chemotherapy

A.P. Pharma sees positive data in late-stage chemo study

John Carroll — Tue, 30 Sep 2008 11:20:36 -0400

A.P. Pharma says its experimental therapy to prevent nausea and vomiting induced by chemotherapy hit the primary endpoint in three of four assessments outlined in a Phase III comparison trial with standard therapy. The study set out to compare the efficacy of two different doses of APF530 with Aloxi in four assessments.

Reuters highlighted the failure of the drug in one of four assessments in its report, but A.P. Pharma's release stressed the positive and the company says it's on track to file for an approval.

According to the biotech, "the results met the primary endpoint of "non-inferiority" (comparability) for three assessments, including moderately emetogenic (acute and delayed onset) and highly emetogenic (acute onset), but did not achieve the primary endpoint of superiority for the highly emetogenic delayed onset assessment."

Researchers also said that the 10 mg dose was more effective than the 5 mg dose and the drug would probably be filed for approval at the higher dose. The Phase 3 trial included 1,395 patients treated at 103 centers in the United States, Poland and India.

"We are highly encouraged with the results of our Phase III trial and are working diligently to get our product approved for marketing as soon as possible," said CEO Ronald Prentki. "According to our market research there are more than 6 million cycles of chemotherapy administered each year in the U.S. We believe this equates to an annual market opportunity in excess of $1 billion."

- read the A.P. Pharma release

Inimex raises $22M in VC

Wed, 04 Jun 2008 06:59:55 -0400

Despite a recent Ernst & Young report on the funding challenges in Canada, Inimex Pharmaceuticals managed to round up a healthy $22 million in Series B funding. The company is launching the first clinical trials of an Innate Defense Regulator (IDR) drug in patients and assessing IDR drugs in a range of disease models. IDRs are novel drugs that selectively trigger the body's innate defenses, protecting against antibiotic-resistant infections and controlling inflammation. CEO John North said IDRs peptides could treat infections related to cystic fibrosis, pneumonia, inflammation and in cancer patients undergoing chemotherapy.

Morningside Venture Investments led the round, along with new investors Roche Venture Fund, Switzerland, CA-based Astellas Venture Management, and BC-based Advantage Life Science Fund II. Additional investors also participated.

- here's Inimex's release

Medarex shares dented on analysts' skepticism

Tue, 03 Jun 2008 06:59:56 -0400

Investors dented the value of Medarex shares after analysts doused its recent claims concerning its late-stage cancer drug ipilimumab with cold water. BMO Capital Market's Jason Zhang says that Medarex doesn't have the data to back up claims that a combination of ipilimumab and dacarbazine work better than ipilimumab alone. Its shares slipped seven percent on the news.

"There is no randomized data with a chemotherapy control supporting ipilimumab's survival-prolonging abilities," said Zhang in a note. Mid-stage study data demonstrated median overall survival of 449 days on the combo therapy compared to 351 days with ipilimumab alone. That was not a statistically significant difference in survival.

- read the AP story

Alfacell stock takes a hit on Onconase data

Thu, 29 May 2008 06:59:56 -0400

New Jersey-based Alfacell took a major hit this morning as it announced that its drug Onconase missed the primary endpoint in a Phase III study. The drug failed to improve survival rates of patients with inoperable malignant mesothelioma. However, a statistically significant improvement in survival was seen in the treatment of UMM patients who failed one prior chemotherapy regimen. Alfacell plans to submit an NDA for this patient population, which it says represents a currently unmet medical need. It expects to complete the filing by the end of 2008. Investors were not impressed with Alfacell's good news/bad news announcement, and took a bite out of the company's stock.

