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SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) September 25, 1995
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Cytogen Corporation
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(Exact name of registrant as specified in its charter)
Delaware 1-14879 22-2322400
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(State or other (Commission (IRS Employer
jurisdiction of File No.) Identification No.)
incorporation)
600 College Road East, CN 5308, Princeton, NJ 08540-5308
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(Address of principal executive offices) (Zip Code)
Registrant's telephone number, including area code (609) 987-8200
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Not Applicable
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(Former name or former address, if changed since last report)
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Item 5. Other Events.
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On September 25, 1995, Cellcor, Inc. ("Cellcor") issued the press release
attached hereto as Exhibit 99. Cytogen Corporation ("Cytogen") and Cellcor are
parties to an Agreement and Plan of Merger dated June 15, 1995, as amended,
pursuant to which Cellcor will merge with and into a wholly-owned subsidiary of
Cytogen, whereupon the separate corporate existence of Cellcor will cease. On
September 13, 1995, Cytogen filed a Registration Statement on Form S-4
(Registration No. 33-62617) under the Securities Act of 1933, as amended,
covering shares of Cytogen common stock, par value $.01 per share, to be issued
to Cellcor stockholders in the merger and in a related subscription offering.
Item 7. Financial Statements and Exhibits.
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(c) Exhibits:
99 Press release issued by Cellcor, Inc. on September 25, 1995.
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SIGNATURES
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Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
CYTOGEN CORPORATION
By: /s/ Thomas J. McKearn
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Thomas J. McKearn
Chief Executive Officer and President
Date: September 27, 1995
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INDEX TO EXHIBITS
Exhibit No. Description Page
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99 Press release issued by Cellcor, Inc. 5
on September 25, 1995.
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Ronald J. Brenner, Ph.D.
Cellcor, Inc.
617-332-2500
For Immediate Release
CELLCOR RECEIVES FDA OK TO PROCEED WITH TREATMENT IND
FOR AUTOLYMPHOCYTE THERAPY IN METASTATIC RENAL CELL CARCINOMA
NEWTON, MA, September 22, 1995 -- Cellcor, Inc. (OTC:CLTX) announced today that
Cellcor's treatment for stage IV metastatic renal cell carcinoma (MRCC) will be
available to the medical community through a Treatment Investigational New Drug
(IND) Program. The Treatment IND program will allow autolymphocyte therapy
(ALT), an immunotherapy which uses a patient's own immune cells to treat
disease, to be available as a treatment option to patients with MRCC who were
not able to participate in ALT clinical trials. This is the first Treatment IND
granted by FDA for a somatic cell-based therapy.
Ronald J. Brenner, President and CEO of Cellcor, stated, "Because patient
accrual for the ALT Phase III pivotal trial is finished and the clinical
development of this product is complete, the Treatment IND is very important, as
there would otherwise be no mechanism by which patients with MRCC could access
the ALT treatment." Cellcor expects to begin patient accrual for the Treatment
IND in fourth quarter 1995. The Treatment IND also allows Cellcor to charge
patients for the cost of the treatment.
Treatment IND Programs represent an effort by the Food and Drug Administration
(FDA) to make investigational drugs available for the treatment of patients with
a serious or immediately life-threatening disease. For investigational drugs to
be eligible for a Treatment IND Program, there can be no comparable or
satisfactory alternative drug or other therapy available to treat the particular
disease in the intended patient population.
As previously announced, Cellcor and CYTOGEN Corporation (NASDAQ:CYTO) have
signed a merger agreement, which both companies expect to complete in October of
this year. ALT will be available through the Treatment IND Program while
Cellcor and CYTOGEN continue to monitor the patients from the Phase III pivotal
trial, prepare an application for submission to FDA and pursue marketing
approval of ALT. Cellcor and CYTOGEN emphasize that no assurances can be given
regarding the timing or outcome of any applications they intend to submit to
FDA.
CYTOGEN is a biopharmaceutical company engaged in the development and marketing
of products for the targeted delivery of diagnostic and therapeutic substances
directly to sites of disease. CYTOGEN uses its patented and proprietary
technologies to develop specific cancer diagnostic imaging and therapeutic
products.
Cellcor, Inc. is a biotechnology company engaged in the development of cellular
therapies with initial application in the treatment of metastatic renal cell
carcinoma and potential application in the areas of infectious disease, such as
chronic hepatitis B.
Physicians who would like more information about the ALT Treatment IND program
can contact the clinical services manager at Cellcor at 1-800-441-7901.
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