posted
All, I've been watching this one. Earnings are going to be posted.
Waiting for FDA approval
what do you think.
BERKELEY HEIGHTS, N.J., Oct. 26 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA - News) announced that the Company will release its Third Quarter 2006 financial results on Tuesday, November 7, 2006. Dr. Raymond P. Warrell, Jr., Chairman and Chief Executive Officer, joined by Richard Moran, Senior Vice President and Chief Financial Officer, will host a conference call and live audio webcast to discuss financial results and recent corporate activities at 8:00 am EST.
Audio replay will be available approximately two hours after the completion of the call, and will be archived for 30 days. Access numbers for this replay are: (800) 642-1687 (U.S./Canada) and (706) 645-9291 (International); conference ID number is: 8803694.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. The Company'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 oligonucleotide program. The Company has submitted a New Drug Application (NDA) to the Food and Drug Administration for the use of Genasense plus fludarabine and cyclophosphamide for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Genta has completed a Marketing Authorization Application to the European Medicines Agency (EMEA) for use of Genasense plus dacarbazine for treatment of patients with advanced melanoma. Genta has additional randomized clinical trials ongoing in patients with acute myeloid leukemia, hormone- refractory prostate cancer, and lung cancer. The leading drug in Genta's small molecule program is Ganite® (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. For more information about Genta, please visit our website at: www.genta.com.
BERKELEY HEIGHTS, N.J., Oct. 6 /PRNewswire-FirstCall/ -- Genta Incorporated (NASDAQ:GNTA) announced that the Company's proposal for a randomized trial of Genasense(R) (oblimersen sodium) Injection in patients with chronic lymphocytic leukemia (CLL) has completed Special Protocol Assessment (SPA) by the Food and Drug Administration (FDA). The SPA, which was submitted in December 2005, documents agreements regarding the trial's design and planned analysis. Genta has filed a New Drug Application (NDA) for Genasense plus chemotherapy, which is currently under review by FDA. The NDA has a target action date for a marketing approval decision by October 29, 2006 under the Prescription Drug User Fee Act (PDUFA).
The proposed trial, which will be conducted in symptomatic patients who have not previously received chemotherapy, would randomize patients to receive fludarabine plus rituximab (Rituxan(R); Genentech, Inc.) with or without Genasense. The pivotal trial in the pending NDA employed a combination of fludarabine plus cyclophosphamide with or without Genasense in patients with relapsed or refractory CLL. The NDA was the subject of a review by FDA's Oncology Drug Advisory Committee (ODAC) on September 6, 2006 and did not receive a majority vote to approve the application.
"We are pleased that FDA had no outstanding issues regarding the design or analysis of this trial, and also with the Agency's agreement that there were no safety issues that precluded the use of Genasense in previously untreated patients," noted Dr. Raymond P. Warrell, Jr., Genta's Chief Executive Officer. "While the NDA remains under active review, we will provide Genasense at no cost to CLL patients in response to single-patient IND requests (also known as "compassionate use" requests). We will not make a decision whether to proceed with this new trial until we have had our requested meeting with FDA to review the status of the pending NDA."
posted
CHICAGO, Oct 17 (Reuters) - Genta Inc. (GNTA.O: Quote, Profile, Research) said on Tuesday its lead cancer drug Genasense received orphan drug designation from regulators in Australia allowing for its use to treat patients with late-stage malignant melanoma, a deadly form of skin cancer.
Genta said the designation was granted for the use of Genasense as treatment for patients with Stage IV malignant melanoma. Orphan drug designation is intended to facilitate the development of drugs that address significant unmet medical needs.
It provides seven years of market exclusivity after approval, grants and tax credits for research and development, and reduced filing fees for marketing applications.
quote:Originally posted by JRB: Looks like the 29th of this month.
