CEGE has a nice looking chart. Seems to be a bottom around 5 and did cross 50MA last Friday. Relative strength is over 50 and volume 2 times the average volume. And just recently were laying off about 25% off their employees and streamlining their business. Focusing on more promising aspects of their business.
"Cell Genesys said that it was making the cuts at a time of financial strength so it could focus on its more promising development programs and discontinue programs with less potential. The move follows the release of promising clinical data last month for the company's GVAX vaccine to treat prostate cancer, leukemia, and pancreatic cancer. The vaccine is in late-stage clinical trials for prostate cancer, and in mid-stage clinical trials for the other cancers."
And eventually there were some insider buying last week (8 seperate buys). This company is now trading at 5.70 and was trading above 15 just over a year ago.
Any thoughts on this one??
Hi,
Triangle breakout...
update:
CEGE: Q1 EPS 8c vs (65c) EPS +112% Y/Y
Tuesday , May 09, 2006 07:02 ET
QUARTER RESULTS
Cell Genesys Inc (CEGE) reported Q1 results ended March 2006. Q1 Revenues were $0.18M; -89.09% vs yr-ago; MISSING revenue consensus by -78.31%. Q1 EPS was 8c; +112.31% vs yr-ago.
Q1 RESULTS Reported Year-Ago Y/Y Chg Estimate SURPRISE
---------- ------------ ------------ ---------- ------------ ----------
Revenues: $0.18M $1.65M -89.09% $0.83M -78.31%
---------- ------------ ------------ ---------- ------------ ----------
EPS: 8c (65c) +112.31% N/A N/A
---------- ------------ ------------ ---------- ------------ ----------
ADDITIONAL COMMENTARY:
The net income for the first quarter of 2006 can be attributed to a gain of $62.7 million associated with the sale of Abgenix stock.
&
CEGE: Needham Cuts to Buy from Strong Buy; Sets Tgt @ $10
Wednesday, May 10, 2006 11:08 ET
Issuer: Cell Genesys Inc (NasdaqNM: CEGE)
Analyst Firm: Needham & Co.
Ratings Action: DOWNGRADE
Current Rating: Buy (from Strong Buy)
Target Price Action: INITIATE
Target Price: $10.00
&
Cell Genesys' anticancer drug fast tracked in US
Thursday , May 11, 2006 21:54 ET
May 11, 2006 (Datamonitor via COMTEX) -- Cell Genesys' GVAX immunotherapy has been granted fast track designation by the FDA for the treatment of advanced prostate cancer. The designation should accelerate the regulatory process for the drug and potentially bring it to market earlier.
GVAX was given the designation as it has shown potential to treat advanced prostate cancer, a life-threatening condition that represents an unmet medical need.
The treatment is currently being studied in two phase III clinical trials expected to enroll approximately 1,200 patients with metastatic hormone-refractory prostate cancer (HRPC). The trial represents one of the largest phase III clinical programs ever conducted in men with advanced prostate cancer.
"We continue to hope that GVAX immunotherapy for prostate cancer may some day offer an improved and less toxic treatment alternative to chemotherapy for patients with this disease," stated Dr Joseph Vallner, president and COO of Cell Genesys.
&
Cell Genesys Reports Interim Results of CG0070 Phase 1 Trial in Bladder Cancer
Monday , May 22, 2006 07:01 ET
SOUTH SAN FRANCISCO, Calif., May 22, 2006 /PRNewswire-FirstCall via COMTEX/ -- Cell Genesys, Inc. (Nasdaq: CEGE) today announced preliminary results of a Phase 1 clinical trial of CG0070 in patients with recurrent bladder cancer who have failed previous therapy with bacillus Calmette-Guerin (BCG), the current standard therapy for recurrent bladder cancer. Nine patients have been treated to date who received escalating single-dose administrations of CG0070. Evidence of anti-tumor activity documented by a complete response at follow-up cystoscopy was obtained in three of the nine patients treated. Treatment was tolerable with no serious adverse events or dose limiting toxicities reported to date. These data were presented today by Donald L. Lamm, M.D., clinical professor at the University of Arizona, at the annual meeting of the American Urological Association (AUA) in Atlanta, GA.
