Hier mal ein interessanter Text zu Matrix, bin investiert und bleibe es! Chart anschauen...;)
Matrix Pins Hopes on Europe When the FDA rejected the company's flagship injectable gel designed to stave off 'no hope' cancers, the Street savaged its shares. With a new
study under way in Europe, there's optimism that a turn-around is possible.
Vancouver, Oct 24, 2001 (smallcapcenter.com via COMTEX) -- When Matrix
Pharmaceuticals (NASDAQ: MATX) was recently hit with the FDA's rejection of its
flagship injectable gel designed to stave off 'no hope' cancers, the Street
savaged its shares.
Today, Matrix is hoping promising new study results presented at the European
Congress on Clinical Oncology (ECCO) will enable it to snag a potentially huge
European market . . . and ultimately make to another run at FDA approval.
Either way, it will put hope into share-shocked MATX investors.
For Matrix, the last few months have been rocky indeed. On September 11, on a
split vote, the FDA advisory panel expressed its uncertainty whether or not
IntraDose(R) (cisplatin/epinephrine) showed the required efficacy in controlling
solid tumors, specifically head and neck tumors. The vote was 9 to 3, with one
abstention, against recommending an okay for the cancer gel.
One observer at the meeting reportedly said that Matrix may have done it to
itself. Although "many" panel members seemed to believe IntraDose may indeed be
effective, "the company did a poor job of designing tests to prove it."
And the Oncologic Drugs Advisory Committee wasn't impressed. The unanimous
ruling was that, based on a standard approval scenario, Matrix Pharmaceutical
had not demonstrated "substantial evidence" that IntraDose is safe and effective
in the treatment of symptomatic recurrent head and neck cancer. In terms of
details, the committee discussed the question of whether or not tumor response
rates in Matrix's two earlier clinical trials were "reasonably likely to predict
clinical benefit." The vote: six ''yes'' and seven ''no.'' Next question: Should
Intradose be approved based on accelerated approval? Three panel members voted
''yes'' and nine ''no'' (with one abstention).
Either way, MATX paid for it. On the heels of the thumbs down, sort of, from the
drug advisory committee (read: an almost automatic rejection from the FDA
itself), MATX was downgraded by Banc of America Securities Corporation, dropping
from Buy to a Market Perform.
When the trading halt came off, MATX tanked, quickly sliding from the
late-August average of around $10 and into the uneasy netherworld of the penny
stock, bottoming out at a 52-week low of 42 cents set on October 1, 2001.
Since then, promising news notwithstanding, the Street still remains wary.
At 12:34 p.m. ET, MATX was down 3.51% or 2 cents to $0.55 on average volume of
289,500 shares versus its three-month daily average of 468,818 shares. Its
52-week high is $17.375 posted on January 18, 2001. Note to spec investors but
its most-recent-quarter (mrq) per-share book value is $1.31.
At publication time, smallcapcenter.com was unable to reach the sole First Call
covering analyst for MATX.
Aside from shedding share value, the debacle saw the luckless Matrix lose a lot
of bodies. On October 10, some 34 or the company's 85 workers at its Fremont,
California headquarters and its San Diego manufacturing facility were
pink-slipped and a decision made to sell the manufacturing facility. Although a
Matrix spokesman put on a brave face, noting that the IntraDose rejection came
from the advisory panel and not the FDA itself, he did allow that "Matrix
believes it is facing an uphill battle and we want to be realistic."
Today, Matrix is allowing itself a bit of hope, courtesy the ECCO meeting in
Lisbon, Portugal.
At today's meeting, Matrix presented new data which it believes has helped to
demonstrate that IntraDose truly does control intractable and deadly solid
tumors found in the liver, head and neck and skin. As well, data from those two
earlier Phase III studies of IntraDose in head and neck cancer and Phase II
studies of metastatic melanoma were tidied up and presented.
The numbers weren't bad, not bad at all.
First, new study results, presented for the first time and covering IntraDose
and its effect on inoperable primary liver cancers.
According to Matrix, the final results of the Phase II, non-randomized,
uncontrolled, multi-center study showed that the gel achieved an overall
response rate of 53% (27 of 51 evaluable patients) with 31% of patients showing
a complete response --100% reduction of the tumor. (Overall response rate is
defined as 50% plus reduction in tumor volume.) Whereas the average median
survival rate of a liver-cancer patient is less than one year, at the time of
data analysis, the Intradose patients showed a median survival rate almost twice
the norm or 22.2 months. (Matrix continues to follow patients to monitor
survival.)
