AML in Biological Technology

Genzyme Withdraws Bioenvision's European Filing of Evoltra(R) in Elderly AML Patients

Will Resubmit With New Data from Ongoing Studies CAMBRIDGE, Mass., March 19 /PRNewswire-FirstCall/ -- Genzyme Corp. (Nasdaq: GENZ ) today announced the withdrawal of the European application to extend the Evoltra(R) (clofarabine) product label to include the treatment of elderly p...

Vion Pharmaceuticals Completes Accrual of 85 Patients to its Pivotal Phase II Trial of Cloretazine(R) (VNP40101M) in Elderly AML

NEW HAVEN, Conn., Aug. 15 /PRNewswire-FirstCall/ -- VION PHARMACEUTICALS, INC. (Nasdaq: VION ) today announced that it had accrued a total of 85 patients to the pivotal Phase II trial of its lead anticancer agent Cloretazine(R) (VNP40101M) in previously untreated elderly patients with de novo...

Sunesis Reports Financial Results for the Second Quarter 2009

... this year with the FDA to gain concurrence on our aml registration strategy." Recent Highlights ...t voreloxin shows promising safety and efficacy in aml and in platinum-resistant ovarian cancer. These pr... single agent voreloxin in newly diagnosed elderly aml patients who are unlikely to benefit from standard...

Phase II Trial Demonstrates Elacytarabine May Increase Survival Threefold in Patients With Late-Stage Leukaemia

...In the Phase II study, 61 patients with late stage aml who failed to respond or relapsed after two separa...cal outcome analysis of 594 similar second salvage aml patients, who were treated at the MD Anderson Canc...r Giles said: "Patients with refractory / relapsed aml today have no standard therapy as existing therapi...

Celator(R) Pharmaceuticals Presents Data on the Activity of CPX-351 Against Leukemia at the European Hematology Association Congress

...e American Society of Hematology (ASH) meeting in late 2008, included complete remissions (CRs) in 1 of 3 patients with ALL and 10 of 44 patients with aml (9 CRs and 1 CRp - complete remission without full platelet recovery). Some of these remissions occurred at dose levels as low as one-third to one-ha...

Isis and Partners Present New Research at the American Association for Cancer Research 2009 Annual Meeting

...creased survival in preclinical models of acute myeloid leukemia (AML) suggesting that antisense drugs targeting STAT5 may offer a new avenue to treat aml and related blood disorders. "The work presented at this year's AACR demonstrates the broad applicability of antisense technology and adds to ou...

Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2008 Financial Results

...EVEAL-1 trial is enrolling newly diagnosed elderly aml patients unlikely to benefit from standard inducti...in combined with cytarabine in relapsed/refractory aml at the 50th Annual Meeting of the American Society...on. Early data show that six of fourteen evaluable aml patients in first relapse enrolled in the Phase 2 ...

Vion Pharmaceuticals Submits New Drug Application for Onrigin(TM)

...sent an important new treatment option for elderly aml patients, many of whom now have no effective thera...ndard remission-induction therapy in patients with aml and myelodysplastic syndromes (MDS); (iii) a Phase... Cancer Society estimates that 13,290 new cases of aml were diagnosed in the U.S. in 2008....

Sunesis Pharmaceuticals Provides Year-End Clinical Update on Voreloxin

...ed to advance the development of voreloxin in both aml and ovarian cancer. We believe voreloxin has the ...stant ovarian cancer study and both of our ongoing aml studies are enrolling well, with 45 aml patients enrolled in the fourth quarter of 2008 al...

Aegera Therapeutics Initiates A Randomized Phase 2 Combination Study of AEG35156 for 1st Line Treatment of Non-Small Cell Lung Cancer

...ation of this randomized Phase 2 study in lung cancer follows very shortly after our publication of positive clinical data from our Phase 1/2 study in aml at the recent ASH conference in San Francisco and represents the first of multiple new clinical trials for this innovative therapy that we hope to ann...

Alfacell's ONCONASE(R) and R-Amphinase Show Anti-Tumor Activity in Chronic Lymphocytic Leukemia and Acute Myeloblastic Leukemia Cells

...lls isolated from 22 patients with newly diagnosed aml were cultured for 24-72 hours with either ONCONASE...oribonucleases showed significant activity against aml cells. The main mechanism of this action was shown...bination of ONCONASE or R-Amph with doxorubicin in aml exhibited significant synergistic cytotoxicity, an...

Vion Pharmaceuticals to Present Survival Data on Laromustine at ASH Annual Meeting

...igin(TM) (laromustine) with cytarabine in elderly patients with acute myelogenous leukemia, with standard remission-induction therapy in patients with aml and myelodysplatic syndromes (MDS), with temozolomide in brain tumors, and with stem cell transplantation in advanced hematologic malignancies, are al...

Aegera Therapeutics' phase 1/2 clinical trial results selected for oral presentation at 2008 ASH Annual Meeting

...cy of AEG35156 in combination with chemotherapy in aml patients in first relapse after a short initial CR...bination therapy may induce high response rates in aml patients not responding to frontline induction the...ytarabine in Patients with Relapsed/Refractory aml Session Name: Acute Myeloid Leukemia - Th...

NIST studies how new helium ion microscope measures up

... (AML), one of the most environmentally stable research facilities in the world. Carefully controlled for vibration, humidity and temperature changes, aml labs are optimal sites to test new microscope technology, say the researchers. What we are learning, explains Postek, goes directly back to the manufa...

Biopure Announces 2008 Third Quarter Financial Results

...he Company's pending application for marketing authorization for Hemopure. The Company decided to apply its limited resources to the submission of the aml protocol and working with the FDA. As previously noted, FDA and the MHRA have communicated about Hemopure. BPAC Meeting On September 11, 2008, Bio...