CG0070, an oncolytic virus therapy, has been shown to destroy cancer cells of multiple types in numerous preclinical studies. CG0070 is the first "armed" oncolytic virus therapy developed by the company, so-named because it has been engineered to include the therapeutic gene for GM-CSF, an immune stimulating hormone which is also a key component in Cell Genesys' lead product platform, GVAX(R) cancer immunotherapies. As a result, CG0070 can potentially destroy cancer cells by two different mechanisms: direct cell killing by the virus and immune-mediated cell killing stimulated by GM-CSF.
The open-label, dose-escalation trial reported today is designed to evaluate intravesical (into the bladder) single-dose administration of CG0070 in patients with superficial bladder cancer who have failed previous therapy with BCG. Three patients are being evaluated at each escalating dose level determined by the number of viral particles of CG0070 administered. The primary endpoints of the study are safety and the determination of a maximum tolerated dose. Secondary endpoints include clinical response based on follow-up cystoscopy and recurrence free survival. Nine patients have been treated to date through the third dose level. Evidence of anti-tumor activity documented by a complete response at follow-up cystoscopy performed at approximately 3 months was obtained in three of the nine patients treated, including two at the first (lowest) dose level and one at the third dose level. The duration of the complete responses after just a single administration of CG0070 were 6, 9, and 3+ months respectively. Treatment was generally tolerable and the majority of treatment-related side effects were local bladder toxicities. No serious adverse events or dose limiting toxicities have been reported to date. Pharmacokinetic studies show detectable CG0070 in the urine in all patients for one to two weeks after treatment. In contrast, very low levels of CG0070 were transiently measurable in the blood of only one of the nine patients, suggesting minimal systemic exposure to the virus. Additionally, GM-CSF was detected in the urine of all patients for at least five days, suggesting that biologically active CG0070 persists in the bladder for at least this time period.
"We are pleased with the early results for CG0070, our lead oncolytic virus therapy product in clinical trials and believe that this study strongly supports advancement of CG0070 into a multiple-dose Phase 1 trial," stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. "We are optimistic that the dual mechanism of action of CG0070 might result in enhanced local anti-tumor activity as well as potential systemic anti-tumor immunity following local administration."
Oncolytic (cancer cell killing) virus therapies represent a new approach in the treatment of patients with cancer and are comprised of adenoviruses, a cause of the common cold, that are engineered to selectively replicate in and destroy cancer cells through the use of tumor- or tissue-specific promoters. Cell Genesys is developing certain of its oncolytic virus therapy products through a global alliance with Novartis AG, which may provide for the further development and commercialization of these products. Additionally, the alliance provided Cell Genesys with preclinical stage product opportunities developed by Novartis, including CG0070. In addition to CG0070, Cell Genesys is also developing CG5757, which is engineered with a secondary telomerase promoter employing technology licensed from Geron Corporation, and may also have the potential to target multiple types of cancer.
The American Cancer Society estimates that approximately 61,500 new cases of bladder cancer will be diagnosed in 2006, and that the majority of these are superficial bladder cancer. Superficial bladder cancer has traditionally been treated by transurethral resection (TUR) upon initial diagnosis, but unfortunately is marked by recurrence in the majority of patients. The current standard therapy after TUR is intravesical BCG. Patients with superficial bladder cancer who fail BCG have limited options. Historically, cystectomy has been the standard of care in this setting. Intravesical chemotherapeutic agents have been tried but with limited efficacy. Additional therapies for recurrent bladder cancer are needed in order to decrease treatment morbidity, increase bladder preservation, and improve long term outcomes.
Cell Genesys is focused on the development and commercialization of novel biological therapies for patients with cancer. The company is currently pursuing two clinical stage product platforms - GVAX(R) cancer immunotherapies and oncolytic virus therapies. Ongoing clinical trials include Phase 3 trials of GVAX immunotherapy for prostate cancer, Phase 2 trials of GVAX immunotherapy for pancreatic cancer and leukemia, and a Phase 1 trial of CG0070 oncolytic virus therapy for bladder cancer. Cell Genesys continues to hold an equity interest in its former subsidiary, Ceregene, Inc., which is developing gene therapies for neurodegenerative disorders. Cell Genesys is headquartered in South San Francisco, CA and has its principal manufacturing operation in Hayward, CA. For additional information, please visit the company's website at www.cellgenesys.com.
