Oblimersen: Augmerosen, BCL-2 antisense oligonucleotide - Genta, G 3139, GC 3139, oblimersen sodium

Drugs in R and D

Volumn 8, Issue 5, 2007, Pages 321-334

[No Author Info available]

Author keywords

[No Author keywords available]

Indexed keywords

CARBOPLATIN; CYCLOPHOSPHAMIDE; DACARBAZINE; DEXAMETHASONE; DOCETAXEL; ETOPOSIDE; FLUDARABINE; MESSENGER RNA; OBLIMERSEN; PROSTATE SPECIFIC ANTIGEN; PROTEIN BCL 2; RITUXIMAB;

ACUTE GRANULOCYTIC LEUKEMIA; ANEMIA; ANTINEOPLASTIC ACTIVITY; AREA UNDER THE CURVE; ARTHRALGIA; ASTHENIA; CHRONIC LYMPHATIC LEUKEMIA; CLINICAL TRIAL; CONSTIPATION; DIARRHEA; DRUG APPROVAL; DRUG HALF LIFE; DRUG INDICATION; DRUG WITHDRAWAL; FATIGUE; FEVER; FOOD AND DRUG ADMINISTRATION; HUMAN; HYPERGLYCEMIA; HYPOPHOSPHATEMIA; INJECTION SITE INFLAMMATION; LETHARGY; LEUKOPENIA; MAXIMUM PLASMA CONCENTRATION; MAXIMUM TOLERATED DOSE; MELANOMA; MULTIPLE CYCLE TREATMENT; MULTIPLE MYELOMA; NAUSEA; NEUTROPENIA; PRIORITY JOURNAL; PROSTATE CANCER; RASH; REVIEW; THROMBOCYTOPENIA; VOMITING;

ANIMALS; ANTINEOPLASTIC AGENTS; CLINICAL TRIALS AS TOPIC; HUMANS; NEOPLASMS; OLIGONUCLEOTIDES, ANTISENSE; PROTO-ONCOGENE PROTEINS C-BCL-2; THIONUCLEOTIDES;

EID: 34548614904     PISSN: 11745886     EISSN: None     Source Type: Journal    
DOI: 10.2165/00126839-200708050-00006     Document Type: Review

References (72)

