Alchemia Announces Initiation of Phase II Trial in Small Cell Lung Cancer
September 12 2011 - 8:30AM
Business Wire
Alchemia Limited (ASX:ACL), today announced the
initiation of recruitment for a Phase II clinical study of its lead
cancer drug HA-Irinotecan in Small Cell Lung Cancer (SCLC). Two
patients have received their first doses of therapy. This
investigator sponsored trial is being conducted at Monash Cancer
Centre, Southern Health and Peninsula Oncology Centre in Melbourne,
Victoria.
This study will examine the effectiveness of HA-Irinotecan,
which utilizes Alchemia’s patented HyACT® technology to target the
anti-cancer drug irinotecan to the tumor. The trial will recruit a
total of 40 patients. Patients will be randomised to receive either
HA-Irinotecan or irinotecan. The primary endpoint will be tumor
stem cell burden during and at the conclusion of the study. On the
safety side, the trial will measure the incidence of grade 3 and 4
toxicity. Secondary endpoints include Progression-Free Survival
(PFS). Alchemia will contribute the study drug, HA-Irinotecan, and
will be responsible for the analysis of circulating tumour cells
and cancer stem cells.
“This is a proof of concept trial for a very promising therapy,”
said Principal investigator Dr. Vinod Ganju. “There are few
treatment options for patients with small cell lung cancer and,
based on the previous experience with HA-Irinotecan in colorectal
cancer, we hope to see improved patient outcomes. This is also the
first trial to directly examine the impact of a therapy on lung
cancer stem cells.”
Cancer stem cells are a small population of cells within the
tumor that are resistant to chemotherapy and which are believed to
be responsible for treatment failure and tumor regrowth. Alchemia’s
HyACT technology targets drugs to CD44, a protein target that is
overexpressed in most cancers and on cancer stem cells. Data
presented by Alchemia at the American Association of Cancer
Research meeting last year showed that drugs formulated using the
HyACT platform showed up to a 40 fold increase in potency against
cancer stem cell populations.
“For a modest investment, this cutting edge trial is expected to
yield important insights into the clinical and commercial value of
our HyACT platform,” said Alchemia CEO, Peter Smith. “This is in
keeping with our strategy of exploring the utility of this flexible
technology whilst focusing Alchemia’s financial resources on the
planned pivotal Phase III study.”
Alchemia is about to initiate recruitment to a 390 patient
pivotal Phase III study of HA-Irinotecan in metastatic colorectal
(bowel) cancer. This study will be used for registration (approval)
of the drug in major markets, the end-points having been agreed
with the US Food and Drug Administration and the European Medicines
Agency. In a previous Phase II study in colorectal cancer,
HA-Irinotecan reduced tumor progression by more than half compared
to unformulated irinotecan.1
About Small Cell Lung Cancer
There are approximately 220,000 new cases of lung cancer in the
US, accounting for around 15% of all new cancer diagnoses and 28%
of cancer deaths. Of all lung cancer cases, 15-20% will be SCLC,
which is particularly aggressive with median survival from
diagnosis of 2-4 months without treatment. Overall, small cell
carcinoma of the lung is associated with the poorest prognosis of
all types of lung cancer; even with treatment 5-year survival is
only 5%. SCLC responds well to chemotherapy but a cure is difficult
to achieve because SCLC has a greater tendency to be widely
disseminated by the time of diagnosis.
About Alchemia: Alchemia is a drug discovery and
development Company founded on its chemistry expertise. The
Company’s lead drug, fondaparinux (a generic version of
GlaxoSmithKline’s Arixtra®, a synthetic anticoagulant mainly used
for the prevention of deep vein thrombosis), was approved and
launched in July 2011 in the U.S. by Alchemia’s marketing partner
Dr Reddy’s Laboratories. Alchemia’s pipeline of assets is built on
two platform technologies: HyACT® (targeted cancer delivery) and
VAST® (drug discovery). The primary objective of the HyACT®
technology is to develop a new generation of anti-cancer drugs
which demonstrate better efficacy. The lead product from the HyACT®
platform is HA-Irinotecan for which a Phase III clinical trial has
been prepared in metastatic colorectal cancer. Dosing of patients
is expected to commence in 2011.
1 Gibbs et al (2010) Hyaluronan-Irinotecan improves
progression-free survival in 5-Fluorouracil refractory patients
with metastatic colorectal cancer: a randomized Phase II trial.
Cancer Chemother. Pharmacol. 2011 Jan; 67(1):153-63
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