- see this release for more
- read the Forbes report

Related Article:
Strativa acquires Onconase rights

JapanBridge pays $26M for ProStrakan patch

Fri, 23 May 2008 06:59:57 -0400

JapanBridge is paying $26 million in upfront and milestone payments for the rights to develop and commercialize Sancuso, a transdermal patch for the prevention of chemotherapy-induced nausea and vomiting. This patch was developed by Scotland's ProStrakan, which submitted an NDA for the drug in 2007 and is awaiting final approval. ProStrakan expects to launch the drug this year. JapanBridge will market Sancuso in Japan, China, Taiwan, Singapore and Malaysia, and receive royalties on sales there.

MPM Capital and Itochu Corporation formed JapanBridge to "address unmet needs for important new Western oncology therapies in the Far East," according to the statement. This is JapanBridge's first deal.

- see this press release for more

Avanti launches bionano company

Fri, 28 Mar 2008 07:59:54 -0400

Avanti Therapeutics launched a new bionanotechnology company for targeted drug delivery called Chikujee Therapeutics. Chikujee will use Avanti's drug delivery technology to enhance the performance of drugs, specifically anti-cancer drugs. The first drug classes the company will focus on are taxols (Paclitaxel and Docetaxel) and camptothecin for chemotherapy. Chikujee is Avanti's third early-stage company.

- here's the release

Related Articles:
Biotech says nano-device can directly target cancer cells. Report
MD considers funds for growing nano-biotech field. Report
Venture capitalists bet big on nanotechnology. Report
Nanotech is promising, but faces hurdles. Report

OncoGenex, Isis report Phase II success

Fri, 15 Feb 2008 06:59:57 -0500

OncoGenex and collaborator Isis Pharmaceuticals say that in a Phase II trial, OGX-011, in combination with either docetaxel or mitoxantrone, was well-tolerated as a second-line treatment for patients with prostate cancer. In addition, the trials demonstrated ongoing survival rates better than results published with chemotherapy alone.

"These data show that the combination of OGX-011 with docetaxel or mitoxantrone may improve treatment outcomes in second-line prostate cancer," said Dr. Fred Saad, the primary investigator in the study. "The data also suggests that re-treatment with docetaxel when combined with OGX-011 may reverse chemotherapy resistance in second-line docetaxel re-treatment." The results were presented at the 2008 Genitourinary Cancers Symposium. Planning is underway for a Phase III study utilizing chemotherapy plus OGX-011 as second-line therapy in patients progressing after a first-line docetaxel regimen.

- see OncoGenex's release for more

Related Articles:
OncoGenex outlines plans for $48 million IPO. Report

FDA extends review time for Genta's appeal

Mon, 14 Jan 2008 06:59:54 -0500

Genta is going to have to wait a little longer before it gets final word on its appeal of the FDA's rejection of Genasense. The feds were supposed to act by the end of last year, but Genta says now that a decision won't be made until sometime in the current quarter. Genta had filed for approval to use Genasense with chemotherapy in patients with relapsed or refractory chronic lymphocytic leukemia.

- check out the release on the appeal

Related Articles:
FDA rejects Genasense. Report
Advisory committee rejects Genta cancer drug. Report
Genasense hits primary endpoint in late-stage cancer trial. Report

Synta scores $1.1B deal with GSK

Wed, 10 Oct 2007 06:59:58 -0400

Synta Pharmaceuticals broke the billion-dollar mark in its new licensing deal with GlaxoSmithKline. Glaxo has agreed to pay Synta $80 million up front and up to $1.1 billion in total for the deal covering STA-4783, which has demonstrated efficacy in improving median survival rates for melanoma patients in a mid-stage study. In Phase II volunteers taking the therapy in combination with chemotherapy had a median survival rate of 12 months compared to 5.6 months for patients receiving chemotherapy alone. Progression free survival at six months jumped from 15 percent to 35 percent. The therapy is about to be tested in a late-stage trial.

Synta, which we recognized as a Fierce 15 company in 2004, has been developing therapies that kill cancer cells by raising oxidative stress levels in cancer cells to the point they self destruct. Normal cells are not affected by the treatment. For Glaxo, the deal underscores its willingness to get out the check book in order to beef up its lineup of late-stage cancer therapies. Glaxo committed $135 million for regulatory approval, $450 million for other indications and $300 million for sales targets. Another $45 million could be invested in Synta stock.