1. Genta Incorporated. Genta Announces 3rd Quarter 2004 Financial Results. Media Release: 9 Nov 2004. Available from: URL: http://www.genta.com
2. Genta Incorporated. Genta Files New Drug Application for FDA Approval of Genasense(R) Plus Chemotherapy for Patients with Advanced or Refractory Chronic Lymphocytic Leukemia. Media Release: 29 Dec 2005. Available from URL: http://www.genta.com
3. Genta Incorporated. Genasense(R) New Drug Application Accepted for Review by FDA. Media Release: 1 Mar 2006. Available from URL: http://www.genta.com
4. Genta Incorporated. Genta Receives Special Protocol Assessment from FDA for Randomized Trial of Genasense(R) Plus Chemotherapy in Chronic Lymphocytic Leukemia. Media Release: 6 Oct 2006. Available from URL: http://www.genta.com
5. Genta Incorporated. Genta Receives FDA Fast Track Designation for Genasense(TM) In Chronic Lymphocytic Leukemia. Media Release: 30 Jun 2003. Available from URL: http://www.genta.com
6. Genta Incorporated. Genta receives orphan drug designation for three new cancer indications. Media Release: 4 Sep 2001. Available from URL: http://www.genta.com
7. Genta Incorporated. Genta receives new fast track designation in U.S. and European orphan drug actions for new cancer indications. Media Release: 20 Sep 2001. Available from URL: http://www.genta.com
8. Genta Incorporated. Genta Incorporated Announces Third Quarter 2006 Financial Results and Corporate Highlights. Media Release: 7 Nov 2006. Available from URL: http://www.genta.com
9. Genta Incorporated. Genasense(R) Marketing Authorization Application in Melanoma Accepted for Review by European Regulatory Agency. Media Release: 01 Feb 2006. Available from URL: http://www.genta.com
10. Genta Incorporated. Genta Completes Marketing Authorization Application to EMEA for Approval of Genasense(R) plus Chemotherapy for Patients with Advanced Melanoma. Media Release: 3 Jan 2006. Available from URL: http://www.genta.com
11. Genta Incorporated. Genta Completes Response to EMEA List of Outstanding Issues for Genasense(R) Marketing Authorization Application in Melanoma. Media Release: 2 Feb 2007. Available from URL: http://www.genta.com
12. Genta Incorporated. CHMP Adopts Negative Opinion on Genasense(R) Application in Melanoma. Media Release: 27 Apr 2007. Available from URL: http://www.genta.com
13. Genta Incorporated, Aventis. FDA Advisory Committee Reviews Genasense(TM) for Use in Advanced Melanoma. Media Release: 3 May 2004. Available from URL: http://www.genta.com
14. Genta Incorporated. Genta Completes New Drug Application for Approval of Genasense(TM) in Patients with Advanced Malignant Melanoma. Media Release: 9 Dec 2003. Available from URL: http://www.genta.com
15. Genta Incorporated. Genta Announces 2nd Quarter 2004 Financial Results. Media Release: 3 Aug 2004. Available from URL: http://www.genta.com
16. Genta Incorporated. Genta announces orphan drug designation from Food and Drug Administration and completes strategic review for its lead compounds, Genasense (TM). Media Release: [2 pages], 7 Aug 2000. Available from URL: http://www.genta.com
17. Genta Incorporated. Genasense(R) Receives Orphan Drug Designation in Australia for Patients With Advanced Melanoma. Media Release: 17 Oct 2006. Available from URL: http://www.genta.com
18. Genta Incorporated, Aventis. Genta and Aventis Report Positive Results in Phase 3 Trial of Genasense(TM) Plus Chemotherapy in Patients with Advanced Malignant Melanoma. Media Release: 10 Sep 2003. Available from URL: http://www.genta.com
19. Genta Incorporated. Genta Reports Fourth Quarter and Year End 2002 Results and Progress. Media Release: 13 Feb 2003. Available from URL: http://www.genta.com
20. Genta Incorporated. Genta Announces New Phase 3 Trial of Genasense(R) in Patients with Advanced Melanoma. Media Release: 18 Apr 2007. Available from URL: http://www.genta.com
21. Genta Incorporated. Genta Initiates Pilot Clinical Trial of Genasense(R) Plus Abraxane(R) and Temodar(R) as First-Line Therapy for Patients with Advanced Melanoma. Media Release: 29 Nov 2006. Available from URL: http://www.genta.com
22. Chi KN, Murray R, Gleave ME, et al. A phase II study of oblimersen sodium (G3139) and docetaxel in patients with metastatic hormone-refractory prostate cancer. 39th Annual Meeting of the American Society of Clinical Oncology: 393 (plus poster) abstr. 1580, 31 May 2003
23. Genta Incorporated. Genasense(TM) Plus Taxotere(R) Reported Active in Patients with Hormone-Refractory Prostate Cancer at ASCO Meeting. Media Release: 3 Jun 2003. Available from URL: http://www.genta.com
24. Webb A, Cunningham D, Cotter F, et al. BCL-2 antisense therapy in patients with non-Hodgkin lymphoma. Lancet 349: 1137-1141, 19 Apr 1997
25. Raynaud F, Foster L, Judson I. Clinical pharmacokinetics of G3139, oligonucleotide antisense to bcl-2. 89th Annual Meeting of the American Association for Cancer Research: 521, 28 Mar 1998
