EVANSTON, Ill., Sept. 4 /PRNewswire/ -- Northfield Laboratories Inc.
(Nasdaq: NFLD) announced today that it has received its necessary approvals at
several sites to begin Phase III trials of its blood substitute product
PolyHeme(R). The randomized, controlled study is expected to take
approximately 12 months and will include 240 patients, at approximately 20
facilities nationwide, who will receive up to 6 units of PolyHeme (equivalent
to 6 pints of blood). These advanced trials are the first Phase III study by
any company to include direct replacement of blood in large volumes.
"We are pleased to have our first sites ready to begin enrollment," said
Richard DeWoskin, chairman and chief executive officer. "We have received a
very strong response, both solicited and unsolicited, from some of the finest
hospitals in the country, which have expressed an interest in participating in
the trials. We do not foresee any delays in enlisting the 20 sites planned
for Phase III trials. Northfield management is quite confident that its
findings in Phase III trials, which are focused on elective surgery, will
affirm findings in earlier trials where PolyHeme actually reduced or
eliminated the need for donated blood in trauma situations."
The Phase III trials follow very successful and unprecedented results from
the company's Phase II trials, which included infusion of up to ten units of
PolyHeme in place of blood in trauma and other urgent need settings. Ten
units represent 100 percent of an average person's blood volume. More than
8 million units of blood are transfused annually in the United States in
trauma and elective surgery settings. This equates to a $3-4 billion market
for either blood therapy or an oxygen carrying substitute product used in
transfusions.
Northfield, a development-stage company, also reported a loss as expected
for its year ended May 31, 1997. For the full year ended May 31, 1997,
Northfield reported a loss of $4.2 or ($0.30) per share compared with a loss
of $4.8 million or ($0.37) for the prior year. For the fourth quarter, the
company had a loss of $1.1 million or ($0.07) per share compared with a loss
of $1.3 million or ($0.09) per share for the same period in 1996. The company
does not have sales or revenues. The loss reflects operating expenses, and
includes the expense associated with the company's clinical trials.
In other news, Northfield reported that part of the results of its Phase
II trials were included in the most recent issue of The Journal of Trauma.
The report, describing the first large volume tests of their kind of a blood
substitute product, indicates there were no safety issues observed and that
PolyHeme appears to be a clinically useful blood substitute. In the company's
Phase II clinical trials, 39 patients were infused with up to 6 units of
PolyHeme (equivalent to 6 pints of blood). In 59 percent of those patients,
there was no need for the use of any allogeneic blood during the first 24
hours following blood loss.
"We are confident that our Phase II trials demonstrated the usefulness of
PolyHeme in urgent acute blood loss situations," said Dr. Steven Gould,
president. "While we are continuing clinical trials administering up to 10
units of PolyHeme in trauma situations, Northfield is now in Phase III trials
of PolyHeme in elective surgery settings." Northfield's product is intended
to replace the need for donated blood. PolyHeme has three key advantages over
transfused blood: it is free of blood borne disease including HIV or
hepatitis virus, has a shelf life of over a year and is universally
compatible, eliminating the time consuming need to type a person's blood in
the case of acute blood loss due to trauma.
Northfield Laboratories was founded in 1985. The Company is headquartered
in Evanston, Illinois, and its stock is traded on the Nasdaq National Market
under the symbol NFLD.
Northfield Laboratories Inc.
(a company in the development stage)
Statements of Operations
Three and Twelve months ended May 31, 1997 and 1996
(In thousands except per share data)
Three months ended Twelve months ended
May 31, May 31, May 31, May 31,
1997 1996 1997 1996
Revenues - license income $--- $--- $--- $---
Costs and expenses:
Research and development 1,259 1,448 5,188 5,223
General and administrative 660 697 2,317 2,509
Total 1,919 2,145 7,505 7,732
Other income and expense:
Interest income 833 863 3,259 2,953
Interest expense -- -- -- --
Total 833 863 3,259 2,953
Net loss $(1,086) $(1,282) $(4,246) $(4,779)
Net loss per share $(0.07) $(0.09) $(0.30) $(0.37)
Shares used in calculation of
per share data 14,060 13,586 13,961 12,849
Northfield Laboratories Inc.
(a company in the development stage)
Balance Sheets
May 31, 1997 and 1996
(In thousands)
Assets May 31, 1997 May 31, 1996
Current assets:
Cash $21,367 $11,689
Short-term marketable securities 38,927 52,296
Prepaid expenses 335 362
Other current assets 418 598
Total current assets 61,047 64,945
Plant and equipment, net 1,263 1,310
Other assets 33 84
Total assets $62,343 $66,339
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable $656 $924
Accrued expenses 122 173
Accrued compensation and benefits 176 178
Total current liabilities 954 1,275
Other liabilities 94 116
Total liabilities 1,048 1,391
Shareholders' equity:
Capital Stock 141 136
Additional paid-in capital 116,012 115,427
Deficit accumulated during the
development stage (54,857) (50,611)
Deferred compensation (1) (4)
Total shareholders' equity 61,295 64,948
Total liabilities and shareholders' equity $62,343 $66,339
SOURCE Northfield Laboratories Inc.
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CONTACT:
Richard DeWoskin, Chief Executive Officer, of
Northfield Laboratories, 847-864-3500; or General Information,
Jeff Wescott, or Media, Bess Gallanis, or Analyst-Broker, Kathy
Brunson, all of The Financial Relations Board, 312-266-7800
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