- check out the release on the agreement
- here's the report from the Wall Street Journal

Related Articles:
Synta therapy slows spread of melanoma. Report
Synta gets fast track for cancer therapy. Report
Synta trial hits endpoint. Report
GSK stakes claim to ASCO spotlight. Report

Read more on: Synta | GlaxoSmithKline

Positive results for AstraZeneca's lung cancer drug

Fri, 21 Sep 2007 06:59:58 -0400

According to Phase II results published in the Journal of Clinical Oncology, AstraZeneca's drug vandetanib (Zactima) improved progression free survival in patients with advanced lung cancer. AstraZeneca is already recruiting 1,400 patients for a Phase III trial of the drug as a second-line treatment of non-small cell lung cancer.

"Given the poor prognosis in advanced non-small cell lung cancer, an increase in time to disease progression can be meaningful to patients," said John Heymach, the study's lead researcher. "The results of Study 6 provide encouraging support, and reinforce further investigation with ZACTIMA in combination with chemotherapy in Phase III trials." Zactima was fast-tracked by the FDA in early 2006.

- see AstraZeneca's release

Related Articles:
AstraZeneca to outsource manufacturing. Report
AstraZeneca cuts 7,600 jobs. Report
AstraZeneca announces restructuring and buyout. Report

Venture capitalists bet big on nanotechnology

Maureen Martino — Wed, 12 Sep 2007 10:42:42 -0400

Venture capitalists are always looking for the next big thing to invest in—and hopefully make loads of cash from. Several investors think they have found just the ticket. These VCs are homing in on companies using nanotechnology to make therapies that destroy cancerous tumors but bypass healthy cells. By encasing drugs in nanoparticles that target only diseased cells, many of the unpleasant side-effects the result from cancer treatment can be avoided.

The first nanoparticle was approved in 1995. Doxil used miniscule fat bubbles (called liposomes) to encapsulate the chemotherapy doxorubicin. Most of the time the bubbles circulated in the blood without a problem, slowly releasing the doxorubicin, but about 10 percent of the bubbles burst, compromising healthy tissue.

Now several companies are looking beyond liposomes to find other forms of nanotechnology that could revolutionize the way cancer is treated:

BIND Biosciences has a pre-clinical nanoparticle that enters the tumor and releases its drug. The company expects to have a drug for either cancer or cardiovascular disease in the clinic by 2009, and won $2.5 million in VC back in January to support its work. Investors included Polaris Ventures and Flagship Ventures.
Tempo Pharmaceuticals has a drug in the works that penetrates tumors and releases two drugs--one to collapse the tumor vasculature and another that gradually releases chemo. Tempo landed $12.1 million in VC in May (also from Polaris), which should help it push a drug into the clinic.
Avidimer Therapeutics’ nanoparticle (called a dendrimer) is shaped like a tree, with the chemo drug methotrexate attached to its branches. Once the dendrimer gets lodged inside the tumor, the tumor is unable to expel the lethal methotrexate. With help from Flagship Ventures and North Coast Technology Investors, Avidimer closed its first-round of funding in August.
Intradigm is pairing nanotechnology with the hot field of RNAi to achieve effective delivery siRNA molecules (one of the two types of RNA); the company gained a hefty $16 million in VC for its work. Alta Partners and Frazier Healthcare Ventures led the round.