Liver cancer (hepatocellular carcinoma/HCC) is the sixth most common cancer
worldwide, and often develops secondary to cirrhosis and chronic viral
hepatitis. It's also a growing danger. In Europe, each year roughly 50,000 new
cases of HCC are reported. In the United States, roughly 11,500 new cases of HCC
are reported each year and, as Hepatitis C and its ilk continue to make inroads
into the baby boomer population, the number is growing rapidly. Bad news for the
stricken but surgical resection and/or liver transplantation are applicable in
only 10% to 20% of cases. The rest die.
ECCO delegates were also presented with Phase II study results from two
identically designed, open-label studies which pitted Intradose against
recurrent, metastatic melanoma. Although the melanoma was the primary target,
doctors had the option of injecting the 'escaped' or multiple tumors in the
patient in question.
According to the study data, IntraDose achieved an overall primary target tumor
response rate of 44% (11 out of 25 patients), with 20% achieving a complete
response. Equally important but 53% of all tumors treated (130 out of 244
tumors) in the melanoma patients achieved a response and 47% (114) achieved a
complete response.
The third ECCO presentation laid out results previously presented in two
randomized, placebo-controlled Phase III studies (i.e. the studies the FDA
advisory panel prodded and poked) involving the local control of recurrent or
refractory head and neck cancers. Here, the overall tumor response rate was 29%
(35 out of 119 patients) with 19% achieving a complete response.
In terms of overall safety, Matrix says that clinical studies to date have shown
that IntraDose is "generally well tolerated" by patients. Compared to standard
intravenous chemotherapy which floods the bloodstream with medication, the
'needle in the tumor' cancer-killing gel shows what the company says is an
"favorable" adverse-event profile with a markedly lower incidence of systemic
toxicities when compared to intravenous chemo's needle in the arm. The most
common side effect, according to Matrix, is localized pain at the injection
site.
However, sometimes things did go wrong. During the Phase III study of head and
neck cancer, six "cerebrovascular events" (CVEs) were reported; once the
injection protocol was changed to exclude tumors directly invading or in close
proximity to the carotid artery, no further CVEs were reported. As well, in the
Phase II study of inoperable liver cancer, three of the 58 patients died, their
deaths being "potentially related" to the IntraDose treatment.
Although IntraDose is clearly not a cure-all panacea against the most deadly of
cancers, Matrix Pharmaceuticals believes it can delay some tumors - and
sometimes stop them cold.
To avoid becoming cold and dead itself, Matrix clearly needs to find a market,
fast. Which means getting regulatory approval, fast.
In Q4 of this year, Matrix will submit an application for approval of IntraDose
for local control of head and neck cancer to the European Medicines Evaluation
Agency (EMEA).
Closer to home, the company notes that the recent FDA review of the its New Drug
Application (NDA) for IntraDose included an initial recommendation against
marketing approval of the gel for treatment of head and neck cancer in the
United States. Girding its loins, Matrix says that, with respect, it believes
the FDA's position on the patient benefits of IntraDose vis-a-vis objective
tumor response is worth re-evaluating.
In turn, and although no dates are being mentioned, Matrix is currently planning
its next foray to gain regulatory approval and bring IntraDose into the United
States market.
Or as Matrix President and Chairman Michael Casey put it: ''Matrix will continue
to explore with the FDA the next steps for IntraDose. Head and neck cancer
patients need new options that will locally control symptomatic tumors, which
may cause serious complications. Matrix believes in IntraDose and its ability to
help cancer patients and their families.''
Based in Fremont, California, Matrix Pharmaceutical Inc. develops and
manufactures novel drug product candidates for solid-tumor cancer. This effort
is based on its internal research and development capabilities and through
in-licensing of product candidates from research institutions or other
pharmaceutical companies. Two product candidates have been, or are being,
evaluated in human clinical trials: IntraDose (cisplatin/epinephrine) Injectable
Gel and MPI 5020 Radiopotentiator. As well, the Company in-licenses product
candidates for development. Example: tezacitabine (FMdC) is an intravenously
administered therapeutic being developed for colorectal, hematologic and other
cancers. Matrix currently owns worldwide marketing rights for all its products
under development, except for tezacitabine in Japan.
For the six months ended June 30, 2001, Matrix revenues rose 66% to $715
thousand. Net loss increased 31% to $14.7 million. Revenues reflect an increased
customer base. Net loss reflects increased S/G/A expenses due to higher
marketing personnel costs.
Smallcapcenter.com's advanced research department gave MATX a signal stockscore
of 2 at 12:45 a.m. EDT on Wednesday.
A company's stockscore is an unbiased summary of numerous technical analysis
indicators like volume and momentum, which are combined to produce a value on a
scale of 1-100 with 100 being the highest level.
By David Leidl
Copyright 2001 Stockgroup.com, All rights reserved.
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