Final Report of Genasense Phase 3 Trial in Melanoma Published in Journal of Clinical Oncology Friday September 15, 8:00 am ET Long-term Followup is Basis of Pending Regulatory Application In Europe Paper Accompanied by Editorial Discussing Treatment Results in Patients with Advanced Disease
BERKELEY HEIGHTS, N.J., Sept. 15 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA - News) announced that results of the Company's Phase 3 trial of Genasense® (oblimersen sodium) Injection in patients with advanced melanoma were published on-line this week in the Journal of Clinical Oncology, ahead of its print publication date of October 10, 2006. The paper is accompanied by an editorial that discusses the trial's results in the context of current options for melanoma treatment. The extended follow-up data from this publication form the basis of a Marketing Authorization Application (MAA) that is currently pending review by the European Medicines Agency (EMEA).
ADVERTISEMENT "In our paper, long-term followup has confirmed the trends that were observed in the earlier analyses," said Dr. Agop Y. Bedikian, Professor of Medicine at M.D. Anderson Cancer Center, Houston, TX, who is the lead author on the paper. "This was the first trial to achieve such a broad array of positive endpoints. I believe the aggregate data indicate that Genasense can be a major addition to chemotherapy for patients with this disease, with a side-effect profile that is highly manageable." The article can be accessed on-line at: http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1.
Genasense, Genta's lead anticancer drug, is a novel targeted therapy that blocks the production of Bcl-2, a protein that appears to be a fundamental cause of resistance to cancer treatment. By knocking down Bcl-2 in cancer cells, Genasense may enhance the effectiveness of chemotherapy in patients with advanced melanoma. A summary of the data from the final analysis appears below.
Efficacy Data
The report is based on long-term data derived from the largest randomized controlled trial that has ever been conducted in patients with advanced melanoma. In this trial, which was conducted at 139 sites in 9 countries, 771 patients were randomly assigned to receive chemotherapy with dacarbazine (DTIC) alone or in combination with Genasense. The paper includes data from a prospectively defined analysis that evaluated 24-months of minimum follow-up on all patients. Unless otherwise noted, these results were based on an intent-to-treat analysis:
Prior to randomization, patients were prospectively stratified according to certain risk factors, including elevated blood levels of an enzyme known as LDH - a factor that previous clinical studies have shown is strongly associated with poor outcome. The final analysis has shown that LDH was the sole stratification factor significantly associated with a treatment interaction. When this treatment effect was evaluated, the efficacy of Genasense was significantly superior for all major efficacy outcomes in patients who had normal LDH at baseline, a group that comprised approximately two-thirds of patients in the trial (N=508). In this group, the following efficacy results were observed:
The most frequent serious adverse events that occurred in greater than or equal to 5% of patients were fever and disease progression (6.2% vs. 2.8%, and 5.1% vs. 4.7%, respectively, for Genasense/DTIC compared with DTIC alone). The most frequent Grade 3 or 4 adverse events that occurred in greater than or equal to 5% of patients were neutropenia (21.3% vs. 12.5%), thrombocytopenia (15.9% vs. 6.4%), leukopenia (7.5% vs. 3.9%), anemia (7.3% vs. 4.7%), and nausea (6.7% vs. 2.5%). Although there was an increase in discontinuations due to adverse events in the Genasense arm (19% vs. 11%), there was no difference in the number of fatal, treatment-emergent adverse events (i.e., events that lead to a death on study or within 30 days from last study treatment).
About Melanoma
Melanoma is the most deadly form of skin cancer. Melanoma is responsible for more than 90% of all skin cancer deaths. The European Network of Cancer Registries estimates that more than 60,000 cases of melanoma are diagnosed each year. The incidence of this disease is increasing by approximately 4 percent annually in the U.S., where it is the number one cause of cancer deaths for women aged 25 to 29. For more information on melanoma, please visit: http://www.nci.nih.gov/cancer_information/cancer_type/melanoma
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 contains 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 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; 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
In at .49 and holding...at least till end of October when they come up against FDA Approval for Genasense. Not likely to pass muster due to 10 to 3 against from preliminary committee decision. But...Genta's pursuing European market approvals. Stock still near enough to it's 52 week low - high is around $ 3.48. They did dilute a few months back to raise capital. Been following it about 2 years now. Genta's had set backs but whether good/bad/ugly, they've always been timely about sharing news with investors...no hocus pocus here. What you see is what you get. GLTA
-------------------- Just the facts, ma'am. Posts: 1083 | From: New Jersey | Registered: Mar 2005
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posted
and....they have incentive to get their minimum pps up to $1.00 per Nasdaq rules...I think they have until February and then they can request a 180 day extension.
