Stammzellentherapie - erste Erfolge !!! - 500 Beiträge pro Seite
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http://www.aktiencheck.de/analysen/default_an.asp?sub=4&page…
22.06.2004
Cryo Cell kaufen
Hot Stocks Investor
Die Experten vom "Hot Stocks Investor" empfehlen den Titel von Cryo Cell (ISIN US2288951088/ WKN 923368) zum Kauf.
Das Unternehmen habe sich auf den Bereich Stammzellentherapie spezialisiert. Cryo Cell biete die Möglichkeit, bei der Geburt eines Kindes aus dem stammzellenreichen Nabelschnurblut Stammzellen zu isolieren und für einen möglichen zukünftigen therapeutischen Einsatz zu konservieren. In einer jüngst positiven Meldung habe das Unternehmen die erfolgreiche Behandlung eines erkrankten Kindes verkünden können. Das Kind sei unter einer genetisch bedingten, schweren Anämie erkrankt gewesen und habe mit Stammzellen eines jüngeren Geschwisters behandelt werden können. In den letzten Tagen habe Cryo Cell verkündet, in Verhandlungen über den Bau einer neuen Anlage in Florida zu stehen.
Nachdem es bei der Aktie seit längerem gebrodelt habe, sei sie am vergangenen Montag unvermittelt mit einem Plus von 41% auf 1,35 USD nach oben geschossen. Auf den ersten Blick sei das viel, nehme man sich aber den Langfristchart zur Hand werde deutlich, dass in 2001 und 2002 die Kurse bei 10 USD gelegen hätten.
Von 2000 bis 2003 habe Cryo Cell die Umsätze von 2 Mio. USD auf knapp 8 Mio. USD steigern können. Im 1. Quartal 2004 sei dem Unternehmen mit 2,6 Mio. USD bislang der höchste Quartalsumsatz gelungen. Operativ sei somit der erste Überschuss erzielt worden, der sich zwar nur bei 270.000 USD bewegt habe, in den kommenden Quartalen aber nochmals durch stärker schwankende Ausgaben in die roten Zahlen zurückgehen könnte. Für die Wertpapierspezialisten sei vor diesem Hintergrund interessant, dass das Unternehmen auf die Profitabilität hinarbeite.
Die Experten von "Hot Stocks Investor" raten den Anlegern die Cryo Cell-Aktie zu Kursen zwischen 1,25 und 1,30 zu kaufen.
22.06.2004
Cryo Cell kaufen
Hot Stocks Investor
Die Experten vom "Hot Stocks Investor" empfehlen den Titel von Cryo Cell (ISIN US2288951088/ WKN 923368) zum Kauf.
Das Unternehmen habe sich auf den Bereich Stammzellentherapie spezialisiert. Cryo Cell biete die Möglichkeit, bei der Geburt eines Kindes aus dem stammzellenreichen Nabelschnurblut Stammzellen zu isolieren und für einen möglichen zukünftigen therapeutischen Einsatz zu konservieren. In einer jüngst positiven Meldung habe das Unternehmen die erfolgreiche Behandlung eines erkrankten Kindes verkünden können. Das Kind sei unter einer genetisch bedingten, schweren Anämie erkrankt gewesen und habe mit Stammzellen eines jüngeren Geschwisters behandelt werden können. In den letzten Tagen habe Cryo Cell verkündet, in Verhandlungen über den Bau einer neuen Anlage in Florida zu stehen.
Nachdem es bei der Aktie seit längerem gebrodelt habe, sei sie am vergangenen Montag unvermittelt mit einem Plus von 41% auf 1,35 USD nach oben geschossen. Auf den ersten Blick sei das viel, nehme man sich aber den Langfristchart zur Hand werde deutlich, dass in 2001 und 2002 die Kurse bei 10 USD gelegen hätten.
Von 2000 bis 2003 habe Cryo Cell die Umsätze von 2 Mio. USD auf knapp 8 Mio. USD steigern können. Im 1. Quartal 2004 sei dem Unternehmen mit 2,6 Mio. USD bislang der höchste Quartalsumsatz gelungen. Operativ sei somit der erste Überschuss erzielt worden, der sich zwar nur bei 270.000 USD bewegt habe, in den kommenden Quartalen aber nochmals durch stärker schwankende Ausgaben in die roten Zahlen zurückgehen könnte. Für die Wertpapierspezialisten sei vor diesem Hintergrund interessant, dass das Unternehmen auf die Profitabilität hinarbeite.
Die Experten von "Hot Stocks Investor" raten den Anlegern die Cryo Cell-Aktie zu Kursen zwischen 1,25 und 1,30 zu kaufen.
http://www.9monate.de/Nabelschnurblut_checkliste.html
http://www.basiccell.de/
http://www.sylab.at/mobile_einfriergeraete.htm
http://www.prosper-hospital.de/medizin/frauenklinik/stammzel…
http://www.parentsguidecordblood.com/germany/summary.de.html
http://www.urbia.de/topics/article/print?id=7630&o=schwanger…
http://www.basiccell.de/
http://www.sylab.at/mobile_einfriergeraete.htm
http://www.prosper-hospital.de/medizin/frauenklinik/stammzel…
http://www.parentsguidecordblood.com/germany/summary.de.html
http://www.urbia.de/topics/article/print?id=7630&o=schwanger…
CRYO-CELL International Inc. Reports on 2004 Annual Shareholders` Meeting Company Announces Strong Performance for the First Six Months of Fiscal 2004
CLEARWATER, Fla., Jul 1, 2004 /PRNewswire-FirstCall via COMTEX/ -- CRYO-CELL
International, Inc. (OTC Bulletin Board: CCEL) (the "Company") reported today on
the results of the Annual Shareholders` Meeting held on June 30, 2003 in
Oldsmar, FL. The slate of Directors nominated for election to the Company`s
Board of Directors was ratified by shareholder vote. Re-elected to serve on the
CRYO-CELL Board of Directors were Messrs. Scott Christian, Anthony Finch, Gaby
Goubran, Charles Nyberg, Dr. Jagdish Sheth and Ms. Mercedes Walton. Grant
Thornton, LLP, was ratified as the Company`s independent auditors. Ms. Walton,
Chairman of the Board and interim CEO, then provided a comprehensive update on
the business highlights of 2003, discussing a year of unprecedented challenges,
as well as significant milestones and successes.
"CRYO-CELL`s core business is expansive and growing with a base of highly
satisfied clients and strong recurring revenue," Ms. Walton stated. The
Company`s 2003 revenues increased to $7.5 million, primarily attributable to
annual storage fee renewals and higher prices for its U-Cord(R) service. Several
factors contributed to the Company`s 2003 operating loss of $7.5 million
including: royalty accruals in conjunction with industry patent litigation;
certain impaired assets; expenses associated with Stem Cell Preservation
Technologies, Inc. and extraordinary legal expenses.
The outlook for 2004 CRYO-CELL performance is, by contrast, very optimistic. Ms.
Walton described several factors contributing to strong year- to-date
performance in 2004 such as: 1) major losses have been stemmed; 2) European
litigation has been settled; 3) a settlement in principle has been reached in
conjunction with shareholder litigation; 3) a new leased facility is under
construction and is expected to be completed by late summer 2004; and 4)
CRYO-CELL`s U-Cord(R) service has recently been re-positioned and includes a
significant price increase that went into effect on June 25, 2004.
The Company distributed a press release highlighting fiscal second quarter and
YTD 2004 results, highlights of which include an 88% YTD revenue increase to
$5.8 million, net income for the six-month period ended May 31, 2004 of
approximately $823,000 and EPS of $.07. The full 10-QSB filing is anticipated on
or before July 15, 2004.
