Dendreon prostate cancer immunotherapy vaccine improves survival; the company develops immunotherapies for cancers
By THOMAS GRYTA - WSJ Apr 14 2009|
Dendreon Corp. reported that its controversial prostate cancer treatment Provenge was successful in prolonging patient survival, a long-awaited critical step seen needed to secure regulatory approval for the drug.
Shares of the Seattle drug developer more than tripled in Tuesday pre-market trading, to more than $23 from the previous close of $7.30, amid hopes for the drug's approval from the Food and Drug Administation.
Investors have waited two years for this news. In late March 2007, a Food and Drug Administration panel endorsed Provenge for approval, but in early May, the FDA declined to approve the treatment without additional clinical data. Since that time, Dendreon has been a controversial name. It has stoked the scorn of skeptical Wall Street analysts and inspired outspoken patient advocates that cite the clean safety record of the drug.
The main goal of the Impact trial was to study overall survival in a group of about 500 patients and is designed to stop once 304 patients have died.
The company is expected to present the full data from the study on April 28 at the American Urological Association's annual meeting.
Dendreon plans to amend its existing marketing application with the FDA in the fourth quarter. The Impact trial was structured according to a Special Protocol Assessment, which is an agreement with the FDA on an acceptable study design to meet requirements for a drug's likely approval.
Provenge is produced from a patient's own cells and administered when the disease no longer responds to hormone blockers. The drug, called an immunotherapy, prompts the immune system to attack the cancer and thus is often referred to as a vaccine.
In October, an interim analysis of the Impact trial showed the results weren't strong enough to warrant an amended application to regulators, but it did show a 20% death-risk reduction for patients on the drug, compared with placebo.
The company had initially expected results from the trial in mid-2009, but moved those projection to late April earlier this year. Some read the move as an increase in patient deaths and ineffectiveness of the drug.
But Dendreon's Chief Executive Mitchell Gold has played down those concerns, partly because the drug's relation to an immune system response makes it more effective as time passes.
Adding to the stock gains Tuesday could be investors looking to cover their short positions. The stock has a large short interest, which measured $19.4 million shares, or 22% of its float, at the end of March. The gains Tuesday will likely force investors to buy shares to cover their exposure.
Some speculate that some of those short bets have been unwound already, leading to a recent rally and heavy volume in the stock.
FROM Dandreon website:
ACTIVE CELLULAR IMMUNOTHERAPY
Dendreon is at the forefront of introducing the first in a new class of therapy known as Active Cellular Immunotherapies (ACIs)An approach that uses live human cells to re-engage the patient's own immune system. The goal of active cellular immunotherapy is to turn the immune system "back on" to elicit a specific long-lasting response against cancer. ACI uses the power of live human cells to re-engage the patient's own immune system. Immune SystemThe complex group of organs and cells that defends the body against infections and other diseases.
Activated T cells may be the immune system's most potent defense against cancer. Although a variety of immune cells participate in the surveillance and elimination of cancer cells, T cells are uniquely endowed to kill specific tumor cell types. When activated to recognize tumor-associated antigens, T cells proliferate and attack cells bearing those antigens. For this reason, the goal of many investigational ACIs is to stimulate and optimize activation of T cells.
The cell orchestrators of T cell activation are antigen presenting cells (APCs). A cell that shows antigen on its surface to other cells of the immune system. This is an important part of an immune response. When encountering tumor-associated antigens in the body, APCs process and display the antigens, and then present them to T cells. When activated by APCs, T cells may recognize and lyse cells bearing those antigens.
The goal of Dendreon's approach is to turn the immune system "back on" to elicit a specific and long-lasting response against cancer. We do this by isolating and activating APCs using proprietary methods. We then fabricate an Antigen Delivery Cassette by combining the APCs with a bio-engineered target antigen. These enhanced APCs now have the ability to alert the patient's T cells to attack the cancer.
PROVENGE Significantly Prolongs Survival in Men With Advanced Prostate Cancer in Pivotal Phase 3 IMPACT Study
- Study Meets Primary Endpoint Showing Statistically Significant Improvement in Overall Survival -
- First Active Immunotherapy for Cancer to Prolong Survival -
- Full Data to be Presented at Plenary Session at Upcoming AUA Annual Meeting -
- Company to Host a Conference Call Today at 9:00 AM ET -
SEATTLE, April 14 /PRNewswire-FirstCall/ -- Dendreon Corporation (Nasdaq: DNDN) announced today that the pivotal Phase 3 IMPACT study of PROVENGE(R) (sipuleucel-T) in men with advanced prostate cancer met its primary endpoint of improving overall survival compared to a placebo control. The magnitude of the survival difference observed in the intent to treat population resulted in the study successfully achieving the pre-specified level of statistical significance defined by the study's design. The safety profile of PROVENGE appeared to be consistent with prior trials.
