Myelofibrosis News and Research

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Positive results from Incyte's COMFORT-I INCB18424 pivotal Phase III clinical trial in myelofibrosis

Incyte Corporation announced today positive top-line results from COMFORT-I, the pivotal Phase III clinical trial of INCB18424 (also known as INC424) in patients with myelofibrosis (MF) being conducted under a Food and Drug Administration (FDA) Special Protocol Assessment (SPA) Agreement. COMFORT-I (COntrolled MyeloFibrosis Study with ORal JAK Inhibitor Treatment) is a double-blind, placebo-controlled Phase III trial involving 309 patients.

21 Dec 2010

Mayo Clinic scientists say JAK inhibitors may help treat patients with myelofibrosis

Two janus kinase (JAK) inhibitors are substantially improving treatment of myelofibrosis in patients, say Mayo Clinic researchers who are presenting results of several clinical trials at the 52nd annual meeting of the American Society of Hematology (ASH) Dec. 4 in Orlando.

7 Dec 2010

Positive interim data from Phase I/II trial of CYT387 in myelofibrosis presented at ASH Annual Meeting

YM BioSciences Inc. today announced positive interim data from the first 60 patients enrolled in the Phase I/II trial for its JAK1/JAK2 inhibitor, CYT387, in myelofibrosis. The results were reported today in an oral presentation at the 52nd American Society of Hematology Annual Meeting being held in Orlando, Florida.

7 Dec 2010

YM BioSciences expands CYT387 Phase I/II clinical trial for myelofibrosis in five sites

YM BioSciences Inc., today reported that the Phase I/II clinical trial for its orally available JAK1/JAK2 inhibitor, CYT387, in patients with myelofibrosis has been expanded to five sites. Of the additional sites, the Stanford Cancer Center (Stanford, California) under Principal Investigator Jason Gotlib, MD has already commenced enrolling patients.

19 Nov 2010

Celgene third quarter non-GAAP total revenue increases 31% to $908 million

Celgene Corporation announced non-GAAP net income of $349.9 million, or non-GAAP diluted earnings per share of $0.75 for the quarter ended September 30, 2010.

28 Oct 2010

EC grants orphan drug designation to S*BIO's SB1518 for treatment of myelofibrosis

S*BIO Pte Ltd today announced that the European Commission (EC) has granted orphan drug designation to SB1518, its potent and orally active JAK2 inhibitor for the treatment of primary myelofibrosis (PMF), post-polycythemia vera myelofibrosis (PPV-MF) and post-essential thrombocythemia myelofibrosis (PET-MF). SB1518 has also received orphan drug designation from the U.S. Food and Drug Administration (FDA) for the treatment of the same disorder.

18 Oct 2010

Incyte Corporation publishes clinical trial data of INCB18424 drug for myelofibrosis treatment

Incyte Corporation, Results from a Phase I/II study of Incyte's janus kinase (JAK) inhibitor with the investigational name INCB18424 (also known as INCB018424 and INC424) were published today in The New England Journal of Medicine, demonstrating marked and durable clinical benefits in patients with myelofibrosis.

16 Sep 2010

JAK oral medication produces lasting relief for patients with myelofibrosis: Researchers

An oral medication produces significant and lasting relief for patients with myelofibrosis, a debilitating and lethal bone marrow disorder, researchers at The University of Texas MD Anderson Cancer Center report in the Sept. 16 New England Journal of Medicine.

16 Sep 2010

Incyte Corporation enters SPA agreement with FDA for INCB18424 inhibitor

Incyte Corporation announced today that it has reached agreement with the U.S. Food and Drug Administration (FDA) regarding a Special Protocol Assessment (SPA) for the design of a pivotal Phase III trial for its JAK1 and JAK2 inhibitor, INCB18424 in patients with polycythemia vera (PV), a blood cancer that belongs to a group of diseases known as myeloproliferative neoplasms (MPNs).

13 Sep 2010

FDA grants Orphan Drug Designation to YM BioSciences' JAK1/2 inhibitor

YM BioSciences Inc., announced that the Office of Orphan Products Development of the U.S. Food and Drug Administration has granted Orphan Drug Designation to the Company's highly-selective JAK1/2 inhibitor, CYT387, for the treatment of myelofibrosis, a chronic debilitating unmet medical need, in which a patient's bone marrow is replaced by scar tissue, and for which treatment options are limited or unsatisfactory.

