Author Archives: Barry Sugarman

Wright Medical Group, Inc. Receives FDA Clearances for the Entire Family of ALLOMATRIX Products

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    ARLINGTON, Tenn.--(BUSINESS WIRE)--July 15, 2004--

  Notification Completes Clearance for Products Currently In Wright's
           ALLOMATRIX(R) Line of Allograft Bone Void Fillers

Wright Medical Group, Inc. (NASDAQ:WMGI), a global orthopaedic
medical device company specializing in the design, manufacture and
marketing of reconstructive joint devices and biologic materials,
today announced receipt of marketing clearance from the United States
Food and Drug Administration (FDA) for ALLOMATRIX(R) C, ALLOMATRIX(R)
Custom, and ALLOMATRIX(R) DR bone graft putties that contain
demineralized bone matrix (DBM) and specific volumes and
configurations of donor matched, cancellous bone chips. Following the
FDA-clearance of ALLOMATRIX(R) Injectable Putty in March of this year,
today's regulatory announcement completes the clearance process for
Wright's entire ALLOMATRIX(R) family of products.

The Company began the 510(k) premarket notification process in
March of 2002, following FDA's clarification to all allograft putty
providers that such products are considered medical devices and are
therefore regulated under the federal Food, Drug, and Cosmetic Act.
The Company has satisfied FDA's medical device requirements for
demonstrating substantial equivalence, including endpoints established
for each product's clinical performance and viral inactivation
potential. The ALLOMATRIX(R) family of products and OSTEOSET(R) 2 DBM
are the only commercially available, FDA-cleared products which
contain demineralized bone matrix (DBM).

Laurence Fairey, President and Chief Executive Officer, commented,
“Wright Medical has demonstrated a successful strategy of using these
specialized formulations to address individual clinical needs targeted
at individual orthopaedic sub-specialties. Wright's ability to
understand and address specific surgical requirements by developing
these focused products reinforces the Company's growing reputation for
its comprehensive understanding and responsiveness to the expanding
bio-orthopaedic market.”

About Wright

Wright Medical Group, Inc. is a global orthopaedic medical device
company specializing in the design, manufacture and marketing of
reconstructive joint devices and biologic materials. The Company has
been in business for more than 50 years and markets its products in
over 40 countries worldwide. For more information about Wright, visit
our website at www.wmt.com.

This press release may contain “forward-looking statements” within
the meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
All statements made in this press release, other than statements of
historical fact, are forward-looking statements. Forward-looking
statements reflect management's current knowledge, assumptions,
beliefs, estimates, and expectations and express management's current
views of future performance, results, and trends. The Company wishes
to caution readers that actual results might differ materially from
those described in the forward-looking statements. Forward-looking
statements are subject to a number of risks and uncertainties,
including the factors discussed in the Company's filings with the
Securities and Exchange Commission (including the Company's annual
report on Form 10-K for the year ended December 31, 2003), which could
cause the Company's actual results to materially differ from those
described in the forward-looking statements. Although the Company
believes that the forward-looking statements are accurate, there can
be no assurance that any forward-looking statement will prove to be
accurate. A forward-looking statement should not be regarded as a
representation by the Company that the results described therein will
be achieved. The Company wishes to caution readers not to place undue
reliance on any forward-looking statement. The forward-looking
statements are made as of the date of this press release. The Company
assumes no obligation to update any forward-looking statement after
this date.

    CONTACT: Wright Medical Group Inc., Arlington

John K. Bakewell, 901-867-4527


    SOURCE: Wright Medical Group, Inc.
“Safe
Harbor” Statement under the Private Securities Litigation Reform Act of
1995: Statements in this press release regarding Wright Medical Group,
Inc.'s business which are not historical facts are “forward-looking
statements” that involve risks and uncertainties. For a discussion of
such risks and uncertainties, which could cause actual results to
differ from those contained in the forward-looking statements, see
“Risk Factors” in the Company's Annual Report or Form 10-K for the most
recently ended fiscal year.

Xenova Group PLC — Tariquidar Phase I Paediatric Study Data Presented at ASCO

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Xenova Group PLC — Tariquidar Phase I Paediatric Study Data Presented at ASCO

Abstract on XR5944 Also Presented

SLOUGH, U.K., June, 7 2004 (PRIMEZONE) — Xenova Group plc (LSE:XEN)
(Nasdaq:XNVA) announced today that the Paediatric Oncology Branch of the
National Cancer Institute (NCI) in Bethesda, U.S., yesterday presented a
poster at the American Society of Clinical Oncology (ASCO) conference in
New Orleans, Louisiana on the paediatric Phase I clinical trial of tariquidar
in children with solid tumours.
The primary objectives of this trial were to assess the toxicity, optimal
dose and pharmacokinetics of tariquidar in children with solid tumours and
to assess the toxicity and pharmacokinetics of the anti cancer drugs in combination
with tariquidar. A total of 18 children have been enrolled into the study
to date, between the ages of 2 and 18 with a range of tumours including Ewing's
Sarcoma, osteosarcoma and adrenocortical carcinoma amongst others.
Tariquidar was administered intravenously over 30 minutes with a starting
dose of 1mg/kg in four patients and then escalated to 1.5mg/kg in six patients
and then to 2.0mg/kg in the eight remaining patients. This was followed by
administration of the anti-cancer drug which was chosen on the basis of tumour
type and prior therapy. Doxorubicin was administered to 11 patients at 50mg/m2,
docetaxel was administered to four patients at 75mg/m2 and vinorelbine was
administered to two patients at 20mg/m2 on days one and eight. Fligrastim
was administered to all patients during the 21 day cycle.
The results of the study showed that tariquidar was well tolerated in
children. Of the 18 subjects enrolled, one patient had a complete response,
one had a partial response and five had stable disease for one to eight cycles
of therapy. Doxorubicin clearance was comparable to previously published
results indicating the clearance of doxorubicin was not altered by pre-treatment
with tariquidar. The future development of tariquidar by Xenova is currently
under review.
Commenting on these results, David Oxlade, Chief Executive Officer of
Xenova, said, “It is encouraging to see these results in children with solid
tumours. The NCI is undertaking a number of exploratory clinical trials with
tariquidar in both adults and children and we look forward to further results
from these studies.”
In addition to this poster, Xenova and Millennium have an abstract published
relating to the on-going Phase I study of XR5944 at the same meeting.

