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Biotech / Medical : Ciphergen Biosystems(CIPH): -- Ignore unavailable to you. Want to Upgrade?


To: tuck who wrote (59)8/16/2002 11:08:42 AM
From: tuck  Read Replies (2) | Respond to of 510
 
>.FREMONT, Calif., Aug. 5 /PRNewswire-FirstCall/ -- Ciphergen Biosystems, Inc. (Nasdaq: CIPH - News) today reported financial results for the second quarter of 2002. For the quarter ended June 30, 2002, total revenue increased 136% to $8.7 million, up from revenue of $3.7 million in the second quarter of 2001. The increase in revenue was due to increased sales of ProteinChip® Systems and Arrays, as well as the inclusion of consumable revenue from Ciphergen's BioSepra Process Division, which was acquired in July, 2001. Ciphergen's gross profit increased to $5.8 million for the second quarter of 2002, up from $2.6 million for the comparable period in 2001. The Company reported a net loss of $7.3 million for the second quarter of 2002, compared to a net loss of $5.8 million for the comparable period of 2001.

"We're pleased to report another solid quarter of growth despite a difficult economic environment for suppliers of research tools and services. The increase in ProteinChip Array revenues, surpassing $1 million in a quarter for the first time, and continued growth in both our Clinical and Process Proteomics business segments, were particularly noteworthy," commented William Rich, President and CEO of Ciphergen. "In addition, we're pleased by the progress of many of our collaborative biomarker discovery efforts geared toward early detection of diseases, such as cancer, using our novel protein expression profiling and pattern recognition methods for predictive phenotyping."

Summary Highlights for the Quarter:

-- Discovery of Cancer Biomarkers and Clinical Proteomics. At the
American Association of Cancer Research (AACR) annual meeting in early
April, a total of 25 clinical proteomics studies covering various
cancers were presented by leading medical research centers based on
work using our ProteinChip Systems. One of these studies, from Brigham
& Women's Hospital at Harvard Medical School, was the subject of an
AACR press briefing; this study identified a potential biomarker for
use in the early detection of ovarian cancer using Ciphergen's SELDI
ProteinChip System.
-- Prostate Cancer Study. The July 1st issue of the prestigious journal
"Cancer Research" published a paper authored by our Biomarker
Center(TM) collaborators at the Virginia Prostate Center. Protein
profiles of serum from 167 prostate cancer patients, 77 patients with
benign prostate hyperplasia, and 82 age-matched unaffected healthy men
were used to train and develop a tree classification algorithm that
used a 9 protein biomarker pattern that correctly classified 96% of the
samples. Further studies are underway as we and our collaborators
extend what we've seen in pilot studies into studies with large sample
sets.
-- Expanding List of Clinical Proteomics Studies. Ciphergen's Biomarker
Centers, in collaboration with prestigious institutions such as Johns
Hopkins, Virginia Prostate Center, MD Anderson and Rigs Hospital
(Copenhagen), continue to discover new disease-associated protein
biomarkers and develop multi-protein assays designed to address a
variety of clinical questions in cancer, cardiovascular, neurology and
infectious diseases. We continue to patent biomarkers and patterns of
biomarkers discovered as part of these studies as well as associated
assays. We expect several of these clinical proteomics studies to be
completed and submitted for publications in leading journals in the
second half of 2002.
-- Major Presence at ASMS Meeting. At the 50th American Society for Mass
Spectrometry (ASMS) meeting, a total of 15 research studies were
presented involving Ciphergen's SELDI ProteinChip technology, several
of which focused on the discovery of biomarkers and patterns of
biomarkers in various cancers. Additional papers featured our
ProteinChip Interface to Tandem Mass Spectrometers for definitive
characterization and identification of biomarkers discovered with our
ProteinChip Systems.
-- Accelerating Patent Activities. Ciphergen filed 7 new patent
applications in the second quarter, more than in any previous quarter.
Many of these applications are directed to multiple biomarkers and
assays resulting from work with our research collaborators. Since the
beginning of 2002, Ciphergen has filed 12 new patent applications.
-- Expanding Process Proteomics. Ciphergen's BioSepra Process Division
process chromatography sorbent sales are growing rapidly. Our novel
MEP sorbents, which are based upon a novel, dual-mode of chromatography
(hydrophobic charge induction chromatography), are used as a
replacement for Protein A sorbents in the large-scale manufacture of
monoclonal antibody based therapeutics. MEP continues to gain
increased market acceptance and is now in the production process of
several protein drugs, now in or entering clinical trials at a number
of biopharmaceutical companies.
-- New ProteinChip Array Introduction. Ciphergen introduced its new line
of H50 Arrays, which provide improved reproducibility and performance
as reversed phase surfaces to selectively bind hydrophobic proteins and
peptides. These H50 Arrays are expected to be a mainstay for users
involved in protein profiling studies.

About Ciphergen

Ciphergen develops, manufactures and markets a family of ProteinChip® Systems and services for clinical, research and process proteomics applications, as well as a broad range of bioseparations media for protein purification through its BioSepra Process Division. ProteinChip Systems and Biomarker Center(TM) collaborative services enable protein discovery, profiling, characterization and assay development to provide researchers with predictive analysis capabilities and a better understanding of biological functions at the protein level. ProteinChip Systems are enabling tools in the emerging field of protein-based biology research, known as proteomics. Proteomics provides a direct approach to understanding the role of proteins in the biology of disease, monitoring disease progression and evaluating the therapeutic effects and side effects of drugs. Ciphergen believes proteomics will be a major focus of biological research by enhancing the understanding of gene function and the molecular basis of disease.

