SmallCapReview.com has been a leading site for information on small cap stocks, penny stocks and microcaps since 1999.
ZIOPHARM Oncology (Nasdaq: ZIOP) $5.60. Today announced that The Committee for Orphan Medicinal Products (COMP) within the European Medicines Agency (EMA) adopted a positive opinion for darinaparsin (Zinapar or ZIO-101) designation as an orphan medicinal product for the treatment of peripheral T-cell lymphoma (PTCL). A positive opinion by the COMP immediately precedes official designation of darinaparsin as an orphan drug by the European Commission (EC). Intravenous darinaparsin has demonstrated evidence of activity in lymphoma, in particular PTCL. ZIOPHARM expects to initiate a registration-directed study of darinaparsin in patients with PTCL by the end of 2011.
What They Do: ZIOPHARM Oncology is a biopharmaceutical company engaged in the development and commercialization of a diverse portfolio of cancer drugs.
Cytori (Nasdaq: CYTX) $5.54. Today announced it has received approval from The Netherlands to initiate a pivotal European trial, named ADVANCE, to investigate adipose-derived stem and regenerative cells (ADRCs), processed by the Celution One System, in the treatment of patients with acute heart attacks. This is the first country and trial-center approval for ADVANCE. Additional country and trial-center approvals are anticipated throughout Europe during the first half of 2011. One of the goals of the trial is to expand the Celution System CE Mark to include acute heart attack claims and to provide economic data to justify its implementation and reimbursement.
ADVANCE is a randomized, placebo controlled, double-blind trial that will enroll up to 360 patients with ST-elevation myocardial infarction in up to 35 centers, predominately in Europe. The primary endpoint of the trial is reduction in infarct size as measured by cardiac magnetic resonance imaging (MRI).
What They Do: Cytori is a leader in providing patients and physicians around the world with medical technologies that harness the potential of adult regenerative cells from adipose tissue.
Soligenix, Inc. (OTCBB: SGNX) $0.18. Today announced that the US Food and Drug Administration (FDA) has granted Orphan Drug Designation to RiVax for the prevention of ricin intoxication. RiVax is a proprietary vaccine that contains a recombinant subunit of the A chain of ricin toxin which induces ricin neutralizing antibodies in humans and animals.
The US Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders that affect fewer than 200,000 individuals within the United States. In addition to providing a seven-year term of market exclusivity for RiVax™ upon FDA approval, Orphan Drug Designation also positions Soligenix to be able to take advantage of certain financial and regulatory benefits, including government grants for conducting clinical trials, waiver of FDA user fees for the potential submission of a Biologics License Application for RiVax, and certain tax credits.
What They Do: Soligenix, Inc. (Soligenix) is a late-stage biopharmaceutical company developing products to treat life-threatening side effects of cancer treatments and serious gastrointestinal diseases, and vaccines for certain bioterrorism agents
About SmallCapReview
Copyright SmallCapReview. SmallCapReview.com is a leading site for news on small-caps, penny stocks and microcaps. SmallCapReview has built a loyal opt-in following for their investor products by providing a newsletter at no cost, sent to subscribers, highlighting select stocks in play, to register visit www.SmallCapReview.com.
