December 7, 2004

GENTA'S GENASENSE, GANITE PERFORM WELL IN STUDIES PRESENTED AT ASH; GENTA SHARES CLIMB

Shares of Genta Inc. rose 48.6 percent after positive trial results from studies of the company's cancer pharma names Genasense (oblimersen sodium) and Ganite (gallium nitrate injection) were presented at the annual meeting of the American Society of Hematology in San Diego.

Researchers presented final results from a Phase I/II trial of Genasense injection plus Celgene Corp.'s Thalomid (thalidomide) and high-dose dexamethasone in patients with relapsed myeloma. The data show of 30 patients who were evaluable for response, 18 achieved a major response, including two complete responses, four near complete responses and 12 partial responses, according to a press release.

In a separate study, 224 patients were randomized to receive Genasense plus dexamethasone or dexamethasone alone. Sixteen of the patients in the combination treatment group achieved a major clinical response (defined as a partial response or a response with greater than or equal to 75 percent reduction of myeloma protein), compared with 20 patients treated with dexamethasone alone. As such, this particular study failed to meet its primary endpoint, which was a statistically significant increase in time-to-disease progression.

Separately, a Phase II trial of Genasense plus Wyeth's Mylotarg (gemtuzumab ozogamicin) showed that the combination could induce complete remissions in patients with acute myeloid leukemia who had relapsed after extensive prior therapy. Twelve of the 48 patients treated with the combination achieved complete remission or complete remission by all criteria except recovery of a normal platelet count. Median time to remission was 25 days.

Researchers also presented positive trial results involving Genta's Ganite. Data from a Phase II trial involving 88 patients with advanced non-Hodgkin's lymphoma showed that Ganite displayed activity in a wide variety of patients with various subtypes of advanced NHL who had failed to respond or had relapsed from other types of treatment. Of patients in the 300 mg/m2/day dose of Ganite group, four patients achieved a complete response or complete unconfirmed response, and six patients exhibited a partial response (overall per-protocol response rate 33 percent). One patient in the 200 mg/m2/day dose group achieved a complete response or complete unconfirmed response while four patients had a partial response (per-protocol response rate 16 percent).

Genta shares closed at $2.05, up $0.67, in heavy trading on the Nasdaq.

November 30, 2004

GENASENSE FAILS IN PHASE III MYELOMA TRIAL

Genta Inc. reported late last week that its pharmaceutical brand Genasense Injection (oblimersen sodium) failed to meet the primary endpoint of a Phase III multiple myeloma trial.

The study compared Genasense plus high-dose dexamethasone against dexamethasone alone in patients who had previously received extensive therapy. The main efficacy measure was the time to development of progressive disease. Full trial results will be presented Dec. 4 at a meeting of the American Society of Hematology.

"While we are disappointed with these results, we plan to analyze this trial in considerably more detail before making decisions regarding the Genasense program in myeloma," said Dr. Raymond Warrell, Jr., chief executive officer of Genta.

Earlier this month, the sanofi-aventis Group terminated its agreement with Genta for the development and commercialization of Genasense, prompting an investor selloff that halved the value of Genta shares. Sanofi-aventis said its decision was based on the negative recommendation of a Food and Drug Administration advisory committee regarding a melanoma indication for Genasense as well as results of a Phase III Genasense trial in chronic lymphocytic leukemia (CLL).

"To be sure, an investment in Genta is not for the faint of heart, as all eyes are focused squarely on a single drug," said investment firm Janney Montgomery Scott LLC in a note last week, CBS MarketWatch reported. "[However], we still believe there is value in the Genasense franchise, as it has shown clinical activity in multiple tumor types, including a Phase III trial in CLL that achieved its primary endpoint."

November 10, 2004

SANOFI-AVENTIS TERMINATES AGREEMENT WITH GENTA FOR GENASENSE CANCER THERAPY

Shares of Genta Inc. plummeted 50 percent after sanofi-aventis Group terminated its agreement with the firm for the development and commercialization of the cancer therapy pharma brand Genasense (oblimersen sodium).

As part of the termination, sanofi-aventis agreed to continue to support the development of Genasense for a six-month period ending May 8, 2005. During that time, the firms will cooperate to ensure a smooth transition of the Genasense program. Genta said it will further the development of the cancer treatment, according to a company press release.

The agreement was originally entered into between Genta and Aventis SA, prior to Aventis being acquired by Sanofi-Synthelabo. Terms of the agreement provided that Aventis co-market Genasense in the United States with Genta and have exclusive rights to the therapy in all other countries. Aventis was anticipated to provide as much as $480 million in cash, equity, milestone payments and convertible debt to Genta as part of the agreement, TheStreet.com reported.

In May, Genta withdrew its New Drug Application for Genasense from the Food and Drug Administration as a potential treatment for malignant melanoma after an FDA advisory committee recommended against approval of the treatment.

