PharmaMar presents new data of Zalypsis® and Irvalec® in pediatric,
solid tumours and lymphoma at the 20th AACR-NCI-EORTC Symposium
23 October 2008
- Irvalec® and Zalypsis® are two compounds of marine origin, with a novel
mechanism of action, in phase I clinical development for the treatment of
various tumors
- A clinical study of 37 patients with solid tumors or lymphoma shows
Zalypsis has a good safety profile and is highly active. These findings
enable the continuation of Zalypsis clinical development
- Irvalec® shows significant antiproliferative activity in trials against
different tumor cell lines, at doses equivalent to the clinical
administration and higher to those obtained with five other antitumoral
compounds of ErbB pathway
- Two new preclinical studies made in collaboration with the European
Consortium for Innovative Therapies for Children with Cancer (ITCC) show
significant activity of the two compounds in pediatric tumors
- PharmaMar, a company of the Zeltia Group, is presenting data on four
trials during the 20th EORTC-NCI-AACR symposium, held in Geneva from 21- 24
October
Geneva, 23 October, 2008: PharmaMar, a biotechnology company of Zeltia
Group, has presented new data on two antitumoral compounds of marine origin,
Zalypsis® and Irvalec®, in Phase I trials in clinical development and in
vitro studies and with animal models.
Zalypsis® is a novel chemical entity related to the marine natural compounds
Jorumycin and the family of Renieramycins, obtained from molluscs and
sponges, respectively. Irvalec®, a new synthetic depsipeptide derived from
PharmaMar Development Program of marine origin compounds, is a new drug with
antiproliferative activity against a wide range of tumors, including breast,
colon, pancreas, lung and prostate.
PharmaMar has presented the results of 4 studies at the 20th annual
symposium of the European Organization for Research and Treatment of Cancer
(EORTC), the U.S. National Cancer Institute (NCI) and the American
Association for Cancer Research (AACR), taking place in Geneva (Switzerland)
from 21 to October 24.
In the first study, the safety of Zalypsis ® in 37 patients with solid
tumors or lymphoma was evaluated. The trial shows a good safety profile of
the drug, which enables the
continuation of its clinical development. The study was made in
collaboration with the Institut Gustave Roussy (Villejuif, France) and the
Northern Centre for Cancer Treatment (Newcastle, United Kingdom).
The second study presented at the Geneva meeting evaluated the activity of
Irvalec® in of colon cancer, breast, ovarian, lung, prostate, head and neck
and pancreas cell lines. Cytotoxicity data obtained with Irvalec® were
compared with five other compounds that inhibit the Erb-B/HER Pathway.
According to the results, Irvalec® shows a significant antiproliferative
activity at doses that may be achieved in the clinic, being a more potent
inhibitor of cell proliferation than other ErB inhibitors used in the
trials, and showing a differential activity profile. The study was made in
collaboration with the Beaujon University Hospital (Clichy, France).
In two other new studies presented at the meeting in Geneva, PharmaMar
evaluated the therapeutic potential of Irvalec® and Zalypsis® in pediatric
tumors.
The preclinical evaluation of the first compound for the treatment of
pediatric cancer was made against six types of pediatric tumors cell lines
that represent 50% of treatment failures in this population: neuroblastoma,
Ewing's sarcoma, rhabdomyosarcoma, acute lymphoblastic leukemia,
medulloblastoma and osteosarcoma. Osteosarcoma and rhabdomyosarcoma cell
lines were the most sensitive to the drug.
The same methodology was followed for the evaluation of Zalypsis®. The most
significant results in in vitro tests were obtained in neuroblastoma and
rhabdomyosarcoma cell lines. The evaluation of the compound in animal models
also showed significant results, especially in the activity in
rhabdomyosarcoma.
The trials were conducted by the R&D Department of PharmaMar in partnership
with the Emma Children's Hospital (Amsterdam, Netherlands), the University
Children's Hospital (Munster, Germany) and the Institut Gustave Roussy
(Villejuif, France), and members of the Innovative Therapies for Children
with Cancer (ITCC) which brings together 35 centres specializing in
pediatric oncology of six European countries.
The aim of the studies carried out in collaboration with ITCC is to
facilitate the identification of new compounds with significant potential in
the treatment of pediatric tumors.
Within PharmaMar Cancer Research Program and as part of the companys
commitment with cancer patients, this biotech company of the Zeltia Group is
also evaluating the therapeutic potential of its marine origin compounds in
pediatric tumors.
About Zalypsis® (PM00104) Zalypsis® (PM00104/50) is a new marine derived compound in Phase II
clinical trials for the treatment of solid tumours. Zalypsis® is a novel
chemical entity related to the marine natural compounds Jorumycin and the
family of Renieramycins, obtained from molluscs and sponges, respectively.