BERKELEY HEIGHTS, N.J., Oct. 6 /PRNewswire-FirstCall/ -- Genta Incorporated (NASDAQ:GNTA) announced that the Company's proposal for a randomized trial of Genasense(R) (oblimersen sodium) Injection in patients with chronic lymphocytic leukemia (CLL) has completed Special Protocol Assessment (SPA) by the Food and Drug Administration (FDA). The SPA, which was submitted in December 2005, documents agreements regarding the trial's design and planned analysis. Genta has filed a New Drug Application (NDA) for Genasense plus chemotherapy, which is currently under review by FDA. The NDA has a target action date for a marketing approval decision by October 29, 2006 under the Prescription Drug User Fee Act (PDUFA).
The proposed trial, which will be conducted in symptomatic patients who have not previously received chemotherapy, would randomize patients to receive fludarabine plus rituximab (Rituxan(R); Genentech, Inc.) with or without Genasense. The pivotal trial in the pending NDA employed a combination of fludarabine plus cyclophosphamide with or without Genasense in patients with relapsed or refractory CLL. The NDA was the subject of a review by FDA's Oncology Drug Advisory Committee (ODAC) on September 6, 2006 and did not receive a majority vote to approve the application.
"We are pleased that FDA had no outstanding issues regarding the design or analysis of this trial, and also with the Agency's agreement that there were no safety issues that precluded the use of Genasense in previously untreated patients," noted Dr. Raymond P. Warrell, Jr., Genta's Chief Executive Officer. "While the NDA remains under active review, we will provide Genasense at no cost to CLL patients in response to single-patient IND requests (also known as "compassionate use" requests). We will not make a decision whether to proceed with this new trial until we have had our requested meeting with FDA to review the status of the pending NDA."
Thanks, I'll have it on my watchlist for Monday morning pre-market.
-------------------- Best Regards and Good Trading
IP: Logged |
posted
BERKELEY HEIGHTS, N.J., Oct 30, 2006 /PRNewswire-FirstCall via COMTEX/ -- Genta Incorporated (NASDAQ GM:GNTA) announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it has extended the review period for the currently pending New Drug Application (NDA) for Genasense(R) (oblimersen sodium) Injection plus chemotherapy for patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Genta has requested a meeting with FDA, and the Company has submitted additional data analyses in support of the application. The FDA has indicated that submission of the new information comprises a major amendment to the NDA and has elected to extend the review period for 90 days to January 29, 2007.
"We are pleased that the FDA has agreed to consider this new information during their review of the Genasense NDA," commented Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development, and Chief Medical Officer. "Our pivotal trial met its primary endpoint in the only controlled clinical trial ever conducted in this patient population. Genasense significantly increased the number and length of durable complete remissions, an endpoint that has consistently defined clinical benefit in leukemia. Our new analyses reinforce that conclusion, and we look forward to continued dialog with FDA regarding this application. While the NDA remains under active review, we will continue to provide Genasense at no cost to CLL patients in response to single-patient, 'compassionate use' requests."
The Genasense NDA was reviewed at a meeting of the FDA's Oncologic Drug Advisory Committee meeting on September 6, 2006 where it failed to receive a majority vote to recommend approval. Information about the application can be accessed at: http://www.fda.gov/ohrms/dockets/ac/06/briefing/2006-4235B1-01- 01Genta-background.pdf.
Genasense in CLL
The NDA for Genasense was based on two separate clinical trials. The first was a Phase 1-2 trial that demonstrated the safety and activity of the drug used as a single-agent in 40 patients who had received extensive anti- leukemic therapy. The second trial was a randomized, multicenter, multinational trial in which 241 patients with relapsed or refractory CLL received standard chemotherapy (fludarabine plus cyclophosphamide) with or without Genasense. The trial met its primary endpoint, which was the demonstration of a statistically significant increase in the proportion of patients who achieved complete or nodular partial remission. Patients with this level of remission have no overt evidence of leukemia. Moreover, these remissions were durable (greater than 6 months in duration), they were associated with significant improvement in signs and symptoms of leukemia, and they lasted significantly longer when induced with Genasense compared with chemotherapy alone.
