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 Biotech / Medical | Genstar GNT(formerly UroGen)-- an interesting speculation


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To: Paul Lee who wrote ()1/20/2000 8:39:00 AM
From: Paul Lee
   of 100
 
Now maybe we can get off the BB
UroGen Corp. Completes $8.2 Million Private Placement
Proceeds to Advance Clinical Development of Hemophilia and Prostate Cancer Products
SAN DIEGO--(BW HealthWire)--Jan. 20, 2000--UroGen Corp. (OTCBB:UROG - news) today announced that it has completed agreements for a private placement of approximately 6.3 million shares of Common Stock and Warrants for 1.75 million shares to selected institutional investors, for aggregate proceeds of approximately $8.2 million.

The company intends to use the proceeds to advance the clinical development of its lead gene therapy product candidate for Hemophilia A, in collaboration with Baxter Healthcare, and its gene therapy product for Prostate Cancer, as well to provide working capital for other general corporate purposes.

``The timing of this financing is particularly favorable, since we are moving towards the initiation of human clinical trials of our lead product, Factor VIII gene therapy for Hemophilia A,' said Robert E. Sobol, M.D., UroGen Corp. chief executive officer.

Evolution Capital, a subsidiary of the Carson Group, acted as placement agent for this transaction that included investments by The Aries Funds, Emerging Growth Management, Clearwater Funds and Perceptive Life Sciences Fund. The Common Stock and Warrants sold have not been registered under the Securities Act of 1933 and may not be offered or sold in the United States, except pursuant to an applicable exemption from the Securities Act regulation requirements.

UroGen Corp. is a biotechnology company currently developing products for the treatment of hemophilia and prostate cancer. The company's hemophilia product is being developed in collaboration with Baxter Healthcare and its prostate cancer product development program has been supported in part by a grant from the National Cancer Institute.

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To: Paul Lee who wrote (14)1/25/2000 1:11:00 PM
From: Elliot Lepler
   of 100
 
Here is the abstract of the article from the journal Blood:

No wonder we rallied back above $6. Urogen will change its name to Genstar Therapeutics.

From GenStar Therapeutics Corp, San Diego, CA; and the Gene Therapy Unit, Baxter Healthcare Corp, Round Lake, IL.

The successful prophylactic treatment of hemophilia A by frequent infusions of plasma concentrates or recombinant factor VIII (hFVIII) indicates that gene therapy may be a potential alternative for the treatment of the disease. For efficient delivery and long-term expression of the hFVIII gene, a novel minimal adenovirus (mini-Ad) vector, MiniAdFVIII, has been developed. The vector is devoid of all viral genes and carries the full-length hFVIII cDNA under the control of the human 12.5-kb albumin promoter. The MiniAdFVIII vector was propagated with the assistance of an ancillary vector in 293 cells and was purified by CsCl banding. Sustained expression of hFVIII at physiologic levels (100-800 ng/mL) was achieved in mice after a single intravenous injection of MiniAdFVIII. The expressed hFVIII had a structure identical to that of recombinant hFVIII, as determined by Western blot analysis. The functionality of the protein was confirmed by the restoration of blood coagulation capacity in MiniAdFVIII-treated hemophilic mice, as determined by tail clipping observations. Although antivector or antihuman FVIII antibodies at various levels were detected, long-term expression of the transgene was observed in the mice that did not generate antibodies against the transgene product. The vector DNA persisted in the liver tissues of the mice with long-term expression. No significant histopathologic findings or toxicities were observed to be associated with the vector in the MiniAdFVIII-treated C57BL/6 mice. These results support the further development of MiniAdFVIII for clinical trials toward the treatment of hemophilia A.

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To: Paul Lee who wrote ()2/1/2000 8:03:00 AM
From: Paul Lee
   of 100
 
UroGen Reports Long-Term Expression of Factor VIII Gene For Hemophilia A
SAN DIEGO--(BW HealthWire)--Feb. 1, 2000--In a study assessing the potential treatment of Hemophilia A, UroGen (OTCBB:UROG - news) announced today that a single injection of UroGen's gene therapy product carrying the gene for human Factor VIII produced therapeutic levels of the clotting factor in the blood of animals. These levels of Factor VIII continued for approximately one year.

``The treatment corrected bleeding abnormalities in mice with Hemophilia A,' said Wei-Wei Zhang, MD, PhD UroGen's senior vice president and chief scientific officer. An advantage of UroGen's gene therapy is its ability to express the entire natural Factor VIII clotting protein. The findings were published in the Feb. 1, 2000 issue of ``BLOOD,' the journal of the American Society of Hematology.

