October 22, 2008
Neotropix(R) Announces Presentation of Relevant Preclinical Results of NTX-010 in Pediatric Oncology Models
Neotropix(R), Inc., a clinical-stage development company focused on neuroendocrine cancer treatments, announced today exciting data from an extensive pediatric preclinical study performed by the National Cancer Institute (NCI) funded Pediatric Preclinical Testing Program on the use of NTX-010 (Seneca Valley Virus-001), a tumor-selective naturally-occurring oncolytic virus. The results support the initiation of clinical development of Neotropix's lead candidate, NTX-010 for the treatment of pediatric cancers. NTX-010 has been developed as a cancer therapeutic to treat some of the most aggressive cancers known which occur in adults including small cell lung cancer, large cell non-small cell lung cancer, as well as other adult cancers such as carcinoid and various neuroendocrine cancers.
The detailed study results are being presented at the 20th Annual Molecular Targets and Cancer Therapeutics International Meeting in Geneva, Switzerland from October 21-24, 2008. The meeting is hosted jointly by the European Organization for Research and Treatment of Cancer (EORTC), the National Cancer Institute (NCI), and the American Association for Cancer Research (AACR).The Pediatric Preclinical Testing Program (PPTP) presentation described encouraging results from an extensive evaluation of NTX-010 in over 30 different tumor models representing the most common types of childhood solid tumors. Extensive analysis has previously determined that these carefully selected models, many derived directly from patients' tumors, are predictive of clinical activity and an important tool for screening promising new drug candidates for their relevance for specific childhood cancers. The PPTP results indicated that NTX-010 was active against a wide range of pediatric solid cancers, including neuroblastoma, rhabdomyosarcoma, Wilms tumors, rhabdoid, Ewing sarcoma and glioblastoma. Complete responses were observed following a single intravenous treatment in the majority of neuroblastoma models and in all alveolar rhabdomyosarcoma tumor models, demonstrating both activity and potency.
Paul Hallenbeck, Ph.D., President and Chief Scientific Officer of Neotropix(R), Inc., commented, "We are very encouraged by the results of this extensive analysis of NTX-010 in pediatric oncology models, particularly because these in vivo cancer models that the NCI has developed can prospectively identify novel agents subsequently shown to have clinical activity against specific cancers of children and adolescents."
Dr. Hallenbeck continued, "We are excited that the NCI-supported Children's Oncology Group Phase I Consortium has expressed the interest to lead an effort to test NTX-010 in pediatric patients with cancer in the near future."
Neotropix(R) has been working closely with many collaborators around the world, including the NCI to create a treatment paradigm shift for hard to treat cancers. The Company has developed an innovative approach to harness the power of natural products screening using viruses to kill or slow down the spread of cancer. The result has been that many viruses have been identified that may provide simple, safe and effective ways to treat patients who would otherwise fail conventional treatments using traditional small molecule and antibody approaches.
About NTX-010 and the Current Clinical Trial
NTX-010 is a natural occurring oncolytic virus, which is highly selective for certain tumor cell types expressing a biomarker that indicates the cancer has neuroendocrine properties such as synaptophysin, chromogranin A, or CD56. At least one of them is required to be positive before treatment. Unlike many previous oncolytic virus product candidates developed by others, NTX-010 is a stable, naturally occurring virus, is systemically deliverable, and has not been observed to be pathogenic to humans, and therefore, has not had to be genetically modified.
NTX-010 is systemically delivered in a single one-hour infusion on an outpatient basis at each of the treatment centers, which simplifies the treatment process for patients. The product is anticipated to have enhanced efficacy and less toxicity than currently approved therapies for permissive cancers.
The clinical trial is being conducted at multiple institutions around the country, including John Hopkins (MD), Mary Crowley (TX), Lahey Clinic (MA) and many U.S. Oncology Cooperative Group treatment sites (FL, IN, NY, OH, SC, TX, VA, and WA). In addition, other treatment centers are joining the trial in the New England area of the U.S.
The current Phase I / II clinical trial is enrolling adults (18 and over) that meet the criteria for the following cancers: carcinoid cancers (all types), large cell lung cancer-neuroendocrine, alveolar rhabdomyosarcoma, neuroblastoma, glioblastoma, Ewing's family of tumors, Wilms tumors, retinoblastoma, rhabdoid, and medulloblastoma. For more about the clinical trials: http://www.clinicaltrials.gov/ct2/show/NCT00314925?term=seneca+valley&rank=1
Also of note, CEO Peter Lanciano of Neotropix(R) will be available for one-on-one meetings with potential investors at the 7th Annual BIO Investor Forum that is taking place from October 29-31, 2008, in San Francisco, CA. At the conference, Mr. Lanciano will present a corporate overview on the Company. For more information, please visit: http://www.investorforum.bio.org/opencms/bif/2008/.
Neotropix(R) Inc., is focused on the development of anti-cancer products that have a high degree of selectivity for cancer cells resulting in an excellent safety and therapeutic efficacy profile. Neotropix(R) develops and commercializes systemically deliverable oncolytic viruses for the treatment of solid tumors. Capitalizing on its unique sources of naturally occurring viruses that selectively target tumors discovered using the company's proprietary technology platform Viruscreen(TM), the Company has the knowledge and skills to translate these discoveries into commercial products. Neotropix(R) is committed to making a difference in the lives of cancer patients.
Neotropix(R) commenced operations in 2005 in Malvern, Pennsylvania. Neotropix (R) is funded by venture-capital investors including Aurora Funds, Quaker BioVentures and VIMAC Ventures. For more information, please visit http://www.neotropix.com.
About the Pediatric Preclinical Testing Program
The NCI-supported Pediatric Preclinical Testing Program (PPTP) is a comprehensive program to systematically evaluate new agents against childhood solid tumor and leukemia preclinical models. The PPTP is supported through an NCI research contract to St. Jude Children's Research Hospital (SJCRH) with Dr. Peter Houghton as the Principal Investigator. Testing occurs both at SJCRH and also at subcontract sites that have expertise in specific childhood cancers, including: Children's Hospital of Philadelphia (John Maris), Albert Einstein Medical Center (E. Anders Kolb & Richard Gorlick), Duke University (Stephen Keir), Texas Tech University Health Sciences Center (Patrick Reynolds), and Children's Cancer Institute Australia (Richard Lock). Detailed information about the PPTP and its testing procedures is available at http://pptp.stjude.org/.
SOURCE: Neotropix(R), Inc.