CEL-SCI Authorizes Expansion of Phase III Clinical Trial to an Additional 4 European Countries; Repros Receives Official FDA Minutes From Type C Meeting for Androxal(R) Print E-mail
By Staff and Wire Reports   
Tuesday, 27 December 2011 18:00
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 27, 2011.

CEL-SCI Corporation (NYSE:CVM) is in the process of expanding its Phase III clinical trial of the investigational therapy Multikine (Leukocyte Interleukin, Injection)* to 4 additional European countries - Spain, Czech Republic, Slovakia and Croatia. These four countries were selected because they have not only the required facilities and well trained scientific and technical personnel with the experience necessary for running this Phase III study, but also because they have a high incidence of head and neck cancer. CEL-SCIs partner, Teva Pharmaceuticals Industries, who has the marketing rights to Croatia has selected 2-3 clinical centers in Croatia that have the capability and interest in conducting this study. The Multikine Phase III study is currently being run in 8 countries, including the US, on 3 continents.

"We are encouraged by recent observations from the study and therefore feel that all resources should be put into getting this study completed as quickly as possible to definitively establish Multikines effectiveness. That is why we are adding as many as 15 clinical centers in these 4 countries, said Geert Kersten, CEL-SCI's Chief Executive Officer.

CEL-SCIs Phase III study is designed to determine if Multikine (Leukocyte Interleukin, Injection) investigational therapy administered prior to current standard of care (Surgery plus Radiotherapy or Surgery plus Concurrent Radiochemotherapy) used for the treatment naive (yet untreated) subjects with Advanced Primary Squamous Cell Carcinoma of the Oral Cavity/Soft Palate (Head and Neck cancer) will result in an increased overall rate of survival versus the subjects treated with standard of care only.


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Repros Therapeutics Inc. (RPRX) ® (Nasdaq:RPRX) announced the Company has received the official FDA minutes from its recent Type C meeting held with the joint divisions of urologic (DRUP) and endocrinologic (DMEP) products. The Company believes the meeting and minutes will help it set the path forward for Androxal. As part of the request for the meeting, Repros asked three questions. The first two dealt with whether or not either the Endocrine or Urology Division would allow the normalization of testicular testosterone synthesis as the only primary endpoint needed for approval. In the third question Repros asked if it was appropriate for both divisions to review the dossier.

Both divisions concurred that a clinically meaningful outcome other than testosterone would be required for approval, and if the drug were to be reviewed in the Endocrine Division, metabolic outcomes would be required as for any other drug intended to improve glycemic indices.  

In the meeting minutes the FDA noted, "DRUP reminded the Sponsor of the pathway provided at prior meetings for the treatment of hypogonadism while preserving semen quality." The minutes further state, "The Sponsor agreed to proceed with a path forward within DRUP. The Sponsor stated that they have data from some of their completed studies and will submit it to DRUP for review. The Sponsor also stated that they are planning to submit a Type B meeting request early next year."

Joseph S. Podolski, President and CEO of Repros Therapeutics, commented, "We are appreciative of the FDA's efforts and willingness to allow the joint meeting. We understand their position and we look forward to submitting the final clinical study reports for ZA-203 and ZA-204 to the Division of Reproductive and Urologic Products (DRUP) late in February to support a Type B meeting in March or April with the goal of reaching agreement for the Androxal Phase 3 study design."



Also Tuesday:  



22nd Century Group, Inc. (OTCBB: XXII), a company focused on smoking cessation and tobacco harm reduction products, today announced X-22, a prescription smoking cessation aid in development consisting of very low nicotine (VLN) cigarettes, showed a reduction of smoking from baseline over the 6-week treatment period in the company’s Phase II-B clinical trial.

Adia Nutrition, Inc. (PINKSHEETS: ADIA) is proud to announce that its "On-the-Go" probiotic powders and chews can now be purchased at Whole Foods throughout Los Angeles and Orange County, California.

AspenBio Pharma, Inc. (NASDAQ: APPY), an emerging in vitro diagnostic company, announced today that it has entered into definitive agreements with certain new and existing institutional investors to sell an aggregate of 1,605,000 shares of its no par value common stock ("Common Stock") and warrants to purchase up to 1,605,000 shares of Common Stock, in a registered direct offering for gross proceeds of approximately $1.6 million, before deducting placement agent's fees and estimated offering expenses.

BioNeutral Group, Inc. (OTCBB: BONU)
, a specialty life science technology-based company, today announced that it has received $400,000 in connection with the Preferred Stock Purchase Agreement (the "Agreement") with Vinfluence Pty Ltd ("Vinfluence"), New South Wales, Australia.

China Botanic Pharmaceutical Inc. (NYSE AMEX: CBP) ("China Botanic" or the "Company"), a developer, manufacturer and distributor of botanical products, bio-pharmaceuticals and Traditional Chinese Medicines ("TCM") in China, today announced that the Company successfully showcased its all-natural products at the 66th PHARMCHINA fair ("the Fair") recently held in Zhengzhou, China.

Cord Blood America, Inc., (OTC Bulletin Board: CBAI), the umbilical cord blood stem cell preservation company focused on bringing the life saving potential of stem cells to families nationwide and internationally, is pleased to announce it has signed an exclusive agreement to store stem cells at its Las Vegas laboratory for the National Children's Leukemia Foundation (NCLF), New York.

Decision Diagnostics Corp., formerly known as InstaCare Corp., (OTCQB: ISCRD), a leading provider of prescription diagnostics, home testing products for the chronically ill, a leading fulfillment provider of direct to patient diabetes programs, and a leading developer of revolutionary cell phone centric e-health products and technologies, today announced that its previously announced 10% Stock Dividend will be Ex-Dividend to all shareholders of record on December 28, 2011.

Endo Pharmaceuticals (Nasdaq: ENDP) today announced that David Holveck, president and CEO will present a corporate overview at the J.P. Morgan 30th Annual Healthcare Conference on Monday, January 9, 2012 at 4:30 p.m. ET.

ICON plc., (NASDAQ:ICLR) (ISIN:IE0005711209),a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, today announced the retirement of Non-Executive Director, Dr. Anthony Murphy to become effective on 31st December 2011.

Meridian Bioscience, Inc., (NASDAQ:VIVO) today announced it has received FDA clearance for a new Clostridium difficile assay, ImmunoCard®C. difficile GDH.

Mylan Inc. (Nasdaq: MYL) today announced that its subsidiary Mylan Pharmaceuticals Inc. has received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Eprosartan Mesylate Tablets, 400 mg (base) and 600 mg (base).

PROTEONOMIX, INC. (OTCBB: PROT), a biotechnology company focused on developing therapeutics based upon the use of human cells and their derivatives, announced today that it has completed all payments required from Proteonomix to commence a Clinical Study entitled "UMK-121 in Patients with Liver Disease."

Sun Healthcare Group, Inc. (NASDAQ: SUNH)
today announced that William A. Mathies, the company's chairman and chief executive officer, and L. Bryan Shaul, the company's chief financial officer, will present at the 30th Annual J.P. Morgan Healthcare Conference on Tuesday, Jan. 10, 2012, at 2:00 p.m. Pacific/5:00 p.m. Eastern.

United Therapeutics Corporation (NASDAQ: UTHR) and its wholly-owned subsidiary, United Therapeutics Europe, Ltd., announced today that the French regulatory agency Agence Francaise de Securite Sanitaire des Produits de Sante (AFSSAPS) has approved intravenous use of Remodulin® (treprostinil) for the treatment of pulmonary arterial hypertension (PAH).



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