Team Work, That is what Life is all about. Here is a Inspirational Speech That Motivates me EveryDay. So i thought I would Share it with all of YOU. We Are All A TEAM Here. We Don't have a say it what the FDA says, But we have a say in how we treat each other Stay Focused Win or Lose :) http//www.youtube.com/watch?v=WO4tIrjBDkk
http://www.genta.com
Ticker Symbol: GETA.OB
Genta Incorporated
200 Connell Drive
Berkeley Heights, NJ 07922
Phone: 908-286-9800
Fax: 908-464-1701
Genta Incorporated operates as a biopharmaceutical company with a diversified product portfolio that is focused on delivering products for the treatment of patients with cancer. Its research portfolio consists of two programs, DNA/RNA Medicines and Small Molecules. The company's lead compound from its DNA/RNA Medicines program is Genasense (oblimersen sodium) injection that is designed to block the production of a protein, known as Bcl-2, which is a fundamental cause of the inherent resistance of cancer cells to anticancer treatments, such as chemotherapy, radiation, and monoclonal antibodies. Genta Incorporated is recruiting patients to the AGENDA Trial, a global Phase III trial of Genasense in patients with advanced melanoma. Its lead drug in its Small Molecule program is Ganite (gallium nitrate injection), which is marketed in the United States for the treatment of symptomatic patients with cancer-related hypercalcemia that is resistant to hydration. The company also develops G4544, an oral formulation of the active ingredient in Ganite, which entered clinical trials as a potential treatment for diseases associated with accelerated bone loss. In addition, it is developing tesetaxel, an orally absorbed, semi-synthetic taxane that is in the same drug class as paclitaxel and docetaxel. The company was founded in 1988 and is based in Berkeley Heights, New Jersey.
Genta has built a broad portfolio of proprietary products in various stages of clinical development. The Company’s lead compound, Genasense® (oblimersen sodium) Injection, has been studied in over 2300 patients with a wide variety of tumor types. At Genta, we are aggressively leveraging our expertise in clinical oncology research by expanding and diversifying our R&D pipeline. We are building a portfolio of products targeted against some of the most deadly diseases and conditions facing patients with cancer today. With four products in the pipeline and on-going clinical trials in all phases of development (Preclinical to Phase III).
Genta’s research platform is anchored by two major programs that center on oligonucleotides (RNA- and DNA- based medicines) and small molecules. Genasense® (oblimersen sodium) Injection is the Company’s lead compound from its oligonecleotide program. The leading drug candidate from the small molecule program is G4544. This compound has the same active ingredient as Ganite (gallium nitrate) Injection, a product currently marketed by Genta. G4544 represents the successful reformulation of the clinically active ingredient into a tablet formulation that can be taken by mouth for extended periods. The IND proposes a dose-ranging trial of G4544 in normal volunteers that will examine safety and pharmacokinetics providing a rapid path to regulatory approval.
For an overview of methodologies and concepts motivating the above, please visit http://www.genta.com/technologies/
GETA Management
Raymond P. Warrell, Jr., M.D. has been our Chief Executive Officer and a member of our Board since December 1999 and our Chairman since January 2001. From 1978 to 1999, Dr. Warrell was associated with the Memorial Sloan-Kettering Cancer Center in New York, where he held tenured positions as Member, Attending Physician, and Associate Physician-in-Chief, and with the Cornell University Medical College, where he was Professor of Medicine. Dr. Warrell also has more than 20 years of development and consulting experience in pharmaceuticals and biotechnology products. He was a co-founder and chairman of the scientific advisory board of PolaRx Biopharmaceuticals, Inc., which originated Trisenox®, a drug for the treatment of acute promyelocytic leukemia. Dr. Warrell holds or has filed numerous patents and patent applications for biomedical therapeutic or diagnostic agents. He has published more than 100 peer-reviewed papers and more than 240 book chapters and abstracts, most of which are focused upon drug development in oncology. Dr. Warrell is a member of the American Society of Clinical Investigation, the American Society of Hematology, the American Association for Cancer Research and the American Society of Clinical Oncology. Among many awards, he has received the U.S. Public Health Service Award for Exceptional Achievement in Orphan Drug Development from the FDA.