posted
Cipan in the race to buy Genta Inc. Autor: José Polaco Data: 12:02 30/10/2006
Lisbon - Cipan inform the Portuguese National Securities Market Commission (CNMV) that had obtained 6,5 millions of shares of Genta Inc at a average price of 0.79 USD. Cipan will notifie tuesday the Portuguese National Securities Market Commission (CNMV) that it was willing to waive the condition of a 75% minimum acceptance level to which its public offer for the acquisition Genta inc shares was subject, taking into consideration that the response received will be sufficient to develop the business project pursued through the takeover bid. Cipan plans to launch a takeover bid for Genta Inc with the payment of 1,25 USD for each of the that responded to the tender offer, this initial offer could reach the limit of price of 1,7 USD for each share of the american company.
posted
BERKELEY HEIGHTS, N.J., Oct 31, 2006 /PRNewswire-FirstCall via COMTEX/ -- Genta Incorporated (GNTA : genta inc com new News , chart, profile, more Last: 0.82+0.03+3.14% 7:54am 10/31/2006 Delayed quote data Add to portfolio Analyst Create alert Insider Discuss Financials Sponsored by: GNTA0.82, +0.03, +3.1% ) announced that target patient accrual has been completed into a randomized Phase 3 trial of Genasense plus chemotherapy in previously untreated patients with acute myeloid leukemia (AML). The trial was conducted by the Cancer and Leukemia Group B (CALGB), the largest U.S. oncology cooperative group, and was sponsored by the National Cancer Institute (NCI). "There is a pressing need to identify new effective treatments in AML, particularly for high-risk patients, and we are highly gratified by the support of the clinical community in completing rapid accrual onto this trial," commented Loretta M. Itri, M.D., President of Pharmaceutical Development and Chief Medical Officer at Genta. "The Company believes a positive result from this trial may be sufficiently robust to support worldwide regulatory applications in AML. We look forward to evaluating these results with our colleagues in CALGB." In this trial, all patients received standard chemotherapy with daunorubicin and cytarabine (ARA-C), and they were randomly assigned to receive Genasense or no additional therapy. Genasense was given during initial therapy (i.e., "induction") and in two additional chemotherapy cycles ("consolidation") after achieving complete remission (CR). This trial enrolled patients over the age of 59 who had not previously received chemotherapy. Due to the accumulation of additional genetic mutations, these patients are known to have an inferior outcome with standard chemotherapy, achieving lower rates of CR that result in shorter survival. The primary endpoint in the trial is a comparison of overall survival; secondary endpoints include percent CR, remission duration, safety, and other assessments. The CALGB has also conducted a number of correlative laboratory tests in this trial, including measurements of Bcl-2, the biochemical target of Genasense. A minimum target of 500 patients was prospectively specified for accrual, a goal that has now been reached. Data from this trial are expected in 2007. About Genasense Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer. About Genta Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. The Company's research platform is anchored by two major programs that center on oligonucleotides (RNA- and DNA- based medicines) and small molecules. Genasense(R) (oblimersen sodium) Injection is the Company's lead compound from its oligonucleotide program. The Company has submitted a New Drug Application (NDA) to the Food and Drug Administration for the use of Genasense plus fludarabine and cyclophosphamide for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Genta has also completed a Marketing Authorization Application to the European Medicines Agency (EMEA) for use of Genasense plus dacarbazine for treatment of patients with advanced melanoma. The leading drug in Genta's small molecule program is Ganite(R) (gallium nitrate injection), which the Company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. For more information about Genta, please visit our website at: www.genta.com.
posted
(RTTNews) - Genta Inc. (GNTA | charts | news | PowerRating) on Tuesday posted financial results for the third quarter, reporting a net loss of $14.9 million or $0.11 per share compared to a loss of $7.9 million or $0.07 per share in the year ago quarter. The company noted that total operating expenses rose to $15.5 million from $8.1 million in the previous year.
The results for the latest quarter were calculated on 135.59 million shares compared to 105.63 million shares in the previous year.
Quarterly revenues rose to $0.15 million from $86 thousand in the previous year.
On average, 3 analysts polled by First Call/Thomson Financial estimated a loss of $0.11 per share on revenues of $0.24 million.
