Allos Therapeutics Starts Cancer Study - Analyst Blog
18 Agosto 2011 - 2:16PM
Zacks
Recently, Allos Therapeutics Inc. (ALTH)
announced the commencement of a late-stage registrational study
(n=549: PDX-017) to evaluate its drug Folotyn in patients with
previously undiagnosed peripheral T-cell lymphoma (PTCL).
Allos intends to study those patients in the trial who have
achieved an objective response on being initially treated with CHOP
(cyclophosphamide, doxorubicin, vincristine, and
prednisone)/CHOP-like regimen.
We remind investors that Folotyn, Allos’ sole marketed product,
is already available in the US (as a monotherapy) for the treatment
of patients with relapsed and/or refractory PTCL. We note that the
drug received accelerated approval from the US Food and Drug
Administration (FDA) for the indication in 2009. The drug was
commercially launched in the US in January 2010.
The accelerated approval program permits the FDA to clear drugs
targeting cancer or other life-threatening diseases on the basis of
initial positive results from clinical trials. Since Folotyn has
been cleared under the above-mentioned program, Allos needs to
conduct post-approval studies regarding the clinical benefit of the
drug in patients suffering from T-cell lymphomas and also evaluate
whether treatment with Folotyn poses a serious risk of altered drug
levels due to organ impairment.
By commencing the late stage registrational study Allos has
fulfilled one of its post-marketing obligations. If Allos tastes
success with this study then it intends to utilize the data to gain
approval for Folotyn for treating patients with previously
undiagnosed PTCL after being treated with a CHOP/CHOP-like regimen.
Moreover, data from the study is also expected to be utilized to
convert the current accelerated approval for relapsed and/or
refractory PTCL to a full approval. We note that Folotyn is
currently under review in the European Union for the treatment of
patients with relapsed and/or refractory PTCL.
The commencement of the registrational trial for previously
undiagnosed PTCL patients follows Allos’ agreement with the FDA in
March 2011, under the agency’s Special Protocol Assessment (SPA)
program, regarding the study’s design.
We believe that investors will focus more on Allos’ impending
merger with AMAG Pharmaceuticals (AMAG) rather
than the label expansion efforts for Folotyn. Per the terms of the
deal, Allos' shareholders will receive 0.128 shares of AMAG per
share of Allos.
The all-stock deal, expected to close by year-end, will involve
a one-time cost in the range of $35 million - $38 million.
Following the deal, AMAG shareholders will own approximately 61% of
the combined company while Allos shareholders will own the
balance.
Our Recommendation
Currently, we are Neutral on Allos. The stock carries a Zacks #3
Rank (Hold rating) in the short-run.
ALLOS THERAPEUT (ALTH): Free Stock Analysis Report
AMAG PHARMA INC (AMAG): Free Stock Analysis Report
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