Contacts:
Xenova Group plc +44 (0)1753 706600 David A. Oxlade, Chief Executive
Officer Daniel Abrams, Finance Director Veronica Cefis Sellar, Head of Corporate
Communications
UK — Financial Dynamics +44 (0)20 7831 3113 David Yates Ben Atwell
US — Trout Group/BMC Communications +1 212 477 9007 Media: Brad Miles Investors: Lee Stern

Xenova Group plc is a UK based biopharmaceutical company focused on the
development of novel drugs to treat cancer and addiction with a secondary
focus in immunotherapy. The Company has a broad pipeline of products in clinical
development, including three cancer programmes: its lead product TransMID(TM),
for the treatment of high-grade glioma, is in Phase III trials, and its novel
DNA targeting agents and XR303 are both in Phase I for cancer indications.
Xenova is also developing two therapeutic vaccines for cocaine and nicotine
addiction, which are in Phase II and Phase I trials respectively. Quoted
on the London Stock Exchange (XEN) and on NASDAQ (XNVA), Xenova employs approximately
112 people throughout its sites in the UK and North America. (Reuters XEN.L;
Bloomberg XEN LN)

For further information about Xenova and its products please
visit the Xenova website at www.xenova.co.uk

For Xenova: Disclaimer to take advantage of the “Safe Harbor” provisions
of the US Private Securities Litigation Reform Act of 1995. This press release
contains “forward-looking statements,” including statements about development
and commercialization of products. Various risks may cause Xenova's actual
results to differ materially from those
expressed or implied by the forward
looking statements, including: unexpected costs and delays, adverse
results
in our drug discovery and clinical development programs; failure to
obtain
patent protection for our discoveries; commercial limitations imposed
by
patents owned or controlled by third parties; our dependence upon
strategic
alliance partners to develop and commercialize products and services;
difficulties
or delays in obtaining regulatory approvals to market products and
services
resulting from our development efforts; the requirement for substantial
funding
to conduct research and development and to expand commercialization
activities;
and product initiatives by competitors. For a further list and
description
of the risks and uncertainties we face, see the reports we have filed
with
the Securities and Exchange Commission. We disclaim any intention or
obligation
to update or revise any forward-looking statements, whether as a result
of
new information, future events or otherwise.

CONTACT: Xenova Group plc
David A. Oxlade, Chief Executive Officer Daniel Abrams, Finance
Director Veronica Cefis Sellar, Head of Corporate Communications +44
(0)1753 706600 UK Financial Dynamics David Yates Ben Atwell +44 (0)20
7831 3113 US Trout Group/BMC Communications Media: Brad Miles
Investors: Lee Stern (212) 477-9007

Cancer in the Parents of Children with Cancer

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Volume 333:1594-1599           December 14, 1995           Number 24

Cancer in the Parents of Children with Cancer

http://content.nejm.org/cgi/content/abstract/333/24/1594

Jørgen H. Olsen, M.D., John D. Boice, Sc.D., Niels Seersholm, M.D.,
Andrea Bautz, and Joseph F. Fraumeni, M.D.

Background Certain types of cancer in children and young adults have
been linked with an increased risk of cancer in close relatives.
However, the relation between childhood cancer and familial risk
remains to be fully assessed in population-based studies.

Methods We conducted a nationwide study in Denmark of 11,380 parents of
children with cancer. The children were identified from records in the
Danish Cancer Registry; their parents were identified from population
registers. The occurrence and rate of cancer in the parents were
determined with use of the Cancer Registry's files and compared with
national incidence rates for various categories of tumor.

Results Overall, 1445 cancers were diagnosed in the parents, as
compared with 1496 expected from national incidence rates, to yield
standardized incidence ratios of 1.0 (95 percent confidence interval,
0.9 to 1.0) for all parents, 1.0 for mothers, and 0.9 for fathers. The
lower rate of cancer among fathers reflected their lower standardized
incidence ratio for lung cancer (0.8; 95 percent confidence interval,
0.6 to 0.9), as calculated from 114 observations.

Conclusions Genetic determinants are important in several types of
childhood cancer, but the genetic susceptibility to tumors does not
generally extend to the parents of children with cancer, nor do the
patterns of incidence point to the influence of shared environmental
factors. Thus, cancer in children should not be viewed as a general
marker for an increased risk of cancer in the patients' parents.

Source Information

From the Division for Cancer Epidemiology, Danish Cancer Society,
Copenhagen, Denmark (J.H.O., N.S., A.B.); and the Epidemiology and
Biostatistics Program, National Cancer Institute, Bethesda, Md.
(J.D.B., J.F.F.).

Address reprint requests to Dr. Olsen at the Danish Cancer Society,
Division for Cancer Epidemiology, Strandboulevarden 49, DK-2100
Copenhagen, Denmark.