Gemin X Biotechnologies Inc.

Gemin X Biotechnologies Inc.

January 06, 2005 08:01 ET

Gemin X Biotechnologies Initiates Phase 1/2 Clinical Trial with GX15-070 in Chronic Lymphocytic Leukemia; FDA Grants Orphan Drug Designation for GX15-070 in CLL


NEWS RELEASE TRANSMITTED BY CCNMatthews

FOR: GEMIN X BIOTECHNOLOGIES INC.

JANUARY 6, 2005 - 08:01 ET

Gemin X Biotechnologies Initiates Phase 1/2 Clinical
Trial with GX15-070 in Chronic Lymphocytic Leukemia;
FDA Grants Orphan Drug Designation for GX15-070 in CLL

MONTREAL--(CCNMatthews - Jan 6, 2005) -

Gemin X Biotechnologies Inc. announced today the initiation of a Phase
1/2 clinical trial in chronic lymphocytic leukemia (CLL) with GX15-070,
a novel, targeted cancer treatment that is designed to induce apoptosis
(natural cell death) by inhibiting the Bcl-2 family of proteins, one of
the most validated and well-studied cancer drug targets. Gemin X also
announced that GX15-070 has been granted orphan drug status by the U.S.
Food and Drug Administration (FDA) for the treatment of CLL.

"The initiation of our second clinical trial in the GX15-070 program and
our attainment of orphan drug designation in CLL underscore the
dedication of the clinical and regulatory teams at Gemin X," said Dan
Giampuzzi, President and Chief Executive Officer of Gemin X. "The orphan
drug program will allow us to efficiently conduct further clinical
studies with GX15-070 and, pending positive results, provide this new
targeted cancer treatment to patients as quickly as possible."

The Phase 1/2 trial in CLL is an open-label, dose-escalation study
designed to evaluate the safety and tolerability of multiple doses of
GX15-070. The trial will also include extensive pharmacokinetic sampling
and pharmacodynamic evaluation. GX15-070 will be administered once every
three weeks to patients with CLL who have previously been treated with
an alkylating agent and Fludarabine.

"GX15-070 is the first small molecule in human trials that targets Bcl-2
proteins, which are involved in many types of cancers," explained Dr.
Thomas Kipps, Deputy Director of UCSD's Comprehensive Cancer Center and
head of the CLL Research Consortium. "In particular, some members of the
Bcl-2 family are thought to play a significant role in the etiology of
CLL, making this disease a logical choice as a development indication. I
look forward to evaluating the compound's potential in this patient
group."

GX15-070 is designed to restore apoptosis, the natural process of cell
death that is often inhibited in cancer cells. Over-expression of the
Bcl-2 protein family inhibits apoptosis and has been observed in a wide
range of cancers, including those of the lymph, breast, lung, prostate
and colon. GX15-070 is specifically designed to inhibit all of the
anti-apoptotic members of the Bcl-2 protein family, thus inducing
apoptosis in cancer cells without damaging normal cells. GX15-070 is
currently being studied in a separate Phase 1 clinical trial for the
treatment of various solid tumor cancers.

About Chronic Lymphocytic Leukemia (CLL)

CLL is a blood cancer that affects an estimated 60,000 Americans and is
diagnosed in approximately 8,190 new patients each year in the U.S.
alone. Although CLL originates in the white blood cells of the bone
marrow, its ability to spread through the blood allows it to metastasize
to many different parts of the body including the spleen, lymph nodes
and liver. Symptoms may progress over many years and may eventually
result in life-threatening complications.

About Orphan Drug Designation

Orphan drug designation is an FDA program designed to encourage the
development of new treatments for diseases or conditions that affect
fewer than 200,000 people in the U.S. Following FDA approval, products
with orphan drug designation are eligible for a seven-year period of
marketing exclusivity. Additional benefits of orphan drug designation
may include protocol assistance, clinical trial support and guidance,
grant funding for research and development, tax credits, and reduced
filing fees for marketing applications.

Gemin X Biotechnologies Inc. specializes in the discovery and
development of novel small-molecule cancer therapeutics based on the
regulation of apoptosis, the body's natural ability to destroy injured
or damaged cells. Gemin X's lead product, GX15-070, is a small molecule,
pan-inhibitor of Bcl-2 proteins. Gemin X is also developing small
molecules that induce apoptosis in p53-defective cancers. Gemin X is
privately held and is located in Montreal, Quebec and Malvern,
Pennsylvania. For additional information please visit Gemin X at
www.geminx.com

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Contact Information

  • FOR FURTHER INFORMATION PLEASE CONTACT:
    Gemin X Biotechnologies Inc.
    Christian Cortis, (514) 281-8989 x 229
    email: ccortis@geminx.com
    or
    Atkins + Associates
    Trista Morrison, (858) 527-3490
    email: tmorrison@irpr.com