&
CEGE: Short Interest DN 5.4% to 5.6M in May 2006
Wednesday, May 24, 2006 16:16 ET
According to new short interest data from NASDAQ, short interest for Cell Genesys Inc (NasdaqNM: CEGE) DECREASED 5.4% to 5,575,745 shares for the month ended mid-May, 2006.
SYMBOL APRIL MAY CHANGE %CHANGE DAYS/COVER
-------- ------------- ------------- ------------- ------------ ----------
CEGE 5,895,527 5,575,745 -319,782 -5.42% 12
Based on CEGE's 20-day average daily share volume of 468,530, it would require approximately 12 day(s) of buying to cover this short interest.
16 slides:
http://wsw.com/webcast/rrshq8/cege/
positive research update:
Cell Genesys Reports Long-Term Follow-Up Data From Phase 2 Trial of GVAX(R) Immunotherapy For Leukemia in Chronic Myelogenous Leukemia
Saturday , June 03, 2006 15:00 ET
SOUTH SAN FRANCISCO, Calif., June 3, 2006 /PRNewswire-FirstCall via COMTEX/ -- Cell Genesys, Inc. (Nasdaq: CEGE) today reported encouraging long-term follow-up data from a Phase 2 trial of GVAX(R) immunotherapy for chronic myelogenous leukemia (CML). A total of 19 CML patients with molecular evidence of persistent leukemia following at least one year of Gleevec(R) (imatinib mesylate) therapy were treated with GVAX immunotherapy while continuing to receive Gleevec. Updated results show that the addition of GVAX immunotherapy to Gleevec therapy reduced persistent leukemic disease in 10 of 19 patients as demonstrated by a complete disappearance (five patients) or a greater than one log (90%) reduction (five patients) in bcr-abl -- a validated genetic marker found on the leukemic cells. The new findings reported today also show that with a median follow up from treatment initiation of 14 months for all patients, the molecular responses are ongoing in the five patients showing a one log or greater reduction in bcr-abl. In addition, four of the 5 patients with a complete disappearance of bcr-abl continue to have undetectable values at the most recent follow up. Of the remaining 10 patients, only one patient has developed cytogenetic progression on therapy and this patient had the highest level of disease burden at study entry. The data were presented today by Dr. Douglas Smith, assistant professor of Hematologic Malignancies at Johns Hopkins Sidney Kimmel Comprehensive Cancer Center at the annual meeting of the American Society of Clinical Oncology (ASCO) in Atlanta, GA.
"We continue to be encouraged by the results of this Phase 2 trial in CML, in particular by the achievement of sustained molecular responses when GVAX is added to ongoing imatinib therapy," stated Joseph J. Vallner, Ph.D., president and chief operating officer of Cell Genesys. "GVAX immunotherapy in our view may represent an important new treatment strategy for CML."
The Phase 2 trial enrolled 19 patients with chronic phase CML. All patients had detectable bcr-abl levels at study entry as measured by a PCR (polymerase chain reaction) assay despite having received at least one year of Gleevec therapy. The median duration of Gleevec therapy prior to study entry was three years. Patients were treated with four injections of GVAX(R) vaccine for leukemia at three-week intervals over a total treatment period of nine weeks and then followed for nine months or longer from treatment initiation. To date, all patients have tolerated treatment well and completed the planned nine months follow-up. Today's presentation also included a new statistical analysis of the levels of bcr-abl observed. An analysis of trends was performed to compare changes in bcr-abl over time in patients pre- and post-treatment. Importantly, the average bcr-abl levels were significantly lower during and following treatment with GVAX immunotherapy for leukemia than in the 3 month period pre treatment (p=0.02 by Chi-squared).
The therapy of CML has improved substantially in recent years as a result of the introduction of Gleevec therapy which is now approved for the first- line treatment of CML in chronic phase. Hematologic responses are seen routinely in the majority of treated patients but complete molecular responses, as measured by quantitative PCR for bcr-abl, occur in less than 10 percent of patients even after 12 months of therapy. Given that the reduction in bcr-abl in patients is positively associated with clinical outcome, new therapeutic strategies to eliminate persistent leukemic disease as evidenced by bcr-abl positive cells are urgently needed.