New Analyses from Phase 3 Trial in CLL Identify Relapsed Patients who Maximally Benefit from Genasense(R) Treatment Wednesday November 8, 8:30 am ET
BERKELEY HEIGHTS, N.J., Nov. 8 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA - News) announced the presentation of new analyses from the Company's randomized Phase 3 trial of Genasense® (oblimersen sodium) Injection in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). In patients who were prospectively stratified as being "non- refractory," Genasense-treated patients were four times more likely to achieve complete remission compared with patients treated with chemotherapy alone. Moreover, these non-refractory patients also achieved a statistically significant increase in overall survival.
ADVERTISEMENT These and other analyses comprised information submitted by Genta to the U.S. Food and Drug Administration last month. Highlights of these data were presented today by Dr. Kanti R. Rai, Chief, Hematology and Oncology, North Shore/Long Island Jewish Medical Center, and Professor of Medicine, Albert Einstein College of Medicine, at the 24th Annual Symposium of the Chemotherapy Foundation in New York.
In the Phase 3 trial, 241 patients with relapsed or refractory CLL were randomly assigned to receive fludarabine plus cyclophosphamide (Flu/Cy) chemotherapy with or without Genasense. This trial -- the first randomized study ever conducted in this patient population -- achieved its primary endpoint, which was a statistically significant increase in the proportion of patients who achieved a complete or nodular partial response (CR/nPR). In addition, the duration of CR/nPR was significantly longer for patients treated with Genasense (median = not reached but exceeding 36+ mos. in the Genasense group vs. 22 mos. for patients treated with chemotherapy alone).
Prior to randomization on this trial, patients were prospectively stratified according to three criteria that reflected their responsiveness to prior chemotherapy. The CR/nPR response to Flu/Cy alone was both equally poor (6-7%) and numerically inferior in all stratification groups. Nonetheless, clear trends were evident across all strata, which suggested the best response to Genasense was achieved in patients who had received less extensive therapy.
Patients who were protocol-defined as "non-refractory" to fludarabine comprised more than 40% of the total population. In non-refractory patients, the Genasense group compared with the chemotherapy-only group achieved:
-- A four-fold increase in CR/nPR (25% [13/51] vs. 6% [3/50]; P = 0.016) -- Increased time-to-progression (median = 12 mos. vs. 10 mos.; P = N.S.) -- Increased overall survival (median not reached but exceeding 39+ mos. vs. 33 mos.; P = 0.05)
Similar trends were observed in the two other strata (i.e., patients who received 1-2 prior regimens, and patients whose response to last therapy was longer than 6 months).
"The Genasense Phase 3 trial met its intent-to-treat primary endpoint across the entire population of relapsed/refractory patients. However, these data clearly define a prospectively specified population that derived maximal benefit from adding Genasense to conventional chemotherapy," commented Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development, and Chief Medical Officer "We are pleased that FDA is taking the additional time to thoughtfully examine these and other new analyses. Together with the community of CLL physician specialists and patients, we look forward to continuing our dialog with the Agency on the pending New Drug Application in CLL."
About Genasense
Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.
About Genta
Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. The company'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 oligonucleotide program. The Company has submitted a New Drug Application (NDA) to the Food and Drug Administration for the use of Genasense plus fludarabine and cyclophosphamide for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Genta has also completed a Marketing Authorization Application to the European Medicines Agency (EMEA) for use of Genasense plus dacarbazine for treatment of patients with advanced melanoma. The leading drug in Genta's small molecule program is Ganite® (gallium nitrate injection), which the company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. For more information about Genta, please visit our website at: www.genta.com.
Safe Harbor
This press release may contain forward-looking statements with respect to business conducted by Genta Incorporated. By their nature, forward-looking statements and forecasts involve risks and uncertainties because they relate to events and depend on circumstances that will occur in the future. Forward- looking statements include, without limitation, statements about:
-- the company's ability to obtain necessary regulatory approval for Genasense® from the U.S. Food and Drug Administration ("FDA") or European Medicines Agency ("EMEA"); -- the safety and efficacy of the company's products or product candidates; -- the company's assessment of its clinical trials; -- the commencement and completion of clinical trials; -- the company's ability to develop, manufacture, license and sell its products or product candidates; -- the company's ability to enter into and successfully execute license and collaborative agreements, if any; -- the adequacy of the company's capital resources and cash flow projections, and the company's ability to obtain sufficient financing to maintain the company's planned operations; -- the adequacy of the company's patents and proprietary rights; -- the impact of litigation that has been brought against the company and its officers and directors; -- the Company's ability to regain compliance with the NASDAQ's listing qualifications; and -- the other risks described under Certain Risks and Uncertainties Related to the company's Business, as contained in the company's Annual Report on Form 10-K and Quarterly Report on Form 10-Q.
