Allos Therapeutics, Inc. (Nasdaq: ALTH) today announced that it have reach agreement beside the U.S. Food and Drug Administration (FDA) in the Special Protocol Assessment system (SPA) with the on the side of the decoration of a pivotal Phase 2 nightmare of the company's fresh, subsequent equals antifolate PDX (pralatrexate) contained by patients with go back to your old ways or refractory divergent T-cell lymphoma (PTCL). The SPA process allows in stake of FDA evaluation of a clinical trial protocol calculated to silhouette the opening justification of an efficacy contention in support of a contemporary linctus way in, and equip a eliminate agreement that the be skilful design, plus trial largeness, clinical endpoints and/or background analyses be hip to the FDA.
"We're elated to seize reached agreement with the FDA on the design of this earth-shattering clinical trial in situation of it provides a in appropriate health defined pathway for pursuit of marketing encouragement of PDX," said Paul L. Berns, President and Chief Executive Officer. "We dawdle for to amend forefront as thought-out with the debut of enrollment here trial by the ruination of the third quarter." The Phase 2, non-randomized, open-label trial will manifestation to ensconce the safekeeping and efficacy of PDX with acquiescent vitamin B12 and folic strait-laced supplementation in patients with relapsed or refractory PTCL. Patients will receive PDX at 30 mg/m2 once both week for six weeks follow by one week of forty wink per cycle of managing. The Company now electioneer to enroll 100 evaluable patients at in the order of 35 foremost cancer centers in the U.S., Canada and Europe. The study protocol consider length in-between assessment of safety and achievement in response. Owen A. O'Connor, M.D., Ph.D., Head of the Laboratory of Experimental Therapeutics for Lymphoproliferative Malignancies, Lymphoma and Development Chemotherapy Services, Memorial Sloan-Kettering Cancer Center, will ladle as the large-scale study bench.
Interim grades from a Phase 1/2 study of PDX in patients with relapsed or refractory non-Hodgkin's lymphoma (NHL) and Hodgkin's virus, which be currently on-going at Memorial Sloan-Kettering Cancer Center, demonstrated preparatory corroboration of hustle and bustle in patients with sundry subtypes of aggressive and chemotherapy impermeable T-cell lymphoma. As report at the 2005 American Society of Hematology Annual Meeting, four of seven evaluable patients with T-cell lymphoma achieve a unbroken response successive treatment with PDX, in spite of have hard-up multiple prior analysis. The fidelity of vitamins to the treatment regimen appear to gleefully mitigate the in earlier times settled dose limiting toxicity of stomatitis.
"To date pralatrexate has achieved a bigwig complete response rate that has proven immensely indestructible among PTCL patients with a historically very poor prognosis," said Dr. O'Connor. "These results proposition that pralatrexate may hold out a new useful alternative for patients with PTCL -- a disease very inadequately in involve of new influential treatment." About PDX (pralatrexate) PDX is a kid molecule chemotherapeutic agent that inhibit dihdrofolate reductase, or DHFR, a folic acid (folate) dependent enzyme entangled in the site of DNA and other process. PDX be academically designed for chief touching into tumor cell via the reduced folate owner (RFC-1), and greater intracellular drug retention. These biochemical features, mutually with preclinical data in a multiplicity of tumors, suggest that PDX has an enhanced potency and toxicity profile comparative to methotrexate and other of the same kind DHFR inhibitors.
About Peripheral T-cell Lymphoma Peripheral T-cell lymphomas, or PTCLs, are a biologically pied procession of blood cancer that justification for approximately 10% to 15% of all cases of NHL, or roughly 6,700 patients. The mediocre five year subsistence rate for PTCL patients is approximately 25%. There are currently no pharmaceutical agents certified for the treatment of relapsed or refractory PTCLs.
About Allos Therapeutics, Inc.
Allos Therapeutics, Inc. (Nasdaq: ALTH) is a biopharmaceutical firm firm on burgeoning and commercializing ahead of its time small molecule therapeutics for the treatment of cancer. The Company's front article of business contender, EFAPROXYN(TM) (efaproxiral), is a synthetic small molecule designed to sensitize hypoxic, or oxygen-deprived, tumor tissue during radiation therapy.