Clinical trials of GVAX cancer immunotherapies are under way for multiple types of cancer including, in addition to leukemia, prostate cancer and pancreatic cancer. The products are comprised of tumor cells that have been modified to secrete GM-CSF, an immune stimulatory hormone, and then irradiated for safety. GVAX cancer immunotherapies are being developed as non patient- specific "off-the-shelf" pharmaceutical products and have demonstrated a favorable side effect profile in over 600 patients treated in clinical trials to date.
&
Separately, Cell Genesys (CEGE:Nasdaq - commentary - research - Cramer's Take) reported what it called encouraging long-term follow-up data from a mid-stage trial of Gvax immunotherapy for chronic myelogenous leukemia. The company said adding Gvax to Novartis' (NVS:NYSE ADR - commentary - research - Cramer's Take) Gleevec reduced persistent leukemic disease in 10 of 19 patients in a study.
"We continue to be encouraged by the results of this phase II trial in CML, in particular by the achievement of sustained molecular responses when Gvax is added to ongoing [Gleevec] therapy," said Joseph Vallner, the president and chief operating officer of Cell Genesys. "Gvax immunotherapy in our view may represent an important new treatment strategy for CML."
The median duration of Gleevec therapy prior to patients entering the study was three years. Patients were given four injections of Gvax at three-week intervals over nine weeks and then followed for nine months or longer. To date, all of the patients have tolerated the treatment well and completed the planned nine months of follow-up.
Clinical trials of Gvax cancer immunotherapies are under way for multiple type
CEGE's direct competitor is DNDN. CEGE's VITAL-1 &2 clinical trials are underway, DNDN's clinical trials are over and the BLA submission is due within the next couple of months and the FDA decision is expected in 1H07.
CEGE is 2 years behind DNDN with a BIG unknown (RISK) - the clinical trial results.
Check my oother DNDN posts with more information about this company (la-onda, I know that you know... ;-) - IMHO, it has the best risk/reward ratio in today's biotechs.
Cell Genesys soars on prostate-cancer data
GVAX drug trial results show longer survivability rate
The shares shot up 11% to $4.78 in recent action, after hitting a session high of $5.05. It marks a turnaround in fortunes for Cell Genesys (CEGE : Cell Genesys Inc
Last: 5.77+1.46+33.87%
3:28pm 04/03/2007
5.77, +1.46, +33.9%) , shares of which have retreated from above the $8 level this time a year ago.
Final results from a key Phase II clinical trial showed that men with advanced prostate cancer who used GVAX had a median survival rate of 35 months, Cell Genesys said. The South San Francisco, Calif.-based company has been testing the therapy in men with advanced hormone-refractory prostate cancer, or HRPC.
The study's results bested previous data compiled on GVAX that showed a median survival rate of 26.2 months. Patients undergoing what's currently the standard chemotherapy regimen for HRPC, which consists primarily of the drugs Taxotere and prednisone, generally have a median survival rate of 18.9 months, Cell Genesys said.
Cell Genesys added that ongoing Phase III clinical trials have been designed to confirm that GVAX can extend the lives of terminal prostate-cancer patients. The trials will be testing how effective GVAX is when used either alone or in combination with Taxotere-based chemotherapy.
The company's has also been running Phase II clinical trials for GVAX in the treatment of pancreatic cancer and leukemia.
The new GVAX data should help Cell Genesys gain some negotiating leverage in discussions with potential marketing partners, CanaccordAdams analyst Joseph Pantginis said.
Competition for Provenge
He added that the GVAX data also outshone that of Provenge, another promising prostate cancer therapy that Dendreon Corp. (DNDN : dendreon corp com
Last: 14.76+0.46+3.22%
3:28pm 04/03/2007
14.76, +0.46, +3.2%) had developed. Last week, an advisory panel of the Food and Drug Administration recommended approval for Provenge, despite some mixed clinical data. The full FDA is expected to render a final decision by May 15.
"Assuming all the caveats of Phase II studies (small patient numbers and open label), Cell Genesys has two independent Phase II studies that significantly outperform the current standard of care, Taxotere, as well as Dendreon's Provenge," wrote Pantginis, in his note Monday.
