Monday October 25, 10:14 am Eastern Time
Company Press Release
SOURCE: Mitotix, Inc.
Mitotix Announces Three U.S. Patents on p16 Tumor
Suppressor Gene - Patented Technology Has Led to Preclinical Programs
in Cancer, Cardiovascular Disease-
CAMBRIDGE, Mass., Oct. 25 /PRNewswire/ -- Mitotix, Inc. announced today that the U.S. Patent and Trademark Office
has issued three broad patents covering the tumor suppressor gene p16, a gene that plays a major role in regulating the cell
cycle and that is directly linked to a variety of major cancer types. The Company has advanced two products based on the
patented technology into pre-clinical studies, with initial human clinical trials for cancer expected to begin next year. The patents
(Nos. 5,968,821, 5,962,316 and 5,889,169), were awarded to the Cold Spring Harbor Laboratory and are exclusively
licensed worldwide to Mitotix.
''The p16 gene, which is widely recognized as one of the most important tumor suppressors identified to date, lies at the heart
of a biochemical pathway that is critical to the process of cell division and is disrupted in virtually all cancers,'' said Muzammil
Mansuri, Ph.D., Mitotix's Executive Vice President, Research. ''The technology underlying these patents provide the
foundation for two drug discovery strategies at Mitotix that have yielded two highly promising pre-clinical drug development
programs. In one program a small molecule compound which mimics the cell cycle inhibitory effect of the p16 tumor suppressor
is being pursued as a treatment for cancer. In a second program, a gene therapy product that combines the p16 and p27 cell
cycle inhibitory genes, is being tested for treatment of cancer and cardiovascular disease/restenosis. The first small molecule
product for the treatment of cancer is expected to enter human clinical trials in 2000,'' said Dr. Mansuri.
Mitotix is developing small molecules that inhibit the Cdk4/Cyclin D1 protein complex, the molecule targeted by the p16 gene,
through an alliance with DuPont Pharmaceuticals and is developing the p16/p27 fusion gene therapy product through a
collaboration with Cell Genesys (Nasdaq: CEGE - news).
Dr. Mansuri noted these patents are part of a large and growing intellectual property portfolio Mitotix has assembled around
the essential genes involved in regulation and control of the cell division cycle. The Company's portfolio of in-house and
licensed patents currently includes 23 issued patents and over 90 pending U.S. and international patent applications.
Specifically, the newly issued patents cover the p16 gene and other members of the INK4 family that function as regulators of
the cell division cycle, genetic constructs for recombinant expression of p16 gene products, oligonucleotide probes for detecting
native and mutant p16 genes and viral vectors, including an adenoviral vector, comprising the p16 gene or related members of
the INK4 family of cell cycle regulatory genes. The p16 gene product functions as a molecular ''off'' switch to halt the cell cycle
by blocking the action of a protein complex called Cdk4/Cyclin D1 essential for progression through the cell division cycle.
Additional research has demonstrated that the p16 gene is missing or altered in 20 percent to 50 percent of all cancers,
including breast, bladder and esophageal tumors and melanomas. The p16 gene was discovered by researchers at Cold Spring
Harbor Laboratory, led by Dr. David Beach, a co-founder of Mitotix. In addition to Dr. Beach, the other inventors on the
patents include: Douglas J. Demetrick, Ph.D., Manuel Serrano, Ph.D., and Gregory J. Hannon, Ph.D.
Update on Proprietary Discovery Programs in Cancer, Systemic Fungal
Infections
The Company also provided an update on its proprietary drug discovery
programs, which focus on cancer and systemic fungal infections. Mitotix's
proprietary drug programs have emerged from innovative functional genomics
technologies and technologies useful for the rapid discovery of genes
essential to fungal cell survival, in addition to its expertise in
understanding the molecular mechanism underlying the cell division cycle.
Mitotix's proprietary cancer programs are focused on tumor apoptosis and angiogenesis, two research approaches with the
potential for specifically targeting cancer cells without harming normal cells. The Company's tumor apoptosis program
capitalizes on innovative functional genomics technology utilizing retroviral cDNA libararies and functional screens that allows
genes to be introduced into human tumor cells and to be assayed directly for their ability to induce apoptosis. This approach
will provide unique and validated anti-cancer enzyme targets, for small molecule drug discovery by Mitotix or with future
pharmaceutical partners.
The Company's anti-angiogenesis program is employing proprietary functional genetic screening tools to rapidly isolate novel
peptides that selectively inhibit new blood vessel formation and block angiogenesis. Mitotix has validated this discovery
approach by identifying peptides and is screening selected sequences in proprietary functional screens for anti-angiogenic
activity.
In the anti-fungal area, Mitotix is focusing on two sets of targets that are essential for the survival of pathogenic fungi such as
Candida albicans, Aspergillus fumigatus and Cryptococcus neoformans. The Company's most advanced antifungal program
targets GGTase (geranylgeranyl transferase) a key enzyme that regulates the signal transduction pathways required for fungal
cell wall integrity and growth. Mitotix is also targeting CAK1, a unique kinase required for fungal cell proliferation but for which
there is no known human counterpart. Both of these targets are consistent with Mitotix's strategy to exploit its expertise in yeast
genetics to identify new antifungal drugs based on novel molecular mechanisms which kill fungal pathogens, are selective, broad
spectrum and safe.
Mitotix, Inc. is a private biotechnology company engaged in the discovery and development of products to diagnose and treat
cancer, cardiovascular disorders, opportunistic infections, and other cell proliferation disorders. The Company's development
programs are based on proprietary patentable knowledge of the molecular pathways that regulate the cycle of cell growth and
division. Mitotix has formed major collaborations in cancer therapeutics with the DuPont Pharmaceuticals Company focused on
cyclin dependent kinase inhibitors, with BASF Pharma focused on cdc25 inhibitors and with Cell Genesys in cardiovascular
and cancer gene therapy. Mitotix is headquartered in Cambridge, Massachusetts.
SOURCE: Mitotix, Inc. |
