Initial Phase I Solid Tumor Data on Celgene's Lead Imid(TM), Revimid(TM)
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`6/7/01 PR Newswire 00:00:00
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`PR Newswire
`Copyright (c) 2001 PR Newswire. All rights reserved.
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`June 7, 2001
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`Initial Phase I Solid Tumor Data on Celgene's Lead Imid(TM), Revimid(TM)
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`WARREN, N.J., June 7 PRNewswire
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`Celgene Corporation (Nasdaq: CELG)
`announced today preliminary results of its initial Phase I safety trial of
`REVIMID(TM), Celgene's lead Immunomodulatory Drug (IMiD(TM)) for the
`treatment of solid tumors. The protocol conducted by Professor Angus
`Dalgleish of the Division of Oncology at the St. Georges Medical School in
`London, enrolled 20 cancer patients. Of those enrolled, 13 had metastatic
`melanoma, 2 pancreatic cancer, 2 non-small cell lung cancer, 2 breast cancer
`and one metastatic renal cancer. After four weeks of therapy, patients were
`evaluated for safety and those whose highly progressive cancers had stabilized
`or decreased in size were entered onto continuing therapy on a named patient
`basis at the discretion of both Dr. Dalgleish and the patient.
`
`Therapy consisted of consecutive one week treatments with 5 mg, 10 mg,
`25 mg and 50 mg per day. REVIMID was well tolerated with the only adverse
`event noted being numbness in one hand in the renal cancer patient. No
`laboratory abnormalities were noted in this study that titrated patients to
`50 mg a day dose. Sedation was not an observed side effect in these patients.
`Thirteen patients were entered into continuing therapy on a named patient
`basis. Eight of these had metastatic melanoma and six of the eight had
`evidence of disease regression. Both patients with pancreatic cancer had
`symptomatic improvement; one of whom had a decline in the CA 19.9 pancreatic
`cancer marker
`"We are encouraged at both REVIMID's tolerability and the initial results
`that indicate that the drug may be active in treating melanoma," said
`Professor Dalgleish. "Based on these results we have expanded the trial by
`adding 60 patients and are increasing the dose".
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`In May, Celgene reported positive findings in preliminary results of
`REVIMID (CDC501), Celgene's lead Immunomodulatory Drug (IMiD(TM)) for the
`treatment of multiple myeloma.
`
`"Based on these results in both solid tumors and multiple myeloma, Celgene
`will focus resources towards pursuing an aggressive regulatory and clinical
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`DR. REDDY’S LABS., INC. EX. 1009 PAGE 1
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`Initial Phase I Solid Tumor Data on Celgene's Lead Imid(TM), Revimid(TM)
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`strategy," said Sol Barer, Ph.D. Celgene's President and Chief Operating
`Officer.
`
`IMiDs are novel, small-molecule, orally available analogs of thalidomide
`that are designed to be more potent and potentially have a superior safety
`profile than the parent compound. Celgene's IMiDs have significantly greater
`immunological activity than thalidomide in in vitro studies. IMiDs were
`reported in the November 1, 2000 issue of BLOOD to enhance T-cell
`proliferation and interleukin (IL)-2 production. In the same report, IMiDs
`were also shown to be potent inhibitors of inflammatory cytokines that include
`TNF-alpha and IL-1beta while stimulating the anti-inflammatory cytokine IL-10.
`IMiDs, including Celgene's current lead clinical candidate REVIMID are covered
`by issued and pending patents in the U.S. and internationally.
`
`Malignant Metastatic Melanoma
`Malignant metastatic melanoma is a cancer predominantly of skin but may
`occur as a primary tumor in other locations including mucous membrane and the
`retina. U.S. incidence of melanoma of the skin has increased 4% annually over
`the past 30 years due to increased exposure to ultraviolet radiation from the
`sun. Prognosis is affected by tumor stage and anatomic location of the
`lesion. Thickness and/or level of invasion of the melanoma are the most
`important local determinants of prognosis, while nodal or widespread
`metastatic disease portends an even poorer prognosis.
`
`The American Cancer Society estimates that 47,000 cases were diagnosed in
`the United States in 2000, of which 9,000 were metastatic. Currently, 90% of
`patients with metastatic disease die, with a median survival of 9 - 12 months,
`while death resulting from less advanced disease is still significant.
`
`Celgene Corporation, headquartered in Warren, New Jersey, is an
`independent biopharmaceutical company engaged in the discovery, development
`and commercialization of small molecule drugs for cancer and immunological
`diseases.
`
`This release contains certain forward-looking statements which involve
`known and unknown risks, delays, uncertainties and other factors not under the
`Company's control which may cause actual results, performance or achievements
`of the Company to be materially different from the results, performance or
`other expectations implied by these forward-looking statements. These factors
`include results of current or pending research and development activities,
`actions by the FDA and other regulatory authorities, and those factors
`detailed in the Company's filings with the Securities and Exchange Commission
`such as 10K, 10Q and 8K reports.
`
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`SOURCE Celgene Corporation
`CONTACT: Robert J. Hugin, Senior Vice President & CFO of Celgene Corporation,
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`DR. REDDY’S LABS., INC. EX. 1009 PAGE 2
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`Initial Phase I Solid Tumor Data on Celgene's Lead Imid(TM), Revimid(TM)
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`732-271-4102
`Web site: http://www.celgene.com
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`---- Index References ----
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`Company: CELGENE CORP
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`News Subject: (Health & Family (1HE30); Economics & Trade (1EC26))
`
`Industry: (Growth Factors & Cytokines (1GR66); Healthcare (1HE06); Pharmaceuticals Regulatory (1PH03);
`Pharmaceuticals & Biotechnology (1PH13); Internal Medicine (1IN54); Healthcare Practice Specialties (1HE49);
`Pharmaceuticals Research & Development (1PH57); Cancer Drugs (1CA21); Oncology & Hematology (1ON95))
`
`Region: (Europe (1EU83); USA (1US73); Americas (1AM92); North America (1NO39))
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`Language: EN
`
`Other Indexing: (AMERICAN CANCER SOCIETY; CELGENE; CELGENE CORP; DALGLEISH; FDA;
`GEORGES MEDICAL SCHOOL; MALIGNANT METASTATIC MELANOMA MALIGNANT; NASDAQ:
`CELG; REVIMID; SECURITIES AND EXCHANGE COMMISSIONSUCH; SOLID TUMOR DATA)
`(AngusDalgleish; Celgene; Celgenewill; D. Celgene; IMiDs; Nolaboratory; Phase; Robert J. Hugin; Sedation; Sol Barer)
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`Word Count: 979
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`End of Document
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`© 2018 Thomson Reuters. No claim to original U.S. Government Works.
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