Loretta M Itri, M.D., F.A.C.P. is President, Pharmaceutical Development and Chief Medical Officer. Previously, Dr. Itri was Senior Vice President, Worldwide Clinical Affairs, and Chief Medical Officer at Ortho Biotech Inc, a Johnson & Johnson company. As the senior clinical leader at Ortho Biotech and previously at J&J’s R.W. Johnson Pharmaceutical Research Institute (PRI), she led the clinical teams responsible for NDA approvals for Procrit® (epoetin alpha), that company’s largest single product. She had similar leadership responsibilities for the approvals of Leustatin®, Renova®, Topamax®, Levaquin®, and Ultram®. Prior to joining J&J, Dr. Itri was associated with Hoffmann-La Roche, most recently as Assistant Vice President and Senior Director of Clinical Investigations, where she was responsible for all phases of clinical development programs in immunology, infectious diseases, antivirals, AIDS, hematology, and oncology. Under her leadership in the areas of recombinant proteins, cytotoxic drugs and differentiation agents, the first successful Product License Application (PLA) for any interferon product Roferon-A® (interferon alfa) was compiled.
The Entire Genta TEAM, can be viewed and researched here http://www.genta.com/about/boardOfDirectors.php?v=2
Stock Information
BNYMellon Shareowner Services
Newport Office Center VII
Jersey City, NJ 07310-1900
Current Share Structure per Ray during RR convention 9-9-09
Float 135 Mill
225-250 mill convertible Notes (Most Locked up long term)
100 mill common warrants
80 mill stock options
Per Ray fully dilluted if everything cashed in this moment Low 500 mill..
Updated Float per Sept 11-09 169,684,485 mill
UpDated Float per Dec 19-09 (SC/13G/A) 191,810,882 Released 1-13-10 http://ih.advfn.com/p.php?pid=nmona&cb=1263426371&article=41096231&symbol=NB%5EGETA
A Phase 3 Randomized Double-Blind, Placebo Controlled Trial of Genasense® Plus Dacarbazine vs. Dacarbazine Alone In Advanced Melanoma
The AGENDA Trial is the second randomized Phase 3 trial in advanced melanoma for Genasense®. The trial is designed to expand evidence for the safety and efficacy of Genasense® combined with dacarbazine for patients who have not previously been treated with chemotherapy. The study will prospectively target patients using a biomarker that identified patients who derived maximal benefit in the preceding trial of Genasense®, including significant increases in overall and progression-free survival.
Genasense® (oblimersen sodium) Injection - ADVANCED MELANOMA
In its initial trial, Genta performed the largest randomized controlled trial that has ever been conducted in patients with advanced melanoma. The melanoma trial was a front-line trial conducted in patients who had not previously received systemic chemotherapy (prior immunotherapy was allowed.) A total of 771 patients were randomized to receive Genasense® (oblimersen sodium) Injection plus dacarbazine (DTIC) or dacarbazine alone. The primary end-point of the study was overall survival; secondary end-points included overall response and progression-free survival (PFS).
Tesetaxel
Tesetaxel is a novel oral semi-synthetic taxane. Taxanes, such as paclitaxel (Taxol®) and docetaxel (Taxotere®), are mainstays of modern anticancer therapy. These drugs are believed to kill cancer cells by disrupting critical cellular proteins. Taxanes have been formally approved by FDA for the treatment of breast, lung, ovarian, gastric, and prostate cancers. However, all currently approved taxanes require intravenous (IV) infusion under close medical supervision. Moreover, both paclitaxel and docetaxel can cause severe, occasionally fatal, infusion reactions, which require pre-medication with steroids and antihistamines. Other serious reactions associated with taxanes include long-lasting damage to peripheral nerves (neuropathy). An oral taxane with the anticancer activity of the IV drugs could provide substantially greater patient safety (by eliminating infusion reactions and precluding the need for pre-medication), a high level of patient convenience, and potentially greater flexibility to explore novel dosing schedules that might improve overall outcomes for patients.