"We view this GVAX Prostate survival update as a strong incremental positive for Cell Genesys that further solidifies our projection that GVAX Prostate will play an integral role in the treatment of prostate cancer," Pantginis added.
Shares of Dendreon, which more than doubled last week on the FDA panel vote for Provenge, again traded higher Tuesday, moving up 5% at $15.05.
CEGE has several good products in the pipeline that make it a good acquistion candidate. :)
Another 25% today!
:o :o :o :o :o :o :o :o
Better than DNDN?
Please search my prior posts and see that I am a VALUE investor and not a trader.
That being said:
I think that CEGE is a very interesting play at this point based on DNDN/Provenge. If the FDA approves Provenge (could be any day thru May 15) - CEGE will technically pop like all other "cancer vaccine" companies.
If the FDA doesn't grant approval to DNDN, CEGE, its main competitor, will also gain since Provenge will then be postpones to 2010, and CEGE (whose trials are SUPPOSED to end by 2010) may have a chance to bit DNDN as the first to market. So this is a VALUE play.
So ... on top of my large DNDN position (holding over 2 years), I have added a much smaller CEGE position for a short term play.
Comments will be appreciated.
The May $5 calls might be an interesting play - at only .35 they represent a pretty limited risk if CEGE doesn't get follow through from DNDN or if DNDN gets approvable. The potential upside on Provenge approval is for CEGE to pop nicely - I would expect it to get up to or above 6.10/sh, if not close to $7 on positive provenge news. I may consider this as it does limit the downside risk substantially.
I bought CEGE at 3.13 and sold it on the recent run-up at 7.05. Nevertheless I am looking to take another position soon.
CEGE has a strong balance sheet and some very interesting compounds in development which imo have the potential for a breakthrough therapy.
Cheers
Quote from: stock-kitty on May 04, 2007, 08:59:34 AM
... and some very interesting compounds in development which imo have the potential for a breakthrough therapy.
Cheers
Don't count on their pipeline THAT much. It is not so easy to recruit patients to PCa clinical trials. It will be tougher with Provenge (DNDN) in the market. Therefore, if Provenge is approved, CEGE is a very quick play. I am still in (small position).
Holding. Scary... :o after watching DNDN :-X
CEGE broke $4 yesterday and will most likely fill the gap down to... 3.50 ???
I wil be ready to pick some up when we get there.
Cheers
Be very very careful... possible (10 mil) shelf offering coming???? ???
Decent move today
CEGE : Buy alert was given on this stock . JMO
If you decide to play this stock do it based on your own DD
All my alerts is"Just My Opinoin"
Up on trial data. I'm not a bio-tech guru...but sounds positive. :)
Cell Genesys Rises on GVAX Trial Results
Friday February 15, 12:44 pm ET
By Marley Seaman, AP Business Writer
Cell Genesys Stock Advances As Study Shows GVAX Prostate Cancer Vaccine Increases Survival
NEW YORK (AP) -- Cell Genesys Inc. shares jumped Friday after the biotechnology company reported clinical test results showing that prostate cancer patients who had an immune response to one of its GVAX vaccines also lived longer.
ADVERTISEMENT
In a midstage trial, Cell Genesys said 34 of 80 patients showed an immune system response to the vaccine, and those patients lived for an average of 43 months. Those who did not have an immune system response lived for an average of 21 months.
The GVAX drug candidates are designed to fight cancer by boosting the immune system's response, and Cell Genesys said the results show the vaccine can stimulate effective responses to prostate cancer which is spreading.
Shares added 21 cents, or 10.8 percent, to $2.18 in afternoon trading on more than double average trading volume.
Twenty-two of the 65 patients for whom samples were available were given a high dose of the vaccine, and those patients who experienced an immune response lived an average of 44.9 months. The higher dose is being used in late-stage trials of the vaccine.
In an interview, Canaccord Adams analyst Joseph Pantginis said the trial shows the vaccine may increase survival more than older drugs do. The current standard of care in prostate cancer is Sanofi-Aventis' Taxotere, he said, and that drug increases survival by an average of 18 or 19 months.
