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CytRx has completed a meeting with representatives of the FDA prior to the submission
of the company's investigational new drug (IND) application for its lead small
molecule drug candidate arimoclomol for the treatment of amyotrophic lateral
sclerosis.
The FDA has granted final approval to Andrx and Alpharma to market generic versions
of Bristol-Myers Squibb's diabetes drug Glucophage (metformin HCl).
The FDA has granted priority-review status to Insmed's new drug application
for SomatoKine, a drug candidate intended to treat growth hormone insensitivity
syndrome.
Researchers at Vical has presented preclinical (mouse) data, supporting the
company's decision to advance into Phase I human testing with an investigational
method of delivering interleukin-2 (IL-2) for patients with recurrent metastatic
melanoma.
EntreMed has presented preclinical results for its lead 2-methoxyestradiol (2ME2)
analogs, demonstrating improved pharmacokinetic parameters, reduced metabolism
and enhanced antitumor activity in preclinical animal models, and representing
the next generation of molecules with potential for broad application in cancer
and other diseases.
Biomira and Merck KGaA of Darmstadt, Germany, announced the start of a Phase
II, single-arm, multicenter, open-label study of BLP25 Liposome Vaccine (L-BLP25).
Insmed has initiated a Phase II clinical trial examining the therapeutic benefit
of treating HIV-Associated Lipodystrophy with SomatoKine, the company's proprietary
once daily IGF-I therapy.
Advanced Viral Research has announced the addition of Jacobi Medical Center
in New York as a new clinical site for its Phase II, multicenter clinical trial
of AVR118 in the U.S.