``These studies indicate the potential utility of UroGen's gene therapy for Hemophilia A and support future evaluation of the system in clinical trials,' noted UroGen President and Chief Executive Officer Robert E. Sobol, MD.

Hemophilia A is a hereditary disease characterized by a deficiency in the blood clotting protein Factor VIII. The disorder results in abnormal bleeding and affects approximately 20,000 individuals in the U.S. The annual cost of treating these patients with Factor VIII preparations exceeds $1.2 billion.

UroGen Corp. is a biotechnology company currently developing gene therapy products for the treatment of Hemophilia A and Prostate Cancer. The company's Hemophilia product is being developed in collaboration with Baxter Healthcare and its Prostate Cancer product development program has been supported in part by a grant from the National Cancer Institute.

This press release contains forward-looking statements, including but not limited to those regarding the gene therapy products. Neither Baxter nor UroGen has entered into any human clinical trials of the gene transfer systems, and the results of any future human clinical trials cannot be predicted. The company does not undertake any obligation to update the information contained herein, which speaks only as of this date.


--------------------------------------------------------------------------------
Contact:

UroGen Corp.
Robert E. Sobol, 858/450-5949

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To: Paul Lee who wrote ()2/11/2000 9:28:00 AM
From: Paul Lee
   of 100
 
rock and roll
SOURCE: UroGen Corp
UroGen Receives FDA Clearance to Enter Human Clinical Trial Of Gene Therapy for Hemophilia A
Key Preclinical Studies Recently Published in BLOOD
SAN DIEGO, Feb. 11 /PRNewswire/ -- UroGen Corp (OTC Bulletin Board: UROG - news) today announced that the U.S. Food and Drug Administration (FDA) cleared the Company's Investigational New Drug (IND) application for a Phase I human clinical trial of its Factor VIII gene therapy product for the treatment of hemophilia A. The Company expects to begin the clinical trial later this year, following review of the clinical trial protocol by the National Institutes of Health Recombinant DNA Advisory Committee.

Research supporting the approval was published in the February 1 issue of BLOOD, the Journal of the American Society of Hematology. These studies, performed in mice with hemophilia A, a deficiency in the clotting protein Factor VIII, demonstrated sustained production of therapeutic levels of Factor VIII following a single injection of UroGen's gene therapy product. The expression of the Factor VIII protein continued for approximately one year following the injection, in effect, correcting the abnormality.

``FDA clearance of this IND application is a significant milestone in the development of our gene therapy product for hemophilia A, as well as a major milestone for the Company,' said Robert E. Sobol, M.D., president and chief executive officer of UroGen. ``We look forward to initiating our human clinical studies, which build on the promising foundation of our pre-clinical research.'

UroGen's gene therapy product for hemophilia A is an improved gene delivery system derived from the common cold virus. In contrast to earlier gene delivery approaches, UroGen's product has been genetically modified to replace all the genes responsible for transmitting the virus with therapeutic genes that are responsible for the production of Factor VIII. This product carries the entire human Factor VIII gene sequence and is designed to result in production of Factor VIII in the liver, one of its normal biological sites of production.

Hemophilia A is a hereditary disease characterized by a deficiency in the blood clotting protein Factor VIII. The disorder results in abnormal bleeding and affects approximately 20,000 individuals in the U.S.

UroGen is a biotechnology Company developing gene therapy products for the treatment of hemophilia A and prostate cancer. The Company's hemophilia product is being developed in collaboration with Baxter Healthcare. Its prostate cancer product development program has been supported, in part, by a grant from the National Cancer Institute. The Company recently announced the completion of an $8.3 million equity financing, which will contribute additional financial resources to the development of these products.

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To: Paul Lee who wrote ()2/24/2000 9:19:00 AM
From: Paul Lee
   of 100
 
somebody else believes

UroGen Corp Completes $17.0 Million Private Placement
-- Proceeds to Advance Clinical Development of Hemophilia and Prostate Cancer Products --
SAN DIEGO, Calif.--(BW HealthWire)--Feb. 24, 2000--UroGen Corp (OTC:UROG - news) today announced that it has completed a private placement of 2.0 million shares of Common Stock at $8.50 per share to the Aries Funds for aggregate proceeds of $17.0 million. The Company intends to use the funds to advance the clinical development of its lead gene therapy product candidate for Hemophilia A, in collaboration with Baxter Healthcare, and its gene therapy product for Prostate Cancer, as well to provide working capital for other general corporate purposes.

``This financing will provide the Company with the capital foundation to aggressively move both of its products into clinical trials,' said Robert E. Sobol, M.D., UroGen Corp Chief Executive Officer.