-------------------- Just the facts, ma'am. Posts: 1083 | From: New Jersey | Registered: Mar 2005
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Independent Analysis of EORTC Trial Confirms Survival Impact of Biomarker Identified in Phase 3 Trial of Genasense(R) in Melanoma Tuesday September 19, 8:00 am ET Surrogate Marker Has Substantial Impact on Survival of Patients with Advanced Melanoma
BERKELEY HEIGHTS, N.J., Sept. 19 /PRNewswire-FirstCall/ -- Genta Incorporated (Nasdaq: GNTA - News) announced the presentation of a collaborative study by Genta and the Melanoma Group of the European Organization for the Research and Treatment of Cancer (EORTC). The results confirmed the strong relationship between patient survival and a biomarker that was prospectively studied in the randomized Phase 3 trial of Genasense® (oblimersen sodium) Injection in patients with advanced melanoma. The results were presented at a scientific meeting, Perspectives in Melanoma X and the Third International Melanoma Research Congress, which was held in The Netherlands.
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The Genasense data derive from the largest randomized controlled trial that has ever been conducted in patients with advanced melanoma. In this trial, 771 patients were randomly assigned to receive chemotherapy with dacarbazine (DTIC) alone or in combination with Genasense. The results of this trial showed that multiple outcomes, including overall survival, progression-free survival, overall response and durable response, were strongly associated with blood levels of an enzyme known as LDH, a biomarker that was a prospectively defined stratification factor.
An independent data set was then used to further assess the reliability of this association. EORTC Study 18951, which matched the Genasense study with respect to enrollment criteria, randomized 363 patients with advanced melanoma to receive DTIC, cisplatin, and interferon with or without Interleukin-2. Baseline LDH measurements from both studies were then segregated into 5 categories, ranging from less than 0.8 times (x) the upper limit of normal (ULN) to greater than 5 x ULN. For all patients in all treatment groups combined, median survival and the percent of patients who survived 2 or more years in each category from both trials are presented in the table below.
Genasense Trial EORTC Trial Median 2-yr. Median 2-yr. No. of Survival Survival No. of Survival Survival LDH (x ULN) Pts (yrs) % Pts (yrs) % Less than 0.8 274 0.96 21 101 1.01 22 0.8 to 1.1 234 0.8 18 69 0.75 20 1.1 to 2.0 157 0.54 9 85 0.75 14 2.0 to 5.0 76 0.31 3 54 0.48 4 Greater than 5.0 19 0.12 0 16 0.18 0
The two sets of independent data confirmed the strong prognostic value of LDH as a continuous variable. The new results also showed that even small variations around the upper limit of normal may signal early aggressive disease that has a substantial impact on survival.
Prior analysis of the Genasense trial showed that treatment with Genasense plus DTIC yielded significantly superior efficacy outcomes in patients with a normal baseline LDH (prospectively defined as less than 1.1 x ULN), a group that comprised approximately two-thirds of patients in the trial (N=508). Further exploratory analysis of this trial tested patients whose LDH was less than 0.8 x ULN. In this group, median survival was 12.3 months for patients in the Genasense group compared with 9.9 months in the DTIC-only group (P=0.0009; hazard ratio = 0.64). The 2-year survival rate was 28% in the Genasense group and 12% in the DTIC group.
Extended follow-up data from the Genasense trial form the basis of a Marketing Authorization Application (MAA) that is currently pending review by the European Medicines Agency (EMEA). A report of this trial can be accessed at: http://www.jco.org/cgi/content/abstract/JCO.2006.06.0483v1
Genasense, Genta's lead anticancer drug, is a novel targeted therapy that blocks the production of Bcl-2, a protein that appears to be a fundamental cause of resistance to cancer treatment. By knocking down Bcl-2 in cancer cells, Genasense may enhance the effectiveness of chemotherapy in patients with advanced melanoma.
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: http://www.genta.com.
Safe Harbor
This press release contains 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 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; 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.
-------------------- One risk I enjoy: daytrading stocks Posts: 273 | From: New York City | Registered: Sep 2004
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posted
Look at this thing moving in pre-market trading, its incredible. They're bound to get their FDA approval with todays news of their phase 3 clinical trial results.