Sanofi-aventis noted in a press release that its decision was based on the advisory committee ruling and on Genta's report of a late-stage clinical trial for Genasense in treating advanced chronic lymphocytic leukemia. The results of the trial, which were released late Monday, met the primary endpoint of providing a statistically significant increase in the major objective response rate (complete remission or a nodular partial remission) when compared with that of patients administered chemotherapy alone.

However, the incidence of certain serious adverse reactions was increased among patients who received Genasense. As of the study cut-off date, there was no statistically significant difference in key secondary endpoints, including time to disease progression and overall survival.

Separately, for the third quarter of 2004, Genta reported $1.4 million in revenue, up from $1.3 million in the comparable period last year. The firm recognized a net loss in the quarter of $5.6 million, or $0.07 per share, compared with a net loss of $17.2 million, or $0.23 per share, in the third quarter of 2003.

Genta shares closed at $1.30, down $1.30, in heavy trading on the Nasdaq.

June 8, 2004

GENASENSE FAILS TO MEET PRIMARY ENDPOINT IN PHASE III TRIAL

Genta Inc. released updated results of its Phase III randomized trial of Genasense (oblimersen sodium) injection plus dacarbazine in patients with advanced melanoma, showing that the regimen did not meet its primary endpoint.

The study involved 771 patients who had not previously received chemotherapy. The patients were randomized to receive Genasense plus dacarbazine or dacarbazine alone.

The trial's primary endpoint, a statistically significant increase in overall survival, was not met. However, patients treated with Genasense plus dacarbazine showed a significant increase in progression-free survival compared with patients treated with dacarbazine alone (74 days vs. 49 days), according to a press release.

In addition, 11 patients who were treated with Genasense plus dacarbazine achieved a complete response compared with two patients in the dacarbazine-alone group. At last follow-up, 10 patients who had achieved a complete response with Genasense plus dacarbazine were alive, at durations ranging from 15 to 38 months after randomization. One of the two patients in the dacarbazine group who achieved a complete response was alive at 19 months.

The study findings were presented at the annual meeting of the American Society of Clinical Oncology in New Orleans.

Genta submitted a New Drug Application for the pharma name Genasense in combination with dacarbazine to the Food and Drug Administration in December 2003. However, on May 13, the company withdrew its application after an FDA advisory committee voted that the data presented with the NDA did not provide substantial evidence of efficacy and safety for Genasense.

Shares of Genta closed at $2.47, down $0.43, or 14.8 percent, in moderate trading on the Nasdaq.

June 1, 2004

IN BRIEF: AVENTIS SA

Aventis SA and Genta Inc. terminated their Expanded Access Program for Genasense (oblimersen sodium) injection in combination with dacarbazine following a May 3 meeting with a Food and Drug Administration advisory committee. The companies made the decision after the committee said that results of the Genasense Phase III metastatic melanoma trial did not provide sufficient evidence to recommend approval. The program would have enabled patients to receive the therapy prior to receipt of FDA approval, Reuters said.

May 14, 2004

GENTA WITHDRAWS GENASENSE MELANOMA NDA; REDUCES WORKFORCE

Late Thursday, Genta Inc. notified the Food and Drug Administration of its decision to withdraw its New Drug Application for Genasense (oblimersen sodium injection), according to a press release.

Genta has requested a meeting with the FDA to review key issues and to identify next steps related to further development of the drug in the treatment of melanoma.

The NDA had been submitted in December 2003 for the use of Genasense plus dacarbazine for the treatment of patients with advanced melanoma. On May 3, an FDA advisory committee recommended against approval for the therapy.

Earlier Thursday, Genta said it will reduce its workforce by 45 percent, or 85 employees, in an initiative designed to conserve its resources and put a greater focus on Genasense.

The company added that it will cease actively marketing its only marketed therapy, Ganite (gallium nitrate injection), indicated to treat cancer-related hypercalcemia that is resistant to hydration.

"We anticipate that the steps we are taking today will conserve cash, thereby allowing time to collect and analyze data from ongoing and recently completed trials," said Genta's Chief Executive Dr. Raymond Warrell, Jr.

"The decision to cease active marketing of Ganite is especially difficult. However, given our funding priorities for Genasense, we no longer believe we can sustain the additional marketing and selling expenses that are required for Ganite to reach profitability," he added.

Shares of Genta closed at $4.85, up $0.17, or 3.6 percent, in moderate training on the Nasdaq.

May 4, 2004

FDA ADVISORY COMMITTEE RECOMMENDS AGAINST GENTA, AVENTIS' GENASENSE CANCER THERAPY

A Food and Drug Administration advisory committee said Monday that Genta Inc. and Aventis SA did not provide substantial evidence of Genasense (oblimersen sodium) injection's effectiveness to outweigh the increased toxicity risk of the therapy when used to treat patients with metastatic melanoma who have not received prior chemotherapy.

Although the advisory committee's position is not binding, the FDA will consider it as the regulatory agency finishes its priority review of the firms' New Drug Application, according to a Genta press release.

