Dynavax Technologies Corporation (Nasdaq: DVAX) $1.50. Today announced that it has selected a clinical vaccine candidate for its novel Universal Flu program, completed key preclinical studies, and is reviewing clinical plans with the FDA in anticipation of initiating a Phase I study by mid-year. Dynavax also said that the trial will be conducted at centers that are members of the Vaccine Testing and Evaluation Units (VTEUs) of the National Institute for Allergy and Infectious Disease (NIAID/NIH). Specifically, Dynavax will collaborate with Dr. Robert B. Belshe, Principal Investigator of the VTEU at St. Louis University in St. Louis, MO and with Dr. Wendy A. Keitel, Principal Investigator, of the VTEU at Baylor University in Houston, TX. Dynavax made its comments today in connection with a Workshop on Influenza Vaccinology sponsored by the President's Council of Advisors on Science and Technology in Washington, D.C.
According to Dino Dina, M.D., President and CEO, "As new pandemic threats such as the H1N1 epidemic of the 2009 flu season emerge, it is becoming increasingly clear that our Universal Flu approach represents an important intervention with the potential to provide broad protection against new strains of the influenza virus. We expect the initial data, including evidence of the biological activity of the vaccine's proprietary components, to be available this year."
Dynavax indicated that a GLP toxicity study demonstrated that its Universal Flu vaccine candidate is well-tolerated, and clinical material for the upcoming trial has been manufactured. Through the addition of two highly conserved antigens, known as NP and M2e, linked to a proprietary TLR9 agonist, Dynavax's Universal Flu vaccine is designed to offer protection against divergent influenza strains, increase the efficacy of standard vaccines, and potentially reduce the dose of vaccine to extend the quantity available during a pandemic.
What They Do: Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops novel products to prevent and treat infectious diseases.
To learn more about Dynavax visit http://www.smallcapreview.com/dvax.htm
GT Solar International (Nasdaq: SOLR) $5.60. Today announced it has signed new contracts totaling more than $200 million for its market-leading DSS450™ ingot growth furnaces and ancillary equipment and services. This includes a $137 million follow-on order from a large Chinese customer, as well as orders from Tianwei New Energy Holdings Co, Ltd., Phoenix Photovoltaic Technology Co, Ltd., Yingli Green Energy Holding Company Ltd., JA Solar Holding Co, Ltd., Taiwan-based Sino-American Silicon Products (SAS), and one other customer. The orders were booked in GT Solar’s current fourth fiscal quarter and revenue for these orders is expected to be recognized in periods subsequent to the current fiscal year.
What They Do: GT Solar International, Inc., based in Merrimack, NH, USA, is a leading global provider of specialized production equipment, process technology and turnkey manufacturing services for the solar power industry.
To read more about GT Solar visit http://www.smallcapreview.com/solr.htm
Sunesis Pharmaceuticals (Nasdaq: SNSS) $0.89. Today announced that it has completed formal End-of-Phase 2 meetings with the U.S. Food and Drug Administration (FDA) related to its lead compound, voreloxin, in acute myeloid leukemia (AML). Sunesis has received feedback and guidance from the FDA in response to proposed plans for further development of voreloxin in the treatment of AML. Based on the development clarity achieved as a result of these meetings, Sunesis intends to proceed with its plan to conduct a randomized, double-blind, placebo-controlled, pivotal Phase 3 trial. This trial will evaluate the overall survival of voreloxin in combination with cytarabine, a widely used chemotherapy in AML, compared to cytarabine with placebo, in patients with relapsed or refractory AML. Sunesis anticipates initiating this multi-national, Phase 3 trial in the second half of 2010.
Sunesis also reported today that, as part of its global development strategy, a pre-submission meeting has been scheduled for the current calendar quarter with the European Medicines Agency (EMA) to obtain EMA's scientific advice on the development program for voreloxin, including the proposed Phase 3 trial.
What They Do: Sunesis is a biopharmaceutical company focused on the development and commercialization of new oncology therapeutics for the treatment of solid and hematologic cancers.
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