For more on VC’s interest in nanotechnology
- read this Wall Street Journal article

Related Articles:
FDA to address nanotechnology standards. Report
Fat bubbles used to deliver chemo. Report
Hot nanoprobes used to slow tumor growth. Report
Nanoparticles used to destroy tumors. Report
"Scrap" DNA can turn off tumor cell division. Report

Erbitux clears late-stage hurdle for lung cancer

Tue, 11 Sep 2007 06:59:57 -0400

ImClone once again is feeling the tonic effects of positive trial data. Its stock price took off this morning, rising 19 percent after its European partner, Merck KGaA, reported that Erbitux helped increase the survival rate of lung cancer patients. The data may help clear the way to a new approval with blockbuster potential. The trial volunteers were diagnosed with advanced non-small cell lung cancer and divided into two groups that received either a combination of Erbitux and chemotherapy or chemotherapy alone. Last July Erbitux failed a separate late-stage study as a treatment for lung cancer.

Good news for ImClone and its U.S. partner, Bristol-Myers, was bad news for Genentech, which saw its share price clip on the news of a potential competitor.

- see ImClone's release on the trial
- read the AP report

ALSO: Repligen says that ImClone has agreed to pay $65 million to settle patent infringement charges related to Erbitux. Release

Related Articles:
ImClone names new CEO. Report
ImClone shares dive after Erbitux fails a Phase III. Report
Erbitux data underscores leaked disappointment. Report
ImClone buoyed by new Erbitux data. Report
ImClone touts survival rate in Erbitux cancer trial. Report

Avastin re-submitted to FDA

Fri, 24 Aug 2007 06:59:58 -0400

Perhaps the second time is the charm for Genentech. The biotech has re-submitted a sBLA to the FDA for Avastin in combination with paclitaxel chemotherapy as a first-line treatment for metastatic breast cancer. In September 2006 Genentech was dealt a setback when the FDA asked to see more data, including an independent review, before it would approve the new indication. Genentech supplied the additional information and the six-month FDA review process will now begin.

- here's the release on the sBLA
- read this article from Forbes

ALSO: Watch a blockbuster cancer drug become a behemoth: Roche has won European regulatory approval for treatment of advanced non-small cell lung cancer with Avastin. FiercePharma

Related Articles:
Genentech touts pipeline prospects as doubts fester. Report
Genentech fights to keep edge in drug development. Report
FDA deals setback to Genentech. Report

Sanofi, Regeneron launch late-stage cancer studies

Thu, 23 Aug 2007 06:59:56 -0400

Sanofi-Aventis and Regeneron say that they have launched two Phase III trials for aflibercept--or VEGF Trap--with chemotherapy for lung and prostate cancer. The program has enormous potential if it succeeds in Phase III. The injectable therapy is designed to block the formation of abnormal blood vessels. VEGF triggers these new blood vessels to form in a process called angiogenesis. The blockbuster Avastin is currently the leading therapy in this field. Sanofi will provide an update on the program during its R&D day on September 17. The companies believe they can start seeking approval of the drug as early as next year.

- check out the release

Related Articles:
Regeneron, Genentech go head-to-head. Report
Regeneron wins rich pact for VEGF trap. Report

SPOTLIGHT: New cancer data from Isis

Tue, 31 Jul 2007 06:59:53 -0400

OncoGenex Technologies and Isis Pharmaceuticals announced encouraging preliminary data from an ongoing Phase II clinical trial of OGX-011 in combination with second-line chemotherapy in patients with metastatic hormone refractory prostate cancer. All patients had progressive disease on or within six months of first-line docetaxel therapy. Patients receiving the combination of OGX-011 and re-treatment with docetaxel in the second-line setting are achieving longer survival, longer progression-free survival and more frequent prostate-specific antigen decreases than patients treated with OGX-011 in combination with mitoxantrone, a standard second-line chemotherapeutic agent. Release

SPOTLIGHT: FDA questions satraplatin

Mon, 23 Jul 2007 06:59:53 -0400

Shares of GPC Biotech and Spectrum Pharmaceuticals took a big hit on Friday after the FDA raised questions regarding their cancer drug satraplatin. Analysts were alarmed that the agency was highlighting a disagreement between two radiologists over the progression of prostate cancer in patients who have failed to respond to chemotherapy. Reviewers may ask for a delay on any decision until final survival data is in. An expert FDA panel is scheduled to review the drug this week. Report