The presentation concluded with Ms. Walton describing the four strategic
priorities for the Company:
1. Focusing on the core business basics as CRYO-CELL accelerates its market and
industry leadership in stem cell preservation services.
2. Growing the business through enhanced service offerings and by building
strategic alliances.
3. Advancing CRYO-CELL`s technological and operational excellence by
implementing significant capital improvements in anticipation of emerging
regulations, and;
4. Improving efficiencies, increasing productivity, and enhancing industry
quality standards while successfully mitigating extraordinary expenses and
growing CRYO-CELL`s gross profit margins.
In summary, Ms. Walton reported that CRYO-CELL`s strategic plan to achieve
transformational success is well on track at a pivotal time of increasing public
awareness and understanding of the significant benefits of umbilical cord blood
stem cell preservation.
Ms. Walton acknowledged the extraordinary efforts and contributions of the
CRYO-CELL team and the collaborative support of CRYO-CELL`s Board of Directors
in staying the course during a challenging transitional period. Ms. Walton
concluded by expressing appreciation to the Company`s patient and loyal
shareholders, while indicating that the Company anticipates a continuing trend
of solid performance building on recent revenue growth, increased earnings and
enhanced shareholder value into the third and fourth quarters of the current
fiscal year.
About CRYO-CELL International, Inc.
Based in Clearwater, Florida, CRYO-CELL is the world`s largest U-Cord(R) stem
cell banking firm, offering high-quality cord blood preservation exclusively for
the benefit of newborn babies and possibly other members of their family.
CRYO-CELL is accredited by the American Association of Blood Banks (AABB).
CRYO-CELL is a publicly traded company. OTC Bulletin Board Symbol ... CCEL.
Expectant parents or healthcare professionals may call 1-800-STOR-CELL
(1-800-786-7235) or visit http://www.CRYO-CELL.com.
Forward-Looking Statement
Statements wherein the terms "believes," "intends," "projects" or "expects" as
used are intended to reflect "forward-looking statements" of the Company. The
information contained herein is subject to various risks, uncertainties and
other factors that could cause actual results to differ materially from the
results anticipated in such forward-looking statements or paragraphs, many of
which are outside the control of the Company. These uncertainties and other
factors include any adverse effect or limitations caused by any governmental
regulations, proceedings or actions, foreign and domestic; any continued or
increased losses, or any inability to obtain acceptable financing, where
desirable in the future, in connection with our operating or growth plans; any
increased competition in our business; any decrease or slowdown in the number of
people seeking to store umbilical cord blood stem cells or decrease in the
number of people paying annual storage fees; the effect of any future reduced
cash position and future inability to access borrowings; any adverse impacts on
our revenue or operating margins due to the costs associated with increased
growth in our business, including the possibility of unanticipated costs
relating to the move into our new facility or the operation of the facility; any
adverse developments impacting our continued relationship with and success of
our licensees, foreign affiliates or investments in, or relationships with,
foreign companies; any inability to achieve increases in revenue or earnings
from umbilical cord blood stem cell storage; any future inability to
substantially achieve the objectives expected from the successful implementation
of our strategy; any decline in public market interest in the Company`s business
sector; any added requirements imposed on us by new laws or SEC regulations and
costs thereof; any technological breakthrough or medical breakthrough that would
render the Company`s business of stem cell preservation obsolete; any material
failure or malfunction in our storage facilities; any natural disaster such as a
tornado, other disaster (fire) or act of terrorism that adversely affects stored
specimens; the potential impact of negative market influences on the Company`s
portfolio of cash, cash equivalents and marketable securities; the costs
associated with defending or prosecuting litigation matters and any material
adverse result from such matters; decreases in asset valuations; any continued
negative effect from adverse publicity in the past year regarding the Company`s
business operations; any new technology rendering the Company`s patented
equipment or business obsolete; any performance failures related to the
Company`s equipment or operations; any negative consequences resulting from
deriving, shipping and storing specimens at a second location; any negative
effect from the filed class action shareholder lawsuits; and other risks and
uncertainties. The foregoing list is not exhaustive, and the Company disclaims
any obligations to subsequently revise any forward-looking statements to reflect
events or circumstances after the date of such statements. Readers should
carefully review the risk factors described in other documents the Company files
from time to time with the Securities and Exchange Commission, including the
most recent Annual Report on Form 10-KSB, Quarterly Reports on Form 10-QSB and
any Current Reports on Form 8-K filed by the Company.
SOURCE CRYO-CELL International, Inc.
CONTACT: Todd Atenhan, CRYO-CELL, +1-727-450-8000, or fax,
+1-727-723-0444, or investor.relations@CRYO-CELL.com
http://www.cryo-cell.com http://www.prnewswire.com
CLEARWATER, Fla., Jul 1, 2004 /PRNewswire-FirstCall via COMTEX/ -- CRYO-CELL
International, Inc. (OTC Bulletin Board: CCEL) (the "Company") reported today on
the results of the Annual Shareholders` Meeting held on June 30, 2003 in
Oldsmar, FL. The slate of Directors nominated for election to the Company`s
Board of Directors was ratified by shareholder vote. Re-elected to serve on the
CRYO-CELL Board of Directors were Messrs. Scott Christian, Anthony Finch, Gaby
Goubran, Charles Nyberg, Dr. Jagdish Sheth and Ms. Mercedes Walton. Grant
Thornton, LLP, was ratified as the Company`s independent auditors. Ms. Walton,
Chairman of the Board and interim CEO, then provided a comprehensive update on
the business highlights of 2003, discussing a year of unprecedented challenges,
as well as significant milestones and successes.
"CRYO-CELL`s core business is expansive and growing with a base of highly
satisfied clients and strong recurring revenue," Ms. Walton stated. The
Company`s 2003 revenues increased to $7.5 million, primarily attributable to
annual storage fee renewals and higher prices for its U-Cord(R) service. Several
factors contributed to the Company`s 2003 operating loss of $7.5 million
including: royalty accruals in conjunction with industry patent litigation;
certain impaired assets; expenses associated with Stem Cell Preservation
Technologies, Inc. and extraordinary legal expenses.
The outlook for 2004 CRYO-CELL performance is, by contrast, very optimistic. Ms.
Walton described several factors contributing to strong year- to-date
performance in 2004 such as: 1) major losses have been stemmed; 2) European
litigation has been settled; 3) a settlement in principle has been reached in
conjunction with shareholder litigation; 3) a new leased facility is under
construction and is expected to be completed by late summer 2004; and 4)
CRYO-CELL`s U-Cord(R) service has recently been re-positioned and includes a
significant price increase that went into effect on June 25, 2004.
The Company distributed a press release highlighting fiscal second quarter and
YTD 2004 results, highlights of which include an 88% YTD revenue increase to
$5.8 million, net income for the six-month period ended May 31, 2004 of
approximately $823,000 and EPS of $.07. The full 10-QSB filing is anticipated on
or before July 15, 2004.
The presentation concluded with Ms. Walton describing the four strategic
priorities for the Company:
1. Focusing on the core business basics as CRYO-CELL accelerates its market and
industry leadership in stem cell preservation services.
2. Growing the business through enhanced service offerings and by building
strategic alliances.
3. Advancing CRYO-CELL`s technological and operational excellence by
implementing significant capital improvements in anticipation of emerging
regulations, and;
4. Improving efficiencies, increasing productivity, and enhancing industry
quality standards while successfully mitigating extraordinary expenses and
growing CRYO-CELL`s gross profit margins.
In summary, Ms. Walton reported that CRYO-CELL`s strategic plan to achieve
transformational success is well on track at a pivotal time of increasing public
awareness and understanding of the significant benefits of umbilical cord blood
stem cell preservation.
