SOURCE: Neotropix, Inc.

October 08, 2008 08:01 ET

Neotropix® Announces Expansion of On-Going Clinical Trial for Adult Neuroendocrine Cancers

Receives Orphan Drug Designation for NTX-010 From the FDA

MALVERN, PA--(Marketwire - October 8, 2008) - Neotropix®, Inc., a clinical-stage development company focused on neuroendocrine cancer treatments, announced today that it has begun enrolling neuroendocrine cancer patients into an expanded clinical trial of its lead candidate, NTX-010 (SVV-001), a tumor-selective naturally-occurring oncolytic virus. Neotropix® also announced that it has been granted Orphan Drug Designation by the U.S. Food and Drug Administration (FDA) of NTX-010 for the treatment of neuroendocrine tumors.

After reviewing safety data from the current Phase I dose escalation study, conducted in neuroendocrine cancer patients, and as previously defined in the on-going protocol, the study is open to recruit more patients at the highest dose planned for long-term drug development. The expansion phase of the study allows the clinical sites to enroll additional patients meeting the enrollment criteria to evaluate safety and efficacy across a range of related cancers. To date, the Company has tested this clinical candidate, primarily in patients with carcinoid cancers of multiple origins, small cell cancer, including lung cancer, pancreatic islet cancer, and neuroendocrine cancers of unknown origin.

Dr. Anthony Williams, Chief Medical Officer of Neotropix®, Inc., commented, "We are encouraged by the analysis of initial results from the on-going Phase I clinical trial of NTX-010, currently being conducted in adult patients with various neuroendocrine cancers, including carcinoid cancers. Based on the safety and efficacy data to date for doses ranging from 107 to 1011, vp/kg, we believe we have adequate support to expand testing of this novel first-in-class drug in adult patients at the highest dose level as per the approved protocol."

The primary objective of the clinical trial is the assessment of safety. Secondary endpoints are the collection of preliminary information regarding anti-tumor activity, including: objective disease response using standardized criteria; time to response; and duration of response, following a single-agent treatment with intravenous NTX-010. It is anticipated that efficacy results from the expansion phase of this open-label, multi-center study will be available in 2009.

In addition to the phase expansion for NTX-010, the Company received Orphan Drug Designation from the U.S. Food and Drug Administration (FDA). The FDA's Orphan Drug Designation is reserved for new therapies in development to treat diseases or conditions that affect fewer than 200,000 people in the U.S. The Orphan Drug Designation provides for an accelerated review process, tax benefits, exemption from user fees and a seven-year period of market exclusivity in the U.S. after product approval. Most neuroendocrine cancers have either no or limited treatments available to slow down or stop the progression of diseases that affects either the elderly or young children.

Peter Lanciano, Chief Exective Officer of Neotropix®, Inc., commented, "The decision by the FDA to grant NTX-010 Orphan Drug Designation in neuroendocrine tumors advances our ability to develop innovative treatments for both the elderly and children suffering from hard-to-treat cancers. Based on Neotropix's current clinical results and pre-clinical testing, this novel product has the potential to be an important new weapon for the treatment of a range of neuroendocrine cancers including small cell lung cancer, one of the most deadly cancers facing society today."

Neotropix® has been working closely with many collaborators around the world, including the National Cancer Institute (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 naturally 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 in development, 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 out-patient 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). Additionally, there are other treatment centers joining the trial in the New England area.

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, please visit: http://www.clinicaltrials.gov/ct2/show/NCT00314925?term=seneca+valley&rank=1

About Neotropix®

Neotropix®, 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® 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™, the Company has the knowledge and skills to translate these discoveries into commercial products. Neotropix® is committed to making a difference in the lives of cancer patients.

Neotropix® commenced operations in 2005 in Malvern, Pennsylvania. Neotropix® is funded by venture-capital investors including Aurora Funds, Quaker BioVentures and VIMAC Ventures. For more information, please visit http://www.neotropix.com.