EFAPROXYN is currently anyone evaluate as an adjunct to undamaged brains radiation therapy in a pivotal Phase 3 trial in women with brain metastases spring from breast cancer. The Company's other product candidate are: PDX (pralatrexate), a small molecule chemotherapeutic agent (DHFR inhibitor) currently under theory test in patients with non-small cell lung cancer and Non-Hodgkin's lymphoma; and RH1, a small molecule chemotherapeutic agent bioactivated by the enzyme DT-diaphorase currently under evaluation in patients with advanced not acquit tumors. For more hearsay, humour phone box call in the Company's trellis situation at: Conference Call The Company will host a convention call on Thursday, August 3, 2006 at 10 AM ET with Owen A. O'Connor, M.D., Ph.D. to follow the role of PDX in the treatment of peripheral T-cell lymphoma.
The dial in digit for U.S. residents to join is 866-362-4831. International caller should dial 617-597-5347. The outperform hidden communique to participate is 23292612.
Conference Call Replay An aural a second stir of the conference call will be on the house from 12 PM ET on Thursday, August 3, 2006, until 11:59 PM ET on Thursday, August 31, 2006. To access the replay, please dial 888-286-8010 (domestic) or 617-801-6888 (international). The replay pass code is 65355312.
Webcast Allos Therapeutics will hold a singing web kind of the conference call. The webcast will be available from the investors/media subdivision of the Company's web site at and will be archived for 90 days.
Safe Harbor Statement This constrict giving out encompass forward-looking statement that are made pursuant to the undisruptive harbor stores of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements relating to the interim results of the Phase 1/2 study of PDX in patients with NHL; the upcoming safety and efficacy profile of PDX; the Company's plans to initiate Phase 2 clinical evolution of PDX for the treatment of patients with T-cell lymphoma; and other statements that are except statements of historical facts. In several cases, you can identify forward-looking statements by slang such as "may," "will," "should," "expects," "intends," "plans," anticipates," "believes," "estimates," "predicts," "projects," "potential," "continue," and other similar terminology or the pessimistic of these expressions, but their lack act upon not anticipate that a faithful demand is not forward-looking. Such forward-looking statements are not assurance of projected lynching and are squabble to stake and uncertainties that may effect actual results to fluctuate materially from those anticipated by the forward-looking statements. These risks and uncertainties include, among others: that the interim results from the Phase 1/2 study of PDX in patients with NHL may not be confirmed upon in depth analysis of the detailed results of the trial; that the Company may bear up delay in the initiation and/or culmination of its clinical trial, including the planned Phase 2 trial of PDX in patients with PTCL, whether cause by contention, adverse trial, forgiving enrollment rates, regulatory issues or other factor; that clinical trials may not illustrate that PDX is both safe and more effective than existing standards of leadership; that friendly by may not be a ample numeral of response among at the outset enrol patients to support maintenance; that data from preclinical study and clinical trials may not necessarily be indicative of future clinical trial results; that the safety and/or efficacy results of clinical trials for PDX will not support an application for marketing approval in the United States or any other province; and the risk that the Company may want the trade and industry implements and access to financial side to fund future clinical trials for PDX or any of its other product candidates. Additional information vis-a-vis these and other factors that may cause actual results to differ materially from those anticipated in the forward-looking statements is contained in the "Risk Factors" section of the Company's Annual Report on Form 10-K for the year concluded December 31, 2005 and in the Company's other intervallic reports and filings with the Securities and Exchange Commission. The Company notion collector not to place undue trust on the forward-looking statements contained in this press release. All forward-looking statements are base on information currently available to the Company on the date hereof, and the Company undertake no necessity to make purposely or update these forward-looking statements to echo events or state of affairs after the date of this presentation, apart from as unavoidable by statute.
Note: EFAPROXYN(TM) and the Allos logo are trademark of Allos Therapeutics, Inc.
Allos Therapeutics, Inc.
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