Ms. Walton acknowledged the extraordinary efforts and contributions of the
CRYO-CELL team and the collaborative support of CRYO-CELL`s Board of Directors
in staying the course during a challenging transitional period. Ms. Walton
concluded by expressing appreciation to the Company`s patient and loyal
shareholders, while indicating that the Company anticipates a continuing trend
of solid performance building on recent revenue growth, increased earnings and
enhanced shareholder value into the third and fourth quarters of the current
fiscal year.
About CRYO-CELL International, Inc.
Based in Clearwater, Florida, CRYO-CELL is the world`s largest U-Cord(R) stem
cell banking firm, offering high-quality cord blood preservation exclusively for
the benefit of newborn babies and possibly other members of their family.
CRYO-CELL is accredited by the American Association of Blood Banks (AABB).
CRYO-CELL is a publicly traded company. OTC Bulletin Board Symbol ... CCEL.
Expectant parents or healthcare professionals may call 1-800-STOR-CELL
(1-800-786-7235) or visit http://www.CRYO-CELL.com.
Forward-Looking Statement
Statements wherein the terms "believes," "intends," "projects" or "expects" as
used are intended to reflect "forward-looking statements" of the Company. The
information contained herein is subject to various risks, uncertainties and
other factors that could cause actual results to differ materially from the
results anticipated in such forward-looking statements or paragraphs, many of
which are outside the control of the Company. These uncertainties and other
factors include any adverse effect or limitations caused by any governmental
regulations, proceedings or actions, foreign and domestic; any continued or
increased losses, or any inability to obtain acceptable financing, where
desirable in the future, in connection with our operating or growth plans; any
increased competition in our business; any decrease or slowdown in the number of
people seeking to store umbilical cord blood stem cells or decrease in the
number of people paying annual storage fees; the effect of any future reduced
cash position and future inability to access borrowings; any adverse impacts on
our revenue or operating margins due to the costs associated with increased
growth in our business, including the possibility of unanticipated costs
relating to the move into our new facility or the operation of the facility; any
adverse developments impacting our continued relationship with and success of
our licensees, foreign affiliates or investments in, or relationships with,
foreign companies; any inability to achieve increases in revenue or earnings
from umbilical cord blood stem cell storage; any future inability to
substantially achieve the objectives expected from the successful implementation
of our strategy; any decline in public market interest in the Company`s business
sector; any added requirements imposed on us by new laws or SEC regulations and
costs thereof; any technological breakthrough or medical breakthrough that would
render the Company`s business of stem cell preservation obsolete; any material
failure or malfunction in our storage facilities; any natural disaster such as a
tornado, other disaster (fire) or act of terrorism that adversely affects stored
specimens; the potential impact of negative market influences on the Company`s
portfolio of cash, cash equivalents and marketable securities; the costs
associated with defending or prosecuting litigation matters and any material
adverse result from such matters; decreases in asset valuations; any continued
negative effect from adverse publicity in the past year regarding the Company`s
business operations; any new technology rendering the Company`s patented
equipment or business obsolete; any performance failures related to the
Company`s equipment or operations; any negative consequences resulting from
deriving, shipping and storing specimens at a second location; any negative
effect from the filed class action shareholder lawsuits; and other risks and
uncertainties. The foregoing list is not exhaustive, and the Company disclaims
any obligations to subsequently revise any forward-looking statements to reflect
events or circumstances after the date of such statements. Readers should
carefully review the risk factors described in other documents the Company files
from time to time with the Securities and Exchange Commission, including the
most recent Annual Report on Form 10-KSB, Quarterly Reports on Form 10-QSB and
any Current Reports on Form 8-K filed by the Company.
SOURCE CRYO-CELL International, Inc.
CONTACT: Todd Atenhan, CRYO-CELL, +1-727-450-8000, or fax,
+1-727-723-0444, or investor.relations@CRYO-CELL.com
http://www.cryo-cell.com http://www.prnewswire.com
CRYO-CELL International, Inc. Reports Results for Second Quarter 2004 Company Reports Net Income, Increased Revenues, Higher Gross Margins, and Strong Cash Position Company is on Track With Strategic Plan to Achieve Transformational Success
CLEARWATER, Fla., Jun 30, 2004 /PRNewswire-FirstCall via COMTEX/ -- CRYO-CELL
International, Inc. (OTC Bulletin Board: CCEL) (the "Company") today announced
consolidated revenues of approximately $3.2 million for the second quarter ended
May 31, 2004, compared to approximately $1.6 million for the second quarter of
fiscal 2003. The 96% revenue increase over the same 2003 period is primarily
attributable to an increase in recurring annual storage revenues and the effects
of successfully implemented price increases during 2003 for newly enrolling
clients.
Net income in the second quarter of 2004 was approximately $608,000, compared to
a net loss of approximately $1.3 million in the second quarter of 2003. The
Company was profitable due to increased revenues and gross profits, coupled with
a 5% decrease in marketing, general and administrative expense compared to 2003
levels. The decrease is primarily attributable to a reduction in professional
fees. The Company`s gross margin increased to 77% of revenue in the second
quarter of 2004 from 59% in the 2003 period. The gross margin improvement is a
result of increased revenues as described above. In order to maintain
profitability, the Company must continue to control operating costs while
increasing revenues and unit growth from its core business. Second quarter
enrollments, a leading indicator of future revenues, increased 8% over first
quarter 2004 levels. As of May 31, 2004, the Company had $3.4 million in
available cash and cash equivalents and no long-term debt.
For the six-month period ended May 31, 2004, the Company`s revenues were
approximately $5.8 million, compared to approximately $3.1 million for the
six-month period ended May 31, 2003. The 88% revenue increase over the same 2003
period is primarily attributable to an increase in recurring annual storage
revenues and the effects of successfully implemented price increases during 2003
for newly enrolling clients. Net income for the six-month period ended May 31,
2004 was approximately $823,000, compared to a net loss of approximately $2.2
million in the 2003 period. The Company was profitable due to increased revenues
as described earlier. The Company`s gross margin increased to 76% of revenue in
the first six months of 2004 from 58% in the 2003 period. The 18% gross margin
improvement is a result of increased revenues as described above.
The Company intends to continue its increased focus on its core business of
marketing its storage program for umbilical cord (U-Cord(TM)) blood stem cells,
operational expansion and strategic market development. During the second
quarter 2004, the Company entered into a 10-year lease agreement to construct a
customized, nearly 18,000 square foot good manufacturing practice (cGMP)
facility in Oldsmar, Florida. This highly secured, technologically advanced
facility is designed to support the expansive and growing base of CRYO-CELL
clients. Located less than five miles from the Company`s current building, the
new CRYO-CELL facility is expected to be completed by late summer 2004. The
estimated capital investment in the newly constructed facility is over $1
million, of which $216,000 had been invested as of May 31, 2004.
"We are very pleased that CRYO-CELL has now reported net income in the first two
quarters of 2004, caused by continued increases in revenues and higher gross
margins," said Mercedes Walton, CRYO-CELL`s Chairman and interim Chief Executive
Officer. "We believe that CRYO-CELL`s strategic plan to achieve transformational
success is well on track at a pivotal time of increasing public awareness and
understanding of the significant benefits of umbilical cord blood stem cell
preservation. We anticipate a continuing trend of solid performance building on
our recent revenue growth, increased earnings and enhanced shareholder value."
About CRYO-CELL International, Inc.
Based in Clearwater, Florida, CRYO-CELL is the world`s largest U-Cord(TM) stem
cell banking firm, offering high-quality cord blood preservation exclusively for
the benefit of newborn babies and possibly other members of their family.