Antisoma drug flunks ovarian cancer trial

Thu, 12 Jul 2007 06:59:57 -0400

The UK's Antisoma says that its experimental therapy for ovarian cancer has failed a clinical trial, triggering a swift loss of about one fifth of the company's share value. The mid-stage trial of ASA404 showed no increase in time to tumor progression when added to chemotherapy. Antisoma still has high hopes, though, that the therapy will prove convincingly effective against lung cancer. Novartis, which inked an $890 million pact on the drug in April, is preparing a Phase III study. "Based on these data, development in ovarian cancer will not be a priority," Antisoma said in a statement.

- see the release
- read the report on the trial results from MarketWatch

Related Articles:
Antisoma adds more positive data for AS1404. Report
Antisoma in licensing talks. Report
Antisoma trial delivers positive returns. Report

ALSO NOTED: NPS sells facility; NICE backs Tysabri; Xolair gets black box warning;and much more...

Tue, 03 Jul 2007 00:01:30 -0400

> As part of its restructuring, NPS Pharmaceuticals has sold its Salt Lake City facility to the University of Utah for $21 million. Report

> The National Institute for Health and Clinical Excellence in England has endorsed Tysabri for MS patients. Release

> The FDA has added a black box warning to Genentech's Xolair for asthma. Report

> Novartis says it will increase its U.S. supply of Fluvirin flu vaccine by 30 percent to 40 percent. Report

> The FDA has approved Tamiflu in 30 mg and 45 mg. Report

> Patients with inoperable non-small cell lung cancer who receive an initial high dose of chemotherapy before their treatment begins can expect an increase in overall survival, according to a new study. Release

> In a remarkable breakthrough for weight research, scientists have reported the discovery of a neurochemical pathway that stimulates the accumulation of fat in animals laboring under chronically high stress and exposed to a diet of junk food. Report

> The heart drug propranolol can be used to interfere with the way the brain stores memories, offering a new approach to treating people with post traumatic stress disorder. Report

And Finally... The first half of 2007 has been tough for biotech stocks. Report

Press Release: GPC Biotech Announces that Partner Pharmion Submits European Marketing Application for Satraplatin

Maureen Martino — Tue, 26 Jun 2007 12:31:18 -0400

GPC Biotech Announces that Partner Pharmion Submits European Marketing Application for Satraplatin

MARTINSRIED/MUNICH, Germany, June 26, 2007 -- PRINCETON, N.J. -- GPC Biotech AG today announced that its partner, Pharmion Corporation , has submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMEA) for satraplatin in combination with prednisone for the treatment of patients with metastatic hormone refractory prostate cancer (HRPC) who have failed prior chemotherapy. This filing is based primarily on data from the SPARC Phase 3 registrational trial.

"We are delighted that Pharmion has submitted the European marketing application for satraplatin," said Bernd R. Seizinger, M.D., Ph.D., Chief Executive Officer. "With over 60,000 people expected to die from prostate cancer in the European Union this year, there is an urgent need for new therapies. We believe that, if approved, satraplatin has the potential to become an important new treatment option for advanced prostate cancer patients who today have very little hope."

GPC Biotech will receive an $8 million milestone payment from Pharmion in connection with EMEA's acceptance of this filing. Under the terms of GPC Biotech's agreement with Spectrum Pharmaceuticals, the acceptance of the MAA by the EMEA will also trigger payments by GPC Biotech to Spectrum in a total amount of $3.2 million, representing a direct milestone payment plus Spectrum's share of the $8 million milestone payment from Pharmion.

About Satraplatin

Satraplatin, an investigational drug, is a member of the platinum family of compounds. Platinum-based drugs are a critical part of modern chemotherapy treatments and are used to treat a wide variety of cancers. All platinum drugs currently on the market require intravenous administration. Satraplatin is an oral compound that clinical trial patients are able to take at home. Satraplatin is not currently approved by the FDA in the United States, by the EMEA in the European Union or any other regulatory authority and no conclusions can or should be drawn regarding its safety and efficacy.

