Romidepsin News and Research

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Moffitt investigators to participate with 16 oral and 50 posters presentations at 53rd ASH meeting

When the American Society of Hematology convenes its 53rd Annual Meeting and Exposition on Dec. 10-13 in San Diego, Calif., researchers from Moffitt Cancer Center will break a new record for Moffitt participants with one plenary presentation, 16 oral presentations and more than 50 poster presentations on new research results in a variety of meeting programs that focus on blood cancer basic science and clinical applications, including bone marrow transplantation and clinical trials results.

5 Dec 2011

Celgene's ISTODAX sNDA granted FDA Priority Review classification for progressive/relapsed PTCL

Celgene Corporation today announced that the U.S. Food and Drug Administration (FDA) has granted Priority Review classification to its Supplemental New Drug Application (sNDA) regarding ISTODAX (romidepsin) for injection for the treatment of peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior therapy.

28 Feb 2011

Celgene announces regulatory submissions for blood cancer therapies REVLIMID and ISTODAX

Celgene International Sàrl announced regulatory submissions for its blood cancer therapies REVLIMID (lenalidomide) and ISTODAX (romidepsin).

5 Jan 2011

Pivotal Phase II study data of romidepsin in relapsed PTCL presented at ASH 2010

Celgene International Sàrl today announced that data from a pivotal Phase II, multicenter, international, open-label study of romidepsin (ISTODAX) in progressive or relapsed PTCL following prior systemic therapy were presented at the 52nd American Society of Hematology Annual Meeting.

6 Dec 2010

$Updated Phase 1 study results of FOLOTYN in patients with refractory CTCL presented at ASH 2010$

Updated Phase 1 study results of FOLOTYN in patients with refractory CTCL presented at ASH 2010

Allos Therapeutics, Inc. today reported updated results from the Company's Phase 1 dose-finding study of FOLOTYN® (pralatrexate injection) which supports the selection of 15 mg/m2 weekly for three weeks out of a four-week cycle as the optimal starting dose and schedule for further evaluation in patients with relapsed or refractory cutaneous T-cell lymphoma. Data were presented at the 52nd American Society of Hematology Annual Meeting in Orlando, Florida.

6 Dec 2010

Cyclacel files Answer and Counterclaims to Celgene's declaratory judgment complaint

Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today announced that it filed its Answer and Counterclaims to the declaratory judgment complaint filed by Celgene Corporation.

18 Jun 2010

Celgene seeks court declaration over claims of romidepsin injection usage for T-cell lymphomas

Cyclacel Pharmaceuticals, Inc., a biopharmaceutical company developing oral therapies that target the various phases of cell cycle control for the treatment of cancer and other serious disorders, today announced that it received a complaint filed by Celgene Corporation seeking a declaration from the court that four Cyclacel-owned patents, which claim the use of romidepsin injection in T-cell lymphomas, are not infringed by Celgene's products and are invalid.

3 May 2010

Celgene reports total revenue of $758M for fourth-quarter of 2009

Celgene Corporation announced non-GAAP (Generally Accepted Accounting Principles) net income of $290.3 million, or non-GAAP diluted earnings per share of $0.62 for the quarter ended December 31, 2009. Non-GAAP net income for the fourth quarter of 2008 was $200.9 million or non-GAAP diluted earnings per share of $0.43. Based on U.S. GAAP, Celgene reported net income of $254.2 million, or diluted earnings per share of $0.54 for the quarter ended December 31, 2009. GAAP net loss for the fourth quarter of 2008 was $149.3 million, or diluted loss per share of $0.33.

28 Jan 2010

Celgene acquires Gloucester Pharmaceuticals

Celgene Corporation today announced it has closed its acquisition of Gloucester Pharmaceuticals following the early termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

18 Jan 2010

Gloucester Pharmaceuticals to be acquired by Celgene

Celgene Corporation and Gloucester Pharmaceuticals Inc., a privately held pharmaceutical company, announced a definitive merger agreement under which Celgene Corporation will acquire Gloucester Pharmaceuticals. Celgene says the acquisition will continue to advance its leadership position in the development of disease-altering therapies through innovative approaches for patients with rare and debilitating blood cancers.

7 Dec 2009

Positive data from Gloucester Pharmaceuticals' ISTODAX study presented at the ASH meeting

Gloucester Pharmaceuticals announced today the presentation of positive data from an analysis of ISTODAX® (romidepsin) in a subset of patients from Gloucester’s registration study in cutaneous T-cell lymphoma (CTCL) at the 51st American Society of Hematology (ASH) Annual Meeting being held in New Orleans, LA.

7 Dec 2009

Presentation of preclinical data demonstrating the combination of ISTODAX and Velcade announced

Gloucester Pharmaceuticals announced today the presentation of preclinical data demonstrating that the combination of ISTODAX® (romidepsin) and Velcade® (bortezomib) resulted in synergistic anti-tumor activity in B-cell non-Hodgkin's lymphoma cell lines.