CRYO-CELL is accredited by the American Association of Blood Banks (AABB).
CRYO-CELL is a publicly traded company. OTC Bulletin Board Symbol ... CCEL.
Expectant parents or healthcare professionals may call 1-800-STOR-CELL
(1-800-786-7235) or visit http://www.CRYO-CELL.com.
Forward-Looking Statement
Statements wherein the terms "believes," "intends," "projects" or "expects" as
used are intended to reflect "forward-looking statements" of the Company. The
information contained herein is subject to various risks, uncertainties and
other factors that could cause actual results to differ materially from the
results anticipated in such forward-looking statements or paragraphs, many of
which are outside the control of the Company. These uncertainties and other
factors include any adverse effect or limitations caused by any governmental
regulations, proceedings or actions, foreign and domestic; any continued or
increased losses, or any inability to obtain acceptable financing, where
desirable in the future, in connection with our operating or growth plans; any
increased competition in our business; any decrease or slowdown in the number of
people seeking to store umbilical cord blood stem cells or decrease in the
number of people paying annual storage fees; the effect of any future reduced
cash position and future inability to access borrowings; any adverse impacts on
our revenue or operating margins due to the costs associated with increased
growth in our business, including the possibility of unanticipated costs
relating to the move into our new facility or the operation of the facility; any
adverse developments impacting our continued relationship with and success of
our licensees, foreign affiliates or investments in, or relationships with,
foreign companies; any inability to achieve increases in revenue or earnings
from umbilical cord blood stem cell storage; any future inability to
substantially achieve the objectives expected from the successful implementation
of our strategy; any decline in public market interest in the Company`s business
sector; any added requirements imposed on us by new laws or SEC regulations and
costs thereof; any technological breakthrough or medical breakthrough that would
render the Company`s business of stem cell preservation obsolete; any material
failure or malfunction in our storage facilities; any natural disaster such as a
tornado, other disaster (fire) or act of terrorism that adversely affects stored
specimens; the potential impact of negative market influences on the Company`s
portfolio of cash, cash equivalents and marketable securities; the costs
associated with defending or prosecuting litigation matters and any material
adverse result from such matters; decreases in asset valuations; any continued
negative effect from adverse publicity in the past year regarding the Company`s
business operations; any new technology rendering the Company`s patented
equipment or business obsolete; any performance failures related to the
Company`s equipment or operations; any negative consequences resulting from
deriving, shipping and storing specimens at a second location; any negative
effect from the filed class action shareholder lawsuits; and other risks and
uncertainties. The foregoing list is not exhaustive, and the Company disclaims
any obligations to subsequently revise any forward-looking statements to reflect
events or circumstances after the date of such statements. Readers should
carefully review the risk factors described in other documents the Company files
from time to time with the Securities and Exchange Commission, including the
most recent Annual Report on Form 10-KSB, Quarterly Reports on Form 10-QSB and
any Current Reports on Form 8-K filed by the Company.
SOURCE CRYO-CELL International, Inc.
CONTACT: Todd Atenhan, CRYO-CELL International, Inc., +1-727-450-8000,
or fax, +1-727-723-0444, or investor.relations@CRYO-CELL.com
URL: http://www.cryo-cell.com http://www.prnewswire.com
CLEARWATER, Fla., Jun 30, 2004 /PRNewswire-FirstCall via COMTEX/ -- CRYO-CELL
International, Inc. (OTC Bulletin Board: CCEL) (the "Company") today announced
consolidated revenues of approximately $3.2 million for the second quarter ended
May 31, 2004, compared to approximately $1.6 million for the second quarter of
fiscal 2003. The 96% revenue increase over the same 2003 period is primarily
attributable to an increase in recurring annual storage revenues and the effects
of successfully implemented price increases during 2003 for newly enrolling
clients.
Net income in the second quarter of 2004 was approximately $608,000, compared to
a net loss of approximately $1.3 million in the second quarter of 2003. The
Company was profitable due to increased revenues and gross profits, coupled with
a 5% decrease in marketing, general and administrative expense compared to 2003
levels. The decrease is primarily attributable to a reduction in professional
fees. The Company`s gross margin increased to 77% of revenue in the second
quarter of 2004 from 59% in the 2003 period. The gross margin improvement is a
result of increased revenues as described above. In order to maintain
profitability, the Company must continue to control operating costs while
increasing revenues and unit growth from its core business. Second quarter
enrollments, a leading indicator of future revenues, increased 8% over first
quarter 2004 levels. As of May 31, 2004, the Company had $3.4 million in
available cash and cash equivalents and no long-term debt.
For the six-month period ended May 31, 2004, the Company`s revenues were
approximately $5.8 million, compared to approximately $3.1 million for the
six-month period ended May 31, 2003. The 88% revenue increase over the same 2003
period is primarily attributable to an increase in recurring annual storage
revenues and the effects of successfully implemented price increases during 2003
for newly enrolling clients. Net income for the six-month period ended May 31,
2004 was approximately $823,000, compared to a net loss of approximately $2.2
million in the 2003 period. The Company was profitable due to increased revenues
as described earlier. The Company`s gross margin increased to 76% of revenue in
the first six months of 2004 from 58% in the 2003 period. The 18% gross margin
improvement is a result of increased revenues as described above.
The Company intends to continue its increased focus on its core business of
marketing its storage program for umbilical cord (U-Cord(TM)) blood stem cells,
operational expansion and strategic market development. During the second
quarter 2004, the Company entered into a 10-year lease agreement to construct a
customized, nearly 18,000 square foot good manufacturing practice (cGMP)
facility in Oldsmar, Florida. This highly secured, technologically advanced
facility is designed to support the expansive and growing base of CRYO-CELL
clients. Located less than five miles from the Company`s current building, the
new CRYO-CELL facility is expected to be completed by late summer 2004. The
estimated capital investment in the newly constructed facility is over $1
million, of which $216,000 had been invested as of May 31, 2004.
"We are very pleased that CRYO-CELL has now reported net income in the first two
quarters of 2004, caused by continued increases in revenues and higher gross
margins," said Mercedes Walton, CRYO-CELL`s Chairman and interim Chief Executive
Officer. "We believe that CRYO-CELL`s strategic plan to achieve transformational
success is well on track at a pivotal time of increasing public awareness and
understanding of the significant benefits of umbilical cord blood stem cell
preservation. We anticipate a continuing trend of solid performance building on
our recent revenue growth, increased earnings and enhanced shareholder value."
About CRYO-CELL International, Inc.
Based in Clearwater, Florida, CRYO-CELL is the world`s largest U-Cord(TM) stem
cell banking firm, offering high-quality cord blood preservation exclusively for
the benefit of newborn babies and possibly other members of their family.
CRYO-CELL is accredited by the American Association of Blood Banks (AABB).
CRYO-CELL is a publicly traded company. OTC Bulletin Board Symbol ... CCEL.
Expectant parents or healthcare professionals may call 1-800-STOR-CELL
(1-800-786-7235) or visit http://www.CRYO-CELL.com.