Safe Harbor Statement

Note Regarding Forward-Looking Statements: This press release contains forward-looking statements, including statements about the ability to use protein biomarkers and patterns of biomarkers for the early detection of various cancers and other diseases or for other predictive medicine applications, the completion of clinical proteomics studies and submission of results for publication in leading journals, the increased customer acceptance of MEP sorbents, and the expectation that H50 Arrays will be a mainstay for users involved in protein profiling studies. Actual results may differ materially from those projected in such forward-looking statements due to various factors, including the ability of Ciphergen and its customer base to use ProteinChip Systems to discover biomarkers and biomarker patterns that have utility in predictive diagnostics and drug discovery, the risk that the BioSepra Process Division will not maintain its recent growth and that MEP will not grow or maintain market acceptance, the risk that H50 Arrays will not become widely used in protein profiling studies, and the continued emergence of proteomics as a major focus of biological research and drug discovery. Investors should consult Ciphergen's filings with the Securities and Exchange Commission, including its Form 10-K for the year ended December 31, 2001 and its Form 10-Q for the quarter ended March 31, 2002, for further information regarding these and the other risks of the Company's business.

NOTE: Ciphergen and ProteinChip are registered trademarks of Ciphergen Biosystems, Inc.

Ciphergen Biosystems, Inc.
Summary Financial Information
(Unaudited)
(in thousands, except per share data)

Three Months Ended Six Months Ended
June 30, June 30,
2001 2002 2001 2002
Revenue $3,663 $8,653 $6,346 $15,467

Cost of revenue 1,027 2,848 2,027 5,350
Gross profit 2,636 5,805 4,319 10,117

Operating expenses:
Research and development 3,013 4,701 5,635 8,621
Sales and marketing 3,382 5,148 6,420 9,928
General and administrative 3,094 3,337 6,447 6,304
Amortization of intangible assets 76 207 152 414
Total operating expenses 9,565 13,393 18,654 25,267

Loss from operations (6,929) (7,588) (14,335) (15,150)

Interest and other income, net 1,115 383 2,537 799
Loss before income taxes (5,814) (7,205) (11,798) (14,351)

Income tax provision -- 92 -- 109

Net loss $(5,814) $(7,297) $(11,798) $(14,460)

Net loss per share, basic and diluted $(0.22) $(0.27) $(0.45) $(0.54)

Shares used in computing net loss
per share 26,429 26,898 26,378 26,846

December 31, June 30,
2001 2002
Cash, cash equivalents and investments
in securities $77,124 $63,700
Total assets 106,816 96,238
Stockholders' equity 93,229 80,430<<


snip

Cheers, Tuck



To: tuck who wrote (59)8/16/2002 11:43:43 AM
From: tuck  Respond to of 510
 
The results from the Hopkins team now make this approach competitive with mammography:

"Estimates of mammography sensitivity range from 75% to 90% with specificity from 90% to 95%. The positive predictive value of mammography for breast cancer ranges from 20% in women under age 50 to 60% to 80% in women age 50-69. Randomized clinical trials (RCTs) have demonstrated a 30% reduction in breast cancer mortality in women 50-69 years who are screened annually or biennially with mammograms."

acpm.org

Cheers, Tuck



To: tuck who wrote (59)12/4/2005 10:15:05 PM
From: tuck  Read Replies (1) | Respond to of 510
 
{[Partial validation of Li et. al.'s breast cancer biomarker study]

>>Breast Cancer Res Treat. 2005 Dec 2;:1-8 [Epub ahead of print]

Serum biomarkers for detection of breast cancers: a prospective study.

Mathelin C, Cromer A, Wendling C, Tomasetto C, Rio MC.

Hopitaux Universitaires de Strasbourg, 1, place de l'hopital, Strasbourg Cedex, France.

Using surface-enhanced laser desorption/ionization-time of flight (SELDI-TOF), Li et al. [Clin Chem 48(8): 1296-1304, 2002] identified 3 serum biomarkers, BC1 (4.3 kDa), BC2 (8.1 kDa) and BC3 (8.9 kDa), whose combination significantly detects breast cancer patients from non-cancer controls. This work aimed to validate these biomarkers in an independent prospective study. We screened 89 serum samples including 49 breast cancers at pT1-4N0M0 (n = 23), pT1-4N1-3M0 (n = 17) or pT1-4N0-3M1 (n = 9) stages, 13 benign breast diseases and 27 healthy women. The BC2 biomarker significance was not recovered. However, we found 2 peaks that we named BC1a (4286 Da) and BC1b (4302 Da), that could correspond to Li's BC1 since they significantly decrease in breast cancers (p < 0.00007 and p < 0.0002, respectively). Similarly, BC3a (8919 Da) and BC3b (8961 Da) are significantly increased in breast cancers (p < 0.02 and p < 0.0002, respectively) and could correspond to the Li's BC3. For each biomarker we defined stringent (no errors) and flexible (less than 10% errors) cut-off values and tested the power of the combined BC1a/BC1b/BC3a/BC3b stringent and flexible profiles to discriminate breast cancers. They identified 33% and 45% cancers, respectively. Applied to the same series, Ca 15.3 test identified 22% patients. Interestingly, in association with the BC1a/BC1b/BC3a/BC3b profiles, Ca 15.3 improved the number of detected cancers indicating that it is an independent parameter. Collectively, our data partially validate those of Li's study and confirm that the BC1 and BC3 biomarkers are helpful for breast cancer diagnosis.<<

Dang, this validation stuff sure takes a long time.

Cheers, Tuck