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Business Strategy Introgen's objective is to be the leader in the development of molecular therapies and other products for the treatment of cancer and other diseases that, like cancer, result from cellular dysfunction and uncontrolled cell growth. Since its inception, Introgen has concentrated on product development. The Company has succeeded in initiating a broad clinical program with multiple agents in clinical development. Introgen's business strategy focuses on market entry for its cancer products that address severe, life-threatening diseases for which alternative treatments are either unsatisfactory or non-existent. Introgen has maximized the probability of successful preclinical and clinical product development by carefully identifying and evaluating molecular therapies based on a strong scientific rationale, sound intellectual property position and significant potential markets. Introgen has established product-driven collaborative arrangements with leading academic institutions, biotechnology companies and pharmaceutical companies. Introgen believes that establishing and maintaining selective collaborations with corporate and academic partners can enable it to effectively and economically leverage its resources to develop and market products. Introgen has in-licensed technologies that can utilize its multiple delivery technologies. By coupling product candidates with its delivery and platform technologies, Introgen has created valuable later stage product candidates and intellectual properties. Back to Top |
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Development Focus As its research and clinical trials have advanced, Introgen has maintained a focus on the requirements of the oncology marketplace. By aligning product development with market dynamics, Introgen has created product candidates that address the needs of patients and physicians. Back to Top |
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Development Capabilities Introgen has an accomplished management team with proven drug development and approval experience, as well as manufacturing infrastructure, clinical and regulatory expertise, product marketing and business management experience. Back to Top |
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Manufacturing Infrastructure Commercialization of a targeted molecular therapy product requires process methodologies, formulations and quality release assays in order to produce high quality materials at a large scale. We believe the expertise we have developed in the areas of manufacturing and process development represents a competitive advantage. We have developed scale-up methodologies for both upstream and downstream production processes, formulations that are safe and stable, and product release assays that support product quality control. We own and operate state-of-the-art manufacturing facilities, including a commercial-scale, validated manufacturing facility designed to comply with the FDA’s Current Good Manufacturing Practice requirements, commonly known as CGMP requirements. We have produced numerous batches of ADVEXIN® therapy clinical material for use in our Phase 1, 2 and 3 clinical trials. The design and processes of the facility used for ADVEXIN® therapy production have been reviewed with the FDA, EMEA and other regulatory authorities. We plan to use our facilities for the market launch of ADVEXIN® therapy. We also use our facilities to produce INGN 241 and other investigative materials for use in clinical trials of those product candidates. From time to time, as requirements for our own products allow, we also manufacture pre-clinical and clinical materials for outside parties for a fee under contract services arrangements. Back to Top |
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Technology See Our Technologies section of the website. Back to Top |
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Market Introgen’s product candidates are designed to address unmet medical needs in cancer treatment. Introgen’s products are designed to be used alone and in combination with surgery, chemotherapy, biologics and radiation therapy to treat a wide range of solid tumors. The FDA, the National Cancer Institute (NCI), and the Centers for Medicare & Medicaid Services are undertaking the Oncology Biomarker Qualification Initiative to expedite the development of novel cancer treatments. These agencies define biomarkers as clinical or biological indicators of disease or therapeutic effects, which can be measured through dynamic imaging tests, laboratory tests on blood or tissue samples as well as by clinically defined parameters. The initiative was developed to employ biomarkers as a way of speeding the development and evaluation of new cancer therapies. Introgen has identified a set of biomarkers associated with high response rates and increased survival in Phase 2 clinical trials of ADVEXIN® therapy in patients with head and neck cancer. The identification of these predictive indicators of ADVEXIN® activity complies with the FDA biomarker initiatives Gendux Molecular Limited, a subsidiary of Introgen, submitted a Marketing Authorization Application, which has been accepted for review, to the European Medicines Agency for ADVEXIN®, a targeted p53 tumor suppressor therapy for the treatment of Li-Fraumeni Syndrome cancers. Back to Top |
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Promising Clinical Results Most anti-cancer agents currently available in the fight against cancer produce severe toxicity and adverse effects. However, in preclinical and clinical studies to date, Introgen's product candidates have shown anti-cancer activity without the severe toxicity typical of most anti-cancer agents. Back to Top |
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Strategic Product Development Introgen’s clinical trial strategy is to test its products on a variety of life-threatening cancers for which there are no effective treatments. Head and neck cancer has been selected as the initial indication. Additional late stage clinical trials in breast and lung cancers will enable Introgen to add follow-on indications. Introgen’s product candidates are being evaluated in late-stage and early-stage cancers, as well as oral pre-malignancies. Back to Top |
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Academic and Corporate Alliances The University of Texas M. D. Anderson Cancer Center - Many of our core technologies were developed by scientists at The University of Texas M. D. Anderson Cancer Center in Houston, Texas, one of the largest academic cancer centers in the world. We sponsor research conducted at M. D. Anderson Cancer Center to further the development of technologies that have potential commercial viability. These efforts have resulted in our becoming a significant corporate sponsor of activities at M. D. Anderson Cancer Center in recent years and have yielded to us exclusive patent and licensing rights to numerous technologies. National Cancer Institute • Introgen entered into a Collaborative Research and Development Agreement (CRADA) with the National Cancer Institute to evaluate the potential effectiveness and superiority of ADVEXIN® to other treatments against a range of cancers including breast, bladder, lung and brain cancers. Academic Licenses and Collaborations • Introgen has established collaborations and license agreements with a number of important academic institutions including M. D. Anderson Cancer Center, University of South Florida Moffitt Cancer Center, The University of Iowa, Sidney Kimmel Cancer Center, The University of Texas Southwestern Medical Center, Columbia University, The University of California at San Diego, the Texas Heart Institute and the Karolinska Institute. Other - Introgen entered into and alliance agreement with Colgate-Palmolive Company to develop and potentially market oral healthcare products. Additionally, we are working with VirRx to investigate vector technologies, specifically replication-competent viral therapies, for delivering products into targeted cells. These technologies form the basis for our INGN 007 product candidate. Introgen also owns a European subsidiary named Gendux Molecular Limited. Gendux Molecular Limited is engaged in the commercialization of targeted molecular therapies to be applied with molecular diagnostic tools to introduce personalized medical products in European markets. Back to Top |