26. Genta Incorporated. Investigator reports on results on Genta's antisense product G3139 in malignant melanoma trial presentation at the Cold Spring Harbor Conference on Prorogrammed Cell Death. Media Release: [3 pages], 1 Oct 1999. Available from URL: http://www.genta.com
27. Cunningham D, Webb A, Waters JS. Preliminary results of a phase I trial of antisense to Bcl-2 in non Hodgkin's lymphoma. Eighth International Congress on Anti-Cancer Treatment: 118, 3 Feb 1998
28. Cotter FE. BCL-2 antisense therapy: in vitro, in vivo and human trial experiences in haematological malignancies. Naunyn-Schmiedeberg's Archives of Pharmacology 358 (Suppl. 1): 205, No. 1, 1998
29. Waters JS, Webb A, Cunningham D. Results of a phase I clinical trial of BCL-2 antisense molecule G3139 (GENTA) in patients with non-Hodgkin's lymphoma. 35th Annual Meeting of the American Society of Clinical Oncology 18: 4, 15 May 1999
30. Jansen B, Wacheck V, Heere-Ress E. A phase I/II study with dacarbazine and bcl-2 antisense oligonucleotide G3139 (GENTA) as a chemosensitizer in patients with advanced malignant melanoma. 35th Annual Meeting of the American Society of Clinical Oncology 18: 531, 15 May 1999
31. Morris MJ, Tong WP, Cordon-Cordo C, et al. A phase I trial of BCL2 antisense drug G3139 (Genta, Inc.) delivered by continuous intravenous infusion alone and in combination with weekly paclitaxel. Clinical Cancer Research 5 (Suppl.): 3732-3733, Nov 1999
32. Tolcher AW, Kuhn J, Basler J, et al. A phase I, pharmacokinetic and biologic correlative study of G3139 (Bcl-2 antisense oligonucleotide) and docetaxel in patients with hormone-refractory prostate cancer. 11th NCI-EORTC-AACR symposium on new drugs in cancer therapy: 148 (plus poster), 7 Nov 2000
33. Genta Incorporated. Investigators report results of Genasense (TM) studies in chronic lymphocytic leukemia. Media Release: [2 pages], 10 Dec 2001. Available from URL: http://www.genta.com
34. Morris MJ, Tong WP, Cordon-Cardo C, et al. BCL-2 antisense (G3139) plus docetaxel for treatment of progressive androgen-independent prostate cancer. European Journal of Cancer 37 (Suppl. 6): 218-219 (plus poster), Oct 2001
35. Marcucci G, Bloomfield CD, Balcerzak SP, et al. Biologic activity of G3139 (Genasense TM), a BCL-2 antisense, in refractory or relapsed acute leukemia. 37th Annual Meeting of the American Society of Clinical Oncology 20: 288 (plus oral presentation), Part 1, 12 May 2001
36. Genta Incorporated. Genasense(TM) Combination With Chemotherapy Reported Useful in Newly Diagnosed Patients With Small Cell Lung Cancer. Media Release: 3 Jun 2003. Available from URL: http://www.genta.com
37. Genta Incorporated. Final Report of Genasense Phase 3 Trial in Melanoma Published in Journal of Clinical Oncology. Media Release: 15 Sep 2006. Available from URL: http://www.genta.com
38. Genta Incorporated. Genasense(R) Phase 3 Results in Malignant Melanoma Updated at ASCO. Media Release: 16 May 2005. Available from URL: http://www.genta.com
39. Chanan-Khan AA, Niesvizky R, Hohl RJ, et al. Randomized multicenter phase 3 trial of high-dose dexamethasone with or without oblimersen sodium (G3139; Bcl-2 antisense; Genasense) for patients with advanced multiple myeloma. Blood 104: 413 (plus poster) abstr. 1477, No. 11, Part 1, 16 Nov 2004
40. Genta Incorporated. Phase 3 Results of Genasense(R) Plus Dexamethasone in Patients With Advanced Multiple Myeloma Presented at ASH Meeting. Media Release: 4 Dec 2004. Available from URL: http://www.genta.com
41. Genta Incorporated. Genasense(R) Significantly Increases Major Responses in Patients with Advanced Chronic Lymphocytic Leukemia. Media Release: 6 Dec 2004. Available from URL: http://www.genta.com
42. Genta Incorporated. Phase 2 Results of Genasense(R) Plus Chemotherapy in Advanced Prostate Cancer Reported at Cancer Conference. Media Release: 23 Feb 2007. Available from URL: http://www.genta.com
43. Marcucci G, Byrd JC, Dai G, et al. Phase 1 and pharmacodynamic studies of G3139, a Bcl-2 antisense oligonucleotide, in combination with chemotherapy in refractory or relapsed acute leukemia. Blood 101: 425-432, 15 Jan 2003
44. Genta Incorporated. Investigators report Genta's antisense drug combined with standard chemotherapy cures human lymphomas and breast cancers in mouse models. Media Release: [3 pages], 19 Apr 1999. Available from URL: http://www.frbinc.com
45. Genta Incorporated. Major progress in aggressive cancer type reported for Genta'a lead antisense drug. Media Release: [1 page], 14 Apr 2000. Available from URL: http://www.genta.com
46. Genta Incorporated. New results from Genta's Gensynergy TM program show marked enhancement of cisplatin activity by Genasense TM in stomach cancer. Media Release: [2 pages], 12 Oct 2001. Available from URL: http://www.genta.com
47. Genta Incorporated. New studies show Genasense (TM) potentiates anticancer actions of Taxotere (R) and Rituxan (R). Media Release: 8 Apr 2002. Available from URL: http://www.genta.com
48. Genta Incorporated. New Experimental Results Show Genasense(R) Enhances Radiation Therapy in Colon Cancer. Media Release: 19 Oct 2005. Available from URL: http://www.genta.com