-------------------- Now We Movin On Up!! Posts: 211 | From: Los Angelos | Registered: Oct 2004
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posted
Don't bank on it....preliminary panel decision was 10 to 3 against and FDA is usually sides with the panel. That being said...today looks GREEN to me
-------------------- Just the facts, ma'am. Posts: 1083 | From: New Jersey | Registered: Mar 2005
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quote:Originally posted by freshpl: should hit 1.00 today
It hit its HOD yesterday near the close of trading. A good 28% I think it was and that was just from Fridays momentum. 1.00 could be hit today also. IMO
-------------------- Now We Movin On Up!! Posts: 211 | From: Los Angelos | Registered: Oct 2004
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posted
There's the 10 AM pullback. The buying pressure is huge today. The company seems to wanna hit that minimum 1.00 bid to stay listed on Nasdaq. EOD and after hours should be interesting even with the in and out early profit takers
-------------------- Now We Movin On Up!! Posts: 211 | From: Los Angelos | Registered: Oct 2004
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posted
So my guess it that European approval for this is looking good. The release today documents exceptional results in the EORTC trials for melanoma. this in my opinion will push the pps higher for a couple more days. The previous rejected trial was for Leukemia treatment in the US. correct me if I'm wrong here.
-------------------- Now We Movin On Up!! Posts: 211 | From: Los Angelos | Registered: Oct 2004
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posted
when can we expect prs with approval or is that not for the short term? is there a good chance this will go much lower than we are now or more upwards potential?
Posts: 1065 | From: switzerland | Registered: Mar 2005
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posted
This stock is recovering because investors realized that though Genta was down it wasn't out aided by positive publication of independent trials. This stock will top off in the next few days/weeks as investors start looking to the FDA approval/disapproval date - end of October - don't know what day. It's popping now, topping off in the near term and probably heading for a major retrace. JMO
-------------------- Just the facts, ma'am. Posts: 1083 | From: New Jersey | Registered: Mar 2005
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posted
ept 19 (Reuters) - Genta Inc. (GNTA.O: Quote, Profile, Research) on Tuesday said it has agreed with institutional investors to sell 20 million shares of common stock through a registered offering for proceeds totaling about $16 million.
The sale is expected to close on or about Sept. 22, the drug maker said in a statement. (Reporting by Himani Sarkar in Bangalore)
_______________________________________
How will this offering affect tomorrows trading
Posts: 169 | From: detroit | Registered: Sep 2003
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posted
I bailed at .95...will get back in once the dust settles...like I said before good, bad or fugly, Genta comes clean on the state of the business in a timely manner.
-------------------- Just the facts, ma'am. Posts: 1083 | From: New Jersey | Registered: Mar 2005
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Item 1.01 Entry Into a Material Definitive Agreement. On September 19, 2006, Genta Incorporated, a Delaware corporation (the "Company"), entered into definitive securities purchase agreements (the "Securities Purchase Agreements") with certain institutional investors pursuant to which the Company has agreed to issue and sell an aggregate of 20,000,000 registered shares of its common stock at $0.79 per share, through a registered direct offering, for aggregate gross proceeds of approximately $15,800,000, before deducting estimated fees and expenses associated with the offering (the "Offering"). The closing is expected to take place on September 22, 2006, subject to the satisfaction of customary closing conditions. The shares of common stock offered by the Company in this transaction were registered under the Company's existing shelf registration statement (File No. 333-114151) on Form S-3, which was declared effective by the Securities and Exchange Commission on May 11, 2004, and the prospectus supplement dated September 19, 2006. Rodman & Renshaw, LLC ("Rodman") acted as the placement agent for the Offering. On September 19, 2006, the Company executed a placement agent agreement (the "Placement Agent Agreement") by and between the Company and Rodman. The Company will pay the placement agent an aggregate fee equal to 5.0% of the gross proceeds of the Offering equal to approximately $790,000, and will pay estimated expenses of the Offering equal to approximately $110,000. A copy of each of the form of Securities Purchase Agreement, the form of Placement Agent Agreement and the related press release of the Company, dated September 19, 2006, are filed herewith as Exhibits 10.1, 10.2 and 99.1, respectively, and are incorporated herein by reference. The foregoing description of the Offering by the Company and the documents related thereto, is qualified in its entirety by reference to such Exhibits. Item 9.01 Financial Statements and Exhibits. (d) Exhibits.
Exhibit No. Description 10.1 Form of Securities Purchase Agreement by and among the Company and the Purchasers dated September 19, 2006.
10.2 Form of Placement Agent Agreement by and between the Company and Rodman & Renshaw LLC dated September 19, 2006.
99.1 Press Release of the Company dated September 19, 2006.
-------------------- Just the facts, ma'am. Posts: 1083 | From: New Jersey | Registered: Mar 2005
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