A Phase 3 registrational trial, called SPARC, is evaluating satraplatin plus prednisone versus placebo plus prednisone in 950 patients with hormone- refractory prostate cancer whose prior chemotherapy has failed. Data from the trial on progression-free survival and on safety have been presented at recent medical conferences. Satraplatin is currently under review by the U.S. FDA for hormone-refractory prostate cancer patients whose prior chemotherapy has failed.

GPC Biotech has a co-development and license agreement with Pharmion GmbH, a wholly owned subsidiary of Pharmion Corporation, under which Pharmion has been granted exclusive commercialization rights to satraplatin for Europe and certain other territories. GPC Biotech in-licensed satraplatin from Spectrum Pharmaceuticals, Inc. in 2002.

Satraplatin has been studied in clinical trials involving a range of tumors. Trials evaluating the effects of satraplatin in combination with radiation therapy, in combination with other cancer therapies and in a number of cancer types are underway or planned.

About GPC Biotech

GPC Biotech AG is a publicly traded biopharmaceutical company focused on discovering, developing and commercializing new anticancer drugs. GPC Biotech's lead product candidate satraplatin is currently under review by the U.S. FDA for hormone-refractory prostate cancer patients whose prior chemotherapy has failed. GPC Biotech is also developing a monoclonal antibody with a novel mechanism-of-action against a variety of lymphoid tumors, currently in Phase 1 clinical development, and has ongoing drug development and discovery programs that leverage its expertise in kinase inhibitors. GPC Biotech AG is headquartered in Martinsried/Munich (Germany), and has a wholly owned U.S. subsidiary headquartered in Princeton, New Jersey. For additional information, please visit GPC Biotech's Web site at www.gpc-biotech.com.

This press release contains forward-looking statements, which express the current beliefs and expectations of the management of GPC Biotech AG, including statements relating to results of the SPARC trial and statements relating to the potential efficacy and safety profile of satraplatin. Such statements are based on current expectations and are subject to risks and uncertainties, many of which are beyond our control, that could cause future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Actual results could differ materially depending on a number of factors, and we caution investors not to place undue reliance on the forward- looking statements contained in this press release. In particular, there can be no guarantee that additional information relating to the safety, efficacy or tolerability of satraplatin may be discovered upon further analysis of data from the SPARC trial or analysis of additional data from other ongoing clinical trials for satraplatin. Furthermore, we cannot guarantee that satraplatin will be approved for marketing in a timely manner, if at all, by regulatory authorities nor that, if marketed, satraplatin will be a successful commercial product. We direct you to GPC Biotech's Annual Report on Form 20-F for the fiscal year ended December 31, 2006 and other reports filed with the U.S. Securities and Exchange Commission for additional details on the important factors that may affect the future results, performance and achievements of GPC Biotech. Forward-looking statements speak only as of the date on which they are made and GPC Biotech undertakes no obligation to update these forward-looking statements, even if new information becomes available in the future.

CONTACT: Martin Braendle, Director, Investor Relations & CorporateCommunications, +49 (0)89 8565-2693, ; In the U.S.:Laurie Doyle, Director, Investor Relations & Corporate Communications,+1-609-524-5884, , both of GPC Biotech AG;Additional Media Contacts: (In Europe) Brian Hudspith of Maitland, +44(0)20 7379 5151, ; (In the U.S.) David Schull ofRusso Partners, LLC, +1-212-845-4271, ir@gpc-biotech.com usinvestors@gpc-biotech.com bhudspith@maitland.co.uk david.schull@russopartnersllc.com

Press Release: Introgen Therapeutics's INGN 225 Molecular Cancer Vaccine Demonstrates Promising Results In Phase 2 Trial