Genta filed its NDA for Genasense in December. An FDA response on that NDA is expected by June 8, Genta said.

"We are committed to [Genesense's] ongoing development and we will work closely with the FDA to determine the appropriate next steps," said Dr. Raymond Warrell, Jr., Genta's chief executive officer.

Dr. Frank Douglas, executive vice president of drug innovation and approval at Aventis, added, "While disappointing, the committee's vote underscores the complexities of treating this devastating disease."

Genta shares closed at $5.11, down $3.49, or 40.6 percent, in heavy Nasdaq trading. Aventis shares closed at $75.21, down $0.30, or 0.4 percent, in light trading on Wall Street.

May 3, 2004

FDA NOT CONVINCED OF EFFICACY OF TWO POTENTIAL ONCOLOGY DRUGS; GENTA, ALLOS SHARES FALL

Shares of Genta Inc. plummeted 40.4 percent and shares of Allos Therapeutics Inc. tumbled 45 percent after documents posted on the Food and Drug Administration's Web site showed that regulatory reviewers are not convinced either of the firms' investigational oncology drugs are effective.

The documents were released in advance of a meeting of the FDA's Oncologic Drugs Advisory Committee scheduled for May 3 and 4. The committee will discuss Genta and Aventis SA's Genasense (oblimersen sodium) for use in combination with dacarbazine for treating advanced melanoma. They will also discuss Allos Therapeutic's RSR13 (efaproxiral sodium) injection for use as an adjunct to whole brain radiation therapy in treating brain metastases from primary breast cancer.

Genta has submitted Phase III trial results to the FDA, during which, 771 patients received Genasense plus dacarbazine or dacarbazine alone every three weeks as first-line chemotherapy for metastatic melanoma. The primary endpoint was overall survival.

While patients who received the combination had significantly longer progression-free survival and a higher response rate, the results failed to show a survival benefit versus dacarbazine alone.

Furthermore, toxicity was higher in the combination arm, and the reviewers pointed out other issues with the secondary endpoint results.

"Any claims of improved efficacy based on secondary endpoints, progression-free survival and anti-tumor response rate are questionable because of the open-label nature of study, missing data and differences in assessment interval between the two treatment groups," they said. "The findings could be falsely positive, especially in view of the lack of confirmation by a second well-controlled and well-conducted trial."

Similarly, another reviewer found that "the evidence submitted in [Allos'] application ... is not convincing and does not support the sponsor's claim of efficacy."

Allos had submitted data from a Phase III trial in which 538 patients received whole brain radiation therapy for brain metastases plus supplemental oxygen with or without RSR 13.

Results showed no statistically significant difference in survival between the two study arms in the intent-to-treat population.

However, the median survival time for a subset of patients with breast cancer was 4.57 months in the control arm versus 8.67 months in the treatment arm. But subgroup findings are only considered exploratory or hypothesis-generating analyses, the document said.

"It is not evident that the apparent survival advantage observed in a single small subgroup of patients with primary breast cancer based on post-hoc analyses is attributable solely to the treatment effect and not due to imbalances in known and unknown prognostic factors," a reviewer concluded.

Shares of Genta closed at $8.60, down $5.83, while shares of Allos closed at $2.55, down $2.09, both in heavy trading on the Nasdaq.

July 1, 2003

GENTA, AVENTIS' LEUKEMIA TREATMENT GENASENSE GRANTED FAST TRACK DESIGNATION BY FDA

Genta Inc. and Aventis SA's Genasense (oblimersen), intended to treat chronic lymphocytic leukemia patients, was granted a fast track designation by the Food and Drug Administration.

The designation as a fast track treatment is specific to a Phase III trial regimen of the drug administered in combination with fludarabine and cyclophosphamide, two standard chemotherapy drugs used in chronic lymphocytic leukemia.

According to Genta, a New Drug Application for a fast track treatment may be filed in separate parts, enabling the company to receive feedback from the FDA on the application as sections are completed.

Chronic lymphocytic leukemia, the most common form of leukemia in adults, is a disease complicated by the risk of infection, severe anemia and thrombocytopenia, and can not be cured in a majority of patients that have the disease. June 27, 2003

IN BRIEF: GENTA INC.

Genta Inc. announced that it has initiated four new, separate trials with its lead cancer treatment Genasense (oblimersen) that can be administered alone or in combination with standard of care chemotherapy. The studies, sponsored by the National Cancer Institute, allow for further study of the treatment to potentially benefit patients whose needs are not being met by current therapies, Genta officials said.

June 12, 2003

IN BRIEF: GENTA INC.

Genta Inc. initiated clinical trials of brand name Genasense (oblimersen) in patients with advanced breast cancer to study the safety and efficacy of the agent in combination with two standard chemotherapy drugs, Aventis SA's Taxotere (docetaxel) and doxorubicin. Genasense blocks production of a protein that is highly expressed in breast cancer patients and contributes to the resistance of cancer cells to treatment.