10 Aug 2010

Incyte second-quarter total revenues increase to $49.8 million

Incyte Corporation today reported second quarter 2010 financial results and described progress for several of its clinical programs.

5 Aug 2010

YM concludes dose-escalation in CYT387 Phase I/II clinical trial for myelofibrosis

YM BioSciences Inc., announced the conclusion of dose-escalation in the Phase I portion of its Phase I/II clinical trial of CYT387 at Mayo Clinic in patients with myelofibrosis. In total, 21 patients were treated in Phase I, with no voluntary withdrawals reported. CYT387 has shown significant activity in reducing spleen size and controlling constitutional symptoms in these patients.

5 Aug 2010

Celgene second-quarter non-GAAP total revenue increases 36% to $850 million

Celgene Corporation announced non-GAAP net income of $323.3 million, or non-GAAP diluted earnings per share of $0.69 for the quarter ended June 30, 2010. Non-GAAP net income for the second quarter of 2009 was $216.0 million or non-GAAP diluted earnings per share of $0.46.

29 Jul 2010

Sanofi-aventis signs agreement to acquire TargeGen

TargeGen, Inc., a privately held biotechnology company focused on the development of small molecule kinase inhibitors today announced that the Company has agreed to be acquired by sanofi-aventis. Under the agreement, the ultimate purchase price will depend on the achievement of certain future milestones events and will total $560M if such milestones are fully realized. The closing of the transaction is expected to occur in the 3rd quarter of 2010.

1 Jul 2010

S*BIO completes enrollment in SB1518 JAK2 inhibitor Phase 2 clinical trials for myelofibrosis

S*BIO Pte Ltd today announced that it has completed enrollment of patients in two separate Phase 2 clinical trials for its potent and orally-active JAK2 inhibitor SB1518 at multiple clinical sites in the U.S. and Australia for the treatment of myelofibrosis (MF).

9 Jun 2010

YM BioSciences raises $3.2M through non-brokered private placement of common shares

YM BioSciences Inc., announced today that it has raised approximately US$3.2 million through a non-brokered private placement of 2,500,000 common shares to be issued at US$1.27. The sale price is at no discount to the closing price of the shares on the NYSE Amex on June 1, 2010.

4 Jun 2010

S*BIO, Onyx Pharmaceuticals expand development, commercialization collaboration for JAK2 Inhibitors

S*BIO Pte Ltd and Onyx Pharmaceuticals, Inc. today announced the expansion of their development collaboration and option and license commercialization agreement for S*BIO's novel JAK2 inhibitors, SB1518 and SB1578, also known as ONX 0803 and ONX 0805, respectively. The expanded agreement builds upon the development and commercialization collaboration between the two companies announced in January 2009.

5 May 2010

Celgene's first-quarter non-GAAP total revenue up 31% to $789 million

Celgene Corporation announced non-GAAP net income of $294.6 million, or non-GAAP diluted earnings per share of $0.63 for the quarter ended March 31, 2010. Non-GAAP net income for the first quarter of 2009 was $205.1 million or non-GAAP diluted earnings per share of $0.44. Based on U.S. GAAP, Celgene reported net income of $234.4 million, or diluted earnings per share of $0.50 for the quarter ended March 31, 2010. GAAP net income for the first quarter of 2009 was $162.9 million, or diluted earnings per share of $0.35.

29 Apr 2010

Pivotal preclinical data of YM BioSciences' CYT387 JAK1/2 inhibitor pre-published in Blood

YM BioSciences Inc., announced the pre-publication of pivotal preclinical data for CYT387, the company's highly selective and potent JAK1/2 inhibitor, currently in a Phase I/II trial for myelofibrosis.

19 Apr 2010

Rebirth of the cursed drug Thalidomide

Thalidomide was once a dreaded name in the Pharmaceutical industry. It was initially marketed in some European countries nearly 5 decades back as a sedative and after millions of pregnant women took it for morning sickness it had devastating results on the babies. The babies were born with flippers instead of limbs a condition known as phocomelia. Since then it has been under strict control.

5 Apr 2010