Forward-Looking Statement
Statements wherein the terms "believes," "intends," "projects" or "expects" as
used are intended to reflect "forward-looking statements" of the Company. The
information contained herein is subject to various risks, uncertainties and
other factors that could cause actual results to differ materially from the
results anticipated in such forward-looking statements or paragraphs, many of
which are outside the control of the Company. These uncertainties and other
factors include any adverse effect or limitations caused by any governmental
regulations, proceedings or actions, foreign and domestic; any continued or
increased losses, or any inability to obtain acceptable financing, where
desirable in the future, in connection with our operating or growth plans; any
increased competition in our business; any decrease or slowdown in the number of
people seeking to store umbilical cord blood stem cells or decrease in the
number of people paying annual storage fees; the effect of any future reduced
cash position and future inability to access borrowings; any adverse impacts on
our revenue or operating margins due to the costs associated with increased
growth in our business, including the possibility of unanticipated costs
relating to the move into our new facility or the operation of the facility; any
adverse developments impacting our continued relationship with and success of
our licensees, foreign affiliates or investments in, or relationships with,
foreign companies; any inability to achieve increases in revenue or earnings
from umbilical cord blood stem cell storage; any future inability to
substantially achieve the objectives expected from the successful implementation
of our strategy; any decline in public market interest in the Company`s business
sector; any added requirements imposed on us by new laws or SEC regulations and
costs thereof; any technological breakthrough or medical breakthrough that would
render the Company`s business of stem cell preservation obsolete; any material
failure or malfunction in our storage facilities; any natural disaster such as a
tornado, other disaster (fire) or act of terrorism that adversely affects stored
specimens; the potential impact of negative market influences on the Company`s
portfolio of cash, cash equivalents and marketable securities; the costs
associated with defending or prosecuting litigation matters and any material
adverse result from such matters; decreases in asset valuations; any continued
negative effect from adverse publicity in the past year regarding the Company`s
business operations; any new technology rendering the Company`s patented
equipment or business obsolete; any performance failures related to the
Company`s equipment or operations; any negative consequences resulting from
deriving, shipping and storing specimens at a second location; any negative
effect from the filed class action shareholder lawsuits; and other risks and
uncertainties. The foregoing list is not exhaustive, and the Company disclaims
any obligations to subsequently revise any forward-looking statements to reflect
events or circumstances after the date of such statements. Readers should
carefully review the risk factors described in other documents the Company files
from time to time with the Securities and Exchange Commission, including the
most recent Annual Report on Form 10-KSB, Quarterly Reports on Form 10-QSB and
any Current Reports on Form 8-K filed by the Company.
SOURCE CRYO-CELL International, Inc.
CONTACT: Todd Atenhan, CRYO-CELL International, Inc., +1-727-450-8000,
or fax, +1-727-723-0444, or investor.relations@CRYO-CELL.com
URL: http://www.cryo-cell.com http://www.prnewswire.com
Market Cap(Th.).......21,601.80
Common Shares Outst.......12,001
Average Daily Volume.....176,000
Common Shares Outst.......12,001
Average Daily Volume.....176,000
interessante Aktie!
WAS STEHT AN ???
Die letzten Tage waren sehr erfreulich für CCEL !!
Die letzten Tage waren sehr erfreulich für CCEL !!
OLDSMAR, Fla., Dec 16, 2004 /PRNewswire-FirstCall via COMTEX/ -- CRYO-CELL
International, Inc. (OTC Bulletin Board: CCEL) (the "Company") is pleased to
announce that on December 14, 2004, the United States District Court for the
District of Delaware issued an order entering a final judgment in favor of
CRYO-CELL International, Inc. ("CRYO-CELL") in patent infringement litigation
filed against it by PharmaStem Therapeutics, Inc. ("PharmaStem"). This order,
which can be viewed at
http://www.CRYO-CELL.com/resources/PharmaStem_121404_ruling.… , effectively
reverses every aspect of the October 2003 trial jury`s verdict of patent
infringement and damages award.
From an historical perspective, PharmaStem initiated patent litigation against
CRYO-CELL and other umbilical cord blood banking firms in February 2002. After a
trial in October 2003 before the Hon. Gregory M. Sleet and a jury, the parties
filed post-trial motions, which were decided by Judge Sleet in an order dated
September 15, 2004 (see CRYO-CELL`s press release dated September 20, 2004). At
that time, Judge Sleet granted the motion of CRYO-CELL and the other defendants
for entry of judgment as a matter of law ("JMOL") on infringement of
PharmaStem`s U.S. Patent No. 5,192,553 ("the `553 patent") reversing the jury`s
verdict on the `553 patent. In the September 15 order, the court denied the
defendants` motion for JMOL in their favor on infringement of U.S. Patent No.
5,004,681 ("the `681 patent"), but granted defendants` motion in the alternative
for a new trial on that issue.
CRYO-CELL subsequently filed a motion asking the Court to reconsider the denial
of JMOL on the `681 patent. The Court`s December 14, 2004 order granted that
motion, directing the entry of judgment in favor of CRYO-CELL and the other
defendants on the `681 patent. The effect of this order is that final judgment
has now been entered in favor of CRYO-CELL and the other defendants on
PharmaStem`s charges of infringement of both patents that were asserted in that
case, marking a final disposition of the case in CRYO-CELL`s favor. PharmaStem
has the right to appeal the decision to the United States Court of Appeals for
the Federal Circuit.
Mercedes Walton, CRYO-CELL`s Chairman and interim CEO, commented, "We are very
pleased that the Court has decided this case in the Company`s favor. We believe
that the Court`s decision has vindicated our long-standing position that
CRYO-CELL`s U-Cord(R) preservation business does not constitute infringement of
PharmaStem`s patents, and we continue to believe that these patents will
ultimately be rendered invalid. While we are certainly pleased with the final
rulings of the Delaware Court, we regret the confusion and disruption created by
this matter in the clinical and expectant parent communities during the course
of the litigation. This decision is a landmark step in clarifying the right of
CRYO-CELL to continue to serve the growing demand for the Company`s services of
preserving non-controversial umbilical cord blood stem cells."
International, Inc. (OTC Bulletin Board: CCEL) (the "Company") is pleased to
announce that on December 14, 2004, the United States District Court for the
District of Delaware issued an order entering a final judgment in favor of
CRYO-CELL International, Inc. ("CRYO-CELL") in patent infringement litigation
filed against it by PharmaStem Therapeutics, Inc. ("PharmaStem"). This order,
which can be viewed at
http://www.CRYO-CELL.com/resources/PharmaStem_121404_ruling.… , effectively
reverses every aspect of the October 2003 trial jury`s verdict of patent
infringement and damages award.
From an historical perspective, PharmaStem initiated patent litigation against
CRYO-CELL and other umbilical cord blood banking firms in February 2002. After a
trial in October 2003 before the Hon. Gregory M. Sleet and a jury, the parties
filed post-trial motions, which were decided by Judge Sleet in an order dated
September 15, 2004 (see CRYO-CELL`s press release dated September 20, 2004). At
that time, Judge Sleet granted the motion of CRYO-CELL and the other defendants
for entry of judgment as a matter of law ("JMOL") on infringement of
PharmaStem`s U.S. Patent No. 5,192,553 ("the `553 patent") reversing the jury`s
verdict on the `553 patent. In the September 15 order, the court denied the
defendants` motion for JMOL in their favor on infringement of U.S. Patent No.
5,004,681 ("the `681 patent"), but granted defendants` motion in the alternative
for a new trial on that issue.
CRYO-CELL subsequently filed a motion asking the Court to reconsider the denial
of JMOL on the `681 patent. The Court`s December 14, 2004 order granted that
motion, directing the entry of judgment in favor of CRYO-CELL and the other
defendants on the `681 patent. The effect of this order is that final judgment
has now been entered in favor of CRYO-CELL and the other defendants on
PharmaStem`s charges of infringement of both patents that were asserted in that
case, marking a final disposition of the case in CRYO-CELL`s favor. PharmaStem
has the right to appeal the decision to the United States Court of Appeals for
the Federal Circuit.
