA) with the FDA. In addition, in September, the Company announced that perifosine had received Orphan-Drug designation in the United States for the treatment of multiple myeloma.
Ron Bentsur, Chief Executive Officer of Keryx Biopharmaceuticals, commented, "This Fast Track designation can significantly reduce the FDA review time of a new drug application, and therefore can expedite the time to market for perifosine in multiple myeloma." Mr. Bentsur added, "We believe that the Fast Track designation, together with the SPA and Orphan Drug status previously granted to us by the FDA for perifosine in multiple myeloma, significantly enhances the value proposition of perifosine in this indication. We are eager to begin the Phase 3 trial later this month."
KRX-0401 (perifosine) is in-licensed by Keryx from Aeterna Zentaris, Inc. (Nasdaq: AEZS; TSX: AEZ) in the United States, Canada and Mexico.
Keryx Biopharmaceuticals, Inc. Reports Aktualisiert Phase 1 / 2 Daten, einschließlich der neuen Survival-Daten, auf KRX-0401 (Perifosine) in der Behandlung von fortgeschrittenem Multiplen Myelom auf der 51. Jahrestagung der American Society of Hematology
Below are some updates and developments from the past week, which I spent in San Francisco for the OneMed, JP Morgan, and other healthcare conferences.
I had the opportunity to meet with the CEO (Ron Bentsur) and CFO (James Oliviero) of Keryx Biopharma (NASDAQ: KERX) on Wednesday and was impressed with the Company's focused strategy and upcoming milestones for 2010 and beyond. As outlined in my overview article last week, I have purchased shares of KERX over the past week on weakness at a slightly higher price range ($2.70-2.75) than I originally projected.
Given the Company's history of in-licensing compounds for development and robust cash position, I inquired if anything was on the horizon in this regard. However, for the near to intermediate term, Keryx plans to remain focused on utilizing its resources (cash / personnel) to get the Phase 3 trials well established before considering any new acquisitions, which is a good strategy given that Keryx is well-funded but still a small-cap drug developer that needs to remain focused.
Approximately $10-11 million is the estimated cost to fund both the short and long-term Phase 3 studies of Zerenex while perifosine has estimated funding of $12 million each to fund the Phase 3 studies for multiple myeloma (ongoing) and colorectal cancer (pending), with an estimate of $25,000-$30,000 per patient to fund the Phase 3 cancer trials. Below is a summary of additional details for upcoming catalysts and milestones for Keryx over this year and beyond that were not included in my overview article last week.
During 2010, Keryx expects to report updated data from its Phase 2 colon cancer study, conduct / update additional earlier stage Phase I/II studies, finalize late-stage trial protocol for colon cancer study, and begin additional late-stage studies for colon cancer in addition to the pending pivotal Phase 3 study of perifosine under a SPA agreement with FDA for multiple myeloma. KERX expects to provide an update on Phase 2 colon cancer survival and other data for perifosine next weekend at GI-ASCO 2010 (Jan. 22-24) as it prepares to begin a pivotal Phase 3 trial of perifosine in colon cancer patients with a Special Protocol Assessment (SPA) with the FDA possible for this indication within the next 2-3 months (i.e. mid-April 2010).
The ongoing Zerenex Phase 2 study in Japan by JT Torii is near completion and Keryx expects the Phase 3 trial to begin during 2H10, which will trigger a development milestone payment that is in the mid single-digit million dollar range. An additional $15 million milestone is possible upon regulatory approval in Japan, with approximately $55 million in remaining milestone payments based on the achievement of sales targets upon commercialization.
Zerenex represents a niche market opportunity within well understood / established class of drugs (phosphate binders) that has a key differentiation of being iron-based compared to existing treatments such as PhosLo, Fosrenol, and Renagel/Renvela. Zerenex is expected to offer an improved safety profile / patient acceptance with reduced GI / bloating side effects and approximately 50% less dosing burden (i.e. taking less pills less often) compared to existing phosphate binders.
In addition, a major secondary endpoint being evaluated is the potential ability of Zerenex to decrease the need for IV-iron and blood cell stimulators (EPO agents such as Epogen and Aranesp) since it is iron based and expected to result in long-term accumulation of the mineral. This may result in a first-line phosphate binder indication (with a goal of capturing 20-25% market share) for Zerenex and advantages that include safety (there is a pending FDA Advisory Panel to discuss safety issues of EPO drugs) and economic (dialysis bundling payment issues - Zerenx has potential to save dialysis providers money by reducing need for IV-iron or EPO agents).
Keryx Reports Statistically Significant Benefit in Survival from Updated Results of a Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of KRX-0401 (Perifosine) in the Treatment of Advanced Metastatic Colon Cancer
Data Reported at the 2010 ASCO GI Cancers Symposium Demonstrate a Statistically Significant Improvement in Both Time to Tumor Progression and Overall Survival in the Perifosine + Capecitabine Arm Versus Placebo + Capecitabine Arm Conference Call to Discuss Data to be Held on Thursday, January 28th at 9am EST