49. Brown BD, Paine-Murrieta GD, Von HOff DD, et al. Intermittent dosing of Bcl-2 antisense (Genasense) increases anti-cancer activity as a single-agent and in combination with cytotoxic chemotherapy. 17th AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics: 65-66 (plus poster) abstr. A39, 14 Nov 2005
50. Genta Incorporated. Preclinical Results Show Genasense(TM) Synergizes with Campath(R) in Chronic Lymphocytic Leukemia. Media Release: 4 Jun 2003. Available from URL: http://www.genta.com
51. Cotter FE, Auer R, corbo M, et al. Oblimersen sodium (G3139) sensitizes malignant B-cells to alemtuzumab induced apoptosis. 39th Annual Meeting of the American Society of Clinical Oncology: 227, 31 May 2003
52. Genta Incorporated. New data reaffirm Genta's molecular target as critical factor for enhancing anticancer treatment. Media Release: [3 pages], 27 Mar 2001. Available from URL: http://www.genta.com
53. Genta Incorporated. Genasense (TM) shown to be highly synergistic with additional anticancer drugs at European Hematology Meeting. Media Release: [2 pages], 25 Jun 2001. Available from URL: http://www.genta.com
54. Genta Incorporated. Single-Agent Activity of Genta?s Lead Anticancer Compound, Genasense(TM), Reported in Nasopharyngeal Carcinoma. Media Release: 9 Apr 2003. Available from URL: http://www.genta.com
55. Genta Incorporated. Preclinical Studies Demonstrate Activity of Genasense(TM) Alone and in Combination with Radiation Therapy. Media Release: 19 Nov 2003. Available from URL: http://www.genta.com
56. Genta Incorporated. Genta Incorporated Announces Fourth Quarter and Year End 2004 Results. Media Release: 17 Feb 2005. Available from URL: http://www.genta.com
57. Genta Incorporated. New Analyses from Phase 3 Trial in CLL Identify Relapsed Patients who Maximally Benefit from Genasense(R) Treatment. Media Release: 8 Nov 2006. Available from URL: http://www.genta.com
58. Genta Incorporated. Updated Analysis from Phase 3 Trial of Genasense(R) in CLL Shows Significant Increase in Duration of Major Responses. Media Release: 13 May 2005. Available from URL: http://www.genta.com
59. Genta Incorporated. Data from Phase 3 Trial of Genasense(R) Confirm Extended Durability of Remission and Benefit in Patients with Relapsed or Refractory Chronic Lymphocytic Leukemia. Media Release: 19 Sep 2005. Available from URL: http://www.genta.com
60. Genta Incorporated. Single-Agent Activity of Genta?s Lead Anticancer Compound, Genasense(TM), Reported in Patients with Advanced Chronic Lymphocytic Leukemia. Media Release: 9 Dec 2002. Available from URL: http://www.genta.com
61. Jansen B, Wacheck V, Heere-Ress E, et al. Systemic treatment with bcl-2 antisense down-regulates tumor content of bcl-2 protein and induces major antitumor responses in patients with melanoma when combined with dacarbazine. 91st Annual Meeting of the American Association for Cancer Research: late-breaking abstracts: 7, 1 Apr 2000
62. Genta Incorporated. Genta's lead antisense drug reported active in malignant melanoma new data on antisense mechanism and clinical response reported in leading journal. Media Release: [3 pages], 17 Nov 2000. Available from URL: http://www.genta.com
63. Jansen B, Wacheck V, Heere-Ress E, et al. Chemosensitisation of malignant melanoma by BCL2 antisense therapy. Lancet 356: 1728-1733, 18 Nov 2000
64. Genta Incorporated. Genta Announces Updated Results From Its Phase 3 Trial of Genasense(TM) for Advanced Melanoma. Media Release: 7 Jun 2004. Available from URL: http://www.genta.com
65. Genta Incorporated. Clinical Study Results Show Genasense(TM) May Delay Progression in Patients With Aggressive Non-Hodgkin?s Lymphoma. Media Release: 2 Jun 2003. Available from URL: http://www.genta.com
66. Genta Incorporated. Genasense(TM) plus Rituxan(R) Reported Active in Non-Hodgkin?s Lymphoma. Media Release: 8 Dec 2003. Available from URL: http://www.genta.com
67. Genta Incorporated. Clinical Activity of Genasense in Patients with Refractory Myeloma Highlighted in Multiple Presentations at International Scientific Meeting. Media Release: 27 May 2003. Available from URL: http://www.genta.com
68. Genta Incorporated. Genasense(TM) Reported Active in Combination with Chemotherapy in Multiple Myeloma. Media Release: 9 Dec 2003. Available from URL: http://www.genta.com
69. Genta Incorporated. Genasense(R) plus Rituximab Reported Active in Patients with Relapsed Non-Hodgkin?s Lymphoma. Media Release: 13 Jun 2005. Available from URL: http://www.genta.com
70. Genta Incorporated. Pilot Clinical Study of Genasense(R) Plus Rituxan(R) and Fludarabine Shows Activity in Chronic Lymphocytic Leukemia. Media Release: 12 Dec 2005. Available from URL: http://www.genta.com
71. Genta Inc. Genta gets early positive results of Genasense clinical trial. Media Release: [3 pages], 13 Nov 2000. Available from URL: http://www.genta.com
72. Cancer Therapy & Research Center. G3139 (Genasense (TM)) in combination with docetaxel (Taxotere (Rm)) shows promise in advanced prostate cancer. Media Release: [4 pages], 12 May 2001