The company does not undertake to update any forward-looking statements. There are a number of factors that could cause actual results and developments to differ materially. For a discussion of those risks and uncertainties, please see the company's Annual Report on Form 10-K for 2005 and its most recent quarterly report on Form 10-Q.
posted
BERKELEY HEIGHTS, N.J., Nov 08, 2006 /PRNewswire-FirstCall via COMTEX/ -- Genta Incorporated (GNTA : genta inc com new News , chart, profile, more Last: 0.72+0.05+6.73% 11:36am 11/08/2006 Delayed quote data Add to portfolio Analyst Create alert Insider Discuss Financials Sponsored by: GNTA0.72, +0.05, +6.7% ) announced the presentation of new analyses from the Company's randomized Phase 3 trial of Genasense(R) (oblimersen sodium) Injection in patients with relapsed or refractory chronic lymphocytic leukemia (CLL). In patients who were prospectively stratified as being "non- refractory," Genasense-treated patients were four times more likely to achieve complete remission compared with patients treated with chemotherapy alone. Moreover, these non-refractory patients also achieved a statistically significant increase in overall survival. These and other analyses comprised information submitted by Genta to the U.S. Food and Drug Administration last month. Highlights of these data were presented today by Dr. Kanti R. Rai, Chief, Hematology and Oncology, North Shore/Long Island Jewish Medical Center, and Professor of Medicine, Albert Einstein College of Medicine, at the 24th Annual Symposium of the Chemotherapy Foundation in New York. In the Phase 3 trial, 241 patients with relapsed or refractory CLL were randomly assigned to receive fludarabine plus cyclophosphamide (Flu/Cy) chemotherapy with or without Genasense. This trial -- the first randomized study ever conducted in this patient population -- achieved its primary endpoint, which was a statistically significant increase in the proportion of patients who achieved a complete or nodular partial response (CR/nPR). In addition, the duration of CR/nPR was significantly longer for patients treated with Genasense (median = not reached but exceeding 36+ mos. in the Genasense group vs. 22 mos. for patients treated with chemotherapy alone). Prior to randomization on this trial, patients were prospectively stratified according to three criteria that reflected their responsiveness to prior chemotherapy. The CR/nPR response to Flu/Cy alone was both equally poor (6-7%) and numerically inferior in all stratification groups. Nonetheless, clear trends were evident across all strata, which suggested the best response to Genasense was achieved in patients who had received less extensive therapy. Patients who were protocol-defined as "non-refractory" to fludarabine comprised more than 40% of the total population. In non-refractory patients, the Genasense group compared with the chemotherapy-only group achieved:
-- A four-fold increase in CR/nPR (25% [13/51] vs. 6% [3/50]; P = 0.016) -- Increased time-to-progression (median = 12 mos. vs. 10 mos.; P = N.S.) -- Increased overall survival (median not reached but exceeding 39+ mos. vs. 33 mos.; P = 0.05)
Similar trends were observed in the two other strata (i.e., patients who received 1-2 prior regimens, and patients whose response to last therapy was longer than 6 months). "The Genasense Phase 3 trial met its intent-to-treat primary endpoint across the entire population of relapsed/refractory patients. However, these data clearly define a prospectively specified population that derived maximal benefit from adding Genasense to conventional chemotherapy," commented Dr. Loretta M. Itri, Genta's President, Pharmaceutical Development, and Chief Medical Officer "We are pleased that FDA is taking the additional time to thoughtfully examine these and other new analyses. Together with the community of CLL physician specialists and patients, we look forward to continuing our dialog with the Agency on the pending New Drug Application in CLL." About Genasense Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer. About Genta Genta Incorporated is a biopharmaceutical company with a diversified product portfolio that is focused on delivering innovative products for the treatment of patients with cancer. The company's research platform is anchored by two major programs that center on oligonucleotides (RNA- and DNA- based medicines) and small molecules. Genasense(R) (oblimersen sodium) Injection is the company's lead compound from its oligonucleotide program. The Company has submitted a New Drug Application (NDA) to the Food and Drug Administration for the use of Genasense plus fludarabine and cyclophosphamide for treatment of patients with relapsed or refractory chronic lymphocytic leukemia (CLL). Genta has also completed a Marketing Authorization Application to the European Medicines Agency (EMEA) for use of Genasense plus dacarbazine for treatment of patients with advanced melanoma. The leading drug in Genta's small molecule program is Ganite(R) (gallium nitrate injection), which the company is exclusively marketing in the U.S. for treatment of symptomatic patients with cancer related hypercalcemia that is resistant to hydration. For more information about Genta, please visit our website at: www.genta.com.