Mercedes Walton, CRYO-CELL`s Chairman and interim CEO, commented, "We are very
pleased that the Court has decided this case in the Company`s favor. We believe
that the Court`s decision has vindicated our long-standing position that
CRYO-CELL`s U-Cord(R) preservation business does not constitute infringement of
PharmaStem`s patents, and we continue to believe that these patents will
ultimately be rendered invalid. While we are certainly pleased with the final
rulings of the Delaware Court, we regret the confusion and disruption created by
this matter in the clinical and expectant parent communities during the course
of the litigation. This decision is a landmark step in clarifying the right of
CRYO-CELL to continue to serve the growing demand for the Company`s services of
preserving non-controversial umbilical cord blood stem cells."
CRYO-CELL Announces Victory in Patent Litigation Delaware Court Finds No Infringement of PharmaStem`s Patents
OLDSMAR, Fla., Dec 16, 2004 /PRNewswire-FirstCall via COMTEX/ -- CRYO-CELL
International, Inc. (OTC Bulletin Board: CCEL) (the "Company") is pleased to
announce that on December 14, 2004, the United States District Court for the
District of Delaware issued an order entering a final judgment in favor of
CRYO-CELL International, Inc. ("CRYO-CELL") in patent infringement litigation
filed against it by PharmaStem Therapeutics, Inc. ("PharmaStem"). This order,
which can be viewed at
http://www.CRYO-CELL.com/resources/PharmaStem_121404_ruling.… , effectively
reverses every aspect of the October 2003 trial jury`s verdict of patent
infringement and damages award.
From an historical perspective, PharmaStem initiated patent litigation against
CRYO-CELL and other umbilical cord blood banking firms in February 2002. After a
trial in October 2003 before the Hon. Gregory M. Sleet and a jury, the parties
filed post-trial motions, which were decided by Judge Sleet in an order dated
September 15, 2004 (see CRYO-CELL`s press release dated September 20, 2004). At
that time, Judge Sleet granted the motion of CRYO-CELL and the other defendants
for entry of judgment as a matter of law ("JMOL") on infringement of
PharmaStem`s U.S. Patent No. 5,192,553 ("the `553 patent") reversing the jury`s
verdict on the `553 patent. In the September 15 order, the court denied the
defendants` motion for JMOL in their favor on infringement of U.S. Patent No.
5,004,681 ("the `681 patent"), but granted defendants` motion in the alternative
for a new trial on that issue.
CRYO-CELL subsequently filed a motion asking the Court to reconsider the denial
of JMOL on the `681 patent. The Court`s December 14, 2004 order granted that
motion, directing the entry of judgment in favor of CRYO-CELL and the other
defendants on the `681 patent. The effect of this order is that final judgment
has now been entered in favor of CRYO-CELL and the other defendants on
PharmaStem`s charges of infringement of both patents that were asserted in that
case, marking a final disposition of the case in CRYO-CELL`s favor. PharmaStem
has the right to appeal the decision to the United States Court of Appeals for
the Federal Circuit.
Mercedes Walton, CRYO-CELL`s Chairman and interim CEO, commented, "We are very
pleased that the Court has decided this case in the Company`s favor. We believe
that the Court`s decision has vindicated our long-standing position that
CRYO-CELL`s U-Cord(R) preservation business does not constitute infringement of
PharmaStem`s patents, and we continue to believe that these patents will
ultimately be rendered invalid. While we are certainly pleased with the final
rulings of the Delaware Court, we regret the confusion and disruption created by
this matter in the clinical and expectant parent communities during the course
of the litigation. This decision is a landmark step in clarifying the right of
CRYO-CELL to continue to serve the growing demand for the Company`s services of
preserving non-controversial umbilical cord blood stem cells."
About CRYO-CELL International, Inc.
OLDSMAR, Fla., Dec 16, 2004 /PRNewswire-FirstCall via COMTEX/ -- CRYO-CELL
International, Inc. (OTC Bulletin Board: CCEL) (the "Company") is pleased to
announce that on December 14, 2004, the United States District Court for the
District of Delaware issued an order entering a final judgment in favor of
CRYO-CELL International, Inc. ("CRYO-CELL") in patent infringement litigation
filed against it by PharmaStem Therapeutics, Inc. ("PharmaStem"). This order,
which can be viewed at
http://www.CRYO-CELL.com/resources/PharmaStem_121404_ruling.… , effectively
reverses every aspect of the October 2003 trial jury`s verdict of patent
infringement and damages award.
From an historical perspective, PharmaStem initiated patent litigation against
CRYO-CELL and other umbilical cord blood banking firms in February 2002. After a
trial in October 2003 before the Hon. Gregory M. Sleet and a jury, the parties
filed post-trial motions, which were decided by Judge Sleet in an order dated
September 15, 2004 (see CRYO-CELL`s press release dated September 20, 2004). At
that time, Judge Sleet granted the motion of CRYO-CELL and the other defendants
for entry of judgment as a matter of law ("JMOL") on infringement of
PharmaStem`s U.S. Patent No. 5,192,553 ("the `553 patent") reversing the jury`s
verdict on the `553 patent. In the September 15 order, the court denied the
defendants` motion for JMOL in their favor on infringement of U.S. Patent No.
5,004,681 ("the `681 patent"), but granted defendants` motion in the alternative
for a new trial on that issue.
CRYO-CELL subsequently filed a motion asking the Court to reconsider the denial
of JMOL on the `681 patent. The Court`s December 14, 2004 order granted that
motion, directing the entry of judgment in favor of CRYO-CELL and the other
defendants on the `681 patent. The effect of this order is that final judgment
has now been entered in favor of CRYO-CELL and the other defendants on
PharmaStem`s charges of infringement of both patents that were asserted in that
case, marking a final disposition of the case in CRYO-CELL`s favor. PharmaStem
has the right to appeal the decision to the United States Court of Appeals for
the Federal Circuit.
Mercedes Walton, CRYO-CELL`s Chairman and interim CEO, commented, "We are very
pleased that the Court has decided this case in the Company`s favor. We believe
that the Court`s decision has vindicated our long-standing position that
CRYO-CELL`s U-Cord(R) preservation business does not constitute infringement of
PharmaStem`s patents, and we continue to believe that these patents will
ultimately be rendered invalid. While we are certainly pleased with the final
rulings of the Delaware Court, we regret the confusion and disruption created by
this matter in the clinical and expectant parent communities during the course
of the litigation. This decision is a landmark step in clarifying the right of
CRYO-CELL to continue to serve the growing demand for the Company`s services of
preserving non-controversial umbilical cord blood stem cells."
About CRYO-CELL International, Inc.
U.a. deswegen stieg CCEL die letzten Wochen so
--------------------------------
http://www.nasdaq.com/asp/quotes_news.asp?cpath=20050104AC…
StemCells, Inc. Announces Filing of IND for Human Neural Stem Cell Transplant Treatment for Batten Disease
PALO ALTO, Calif.--(BUSINESS WIRE)--Jan. 4, 2005--
Phase I Clinical Trial at Stanford Would Be First-Ever Using Transplantation of Human Neural (Brain) Stem Cells
StemCells, Inc. (NASDAQ: STEM) today announced the filing of its first Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). Subject to approval, the Company plans to begin its first clinical investigation of its human neural (brain) stem cells (HuCNS-SC - StemCells` proprietary neural cell therapy product) in Batten disease. Batten disease is a rare, fatal genetic disorder that affects the central nervous system of children. If approved by the FDA, this would mark the first-ever FDA-approved clinical trial to use a purified composition of human neural stem cells as the potential therapeutic agent.
On approval of the IND by the FDA, the study will be conducted at Lucile Packard Children`s Hospital/Stanford University Medical Center (LPCH/SUMC) under the direction of Stephen L. Huhn, MD, FACS, FAAP, Chief of Pediatric Neurosurgery and Gregory M. Enns, MB, ChB, Assistant Professor and Director, Biochemical Genetics Program, Division of Medical Genetics.