In a client note, Pantginis said he thinks Cell Genesys will form a partnership later this year that will help it develop the GVAX vaccines. He named Bristol-Myers Squibb Co. and GlaxoSmithKline as potential partners.
The San Francisco-based company is also developing the vaccines as treatments for pancreatic cancer and leukemia.
Keeps going. :o
just fyi:
:-X
Cell Genesys Halts VITAL-2 GVAX Trial in Advanced Prostate Cancer
Wednesday, August 27, 2008 07:10ET
SOUTH SAN FRANCISCO, Calif., Aug 27, 2008 (BUSINESS WIRE) -- Cell Genesys, Inc. (Nasdaq:CEGE) today announced that it has terminated VITAL-2, the second of two Phase 3 clinical trials of GVAX immunotherapy for prostate cancer, which compares GVAX immunotherapy in combination with Taxotere(R) (docetaxel) to Taxotere plus prednisone in patients with advanced-stage prostate cancer. The Company ended the trial as recommended by its Independent Data Monitoring Committee (IDMC) which, in a routine safety review meeting held this week, observed an imbalance in deaths between the two treatment arms of the study. To date, VITAL-2 enrolled 408 patients. The IDMC based its recommendation on 114 deaths of which 67 occurred in the GVAX plus Taxotere combination treatment arm and 47 deaths occurred in the Taxotere control arm. At this time, a specific cause for the imbalance in deaths has not been identified and the IDMC reported no new safety issues for GVAX when administered in combination with Taxotere. The Company plans to fully analyze the clinical data from these patients to attempt to understand the potential cause for the higher rate of deaths observed in the GVAX immunotherapy plus Taxotere combination arm, including an assessment of potential imbalances between the two arms of the study such as baseline characteristics and prognostic factors, as well as other treatment variables. In light of the IDMC's observation with respect to VITAL-2, the Company has requested that the IDMC perform a previously unspecified futility analysis of VITAL-1, the other Phase 3 clinical trial of GVAX immunotherapy for prostate cancer. The Company expects the results of the VITAL-1 futility analysis in approximately one month.
"Patient safety is always our paramount concern and so we have immediately responded to the recommendation of the IDMC. We are currently notifying all participating clinical trial sites and regulatory agencies that enrollment of new patients into VITAL-2 has been suspended as has treatment with GVAX immunotherapy for prostate cancer of patients enrolled in the study," stated Stephen A. Sherwin, M.D., chairman and chief executive officer of Cell Genesys. "Notwithstanding this disappointing outcome, we would like to acknowledge the courage and commitment of the patients and physicians who have participated in this trial."
Dr. Sherwin continued, "The observation in the VITAL-2 trial is very surprising to us, and we have therefore asked the IDMC to conduct a previously unplanned futility analysis of VITAL-1 in order to determine the overall prospects for our ongoing development program for this product. Moreover, with the cessation of VITAL-2, we expect to make commensurate adjustments to our business operations and we will provide further details regarding this in the near future. As a reminder, the company ended the second quarter of 2008 with $166 million in cash."
VITAL-2 was a multi-center, randomized, controlled Phase 3 clinical trial designed to evaluate the safety and efficacy of GVAX immunotherapy for prostate cancer used in combination with Taxotere chemotherapy compared to the use of Taxotere chemotherapy and prednisone in hormone-refractory prostate cancer (HRPC) patients with metastatic disease who are symptomatic with cancer-related pain. The primary endpoint of the trial was an improvement in survival. VITAL-2 was initiated in June 2005 and to date had enrolled 408 patients at 115 clinical trial sites located in North America and the European Union. VITAL-1, the other Phase 3 clinical trial of GVAX immunotherapy for prostate cancer, is designed to compare GVAX cancer immunotherapy as a monotherapy to Taxotere chemotherapy plus prednisone in earlier stage HRPC patients with metastatic disease who are asymptomatic with respect to cancer-related pain. The primary endpoint of the trial is an improvement in survival. In 2007, the VITAL-1 trial completed enrollment with 626 patients. In January 2008, Cell Genesys announced that the IDMC had completed a pre-planned interim analysis for VITAL-1 and recommended that the study continue, providing no further information to the company other than the recommendation to continue the trial.