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Innnovate Oncology (IOVO)

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Last Post: 1/9/2006 2:25:41 PM - Followers: 0 - Board type: Free - Posts Today: 0

Innovate Oncology's Product Portfolio One in three Americans will be diagnosed with cancer, and two out of three diagnosed with the disease will die from it, according to Reuters Business Insight. Our objective is to provide cancer patients with effective and safe therapeutics that save or prolong their lives. We are developing a diversified product portfolio targeting multiple forms of cancer, including three of the most prevalent: breast, prostate and colon cancer. Our pipeline of seven drugs consists of five drug candidates in or beginning clinical trials and two in pre-clinical stages of development. The clinical candidates can be divided into the following categories: New Chemical Entities ("NCE"), therapeutic switches of existing drug in the market that are not indicated currently to treat cancer, and reformulations of drugs in the market indicated to treat cancer. The portfolio of clinical candidates includes two NCEs, which may have the greatest commercial potential, but also carry the highest risk precisely because of their novelty. The portfolio's therapeutic switch offers the advantages of being a proven drug that we believe may have medical and market value that isn't realized fully by its current use. Like a therapeutic switch, reformulating an existing, FDA-approved compound offers lower risk to the Company because it's a validated therapy and potentially less expensive to develop. We believe this diversified approach balances the risks and rewards inherent in each drug candidate and its particular development program. Our portfolio is characterized by compounds that have multiple mechanisms of action, which, we believe might substantially increase a compound's clinical efficacy. Also, several of these products are lead compounds derived from novel technologies with the potential for follow-on compounds to be developed into separate products for related indications. Phase of Development Product ------------------------------------------------------- Candidate Indication Pre-Clinical Phase I Phase II Phase III INOC-001 Chemo-Resistance Inhibitor X X X INOC-002 Chemotherapy Potentiator X X X INOC-005 Capridine Beta X X INOC-009 Oral Paclitaxal Formulation X X INOC-010 Polymer-Formulated Camptothecin X X INOC-016 HER2 Oncogene Inhibitor X INOC-019 Prostate Tumor Suppressor X </TABLE> "Pre-Clinical" refers to the series of tests in the laboratory and those performed on animals after a lead molecule has been identified. Basic pharmacology is completed in this phase as well as the toxicology required for human testing, which may be ongoing. Primary and secondary manufacturing of the active compound and the method of drug delivery (intravenous or tablet, for example) will be established during this time. Testing in humans is expected to begin within 18 and 24 months. Pre-clinical tests must be completed before an Investigational New Drug application ("IND") can be submitted to the FDA. "IND" refers to the preparation of an Investigational New Drug application, the process by which a drug is submitted to the FDA to receive approval for human testing. "Phase I" refers to the stage in which compounds are tested for safety, maximal tolerated dose and pharmacokinetics in volunteers without the disease. "Phase II" refers to the initial stages of compound testing in patients with the disease (a particular indication) or symptoms of interest for ultimate New Drug Application ("NDA") approval and labeling. This stage first demonstrates the compound's efficacy and dosing range, and expands the safety profile. "Phase III" refers to the rigorously controlled test of a new drug in a large population of patients with the disease. After the successful conclusion of Phase III clinical trials, an NDA is filed with the FDA for approval to market the drug. INNOVATE PRODUCTS IN DEVELOPMENT: CLINICAL CANDIDATES INOC-001 Chemo-resistance Inhibitor Description. INOC-001 is the lead drug candidate in our portfolio. Our management believes that the compound offers a novel approach to overcoming resistance to chemotherapy that many patients develop over the course of treatment. The compound, which is marketed as an anti-viral drug in Germany and other European countries, is being tested to treat metastatic pancreatic cancer. In pre-clinical studies, INOC-001 demonstrated an ability to reduce toxic side effects, slow disease progression and increase survival rates when used in conjunction with some chemotherapeutic drugs. Pre-clinical experiments have shown evidence of INOC-00l inhibiting several genes responsible for chemo-resistance as well as using multiple mechanisms of action. We have completed a Phase I trial with various types of solid tumors and chemotherapy regimens and have documented early efficacy in patients with pancreatic cancer. Market Opportunity. The American Cancer Society estimates that in 2005, 32,180 people in the U.S. will be diagnosed with pancreatic cancer and 31,800 patients will die from the disease. The five-year survival rate is only 4.4%, making it one of the most lethal forms of cancer. Fewer than 10% of patients respond to treatment. Partnerships. Cynat Oncology a wholly