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H101(Oncorine) |
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H101 is a gene-engineered
adenovirus, which selectively replicates
in cancer cells and spares normal cells. This replication
conduces to the lyses of the cancer cell... New viruses
stemmed of the adenovirus replication and released from
the lysed cell can then infect other cancer cells. In
fact the deletion of early parts of the gene (E1B-55
and E3) allows the virus to induce only the lyses of
tumor cell and not normal cell. Without this deletion,
after an adenovirus injection, the P53
would over-express it-self into normal cells and prevent
an effective replication.
The side effects of a H101 treatment are mild compared
with those of chemotherapy (myelotoxicity,
hepatotoxicity, vomiting, nausea,
hair loss…). Patients may have a fever, local pain of
injected sites or some flu symptoms. Moreover, running
a temperature may help this oncolytic virus replicate
and enhance the anti-tumor efficacy.
H101 in combination with chemotherapy is efficient
in treating Head and Neck cancer (including nasopharyngeal
carcinoma in China). Sunway is currently
working on away of using H101 in treating Non-small-cell
lung cancer with chemotherapy.
Sunway Biotech Co.,Ltd has conducted preclinical, Phase
I/II/III trials for H101. H101 is one of Sunway Biotech’s
most advanced targeted oncolytic agent in Head
and Neck Squamous Carcinoma. These studies
succeeded in defining the effective viral
dose, dosing regimen,
appropriate patient population, safety and efficiency
clinical profiles. The success of these trials allows
Sunway Biotech Co.,Ltd to obtain the regulatory approval
for H101 from the Chinese State
Food and Drug Administration in Q3 2005.
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| Schematic diagram of constructed adenovirus
(H101): |
the deletion of adenoviral early region
genes to form oncolytic virus.
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