posted
Weird how this just sits still all day. This morning I really thought it would at least hit 15%. The clinical news should have really sent it running but it looks like MMs held it back.
-------------------- Rule 1: Always Protect Your Capital Rule 2: Earn slow, Don't lose fast
IP: Logged |
quote:Originally posted by Hustla: Weird how this just sits still all day. This morning I really thought it would at least hit 15%. The clinical news should have really sent it running but it looks like MMs held it back.
Yeah great news but a very uneventful day for the PPS. Unfortunately I bought this too high this morning and had to sell for a small loss this afternoon. Where's an FDA approval when you need one.
-------------------- Best Regards and Good Trading
IP: Logged |
posted
BERKELEY HEIGHTS, N.J., Nov 09, 2006 /PRNewswire-FirstCall via COMTEX/ -- Genta Incorporated (GNTA : genta inc com new News , chart, profile, more Last: 0.76+0.03+4.10% 10:47am 11/09/2006 Delayed quote data Add to portfolio Analyst Create alert Insider Discuss Financials Sponsored by: GNTA0.76, +0.03, +4.1% ) announced the presentation of new data related to the Company's research program in solid tumors. In preclinical models, high- dose intermittent treatment with Genasense was both efficacious and associated with increased uptake of the drug within tumors. The use of Genasense plus Abraxane(R) (paclitaxel protein-bound particles; Abraxis Oncology, Inc.) and Temodar(R) (temozolomide; Schering Plough, Inc.) also proved synergistic in a highly aggressive model of malignant melanoma. As shown in the figure, this triple combination showed extremely prolonged suppression of tumor growth. The data were presented today at the 18th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, Prague, Czech Republic. Both the intermittent dosing regimens, as well as certain of the drug combinations, are expected to be rapidly translated into clinical trials. In this program, initial studies evaluated Genasense in several dosing schedules using xenograft models of human lung cancer, colon cancer and melanoma. Treatment every 3 days was demonstrably more effective than continuous daily dosing. Intravenous treatment as infrequently as twice per week was active and potentiated the activity of multiple kinase inhibitors (erlotinib, imatinib, sunitinib, and sorafenib) used either alone or in combination with a taxane. In all tumors, the combination of Genasense combined with a taxane and kinase inhibitor was highly effective, and regimens were identified that were well-tolerated during repeated cycles and maximized tumor suppression. "In order to extend these observations, we have initiated a clinical trial to evaluate intermittent dosing of Genasense by both subcutaneous injection and brief intravenous infusion," said Dr. Bob D. Brown, Vice-President, Research and Technology. "From a clinical standpoint, our results using intermittent dosing may eventually obviate the current requirement for continuous IV infusion. These results together with the combination data in melanoma, and with various kinase inhibitors in multiple tumors, will facilitate our ongoing development of clinical regimens that are significantly more "patient friendly".
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Genta presented at the Lazard yesterday. Positive reactions.
Up 3.75% to .83 Highest in Months.
FDA approval by end of Jan.