UroGen recently announced that the U.S. Food and Drug Administration (FDA) cleared the Company's Investigational New Drug (IND) application for a Phase I human clinical trial of its Factor VIII gene therapy product for the treatment of hemophilia A. The company expects to begin the clinical trial later this year, following review of the clinical trial protocol by the National Institutes of Health Recombinant DNA Advisory Committee.

Research supporting the approval was published in the February 1 issue of BLOOD, the journal of the American Society of Hematology. These studies, performed in mice with hemophilia A, a deficiency in the clotting protein Factor VIII, demonstrated sustained production of therapeutic levels of Factor VIII following a single injection of UroGen's gene therapy product. The expression of the Factor VIII protein continued for approximately one year following the injection, in effect, correcting the abnormality.

Evolution Capital, a subsidiary of the Carson Group, acted as placement agent for this transaction.

The Common Stock sold has not been registered under the Securities Act of 1933 and may not be offered or sold in the United States, except pursuant to an applicable exemption from the Securities Act regulation requirements.

UroGen Corp. is a biotechnology company currently developing products for the treatment of hemophilia and prostate cancer. The company's hemophilia product is being developed in collaboration with Baxter Healthcare and its prostate cancer product development program has been supported in part by a grant from the National Cancer Institute.

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To: Paul Lee who wrote (18)3/4/2000 3:42:00 PM
From: Elliot Lepler
   of 100
 
I can not believe that nobody has posted here. UROG has moved from pennies to $20 per share. The company will begin clinical trials for a treatment of hemophilia within months.

A comparable company, Avigen (AVGN) sells with a market cap of over $1 billion.

Beyond hemophilia, Urogen has a very promising treatment for prostate cancer. The potential revenue is clearly in the billions. Although the stock has made a terrific run and may be due for some consolidation, it could also keep going, maybe to $50 or much higher.

Does anyone read this?

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To: Elliot Lepler who wrote (19)3/4/2000 3:57:00 PM
From: Paul Lee
   of 100
 
Well, Elliot i'm still here. It is amazing with all the volume trading in the last few weeks no one has found us little orphans. Actually I have a target closer to 70.

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To: Elliot Lepler who wrote (19)3/5/2000 10:02:00 PM
From: Pete Edelman
   of 100
 
Elliott, there is a small audience out here, who probably don't have lot to contribute to the conversation, yet, but are very interested in what contributors such as yourself and others have to say. thanks..

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To: Paul Lee who wrote ()3/27/2000 10:07:00 AM
From: Paul Lee
   of 100
 
National Cancer Institute to Support UroGen's Development of Prostate Cancer Gene Therapy
SAN DIEGO--(BW HealthWire)--March 27, 2000--UroGen (OTC:BB:UROG) today announced that the National Cancer Institute (NCI) has awarded a SBIR grant to support development of the Company's prostate cancer gene therapy product. The award, over $500,000 for two years, was issued to further develop UroGen's adenoviral vector gene therapy technology for the treatment of prostate cancer.

``This therapeutic is unique due to its multiple modes of action. The adenoviral vector destroys tumor cells directly at the site of injection, sensitizes tumor cells to radiation therapy and activates the immune system to kill tumor cells that have spread through the body', stated Wei-Wei Zhang, M.D., Ph.D., Senior Vice President and Chief Scientific Officer of UroGen Corp. Initial applications of this adenoviral vector technology will be concentrated on prostate cancer, however the approach may be employed for treating other cancers.

The product has been designed to replicate in and destroy prostate cancer cells and to deliver the therapeutic gene interleukin-3 to the tumor site. Interleukin-3 gene therapy sensitizes tumors to the effects of radiation and stimulates anti-tumor immune responses capable of eradicating metastatic disease. In animal tumor models, a single injection of the adenoviral vector completely eradicated tumors and the combination of interleukin-3 cytokine gene therapy with radiotherapy was curative, resulting in enhanced efficiency of radiation therapy and anti-tumor immune responses.

``UroGen will use this funding to further the development of its prostate cancer gene therapy product and bring it to the clinic', said Robert E. Sobol, M.D., UroGen's President and Chief Executive Officer. UroGen intends to begin human trials for its first gene therapy based product, for the treatment of hemophilia, in 2000.

UroGen is a biotechnology company developing gene therapy products for the treatment of hemophilia A and prostate cancer. The Company's hemophilia product is being developed in collaboration with Baxter Healthcare. Its prostate cancer product development program has been supported, in part, by a previous grant from the National Cancer Institute. The Company recently announced the completion of approximately $25 million in equity financings, which will contribute additional financial resources to the development of these products.

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To: Elliot Lepler who wrote (19)3/27/2000 12:35:00 PM
From: Annie
   of 100
 
so doc, why does the market not like today's announcement?

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