Zalypsis binds to DNA and is cytotoxic; however, it does not activate the
DNA damage checkpoint response. Thus, Zalypsis has cytotoxic effects
dependent on DNA binding that are not associated with DNA damage. In
pre-clinical trials, Zalypsis demonstrated strong in vitro and in vivo
antitumoural activity in a wide variety of solid and haematological tumour
cell lines and human transplantable breast, gastric, prostate and renal
xenografted tumours. Zalypsis also demonstrated a manageable and reversible
preclinical toxicology profile.
About Irvalec® (PM02734) Irvalec® is a new depsipeptide from PharmaMars internal research
program for derivatives of the marine natural compounds. PM02734 is
manufactured synthetically by PharmaMar. Preliminary in vitro in-house
studies identified PM02734 as a new antiproliferative drug demonstrating
activity against a broad spectrum of tumor types: breast, colon, pancreas,
lung and prostate, among others. PM02734 has been selected for clinical
development based on its in vivo activity in xenografted human tumors, as
well as an acceptable non-clinical toxicology profile. PM02734 is in Phase I
clinical trials in patients with advanced malignant solid tumors.
PharmaMar PharmaMar is the world-leading biopharmaceutical company of the Zeltia
Group, and is committed to advancing the treatment of cancer through the
discovery and development of new marine-derived medicines. PharmaMar has
four novel compounds in clinical development. Yondelis® has received
Authorization for Commercialization from the European Commission for
treating advanced soft tissue sarcoma. Yondelis® is currently being marketed
in the European Union for the treatment of soft tissue sarcomas in adults
after failure of standard therapy. Aplidin®, Zalypsis®, and Irvalec® are
other marine-derived new agents in clinical development by PharmaMar, which
also has a rich pipeline of preclinical candidates, and a strong R&D
program.
For further information:
Media Relations (Ph: +34 91 846 60 00)
Fernando Mugarza
Carlos Martínez de la Serna
Carolina Lanzas Otazu
Capital Markets (Ph: +34 91 444 45 00)
Alfonso Hurtado de Mendoza
Florencia Radizza
This press release is also available in the News area at www.pharmamar.com
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 Neotropixs 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
AnnualMolecular 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 Childrens 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, Ewings 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 companys 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 Childrens 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: Childrens 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 Childrens
Cancer Institute Australia (Richard Lock). Detailed information about the PPTP
and its testing procedures is available at
http://www.pptp.stjude.org.
FDA Approves Orphan Drug Status for Revolutionary
Cancer Drug for Children
LOS ANGELES, Calif.
– October 20, 2008 – The Cure Our
Children Foundation, a nonprofit charitable foundation dedicated to children,
announced today that the U.S. Food and Drug Administration (FDA) has approved
the Orphan Drug Designation of the foundation’s unique drug product for children
with Ewing’s Sarcoma cancer.The efforts
to develop this drug were made possible by the generous volunteers and researchers
in private industry and at two universities.
Orphan Drug status allows for
recognition of the potential viability of a drug therapy while providing a
variety of benefits during the drug approval process.These benefits include waivers of certain FDA
fees, the availability of government grants, and FDA attention and assistance
during the review process.
This ground-breaking new drug
combines two modern technologies: biotechnology and nanotechnology.This incredible technology is analogous to
the concept of a Trojan Horse, and is expected to have very far reaching
implications for other cancer treatments.The product consists of cell matter that is modified to have the same
genetic code as the cancer cells, but that matter is not viable food for the tumor
cells.The cell matter is then placed in
a nanotechnology formulation which allows the matter to migrate through the
body’s own vessels directly to the tumor cells.When the tumor cells uptake the matter, they cannot reproduce, and they
die.Key elements of this drug technology are:
·Fewer side effects may be possible
·The drug is directed only at the tumor cell and not at healthy cells
·The product is so small that it migrates right through blood vessels
and cell walls
·This technology may be applied to other diseases in the future that
have a genetic component
The
President of the foundation, Barry Sugarman, a 30-year veteran executive and
consultant in the pharmaceutical industry, and father of a son who has survived
Ewing’s Sarcoma, will continue the development
of the drug product by raising money from individuals and foundations.
The
Cure Our Children Foundation identifies important under-researched children's
issues and devotes extensive resources to educate and guide parents,
professionals, government and the public.The foundation website at www.cureourchildren.org
receives thousands of website visits every month.The results of the research are provided as a
public service, and are supported by donations to the foundation.The foundation has a number of other research
projects underway that will continue to benefit children and families.
Contact:Barry Sugarman, B.S.ENGR., President, The
Cure Our Children Foundation, mailto:barry@cureourchildren.org ,Phone: 310-355-6046, Fax: 310-454-9592,
http://www.cureourchildren.org
PharmaMar presents new data of Zalypsis® and Irvalec® in pediatric, solid tumours and lymphoma at the 20th AACR-NCI-EORTC Symposium