The 512-patient, multi-center, randomized, double-blind, placebo-controlled IMPACT (IMmunotherapy for Prostate AdenoCarcinoma Treatment) study enrolled men with metastatic androgen-independent prostate cancer was conducted under a Special Protocol Assessment agreement with the U.S. Food and Drug Administration (FDA).
PROVENGE is Dendreon's investigational product candidate for men with advanced prostate cancer and may represent the first in a new class of active cellular immunotherapies specifically designed to engage the patient's own immune system against cancer.
Detailed results from the IMPACT study will be presented during a plenary session at the American Urological Association's Annual Meeting in Chicago on Tues., Apr. 28 at 2:20 pm CT.
"Survival is the gold standard outcome for oncology clinical trials, and overall survival was the primary endpoint of the IMPACT trial. The positive results from this landmark study provide confirmatory evidence demonstrating that treatment with PROVENGE may prolong survival," said Mitchell H. Gold, M.D., president and chief executive officer of Dendreon. "We are immensely grateful to our clinical investigators and the more than 1,000 men with advanced prostate cancer who have participated in our studies over the last decade and whose courage and contribution have significantly advanced the understanding and treatment of prostate cancer and the potential role of cancer immunotherapies."
"The successful outcome from the Phase 3 IMPACT study provides validation of the long-pursued goal of harnessing the human immune system against a patient's own cancer," continued Dr. Gold.
Because the data meet the criteria and specifications outlined in its Special Protocol Assessment (SPA) agreement with the FDA, Dendreon intends to file an amendment to its existing Biologic License Application (BLA) in the fourth quarter of this year to gain licensure of PROVENGE.
Prostate cancer is the most common non-skin cancer in the United States and the third most common cancer worldwide. More than one million men in the United States have prostate cancer, with an estimated 186,320 new cases and approximately 28,660 men who were expected to die from the disease in 2008. Currently there are limited treatment options for men with advanced, metastatic prostate cancer.
Conference Call Scheduled for Today at 9:00 a.m. ET
Dendreon will host a conference call today at 9:00 a.m. ET. To access the live call, dial 1-877-419-6594 (domestic) or 719-325-4855 (international).. The call will also be audio webcast and will be available from the Company's website at www.dendreon.com under the "Investor/Webcasts and Presentations" section. A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-888-203-1112 (domestic) or 719-457-0820 (international); the conference ID number is 8182435. The replay will be available from 12:00 p.m. ET on April 14, 2009 until midnight April 16, 2009. In addition, the webcast will be archived for on-demand listening for 30 days at www.dendreon.com.
PROVENGE (R) (sipuleucel-T), an investigational product in development for men with androgen-independent prostate cancer, may represent the first product in a new class of active cellular immunotherapies (ACIs). PROVENGE and other ACIs are uniquely designed to use live human cells to engage the patient's own immune system with the goal of eliciting a specific long-lasting response against cancer. In controlled clinical trials, the most common adverse events were chills, fever, headache, fatigue, shortness of breath, vomiting and tremor. These events were primarily low grade with a short duration of 1-2 days following infusion.
Dendreon Corporation is a biotechnology company whose mission is to target cancer and transform lives through the discovery, development and commercialization of novel therapeutics. The Company applies its expertise in antigen identification, engineering and cell processing to produce active cellular immunotherapy product candidates designed to stimulate an immune response. Dendreon is also developing an orally-available small molecule that targets TRPM8 that could be applicable to multiple types of cancer as well as benign prostatic hyperplasia. The Company has its headquarters in Seattle, Washington and is traded on the Nasdaq Global Market under the symbol DNDN. For more information about the Company and its programs, visit www.dendreon.com.
Except for historical information contained herein, this news release contains forward-looking statements that are subject to risks and uncertainties surrounding the efficacy of PROVENGE to treat men suffering from prostate cancer, risks and uncertainties surrounding the presentation of data to the FDA and approval of product applications by the FDA and risks and uncertainties inherent in the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics. Factors that may cause such differences include risks related to our limited operating history, risks associated with completing our clinical trials, the risk that the safety and/or efficacy results of existing clinical trials or from additional clinical trials for PROVENGE will not support approval for a biologics license, the risk that the FDA may interpret data differently than we do or require more data or a more rigorous analysis of data than expected, the risk that the FDA will not approve a product for which a biologics license has been applied, the risk that the results of a clinical trial for PROVENGE or other product may not be indicative of results obtained in a later clinical trial, risks that we may lack the financial resources and access to capital to fund required clinical trials or commercialization of PROVENGE, our dependence on the efforts of third parties, and our dependence on intellectual property. Further information on the factors and risks that could affect Dendreon's business, financial condition and results of operations are contained in Dendreon's public disclosure filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov.
SOURCE Dendreon Corporation