owned subsidiary of Bioaccelerate, is a joint venture partner in Resistys, Inc. with Avantogen formerly known as Australian Cancer Technology ("ACT"). As part of Bioaccelerate's obligation to provide six clinical products to Innovate, Bioaccelerate transferred 100% of the capital stock of Cynat Oncology to Innovate on March 16, 2005 following an announcement on February 14, 2005, that Bioaccelerate would assign its rights to develop and commercialize INOC-001 to Innovate. The Company is sharing the development costs equally with its partner as well as an exclusive license to market the product in the U.S. and Canada. Status. On December 15, 2004, Bioaccelerate announced it had initiated a Phase I/II clinical trial for the treatment of metastatic pancreatic cancer with its co-development partner ACT. The eight-month study will include 22 patients with metastatic pancreatic cancer and will be conducted at three leading centers in Germany: Chemnitz Clinics in collaboration with the Technical University Dresden; Munich University of Technology's Kilinikum rects der Isar; and University of Munich Hospital's Klilnikum Gro(beta)hadern. The trial is being managed by Swiss CRO Hesperion. INOC-001 tablets are administered in conjunction with conventional chemotherapy agents and will be evaluated in this study with Gemcitabine. Eighteen patients have been enrolled and dosed. Patents. A U.S. patent, number US 6,589,941 was granted for the compound in 2003 and another U.S. patent is pending. A patent was issued under the terms of the Patent Cooperative Treaty ("PCT"), which is adhered to by more than 100 countries. INOC-002 Chemotherapy Potentiator Description. INOC-002 is an enhancement and a new dosing regimen of an intravenous drug approved to treat colon cancer. The Company intends to test a novel dosing regimen, administering the drug simultaneously with capecitabine, a commonly used chemotherapeutic agent. Administering the drugs simultaneously could make capecitabine more effective, and therefore may permit a lower dose, which in turn would reduce toxic side effects. The Company believes that current dosing regimens based on its labeled use as an anti-worming agent have not optimized the potential synergistic effect of INOC-002 that could be achieved by combined dosing. The lead indication of INOC-002 is a post-operative adjuvant therapeutic agent. Market Opportunity. Colorectal cancer is the third most prevalent form of cancer globally, according to Reuters Business Insight. Its annual mortality rate is almost as high as the mortality rates for breast and prostate cancer patients combined even though the patient population for those two types of cancer is more than four times the size of the colorectal patient population. In 2003, approximately 889,000 patients were being treated for the disease and 428,000 new patients were diagnosed. Partnerships. On August 6, 2004, Bioaccelerate entered into an agreement with Targent, Inc. to acquire eight patents and certain confidential information related to INOC-002. Bioaccelerate assigned this agreement to Innovate on March 16, 2005 subject to consent by Targent. The agreement between Bioaccelerate and Targent requires consent by the other party to any assignment which consent may not be unreasonably withheld or delayed. Bioaccelerate has sought consent from Targent to the assignment and is awaiting confirmation by Targent. The Company is responsible for the drug development costs as well any maintenance fees on patents and patent applications. Status. Pre-clinical trials confirmed the additive effect of INOC-002. The Company plans to initiate its clinical program within a year. . Patents. Eight patent applications were filed between December 1, 2000 and March 15, 2005 for patents in the U.S., Canada, Europe, Australia, Japan, Hong Kong and an international patent. INOC-005 Capridine Beta Description. INOC-005 is an NCE to treat prostate cancer. The compound renders aggressive hormone-independent prostate cells hormone-sensitive and therefore may be effective in treating both hormone-sensitive and hormone-insensitive tumors in combination with anti-androgen therapy. In pre-clinical development, INOC-005 also showed activity against leukemia, melanoma, lung, colon, ovarian, renal and bladder cancer. Toxicology studies indicate that this compound may have lower bone marrow toxicity. Market Opportunity. In 2003, approximately 300,000 men in the seven major market countries (U.S., France, Germany, Italy, Spain, Japan and the UK) were diagnosed with prostate cancer; the total patient population was 1,774,000, according to Reuters Business Insight. Those patients had a 99.7% one-year survival rate and a 96.8% five-year survival rate. Treatment for prostate cancer is one of the success stories in oncology research. Nonetheless there's room for improvement given the prevalence of the disease. Partnerships. On March 31, 2005, the Company entered into an agreement with Prostagenics, LLC pursuant to which, Innovate obtained the global patent rights to develop and commercialize INOC-005. Status. Pre-clinical development has been completed. The Company expects to file an IND application by mid 2006 to conduct Phase I clinical trials for advanced prostate cancer. Patents. A U.S. patent, number US 6,589,961 was granted to this product candidate in 2003. Seven other patent