NEW HAVEN, FEB 20 - VION today announced that it will proceed with a Phase I human clinical trial
of the lead candidate VNP40101M from its Sulfonyl Hydrazine Prodrug (SHP) family
of novel and potent alkylating (DNA-damaging) agents, and that the
Investigational New Drug (IND) application for VNP40101M, which was submitted to
the Food and Drug Administration in January, is active as of February 10, 2001.
The trial, which will assess the product's safety and maximum tolerated dose, is
expected to begin in approximately 2 months and to enroll 20-30 patients.
Alkylating agents are important components of several standard treatment
regimens for cancer. The individual properties of an alkylating agent determine
its pattern of activity and toxicity and therefore its clinical application.
Preclinical studies of VNP40101M indicated unique and advantageous features,
which could lead to an enhanced spectrum, or improved antitumor activity,
compared to the standard available alkylating agents. For example, in addition
to damaging DNA, VNP40101M also inhibits a key enzyme (AGT) involved in the
repair of the DNA damage. Thus, it blocks a major mechanism of drug resistance
common to several of the standard alkylating agents. VNP40101M also exhibited
excellent penetration across the blood brain barrier in mice, and a high degree
of antitumor activity against intra-cranially implanted leukemia cells. The
latter distinguishes VNP40101M from many anticancer agents that have difficulty
penetrating into the brain, a site where primary tumors can occur and a common
site of metastases for several other solid tumors. Overall, VNP40101M
demonstrated a broad spectrum of antitumor activity in preclinical animal
models, including activity against tumor cells that are resistant to several of
the alkylating agents in common use today.
Alan Sartorelli, Ph.D., Professor of Pharmacology at the Yale University School
of Medicine, a member of Vion's Board of Directors and Scientific Advisory
Board, and lead scientist in the initial discovery and development of the SHP
family of agents, stated, " VNP40101M is among the most active anticancer agents
we have tested in animal models. Not only does it inhibit a common mechanism of
resistance to certain standard alkylating agents, the DNA damage that it causes
is difficult to detect by the tumor cell 's repair mechanisms. I am excited by
the prospects for this agent to provide benefit to patients with cancer."
Alan Kessman, president and CEO of Vion, stated, "The expertise of our
preclinical biology and development groups is demonstrated by the speed with
which we completed formulation and toxicology studies on VNP40101M and submitted
a successful IND application to the FDA. We are very excited about VNP40101M
from the perspective of its potential contribution to cancer patients and the
additional strength and diversity it gives Vion as a company. In addition to the
TAPET'r' bacterial vector and Triapine'r', VNP40101M will be the third agent
that Vion is developing for the treatment of cancer. All three of these agents
have the potential to be effective against many different types of cancer."
Vion Pharmaceuticals, Inc. is a biopharmaceutical company engaged in the
research, development and commercialization of cancer treatment technologies.
Vion's product portfolio consists of TAPET, a drug delivery platform, and cancer
therapeutics (Triapine and Sulfonyl Hydrazine Prodrugs). TAPET uses genetically
altered strains of Salmonella as a bacterial vector, or vehicle, for delivering
cancer-fighting drugs preferentially to solid tumors and is currently being
evaluated for safety and colonization in several Phase I trials. Triapine, which
is designed to prevent the replication of tumor cells by blocking a critical
step in the synthesis of DNA, is currently being evaluated for its safety in
several Phase I clinical trials. VNP40101M is a member of the Sulfonyl Hydrazine
Prodrug class, compounds that are designed to be converted to unique potent,
alkylating agents and is expected to begin Phase I trials for safety within the
next two months. |