7 Dec 2009

Positive final data from Phase 2 study of ISTODAX presented

Gloucester Pharmaceuticals announced today the presentation of positive final data from a Phase 2 study of ISTODAX® (romidepsin) in peripheral T-cell lymphoma (PTCL) conducted by the National Cancer Institute (NCI) at the 51st American Society of Hematology (ASH) Annual Meeting being held in New Orleans, LA.

6 Dec 2009

ISTODAX included in the updated NCCN Clinical Practice Guidelines in Oncology

Gloucester Pharmaceuticals announced today that ISTODAX® (romidepsin) has been included in the updated National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology™ as a suggested systemic treatment option for patients with mycosis fungoides and Sézary syndrome—two of the most common types of cutaneous T-cell lymphoma (CTCL).

4 Dec 2009

Multiple presentations from clinical and preclinical studies of ISTODAX to be presented

Gloucester Pharmaceuticals today announced multiple presentations from clinical and preclinical studies of ISTODAX® (romidepsin) at the upcoming 51st American Society of Hematology (ASH) Annual Meeting being held in New Orleans, Louisiana, at the Ernest N. Morial Convention Center, December 5 – 8, 2009.

25 Nov 2009

NCCN Guidelines adds ofatumumab and romidepsin as therapy options for CLL

Two recent FDA approvals have prompted the National Comprehensive Cancer Network (NCCN) to update the NCCN Clinical Practice Guidelines in Oncology(TM) for Non-Hodgkin's Lymphomas to include ofatumumab (Azerra(TM), GlaxoSmithKline) and romidepsin (Istodax(R), Gloucester Pharmaceuticals) as treatment options for select patients with two types of Non-Hodgkin's Lymphomas.

24 Nov 2009

FDA approves Istodax for treatment of Cutaneous T-cell Lymphoma

The U.S. Food and Drug Administration has approved Istodax (romidepsin), an injectable medication, for treatment of patients with a rare form of cancer known as Cutaneous T-cell Lymphoma (CTCL).

10 Nov 2009

Gloucester’s romidepsin recommended for approval by the FDA Oncologic Drug Advisory Committee

Gloucester Pharmaceuticals announced today that the Oncologic Drug Advisory Committee (ODAC) appointed by the U.S. Food and Drug Administration (FDA) voted 10 in favor with one abstention to recommend approval of romidepsin to treat patients with cutaneous T-cell lymphoma (CTCL). CTCL is a type of non-Hodgkin's lymphoma, which is a cancer of the immune system.

3 Sep 2009

Gloucester Pharmaceuticals raises funds for the development of romidepsin

Gloucester Pharmaceuticals today announced that it has raised $29 million in a Series D financing. The proceeds will be used to support the ongoing development of romidepsin, a novel histone deacetylase (HDAC) inhibitor for the treatment of T-cell lymphomas and other hematologic malignancies.

26 Aug 2009

Gloucester Pharma announces FDA Advisory Committee Meeting to discuss Romidepsin NDA

Gloucester Pharmaceuticals will discuss the New Drug Application for romidepsin to treat patients with cutaneous T-cell lymphoma (CTCL) at the Oncologic Drugs Advisory Committee (ODAC) meeting on September 2, 2009.

18 Aug 2009

Romidepsin News and Research

Moffitt investigators to participate with 16 oral and 50 posters presentations at 53rd ASH meeting

Celgene's ISTODAX sNDA granted FDA Priority Review classification for progressive/relapsed PTCL

Celgene announces regulatory submissions for blood cancer therapies REVLIMID and ISTODAX

Pivotal Phase II study data of romidepsin in relapsed PTCL presented at ASH 2010

Updated Phase 1 study results of FOLOTYN in patients with refractory CTCL presented at ASH 2010

Cyclacel files Answer and Counterclaims to Celgene's declaratory judgment complaint

Celgene seeks court declaration over claims of romidepsin injection usage for T-cell lymphomas

Celgene reports total revenue of $758M for fourth-quarter of 2009

Celgene acquires Gloucester Pharmaceuticals

Gloucester Pharmaceuticals to be acquired by Celgene

Positive data from Gloucester Pharmaceuticals' ISTODAX study presented at the ASH meeting

Presentation of preclinical data demonstrating the combination of ISTODAX and Velcade announced

Positive final data from Phase 2 study of ISTODAX presented

ISTODAX included in the updated NCCN Clinical Practice Guidelines in Oncology

Multiple presentations from clinical and preclinical studies of ISTODAX to be presented

NCCN Guidelines adds ofatumumab and romidepsin as therapy options for CLL

FDA approves Istodax for treatment of Cutaneous T-cell Lymphoma

Gloucester’s romidepsin recommended for approval by the FDA Oncologic Drug Advisory Committee

Gloucester Pharmaceuticals raises funds for the development of romidepsin

Gloucester Pharma announces FDA Advisory Committee Meeting to discuss Romidepsin NDA

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