Alchemia Announces Successful Pre-IND Meeting With the US FDA
February 01 2008 - 9:00AM
Business Wire
Australian drug developer, Alchemia Limited (ASX:ACL), today
announced agreement on the HA-irinotecan clinical development
program, following a pre-investigational new drug (pre-IND) meeting
with the United States (US) Food & Drug Administration (FDA).
Chief Executive, Dr Peter Smith, said that the company was
delighted with the outcome of the discussions. �Alchemia now has a
very clear path to market for HA-irinotecan following on from the
highly successful Phase II clinical trial completed last year.
During our pre-IND meeting with the FDA, the agency agreed on the
proposed pivotal trial design and we will file our IND application
to begin the trial in the very near future. This is a major
milestone for Alchemia.� The proposed study will enroll around 400
patients with metastatic colorectal cancer who have failed previous
treatments. Half of the patients will receive Alchemia�s
HA-irinotecan in combination with Erbitux� whilst the control arm
will receive unmodified irinotecan plus Erbitux�. The primary
endpoint will be progression-free survival (PFS). The study will be
double-blinded such that the patient and the clinician will not
know which treatment is being administered. Alchemia plans to seek
approval for HA-irinotecan in the US through the 505(b)(2) NDA
regulatory route. The 505(b)(2) process is designed to save time
and money as compared to a full NDA (new drug application).
HA-irinotecan qualifies for the 505(b)(2) route since it is a new
formulation of a currently approved drug, irinotecan. * Alchemia is
currently in the process of determining the brand name for HyCAMP
due to the potential for confusion with GlaxoSmithKline�s
anticancer drug Hycamtin�. Until the name is finalized the company
will in future refer to the product as HA-irinotecan. The generic
name will be �hyaluronan-irinotecan solution for infusion�. About
Alchemia Limited � www.alchemia.com.au Alchemia is a drug discovery
and development Company founded on its chemistry expertise. The
Company�s lead program is fondaparinux (synthetic heparin, a
generic version of GlaxoSmithKline�s Arixtra�) which is expected to
generate near term revenues for the company in 2009 and was
recently partnered with Dr Reddy�s Laboratories Inc. for the US
market. Alchemia�s pipeline of assets is built on two platform
technologies: HyACT� (targeted cancer delivery) and VASTTM (drug
discovery). HA-irinotecan, for the treatment of colorectal cancer,
recently achieved positive Phase II clinical trial results. About
HA-irinotecan (HyCAMP) HA-irinotecan is Alchemia's most advanced
anticancer product. It is produced with HyACT technology which
combines the chemotherapeutic drug irinotecan (Pfizer's Camptosar�)
with hyaluronic acid (HA). In May 2007, Alchemia reported results
from a Phase II clinical trial. HA-irinotecan not only allowed more
cycles of therapy to be administered to cancer patients, but also
produced a statistically significant increase in disease control
and more than a doubling in progression free survival. Alchemia
acknowledges the financial support of NovoZymes Biopolymer A/S for
the clinical study. About Pre-IND Meetings -
www.fda.gov/cder/handbook/premtg.htm Prior to clinical studies, the
sponsor needs evidence that the compound is biologically active,
and both the sponsor and the FDA need data showing that the drug is
reasonably safe for initial administration to humans. Under FDA
requirements, the sponsor usually must first submit data showing
that the drug is reasonably safe for use in initial, small-scale
clinical studies. Pre-clinical meetings are conducted with the
appropriate review division that would review the drug marketing
application and these meetings are typically requested by the
sponsor of a drug. Meetings at such an early stage in the process
are useful opportunities for open discussion about testing phases,
data requirements, and any scientific issues that may need to be
resolved prior to IND submission. At these meetings, the sponsor
and FDA discuss and agree upon the design of the animal studies
needed to initiate human testing. ERBITUX� (Cetuximab) is
prescribed to colorectal cancer patients whose cancer has
metastasised. The drug is administered in combination with
Camptosar� (irinotecan) to patients whose cancer has progressed
after receiving chemotherapy with Camptosar�. ERBITUX� is also
indicated for the treatment of a certain type of head and neck
cancer. Arixtra(R) and Hycamtin(R) are registered trademarks of
GlaxoSmithKline. VAST(TM), HyCAMP and HyACT(R) are trademarks of
Alchemia and Alchemia Oncology. ERBITUX(R) is a registered
trademark of ImClone Systems Incorporated.
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