Maureen Martino — Mon, 29 Jan 2007 11:11:02 -0500

Introgen Therapeutics's INGN 225 Molecular Cancer Vaccine Demonstrates Promising Results In Phase 2 Trial

AUSTIN, Texas -- Approximately half of patients with advanced small cell lung cancer responded to Introgen Therapeutics, Inc.'s INGN 225 molecular cancer vaccine in combination with subsequent chemotherapy. The encouraging Phase 2 clinical data were presented over the weekend by Introgen's collaborator Dr. Scott Antonia of the H. Lee Moffitt Cancer Center & Research Institute. Patients in the study achieved a 52 percent objective tumor response rate and 41 percent of patients were still alive one year after receiving the immunotherapy. Historically, tumor responses to second-line chemotherapy are between 6 and 30 percent and most patients survive for less than 6 months. The data imply that INGN 225 immunotherapy can sensitize cancer cells to the effects of chemotherapy restoring its effectiveness. INGN 225 is a cancer vaccine containing the p53 gene. p53 is called the "Guardian of the Genome," and is known to help restore normal cellular function and to promote apoptosis, or programmed cell death in abnormal cells such as cancer cells, allowing tumors to die when treated with chemotherapy.

Dr. Antonia, associate professor in the Department of Interdisciplinary Oncology and Molecular Medicine, reported the data during the Fourth Biennial Meeting of Molecular Targets in Cancer Therapy in Clearwater Beach, Florida. An interim analysis of the phase 2 clinical trial was previously published in the medical journal Clinical Cancer Research.

"Data from Introgen's study in lung cancer patients, as well as other published studies, supports the novel approach of using a combination of immunotherapy and chemotherapy to treat cancer patients," said Dr. Dmitry Gabrilovich, also of H. Lee Moffitt Cancer Center & Research Institute, organizer of the conference and co-principal investigator of the clinical trial. "INGN 225 sensitized tumors to the effects of platinum and taxane chemotherapies. Of particular interest, some patients who previously failed platinum chemotherapy responded to platinum re-treatment. These findings have important implications for improving the efficacy of these widely utilized cancer chemotherapies."

INGN 225 is an immunotherapy (vaccine) that utilizes an adenovector to deliver the p53 gene to a patient's immune cells, stimulating an anti-tumor immune response. Induction of p53-specific immune responses were observed following INGN 225 therapy and were found to correlate with increased tumor responses to the administered chemotherapy.

Introgen Therapeutics, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted molecular therapies for the treatment of cancer and other diseases. Introgen is developing molecular therapeutics, immunotherapies, vaccines and nano-particle therapies to treat a wide range of cancers using tumor suppressors and cytokines. Introgen maintains integrated research, development, manufacturing, clinical and regulatory departments and operates multiple manufacturing facilities including a commercial scale cGMP manufacturing facility.

Statements in this release that are not strictly historical may be "forward-looking" statements, including those relating to Introgen's future success with its INGN 225 clinical development program for treatment of lung and other cancers. The actual results may differ from those described in this release due to risks and uncertainties that exist in Introgen's operations and business environment, including Introgen's stage of product development and the limited experience in the development of gene-based drugs in general, dependence upon proprietary technology and the current competitive environment, history of operating losses and accumulated deficits, reliance on collaborative relationships, and uncertainties related to clinical trials, the safety and efficacy of Introgen's product candidates, the ability to obtain the appropriate regulatory approvals, Introgen's patent protection and market acceptance, as well as other risks detailed from time to time in Introgen's filings with the Securities and Exchange Commission including its filings on Form 10-K and Form 10-Q. Introgen undertakes no obligation to publicly release the results of any revisions to any forward-looking statements that reflect events or circumstances arising after the date hereof.

EDITOR'S NOTE: For more information on Introgen Therapeutics, or for a menu of archived press releases, please visit Introgen's Website at: www.introgen.com.

Contact: Introgen Therapeutics, Inc. Naomi Puhl, 512-708-9310, ext. 341 n.puhl@introgen.com