PR BERKELEY HEIGHTS, N.J., Nov. 29 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA) announced that the Company has initiated a new clinical study that will evaluate the Company's lead anticancer drug, Genasense(R) (oblimersen sodium) Injection in patients with advanced melanoma. This trial is the first follow-on study to Genta's randomized Phase 3 trial of Genasense plus dacarbazine that showed benefit across multiple clinical endpoints in patients with advanced melanoma who had not previously received chemotherapy. The new study represents the rapid clinical translation of preclinical results that demonstrated marked anticancer synergy when Genasense was combined with Abraxane(R) (paclitaxel protein-bound particles; Abraxis Oncology, Inc.) and Temodar(R) (temozolomide; Schering Plough, Inc.). Both of these chemotherapy agents have recently entered Phase 3 clinical trials in patients with advanced melanoma. The new pilot study will evaluate the safety, efficacy, pharmacokinetics and pharmacodynamics of the three-drug combination in chemotherapy-naive patients whom have normal levels of a key biomarker, serum lactate dehydrogenase (LDH). Several dosing schedules will be examined in order to develop a regimen that may optimize safety and efficacy for additional testing. The study will be led by Dr. Anna Pavlick, Director, NYU Melanoma Program, Assistant Professor of Medicine and Dermatology, New York University Cancer Institute, New York, NY. The activity of this drug combination is supported by preclinical data that were presented earlier this month in Prague at the 18th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics. Information on this presentation can be accessed at: http://www.genta.com/Genta/InvestorRelation/2006/press_20061109.html. Results from the previous randomized trial of Genasense plus dacarbazine can be accessed at: http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1. "Our goal with this trial is to further evaluate the potential for Genasense to synergize with a taxane combined with temozolomide, drugs that are widely used in patients with advanced metastatic melanoma," commented Dr. Pavlick. "Genasense has demonstrated significant benefit in melanoma patients compared with dacarbazine chemotherapy used alone. We hope that this new combination may provide an enhanced level of anti-melanoma activity using a "patient friendly" regimen for patients who suffer with this devastating disease."
BERKELEY HEIGHTS, N.J., Dec. 8 /PRNewswire-FirstCall/ -- Genta Incorporated today announced that the Company has been notified of preliminary results from a randomized Phase 3 trial of chemotherapy with or without Genasense(R) (oblimersen sodium) Injection that was conducted in older, previously untreated patients with acute myelogenous leukemia. According to the analysis conducted by the Cancer and Leukemia Group B, the trial failed to meet its primary endpoint of overall survival. Further analyses of these data will be submitted for presentation at a scientific meeting. This study was sponsored by the Division of Cancer Treatment and Diagnosis, National Cancer Institute (NCI), under a Cooperative Research and Development Agreement between Genta and NCI.
Genta Receives Non-Approvable Notice for Application of Genasense(R) in Patients With Chronic Lymphocytic Leukemia Print E-mail Enable live quotes RSS Digg it Del.icio.us Related **** Posts & Articles Last Update: 9:00 AM ET Dec 15, 2006
BERKELEY HEIGHTS, N.J., Dec 15, 2006 /PRNewswire-FirstCall via COMTEX/ -- Genta Incorporated (GNTA GNTA News , chart, profile, more
Delayed quote data Add to portfolio Analyst Create alert Insider Discuss Financials Sponsored by: ) today announced that the Company has received notice that its New Drug Application (NDA) for the use of Genasense plus chemotherapy in patients with chronic lymphocytic leukemia (CLL) has been deemed non-approvable by the Food and Drug Administration. "We are keenly disappointed by this decision," said Dr. Raymond P. Warrell, Jr., Genta's Chief Executive Officer. "We believe that Genasense has amply demonstrated its efficacy and safety in patients with relapsed and refractory CLL in a carefully designed and executed randomized clinical trial. As we decide on next steps with this application, we will continue working to seek worldwide approval of Genasense for patients who have advanced cancer." About Genasense Genasense inhibits production of Bcl-2, a protein made by cancer cells that is thought to block chemotherapy-induced apoptosis (programmed cell death). By reducing the amount of Bcl-2 in cancer cells, Genasense may enhance the effectiveness of current anticancer treatment. Genta is pursuing a broad clinical development program with Genasense evaluating its potential to treat various forms of cancer.
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