"This is truly a significant milestone, not only for StemCells, Inc., but also for all scientists who have been seeking to evaluate possible therapies for neural and neurodegenerative diseases," said Martin McGlynn, chief executive officer of StemCells, Inc. "Our pre-clinical research has shown great promise and this filing is an essential step in discovering how to translate those pre-clinical results into treatment of human victims of terrible disorders like Batten disease and other neurodegenerative lysosomal storage diseases. It is only a first step, though - this is a Phase I, or safety, trial, from which we hope to learn about the behavior of the cells when they are transplanted into a human recipient. There will be many other steps to take before we arrive. But it is our hope that transplantation of human neural stem cells could prove to be a platform technology for a wide range of conditions for which there is now no reliable and effective treatment."
"We are looking forward to working with the scientists at StemCells in this historic clinical trial," said Dr. Huhn, at Stanford University School of Medicine. "We are exploring new territory, which dictates that we proceed with due caution. I believe, however, that our path has been determined by rigorous research and a well-designed protocol. Physicians have been essentially helpless to assist children suffering from Batten`s, and all of us involved in this trial are hoping it will lead to a future in which we will have an efficient treatment, or even a cure. As a pediatric neurosurgeon, I am particularly excited about this avenue of research."
About the Clinical Trial
The proposed Phase I trial is designed to investigate the safety of HuCNS-SC in the treatment of infantile and late-infantile neuronal ceroid lipofuscinosis (NCL), the most severe forms of a group of disorders commonly referred to as Batten disease. The trial will be an open label study of two dose levels involving three subjects in each of two cohorts. The primary objective of the trial will be to measure the safety of HuCNS-SC. However, the trial will also evaluate HuCNS-SC`s ability to affect the progression of the disease. The patient/subject evaluation will be up to one year post HuCNS-SC transplantation. Candidates from anywhere in the world will be referred by their primary physicians to the Co-principal Investigators at LPCH/SUMC. Potential patients will be tested for eligibility and then evaluated for baseline disease status prior to transplantation. The Company is committed to following the effects of this therapy long-term, so potential trial patients will also be asked to commit to a four year follow-up study.
About Batten Disease
Batten disease is named after the British pediatrician who first described the juvenile form of NCL in 1903. It is also known as Spielmeyer-Vogt-Sjogren-Batten disease. The name is now commonly used to encompass all three forms of NCL. The forms of NCL are classified by age of onset (infantile, late infantile and juvenile) but are more precisely classifiable in terms of the specific enzyme causing the disease. They all have the same basic cause - lack of a lysosomal enzyme - and similar progression and outcome, but are all genetically different. Children with Batten disease suffer seizures, progressive loss of motor skills, sight and mental capacity, eventually becoming blind, bedridden and unable to communicate. Today, Batten disease is always fatal.
In two sub-types of the NCLs - infantile and late infantile or, more technically, CLN1 and CLN2 - normally secreted housekeeping lysosomal enzymes are either defective or missing altogether, as a result of gene mutations. Lack of either enzyme causes a buildup of lipofuscin (aggregates of lipids and proteins) primarily in the brain and leads to neuronal cell loss.
In the proposed clinical trial, HuCNS-SC will be transplanted in the CLN1 and CLN2 patients in part to determine if the transplanted cells secrete the missing lysosomal enzymes in the brains of affected individuals. HuCNS-SC have been shown to produce both PPT1 and TPP-I enzymes, providing a scientific justification for enzyme replacement and cellular rescue in this indication. In preclinical models of PPT1 deficiency, the corresponding enzyme activity increases with time after transplantation.
About HuCNS-SC and the Clinical Trial
StemCell`s human central nervous system stem cells (HuCNS-SC) are a somatic cell therapy product consisting of neural cells prepared under controlled conditions. Neural stem cells, a rare subset of brain cells, are isolated from the human fetal brain, purified, propagated, and tested; they are then frozen in cell banks from which HuCNS-SC doses can be prepared.
NCLs are lysosomal storage disorders brought on by inherited genetic mutations in CLN1 gene, which codes for palmitoyl-protein thioesterase 1 (PPT1) and in the CLN2 gene, which codes for tripeptidyl peptidase I (TPP-I). The consequence of these mutations is the accumulation of lipofuscin-like fluorescent inclusions in various cell types that eventually lead to cell degeneration. Presumably, non-degraded lysosomal substrates accumulate to the point where they interfere with normal cellular and tissue function and lead to the pathological manifestations of the related disease. To correct the major defect in these subjects, enzyme would have to be available in the brain where it can be taken up by the enzyme deficient cells. A property of HuCNS-SC is production of both PPT1 and TPP-I enzymes. Thus, placement of HuCNS-SC in appropriate places in the brain has the prospect of replacing the missing enzyme.
About StemCells, Inc.
StemCells, Inc. is a development stage biotechnology company focused on the discovery, development and commercialization of stem cell-based therapies to treat diseases of the nervous system, liver, and pancreas. The Company`s stem cell programs seek to repair or repopulate neural or other tissue that has been damaged or lost as a result of disease or injury. StemCells is the first company to directly identify and isolate human neural stem cells from normal brain tissue. These stem cells are expandable into cell banks for therapeutic use, which demonstrates the feasibility of using normal, non-genetically modified cells as cell-based therapies. StemCells is the only publicly traded company solely focused on stem cell research and development and has more than 40 U.S. and 100 non-U.S. patents, as well as 100 patent applications pending worldwide. Further information about the Company is available on its web site at: www.stemcellsinc.com.
Apart from statements of historical facts, the text of this press release constitutes forward-looking statements regarding, among other things, the future business operations of StemCells, Inc. ("the Company"). The forward-looking statements speak only as of the date of this news release. StemCells does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management`s current views and are based on certain assumptions that may or may not ultimately prove valid. The Company`s actual results may vary materially from those contemplated in the forward-looking statements due to risks and uncertainties to which the Company is subject, including uncertainties regarding the Company`s ability to obtain the capital resources needed to continue its current research and development operations and to conduct the research, preclinical development and clinical trials necessary for regulatory approvals; the uncertainty whether the FDA will approve the IND and permit the Company to proceed to clinical testing; the uncertainty regarding the outcome of the Phase I clinical trial and any other trials the Company may conduct in the future; the uncertainty regarding the validity and enforceability of issued patents; the uncertainty whether any products that may be generated in the Company`s stem cell programs will prove clinically effective and not cause tumors or other side effects; the uncertainty whether the Company will achieve revenues from product sales or become profitable; uncertainties regarding the Company`s obligations in regard to its former encapsulated cell therapy facilities in Rhode Island; and other factors that are described in Exhibit 99 to the Company`s Annual Report on Form 10-K titled "Cautionary Factors Relevant to Forward-Looking Statements."
CONTACT: StemCells, Inc.Judi Lum, 650-475-3100
or
Schwartz Communications, Inc.
Media:
781-684-0770 or 415-512-0770
stemcells@schwartz-pr.com
SOURCE: StemCells, Inc.
--------------------------------
http://www.nasdaq.com/asp/quotes_news.asp?cpath=20050104AC…
StemCells, Inc. Announces Filing of IND for Human Neural Stem Cell Transplant Treatment for Batten Disease
PALO ALTO, Calif.--(BUSINESS WIRE)--Jan. 4, 2005--
Phase I Clinical Trial at Stanford Would Be First-Ever Using Transplantation of Human Neural (Brain) Stem Cells
StemCells, Inc. (NASDAQ: STEM) today announced the filing of its first Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA). Subject to approval, the Company plans to begin its first clinical investigation of its human neural (brain) stem cells (HuCNS-SC - StemCells` proprietary neural cell therapy product) in Batten disease. Batten disease is a rare, fatal genetic disorder that affects the central nervous system of children. If approved by the FDA, this would mark the first-ever FDA-approved clinical trial to use a purified composition of human neural stem cells as the potential therapeutic agent.
