An analysis of imclone systems incorporated a biopharmaceutical company

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An analysis of imclone systems incorporated a biopharmaceutical company

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These findings should expand treatment options for patients with cancer," said Alexander J. These three studies demonstrate significant improvements in 1st, 2nd and refractory mCRC patient outcomes including overall survival, survival without disease progression, tumor shrinkage and improvements in patient quality of life versus various standards of care.

Forward-looking information is subject to certain risks, trends and uncertainties that could cause actual results to differ materially from those projected.

Many of these factors are beyond the company's ability to control or predict. Important factors that may cause actual results to differ materially and could impact the company and the statements contained in this news release can be found in the company's filings with the Securities and Exchange Commission including quarterly reports on Form Q, current reports on Form 8-K and annual reports on Form K.

For forward-looking statements in this news release, the company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of The company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise.

Contact Investors and Media: Curative surgical resection is the therapeutic goal for the roughly one third of colorectal cancer patients who have metastatic disease confined to the liver. This can be accomplished by new treatments that increase the likelihood that curative surgery can be performed," said Eric Rowinsky, M.

The EPIC study showed that ERBITUX, in combination with irinotecan, significantly improved survival without progression and provided a superior quality of lif e for patients versus those patients receiving irinotecan alone.

The primary endpoint was overall survival. Analyses of secondary endpoints such as progression-free survival, response rate, disease control rate, safety, and quality of life are currently ongoing.

SEC Info - Imclone Systems Inc - ‘K’ for 12/31/07

In one of these studies, favorable overall survival, progression-free survival, response rate and safety were observed when ERBITUX was added to gemcitabine and a platinum-based chemotherapy.

On-going trials are continuing to investigate additional combinations of ERBITUX with chemotherapy and biologics in patients with this aggressive cancer for whom treatment options remain acutely limited. This difference, however, was not statistically significant.

In vitro assays and in vivo animal studies have shown that binding of ERBITUX to the EGFR blocks phosphorylation and activation of receptor-associated kinases, resulting in inhibition of cell growth, induction of apoptosis, and decreased matrix metalloproteinase and vascular endothelial growth factor production.

EGFR is part of a signaling pathway that is linked to the growth and development of many human cancers, including those of the head and neck, colon and rectum.

Collaboration Agreement

ERBITUX Cetuximabin combination with radiation therapy, is indicated for the treatment of locally or regionally advanced squamous cell carcinoma of the head and neck. ERBITUX as a single agent is indicated for the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck for whom prior platinum-based therapy has failed.

ERBITUX is indicated for the treatment of EGFR-expressing, metastatic colorectal carcinoma mCRC in combination with irinotecan for patients who are refractory to irinotecan-based che motherapy, and as a single agent for patients who are intolerant to irinotecan-based therapy.

Caution must be exercised with every ERBITUX infusion as there were patients who experienced their first severe infusion reaction during later infusions. Longer observation periods may be required in patients who experience infusion reactions.

ERBITUX in combination with radiation therapy should be used with caution in patients with known coronary artery disease, congestive heart failure and arrhythmias.

Close monitoring of serum electrolytes, including serum magnesium, potassium, and calcium during and after ERBITUX therapy is recommended. Severe cases of interstitial lung disease ILDwhich was fatal in one case, occurred in l ess than 0. In clinical studies of ERBITUX, dermatologic toxicities, including acneform rash, skin drying and fissuring, and inflammatory and infectious sequelae eg, blepharitis, cheilitis, cellulitis, cyst were reported.

Subsequent to the development of severe dermatologic toxicities, complications including S. Sun exposure may exacerbate these effects. Two of 21 patients died, one as a result of pneumonia and one of an unknown cause.

Four patients discontinued treatment due to adverse events. Two of these discontinuations were due to cardiac events myocardial infarction in one patient and arrhythmia, diminished cardiac output, and hypotension in the other patient.

Electrolyte repletion was necessary in some patients and in severe cases, intravenous replacement was required. The overall incidence of late radiation toxicities any grade was higher with ERBITUX in combination with radiation therapy compared with radiation therapy alone.

The following sites were affected: The incidence of Grade 3 or 4 late radiation toxicities were generally similar between the radiation therapy alone and the ERBITUX plus radiation therapy arms. About ImClone Systems Incorporated:ImClone Company Marks means the Trademarks Controlled by ImClone or its Affiliates, whether on the Effective Date or during the Term, that are designated by ImClone pursuant to Article (b) for use on or in connection with the Development and Commercialisation of .

From to , Mr. Johnson was chief executive officer of ImClone Systems Incorporated, a biopharmaceutical development company, and was also a member of ImClone’s board of directors until it became a wholly owned subsidiary of Eli Lilly in Medarex, Inc.

(Medarex) is a biopharmaceutical company focused on the discovery, development and commercialization of human antibody-based therapeutic products. The Company, along with its partners, is developing fully human antibody therapeutics for a range of diseases through the use of its UltiMAb technology platform for generating antibodies.

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From to , Mr. Johnson was chief executive officer of ImClone Systems Incorporated, a biopharmaceutical development company, and was also a member of ImClone.

Since , he held leadership positions of increasing responsibility at ImClone Systems Incorporated.

An analysis of imclone systems incorporated a biopharmaceutical company

He led ImClone's Worldwide Commercial Organization, responsible for commercial aspects for the planning and launch of Erbitux(R) across multiple indications.

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