To learn more about this ground breaking drug Tesetaxel please visit http://www.genta.com/clinical_development/tesetaxel.php?v=6
Oral Gallium Compound (G4544) is another powerful drug being tested by Genta.
For more info on (G4544) please visit http://www.genta.com/pipeline/oralgallium.php?v=5
GNTA Products in Circulation
Ganite -- Cancer Drug
Website: http://www.ganite.com/index.shtml
For more technical information on this drug, please visit: http://www.ganite.com/prescribing/clinical_pharmacology.shtml
Ganite: Already Marketed: http://www.ganite.com/
On July 13, 2009, Genta Incorporated (the “Company”) issued a press release announcing that shares of the Company’s common stock will begin trading on July 13 under the symbol GETA.OB after implementation of the Company’s previously announced one-for-fifty reverse stock split of its common stock. The reverse split will reduce the outstanding number of shares of Genta’s common stock from approximately 5.4 billion to approximately 108 million shares
10Q Aug 14 2009 http://ih.advfn.com/p.php?pid=nmona&cb=1251554075&article=39059362&symbol=NB%5EGETA
11.
Subsequent Events
From July 1, 2009 through July 31, 2009, holders of 2008 Notes have voluntarily converted approximately $0.7 million of their notes, resulting in an issuance of approximately 7.0 million shares of common stock. At July 31, 2009, approximately $2.2 million of the 2008 notes were outstanding.
From July 1, 2009 through July 31, 2009 holders of April 2009 Notes have voluntarily converted approximately $0.7 million of their notes resulting in an issuance of approximately 7.0 million shares of common stock. At July 31, 2009, approximately $5.3 million of the April 2009 Notes were outstanding.
On August 6, 2009, the Company entered into an amendment whereby, among other things, the certain accredited institutional investors who were parties to the July 2009 securities purchase agreement agreed to purchase $10 million of additional notes and warrants having the same terms of the July 2009 Notes as well as shares of common stock, increasing their aggregate investment to $13 million.
From July 7, 2009 through July 31, 2009, holders of July 2009 Notes have voluntarily converted approximately $1.4 million of their notes, resulting in an issuance of approximately 13.5 million shares of common stock. At July 31, 2009, approximately $0.8 million of the July 2009 Notes were outstanding
9-9-09 RR conference. Here is the Financial Picture on the Short term 
Here is some pure Genasense®. Info
About AGENDA
AGENDA is a Phase 3, randomized, double-blind, placebo-controlled trial that is intended to support global registration of Genasense for patients with advanced melanoma. The study was designed to confirm certain safety and efficacy results obtained in a prior randomized trial of Genasense combined with dacarbazine (DTIC) in patients who have not previously received chemotherapy (GM301). AGENDA employs a biomarker to define those patients who derived maximum clinical benefit during the preceding study. These patients are characterized by low-normal levels of LDH (lactate dehydrogenase), a tumor-derived enzyme that is readily detected in blood.
Analysis of those efficacy outcomes in GM301, which were observed in 274 patients, showed the following results:
| Endpoint | Genasense/DTIC | DTIC | Hazard Ratio | P |
| Overall response | 20.8% | 7.2% | | 0.002 |
| Durable response | 10.7% | 2.4% | | 0.007 |
| Progression-free survival, median | 3.6 mos. | 1.6 mos. | 0.58 | <0.0001 |
| Overall survival, median | 12.3 mos. | 9.9 mos. | 0.64 | 0.0009 |
A scientific publication that describes efficacy and safety results the prior study (GM301) can be accessed at: http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1. The co-primary endpoints of AGENDA are progression-free survival (PFS) and overall survival
Attention old and new Gentonians, Here is a couple of upcomming events
1.) AGENDA phase 3 results. approx Oct 7th I will update as more info pours in
BERKELEY HEIGHTS, NJ - April 7, 2009 - Genta Incorporated (OTCBB: GNTA.OB) announced that the Company had completed patient enrollment into AGENDA, a Phase 3 trial of Genasense® (oblimersen sodium) Injection in patients with advanced melanoma. Final accrual totaled 315 subjects. We currently project that the final assessment of progression-free survival (PFS) will be analyzed approximately 6 months after the last patient has been enrolled. If positive, we plan discussions with global regulatory agencies regarding submissions for marketing approval based on this result coupled with our extensive prior data." Overall, 315 patients were registered in the AGENDA trial. A total of 79 sites in 12 countries were opened in Europe, the U.S., Canada, and Australia.