Genzyme Reports Strong Second-Quarter Growth

...ne treatment for pediatric patients with acute lymphoblastic leukemia. Genzyme is developing Clolar for use globally as a first-line therapy for adult aml and myelodysplastic syndromes, significantly larger indications that the company estimates will drive peak annual sales of the product to approximatel...

Lorus Therapeutics Announces Publication of a Clinical Study Demonstrating Encouraging Results with LOR-2040 in Combination with Cytarabine in Patients with Acute Myeloid Leukemia (AML)

...er Research 2008; 14 (12): 3889-3895). This was the first clinical study in aml with GTI-2040, now known as LOR-2040. The primary author, Dr Rebecca Klis... relationship of the targeted activity of LOR-2040 to clinical responses in aml patients less than 60 years of age. Downregulation of R2, the target of LOR...

Genzyme Reports Strong First-Quarter Growth

...ted States later this year to include an adult aml indication. This application will be based on ...he CLASSIC II clinical trial involving older adult aml patients. Preliminary data from this trial wi... Genzyme is developing a new filing for the adult aml indication in Europe. This follows its withdr...

ARIUS presents new findings for anti-cancer antibody programs at AACR

... Anti-CD44 antibody, ARH460-16-2, binds to human aml CD34+CD38- cancer stem cells and demonstrates anti-tumor activity in an aml xenograft model. Abstract Number 3976. Experimenta...ntibody shows very potent anti-tumor effects in an aml tumor model (57% tumor growth inhibition at a 10 m...

Sunesis Pharmaceuticals Reports Fourth Quarter and Full-Year 2007 Financial Results

...n with cytarabine in relapsed or refractory aml patients is in progress. Sunesis plans to begin ...se schedule in previously untreated elderly aml patients in the first half of 2008. Sunesi...cts to report data later this year for both aml clinical trials. -- Results from a non-clinical...

ARIUS announces five abstracts selected for presentation at 2008 AACR Annual Meeting

... Abstract Number 3976: "Anti-CD44 antibody, ARH460-16-2, binds to human aml CD34+CD38- cancer stem cells and demonstrates anti-tumor activity in an aml xenograft model." Experimental and Molecular Therapeutics 32, Tuesday, Apri...

ARIUS presents new findings showing therapeutic antibody inhibits human leukemic cancer stem cells

...e long-term survival expectation for patients with aml is poor due to disease relapse and resistance to c... for increasing survival and decreasing relapse in aml and possibly other forms of leukemia." "ARIUS is...s highly expressed and differentially expressed in aml versus normal stem cells (42.7+10.1% verus 9.9+2.8...

ARIUS announces fourth quarter and year-end fiscal 2007 financial results

... primate model. - Achieved significant and potent tumor growth inhibitory activity in in vivo animal models of breast, prostate, liver, and aml cancers. - Engaged the manufacturer Avid Bioservices to produce ARIUS' lead anti-CD44 MAb under Current Good Manufacturing Practices ("cGMP") ...

Arius completes Pre-IND Meeting with FDA for Lead CD44 Cancer Stem Cell Program

...imiting toxic effects at doses up to 95 mg/kg and significant tumor growth inhibitory activity in in vivo animal models of breast, prostate, liver and aml cancers. The Company will now complete manufacturing and advanced toxicology studies toward filing the IND later this year. About ARIUS ARIUS is a...

ARIUS announces manufacturing agreement with Avid Bioservices for CD44 Cancer Stem Cell antibody

...miting toxic effects at doses up to 95 mg/kg and significant tumor growth inhibitory activity in in vivo animal models of breast, prostate, liver, and aml cancers. The CD44 Cancer Stem Cell program was generated using ARIUS' proprietary FunctionFIRST(TM) technology, which selects antibodies based on thei...

Three Astex Drug Candidates to be Presented at the 2007 American Society of Hematology Annual Meeting

...idence of the anti-leukemic activity of AT9283 at well-tolerated doses in patients with relapsed and refractory haematological malignancies, including aml and CML. These results are encouraging and support further clinical development of AT9283." In addition to AT9283, AT7519 and AT9311, Astex has disc...

ARIUS announces cancer stem cell antibody program successfully completes first toxicology study

... ARIUS' CD44 targeting antibody has demonstrated significant tumor growth inhibitory activity in in vivo animal models of breast, prostate, liver, and aml cancers. In breast cancer models, the antibody demonstrated tumor regression with increased survival at all doses. Two humanized versions of the antib...

Genzyme Affirms Purchase Price for Bioenvision at $5.60 Per Outstanding Share

...s associated with, and investment required for, the further development of clofarabine. We now all know that clofarabine will not be approved in adult aml in the European Union until 2008, at the earliest." Genzyme added that the merger agreement represents the culmination of a thorough auction process ...

Lorus Advances Clinical Development of GTI-2040 Combined with Ara-C in Acute Myeloid Leukemia

...& CEO of Lorus. "The clinical data for GTI-2040 in aml are consistent with an antisense mode of action, a...provide an important new treatment opportunity for aml patients." This new advanced Phase II clinical tr... including HiDAC, is a key component of nearly all aml regimens, for induction, consolidation or salvage ...

Sunesis Pharmaceuticals Announces Reorganization to Focus Resources and Build Value in Clinical-Stage Programs

...latory advisors to design a registration trial for the treatment of elderly aml patients which it plans to initiate by the end of 2008. Additionally, Sunes...is will soon begin dosing patients in a Phase 1b clinical trial of relapsed aml patients, combining SNS-595 with cytarabine, the leading treatment standard...