applications have been filed for this compound in the U.S., Canada, Mexico, Europe and Israel. INOC-009 Oral Paclitaxal Description. INOC-009 is a reformulation of a commonly used intravenous chemotherapeutic agent that treats several types of cancer, including breast, ovarian and AIDS-related Kaposi's sarcoma. This new, oral formulation improves the drug's solubility and therefore facilitates absorption into the bloodstream. The formulation also prevents efflux of the drug from the intestine. Market Opportunity. Breast cancer is the second most common form of cancer worldwide, according to the World Health Organization's World Cancer Report. An existing intravenous paclitaxal product (Taxol(R)) was one of the top 10 selling cancer drugs in 2004 with sales of more than $1.2 billion. Partnerships. On July 15, 2004, Bioaccelerate entered into a license and co-marketing agreement with Supratek, Pharma, Inc. to develop INOC 009 to treat cancer in humans. Innovate is already a licensee under the terms of the agreement but Bioaccelerate has also assigned its rights under this agreement to Innovate on March 16, 2005, subject to receipt of Supratek's written consent, which can not be unreasonably witheld. Bioaccelerate has sought that consent and is awaiting confirmation by Supratek. Status. Pre-clinical testing has been completed. The Company expects to file an IND application with the FDAmid 2006. Patents. Supratek owns a total of four "composition of matter" patents numbers US 5,817,321, 6,060,518, 6,277,410 and 6,387,406 in the U.S. related to its proprietary technology and is responsible for maintenance and upkeep of its patents INOC-010 Polymer-Formulated Camptothecin Description. INOC-010 is a reformulation that uses an innovative, proprietary carrier technology to treat drug-resistant tumors. This technology has demonstrated improved efficacy compared with the previous formulation because it increases the amount of the drug taken up by tumor cells and inhibits drug efflux associated with tumor resistance. This intravenous reformulation of topotecan showed no apparent change in toxicity during pre-clinical tests to treat melanoma, breast and lung cancer. Market Opportunity. Topotecan is currently indicated to treat ovarian cancer and small cell lung cancer. Partnerships. On November 10, 2004, Bioaccelerate entered into a licensing and co-marketing agreement with Supratek Pharma, Inc. to develop, seek regulatory approval and, in major markets, commercialize INOC-010. Supratek granted Bioaccelerate an exclusive global license to its intellectual property related to INOC-010. Innovate is also a licensee under the terms of the agreement but Bioaccelerate has also assigned its rights under this agreement to Innovate on March 16, 2005, subject to receipt of Supratek's written consent, which consent can not be unreasonably withheld. Bioaccelerate has sought that consent and is awaiting confirmation from Supratek. Status. Pre-clinical testing is complete. The Company expects to file an IND application with the FDA in 2006. Patents. Supratek owns a total four "composition of matter" patents in the U.S. related to its proprietary technology and is responsible for maintenance and upkeep of its patents. PRE-CLINICAL PROJECTS INOC-016 HER2 Oncogene Inhibitor Description. INOC-016 is a small molecule that has been shown to inhibit expression of the HER2 gene that is over expressed in 30% of all breast cancer tumors and is associated with a poor outcome. Herceptin(R) is a monoclonal antibody that binds to HER2 on tumor cells. It is currently marketed and approved for use with chemotherapy to treat advanced breast cancer. The Company believes that INOC-016, by preventing the expression of the gene, may lead to a more complete eradication of the HER2 protein and therefore be more efficacious in the management of breast cancer. Status. In pre-clinical testing of this drug, INCO-016 has been shown to stop the growth of breast cancer tumors in animal models. Partnerships. On January 4, 2005, Bioaccelerate entered into an exclusive license agreement with Baylor College of Medicine granting Bioaccelerate worldwide exclusive rights to patents and other intellectual property rights associated with INOC-016 to develop and commercialize the compound. Bioaccelerate conditionally assigned this agreement to Innovate on March 16, 2005. Patents. A U.S. patent application was filed in 2003 and a joint PCT/U.S. patent application was filed in 2003. Baylor is responsible for filing, prosecuting and maintaining all patents. The Company will pay all legal costs associated with these patents. INOC-019 Prostate Tumor Suppressor Description. A peptide derived from a novel, proprietary tumor suppressor protein designed to induce the death of prostate cancer cells in vitro and in animal models. Partnerships. On March 15, 2005, Bioaccelerate entered into a license agreement with Northwestern University. The agreement granted Bioaccelerate an exclusive global license to the patent rights to develop and commercialize INOC-019. Bioaccelerate assigned this agreement to Innovate on March 16, 2005. Patents. A U.S. patent, number US 6,780,984 was granted for this compound in 2004. http://www.innovateoncology.com Innovate Oncology, Inc. Sujay R. Kango, 646-723-8944 sujay.kango@innovateoncology.com
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