2.) May 19th, 2009
- AGENDA Trial Passes Futility and Safety Analysis
- Intent-to-File Notice Submitted to EMEA
Genta has submitted an "intent-to-file" notice via the centralized procedure to the European Medicines Agency (EMEA), along with a request for assignment of rapporteurs. Such notice is required prior to submission of a Marketing Authorization Application (MAA). "Futility analyses after completing accrual have been occasions for failure of two other Phase 3 melanoma drugs earlier this year," said Dr. Raymond P. Warrell, Jr., Genta's Chief Executive Officer. The next milestone is release of final data on progression-free survival (PFS), which is expected in the 4th quarter of this year. If positive, we expect our regulatory applications for Genasense will be based on statistically significant and clinically meaningful improvements in PFS."
August 14th, 2009
AGENDA Phase 3 trial in melanoma passes post-accrual futility analysis
- AGENDA results expected Fourth Quarter 2009
- Genasense in novel combination shows promising activity in melanoma
- Genasense® 1-hour infusion initiated in melanoma
- Additional core patents issued for Genasense®
- Tesetaxel trial shows early efficacy and safety
Timeline of events that have occured within the last 6months.
Fri Oct 9 2009 Ray&Loretta Personal Shares
| Documents | [Amend]General statement of acquisition of beneficial ownership
Acc-no: 0001144204-09-052415 (34 Act) | 2009-10-09 | 005-42004
091114755 |
Fri Nov 20th 2009 Genasense® Given as High-Dose IV Infusion with Chemotherapy Shows Promising Activity in Advanced Melanoma http://ih.advfn.com/p.php?pid=nmona&cb=1259362340&article=40450268&symbol=NB%5EGETA
Mon Nov 16th 2009 Genta Announces Third Quarter 2009 Financial Results and Restructuring to Focus on Core Oncology Initiatives http://ih.advfn.com/p.php?pid=nmona&cb=1259362340&article=40373087&symbol=NB%5EGETA
Mon Nov 16th 2009 Genta Announces Results of AGENDA Phase 3 Trial of Genasense® in Patients with Advanced Melanoma http://ih.advfn.com/p.php?pid=nmona&cb=1259362340&article=40372984&symbol=NB%5EGETA
Wed Oct 28th 2009 Genta Incorporated Announces Conference Call to Review Top-Line Results of AGENDA Phase 3 Trial of Genasense® in Patients with Advanced MelanomaBusiness Wire http://finance.yahoo.com/news/Genta-Incorporated-Announces-bw-1796133311.html?x=0&.v=1
Thu Sept 24th 2009 _s1.http://www.sec.gov/Archives/edgar/data/880643/000114420409049829/v161102htm (Financing)
Fri Sept 4th 2009 Genta Announces Closing of $10 Million in Two Offerings of Common Stock and Convertible Notes http://www.genta.com/investor%20relations/pressreleases2.php?v=4&option=com_content&task=view&id=60&Itemid=&CID=449&SHID=&COID=
Mon Aug 24th 2009 Genta Announces Webcast of 2009 Annual Shareholders Meeting http://www.genta.com/investor%20relations/pressreleases2.php?v=4&option=com_content&task=view&id=60&Itemid=&CID=447&SHID=&COID=
Fri Aug 14th 2009 Genta Incorporated Announces Second Quarter 2009 Financial Results http://www.genta.com/investor%20relations/pressreleases2.php?v=4&option=com_content&task=view&id=60&Itemid=&CID=445&SHID=&COID=
Mon Aug 10th 2009 Genta Incorporated to Host Conference Call to Discuss Second Quarter 2009 Highlights and Financial Results http://www.genta.com/investor%20relations/pressreleases2.php?v=4&option=com_content&task=view&id=60&Itemid=&CID=443&SHID=&COID=
