Neotropix® Announces Presentation of Relevant Preclinical Results of NTX-010 in Pediatric Oncology Models

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http://www.neotropix.com/news_20081022.htm

 

Neotropix® Announces
Presentation of Relevant Preclinical Results of NTX-010 in Pediatric Oncology
Models


Malvern, PA, October 22, 2008 – Neotropix®,
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®, 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® 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:

www.clinicialtrials.gov


Also of note, CEO Peter Lanciano of Neotropix®
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:

www.investorforum.bio.org


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

 

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://www.pptp.stjude.org.

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