On approval of the IND by the FDA, the study will be conducted at Lucile Packard Children`s Hospital/Stanford University Medical Center (LPCH/SUMC) under the direction of Stephen L. Huhn, MD, FACS, FAAP, Chief of Pediatric Neurosurgery and Gregory M. Enns, MB, ChB, Assistant Professor and Director, Biochemical Genetics Program, Division of Medical Genetics.
"This is truly a significant milestone, not only for StemCells, Inc., but also for all scientists who have been seeking to evaluate possible therapies for neural and neurodegenerative diseases," said Martin McGlynn, chief executive officer of StemCells, Inc. "Our pre-clinical research has shown great promise and this filing is an essential step in discovering how to translate those pre-clinical results into treatment of human victims of terrible disorders like Batten disease and other neurodegenerative lysosomal storage diseases. It is only a first step, though - this is a Phase I, or safety, trial, from which we hope to learn about the behavior of the cells when they are transplanted into a human recipient. There will be many other steps to take before we arrive. But it is our hope that transplantation of human neural stem cells could prove to be a platform technology for a wide range of conditions for which there is now no reliable and effective treatment."
"We are looking forward to working with the scientists at StemCells in this historic clinical trial," said Dr. Huhn, at Stanford University School of Medicine. "We are exploring new territory, which dictates that we proceed with due caution. I believe, however, that our path has been determined by rigorous research and a well-designed protocol. Physicians have been essentially helpless to assist children suffering from Batten`s, and all of us involved in this trial are hoping it will lead to a future in which we will have an efficient treatment, or even a cure. As a pediatric neurosurgeon, I am particularly excited about this avenue of research."
About the Clinical Trial
The proposed Phase I trial is designed to investigate the safety of HuCNS-SC in the treatment of infantile and late-infantile neuronal ceroid lipofuscinosis (NCL), the most severe forms of a group of disorders commonly referred to as Batten disease. The trial will be an open label study of two dose levels involving three subjects in each of two cohorts. The primary objective of the trial will be to measure the safety of HuCNS-SC. However, the trial will also evaluate HuCNS-SC`s ability to affect the progression of the disease. The patient/subject evaluation will be up to one year post HuCNS-SC transplantation. Candidates from anywhere in the world will be referred by their primary physicians to the Co-principal Investigators at LPCH/SUMC. Potential patients will be tested for eligibility and then evaluated for baseline disease status prior to transplantation. The Company is committed to following the effects of this therapy long-term, so potential trial patients will also be asked to commit to a four year follow-up study.
About Batten Disease
Batten disease is named after the British pediatrician who first described the juvenile form of NCL in 1903. It is also known as Spielmeyer-Vogt-Sjogren-Batten disease. The name is now commonly used to encompass all three forms of NCL. The forms of NCL are classified by age of onset (infantile, late infantile and juvenile) but are more precisely classifiable in terms of the specific enzyme causing the disease. They all have the same basic cause - lack of a lysosomal enzyme - and similar progression and outcome, but are all genetically different. Children with Batten disease suffer seizures, progressive loss of motor skills, sight and mental capacity, eventually becoming blind, bedridden and unable to communicate. Today, Batten disease is always fatal.
In two sub-types of the NCLs - infantile and late infantile or, more technically, CLN1 and CLN2 - normally secreted housekeeping lysosomal enzymes are either defective or missing altogether, as a result of gene mutations. Lack of either enzyme causes a buildup of lipofuscin (aggregates of lipids and proteins) primarily in the brain and leads to neuronal cell loss.
In the proposed clinical trial, HuCNS-SC will be transplanted in the CLN1 and CLN2 patients in part to determine if the transplanted cells secrete the missing lysosomal enzymes in the brains of affected individuals. HuCNS-SC have been shown to produce both PPT1 and TPP-I enzymes, providing a scientific justification for enzyme replacement and cellular rescue in this indication. In preclinical models of PPT1 deficiency, the corresponding enzyme activity increases with time after transplantation.
About HuCNS-SC and the Clinical Trial
StemCell`s human central nervous system stem cells (HuCNS-SC) are a somatic cell therapy product consisting of neural cells prepared under controlled conditions. Neural stem cells, a rare subset of brain cells, are isolated from the human fetal brain, purified, propagated, and tested; they are then frozen in cell banks from which HuCNS-SC doses can be prepared.
NCLs are lysosomal storage disorders brought on by inherited genetic mutations in CLN1 gene, which codes for palmitoyl-protein thioesterase 1 (PPT1) and in the CLN2 gene, which codes for tripeptidyl peptidase I (TPP-I). The consequence of these mutations is the accumulation of lipofuscin-like fluorescent inclusions in various cell types that eventually lead to cell degeneration. Presumably, non-degraded lysosomal substrates accumulate to the point where they interfere with normal cellular and tissue function and lead to the pathological manifestations of the related disease. To correct the major defect in these subjects, enzyme would have to be available in the brain where it can be taken up by the enzyme deficient cells. A property of HuCNS-SC is production of both PPT1 and TPP-I enzymes. Thus, placement of HuCNS-SC in appropriate places in the brain has the prospect of replacing the missing enzyme.
About StemCells, Inc.
StemCells, Inc. is a development stage biotechnology company focused on the discovery, development and commercialization of stem cell-based therapies to treat diseases of the nervous system, liver, and pancreas. The Company`s stem cell programs seek to repair or repopulate neural or other tissue that has been damaged or lost as a result of disease or injury. StemCells is the first company to directly identify and isolate human neural stem cells from normal brain tissue. These stem cells are expandable into cell banks for therapeutic use, which demonstrates the feasibility of using normal, non-genetically modified cells as cell-based therapies. StemCells is the only publicly traded company solely focused on stem cell research and development and has more than 40 U.S. and 100 non-U.S. patents, as well as 100 patent applications pending worldwide. Further information about the Company is available on its web site at: www.stemcellsinc.com.
Apart from statements of historical facts, the text of this press release constitutes forward-looking statements regarding, among other things, the future business operations of StemCells, Inc. ("the Company"). The forward-looking statements speak only as of the date of this news release. StemCells does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management`s current views and are based on certain assumptions that may or may not ultimately prove valid. The Company`s actual results may vary materially from those contemplated in the forward-looking statements due to risks and uncertainties to which the Company is subject, including uncertainties regarding the Company`s ability to obtain the capital resources needed to continue its current research and development operations and to conduct the research, preclinical development and clinical trials necessary for regulatory approvals; the uncertainty whether the FDA will approve the IND and permit the Company to proceed to clinical testing; the uncertainty regarding the outcome of the Phase I clinical trial and any other trials the Company may conduct in the future; the uncertainty regarding the validity and enforceability of issued patents; the uncertainty whether any products that may be generated in the Company`s stem cell programs will prove clinically effective and not cause tumors or other side effects; the uncertainty whether the Company will achieve revenues from product sales or become profitable; uncertainties regarding the Company`s obligations in regard to its former encapsulated cell therapy facilities in Rhode Island; and other factors that are described in Exhibit 99 to the Company`s Annual Report on Form 10-K titled "Cautionary Factors Relevant to Forward-Looking Statements."
CONTACT: StemCells, Inc.Judi Lum, 650-475-3100
or
Schwartz Communications, Inc.
Media:
781-684-0770 or 415-512-0770
stemcells@schwartz-pr.com
SOURCE: StemCells, Inc.
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