Tue Jul 14th 2009 New Publication Confirms Critical Link of LDH Biomarker in Genasense® Trials to Overall Survival in Advanced Melanoma http://www.genta.com/investor%20relations/pressreleases2.php?v=4&option=com_content&task=view&id=60&Itemid=&CID=442&SHID=&COID=
Mon Jul 13th 2009 Genta Implements Reverse Stock Split http://www.genta.com/investor%20relations/pressreleases2.php?v=4&option=com_content&task=view&id=60&Itemid=&CID=441&SHID=&COID=
Tue Jul 7th 2009 Genta Raises $10 Million in Offering of Common Stock and Convertible Notes http://www.genta.com/investor%20relations/pressreleases2.php?v=4&option=com_content&task=view&id=60&Itemid=&CID=440&SHID=&COID=
Mon Jun29th 2009 Genta Incorporated Announces Delay in Implementation of Reverse Common Stock Split http://www.genta.com/investor%20relations/pressreleases2.php?v=4&option=com_content&task=view&id=60&Itemid=&CID=439&SHID=&COID=
Fri Jun 26th 2009 Board of Directors of Genta Incorporated Announce Reverse Split of Company¿s Common Stock http://www.genta.com/investor%20relations/pressreleases2.php?v=4&option=com_content&task=view&id=60&Itemid=&CID=438&SHID=&COID=
Wed Jun 3rd 2009 Genasense® Combined with Temodar® and Abraxane® Shows Preliminary Evidence of High Response Rates and Extended Survival in Patients with Advanced Melanoma http://www.genta.com/investor%20relations/pressreleases2.php?v=4&option=com_content&task=view&id=60&Itemid=&CID=437&SHID=&COID=
Mon Jun 1st 2009 New Clinical Data for Tesetaxel, a Leading Oral Taxane, Show Anticancer Activity and Acceptable Safety in Ongoing Study http://www.genta.com/investor%20relations/pressreleases2.php?v=4&option=com_content&task=view&id=60&Itemid=&CID=436&SHID=&COID=
Tue May 19th 2009 Independent Data Monitoring Board Recommends Continuation to Completion of Genta’s Phase 3 Trial of Genasense® in Advanced Melanomahttp://www.genta.com/investor%20relations/pressreleases2.php?v=4&option=com_content&task=view&id=60&Itemid=&CID=433&SHID=&COID=
Wed Apr 29th 2009 Genta Updates Late-Stage Progress of its Phase 3 Trial of Genasense® in Advanced Melanoma http://www.genta.com/investor%20relations/pressreleases2.php?v=4&option=com_content&task=view&id=60&Itemid=&CID=429&SHID=&COID=
Tue Apr 28th 2009 Genta Announces Allowance of Two Key European Patents for Genasense® http://www.genta.com/investor%20relations/pressreleases2.php?v=4&option=com_content&task=view&id=60&Itemid=&CID=428&SHID=&COID=
Thu Apr 23rd 2009 Genta Announces Presentations for Two Lead Compounds, Genasense® and Tesetaxel, at 2009 Annual ASCO Meeting http://www.genta.com/investor%20relations/pressreleases2.php?v=4&option=com_content&task=view&id=60&Itemid=&CID=427&SHID=&COID=
Tue Apr 7th 2009 Genta Announces Completion of Patient Enrollment into Global Phase 3 Trial of Genasense® in Advanced Melanoma http://www.genta.com/investor%20relations/pressreleases2.php?v=4&option=com_content&task=view&id=60&Itemid=&CID=426&SHID=&COID=
2010 ASCO June 4-8, 2010 in Chicago, IL http://www.asco.org/ASCOv2/Meetings/ASCO+Annual+Meeting
Next Melanoma Conf is a big one In Berlin Germany Nov 19-21st. http://melanomacongress2009.org/index.php?site=1
Notice Genta is a Major Sponsor. It would be quite embarrassing if a couple weeks earlier they released lousy AGENDA results. Things are starting to add up and is looking really good. This may be where they push for EMEA approval.
